YS% ,Xld M%Cd;Dka;S%L Iudcjd§ Ckrcfha .Eiü M;%H W;S Úfyi the Gazette of the Democratic Socialist Republic of Sri Lanka EXTRAORDINARY

YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha .eiÜ m;%h w;s úfYI The Gazette of the Democratic Socialist Republic of Sri Lanka EXTRAORDINARY

wxl 2144$20 - 2019 Tlaf;dan¾ ui 09 jeks nodod - 2019'10'09 No. 2144/20 - WEDNESDAY, OCTOBER 9, 2019

(Published by Authority) PART I : SECTION (I) — GENERAL Government Notiﬁ cations

Order No. 01 NATIONAL MEDICINES REGULATORY AUTHORITY ACT, NO. 5 OF 2015

Order under section 60 (2)

BY VIRTUE of the powers vested in me by section 60 (2) of the National Medicines Regulatory Authority Act, No. 5 of 2015, I, Prof. Asita De Silva, Chairman of the National Medicines Regulatory Authority, do by this Order, inform the public that the medicines speciﬁ ed in the Schedules here to have been registered with the National Medicines Regulatory Authority.

Prof. ASITA DE SILVA Chairman, (For and on behalf of) National Medicines Regulatory Authority Colombo August 8, 2019

1A—PG 4679 - 257 (10/2019) This Gazette Extraordinary can be downloaded from www.documents.gov.lk 2 I fldgi ( ^I& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 Full Full Reg. Type COL- UMN-VIII 14 14 COL- UMN-VII Issue Date VI INDIA 05-Apr-15 Full SRI LANKA 16-May- THAILAND 28-Apr-16 Full SRI LANKA 19-Oct-14 Full THAILAND 28-Apr-15 Full SRI LANKA 14-Jun-17 Years Two THAILAND 28-Apr-15 Full SRI LANKA 01-Jan-18 Provisional POLAND 24-Mar- INDIA 07-Jan-15 Full Country

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tt tt tt COLUMN-IV COLUMN-V COLUMN- Health (Pvt) Ltd Benckiser Ltd (Lanka) Benckiser Ltd (Lanka) Benckiser Ltd (Lanka) Pharmaceu (Pvt) Ltd Importer Name III MIXTURE N/A Gamma Pharma- LOZENGES Recki SYRUP N/A M S J Industries SYRUP N/A M S J Industries LOZENGES Recki Form SCHEDULE - I THERASIL LOZENGES Steuart George GAMMA'S GRIPE MIXTURE STREPSILS STREPSILS ORIGINAL MORISON S GRIPE MIXTURE STREPSILS COOLSTREPSILS LOZENGES Recki MORISON S GRIPE MIXTURE STREPSILS STREPSILS HONEY & LEMON SANISCUB CSANISCUB SOLUTION (Pvt) Ltd Ceyoka Sirmaxo COLUMN-I COLUMN-II COLUMN- cial Name Brand Name Dosage fi GLIPE MIXTURE WITH OIL OF AMITHI B PBCO GLIPE MIXTURE WITH OIL OF AMITHI B PBCO 1.0% & ZIMGIBAR 1% SODIUM BICARBONATE DICHLOROBENZYL ALCOHOL 1.2mg ALCOHOL DICHLOROBENZYL 0.6m+ LOZENGES (2,4)+AMYLMETACRESOL INFANT CARMINATIVE SYRUP SODIUM SYRUP CARMINATIVE INFANT +DIL OIL BP 0.1% BICARBONATE DICHLOROBENZYL ALCOHOL 1.2mg ALCOHOL DICHLOROBENZYL 0.6m+ LOZENGES (2,4)+AMYLMETACRESOL INFANT CARMINATIVE SYRUP OIL OF ANETHI BPC SYRUP CARMINATIVE INFANT BP 1% 0.1% SODIUM BICARBONATE DICHLOROBENZYL ALCOHOL 1.2mg ALCOHOL DICHLOROBENZYL 0.6m+ LOZENGES (2,4)+AMYLMETACRESOL OFFICINALE (GINGER) EXTRACT 0.48% FOR 0.48% FOR OFFICINALE (GINGER) EXTRACT CHILDREN 4 DICHLOROBENZYL ALCOHOL 1.2mg ALCOHOL DICHLOROBENZYL 0.6m+ LOZENGES (2,4)+AMYLMETACRESOL CHLOROXYLENOL LIQUID 4.8% APPLICATIONCHLOROXYLENOL DETTOL LIQUID N/A CDDEF Manu- Of BENZALKONIUM CHLORIDE,CETRIMID 0.01%,0.2% CHLORIDE,CETRIMID BENZALKONIUM DRAPOLENE CREAM 2.5%+ISOPROPYL GLUCONATE CHLORHEXIDINE BP 70% ALEOHOL GlaxoSmithkiline 8 7 6 9 5 4 3 1 2 10 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 3 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 Full Full Full Full Full Full Full Full Full Full Full Two Years Two Two Years Two 14 15-Aug-17 JAPAN 06-Apr-15 JAPAN 06-Apr-15 SRI LANKA 11-Apr-14 INDIA 04-Jun-16 INDIA 10-Jun-15 INDIA 18-Jan-14 SRI LANKA 17-Oct-16 SRI LANKA 16-Jun-18 SRI LANKA 22-Oct-14 SRI LANKA 08-Feb-18 cals cals cals cals cals cals cals cals ti ti ti ti cals Co cals Smithkline Hisamitsu Pharmaceu Co Inc Inc Hisamitsu Phar- maceu ti Incepta Incepta Pharmaceu Ltd Glaxo Wellcome Wellcome Glaxo Gamma Unicure Unicure Ramadies (Pvt) Ltd Pharmaceu (Pvt) Ltd Biolab Co Ltd THAILAND 24-May- Shefa Healthcare Healthcare Shefa (Pvt) ltd Shefa Healthcare Healthcare Shefa (Pvt) ltd M S J Industries M S J Industries Beecham (Pvt) Ltd (Ceylon) Ltd (Ceylon) Pharmaceu Pvt Ltd Akbar (Ceylon) (Pvt) Ltd (Ceylon) Astron (Pvt) LtdAstron SRI LANKA 13-Nov-15 td cals cals cals cals ti ti health ti Pharmaceu (Pvt) Ltd Pharmaceu (Pvt) Ltd Imports (Pvt) Ltd Health (Pvt) L Emar Pharma (Pvt) Ltd Health (Pvt) Ltd George Steuart Steuart George Health (Pvt) Ltd N/A POWDER SUSPENSION SOLUTION SYRUP N/A SCHEDULE - I MAXMOL TABLETS Steuart George SALONPAS PATCH Akbar SALONPAS PATCH Akbar PANADOL TABLETS N/A PARACETOL LIQUID N/A FLANIL CREAM Steuart George MAXMOL ORAL ***** ORAL PANADOL PANADOL SYRUP MINERVA ORAL ACETAMIN TABLETS Ci WINTERPAN GEL N/A RAPISOL TABLETS N/A METHYL SALICYLATE COMPOUND GEL COMPOUND METHYL SALICYLATE METHYL SALICYLATE 6.3% ,MENTHOL 5.7% METHYL SALICYLATE ACETATE 1. 2% & TOCOPHEROL ,CAMPHAOR METHYL SALICYLATE 6.3% ,MENTHOL 5.7% METHYL SALICYLATE ACETATE 1. 2% & TOCOPHEROL ,CAMPHAOR PARACETAMOL TABLETS BP 500MG TABLETS PARACETAMOL ORAL REHYDRATION SALTS BP 21.5G SALTS ORAL REHYDRATION B.P ORAL SOLUTION (PAEDIATIC) PARACETAMOL 120MG/5ML METHYL SALICYLATE 10.2% + MENTHOL 5.44% METHYL SALICYLATE EUGENOL 1.36% PEDIATRIC PARACETAMOL ORAL SOLUTION B.P ORAL SOLUTION PARACETAMOL PEDIATRIC 120MG/5ML PARACETAMOL TABLETS BP 500MG TABLETS PARACETAMOL PARACETAMOL TABLETS 500MG TABLETS PARACETAMOL BP 500MG TABLETS PARACETAMOL PARACETAMOL (PAEDRIATIC) ORAL SUSPENSION B.P (PAEDRIATIC) PARACETAMOL 120MG/5ML-Elixir PARACETAMOL (PAEDRIATIC) ORAL SOLUTION B.P ORAL SOLUTION (PAEDRIATIC) PARACETAMOL 120MG/5ML 11 21 14 13 12 15 16 23 22 19 20 18 17 4 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 COLUMN-VIII VII COLUMN- Issue Date Reg. Type VI Country INDIA 03-Oct-14 Full INDIA 18-Jan-17INDIA Full 28-May-14SRI LANKA 27-Sep-17 Full SRI LANKA Full 27-Sep-15INDIA Full 02-Mar-14INDIA Full 05-Dec-14MALAYSIA Full 28-May-14 Full THAILAND 19-Aug-15 Full SRI LANKA 22-Dec-14 Full Ltd Laboratories (Pvt) Ltd Zim Laboratories Ltd Abbott India Ltd INDIAIndoco Remedies 01-Jan-18India Provisional Laboratories (Pvt) Ltd Inter Pharm (Pvt) Ltd Raptakos Brett & Company Ltd Hoe Pharmaceuticals SDN BHD State Pharmaceuticals Manufacturer Corporation Patana Co Ltd (Contd.) maceuticals (Pvt) Ltd Healthcare lanka Ltd Hemas Pharma- ceuticals (Pvt) Ltd Ceyoka (Pvt) Ltd Leben Ltd Pharma Associates Indoscan (Pvt) Ltd State Phar- maceuticals Manufacturer Corporation

TABLETS Sunshine SUSPENSION SUSPENSION TABLETS Inter Pharm (Pvt) SUSPENSION SUSPENSION TABLETS SCHEDULE - II (GROUP A) SCHEDULE - II (GROUP DIGENE MINT DIGENE MINT FLAVOUR VISCID DSANTAGTT ORAL ORAL GASTRIL- LEMON GASTRIL-MINT TABLETSANTAGIT TABLETSCATOXYMAG-N ORAL Ceyoka (Pvt) Ltd Leben Inter Pharm (Pvt) ZELLOX -11 ORAL ANTACIL GELANTACIL GEL Sonali & Sudesh Thai Nakorn COLUMN-I COLUMN-II COLUMN-III COLUMN-IV COLUMN-V COLUMN- cial Name Brand Name Dosage Form Importer Name Manufacturer Man- fi SILICATE HYDR 50MG+MAG.HYDR. 25MG SILICATE SIMETHICONE 25MG 100MG+SIMETHICONE 25MG/5ML 400MG+SIMETHICONE 50MG/5ML (LEMON Flavour) USP TABLETS (Mint Flavour) USP TABLETS HYDROXIDE+SIMETHICONE 50MG 200MG+MAGNESIUM BP BP HYD.100MG+MAGNESIUM TRISLICATE 100MG BP ALGINATE 200MG+SODIUM 8OOMG+MAGNESIUM HYDROXIDE 800MG+SIMETHICONE Of 960MG+MAGNESIUM HYDROXIDE 330MG+ SIMETHICONE 60MG 2 300MG+MAG.ALUM. ALUM.HYDR. DRIED GEL 3 ALUM.HYDR.306MG+MAG.HYDR 4 400MG+MAG.HYDR ALUM.HYDR.GEL 5 ALUMINIUM +MAGNESIUM & SIMETHICONE 6 ALUMINIUM +MAGNESIUM & SIMETHICONE 7 ALUMINIUM 400MG+MAGNESIUM 400MG) 8 ALUMINIUM HYD.GEL. 9 ALUMINIUM HYDROXIDE 1 400MG USP TABLETS ALBENDAZOLE ALBEZIM TABLETS Phar- Tabrane 11 500MG ALUMINIUM HYDROXIDE B.P ***** CHEWABLE 10 ALUMINIUM HYDROXIDE I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 5 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 30-Nov-16 Full 27-Nov-14 Full 08-May-16 Full INDIA 07-Nov-14 Full THAILAND 07-Dec-14 Full AUSTRA- LIA SRI LANKA 01-Jun-17Years Two SRI LANKA 25-Apr-17Years Two SRI LANKA 27-Jun-17Years Two SRI LANKA 18-Jul-16 Full SRI LANKA 11-May-17Years Two SRI LANKA 01-Jan-17 Full BANGLA- DESH MALAYSIA 30-Apr-17 Full BANGLA- DESH SRI LANKA 29-Oct-15 Full B D H Industries Ltd Biolab Co Ltd THAILAND 15-Oct-18 Drugs P T Laboratories Full (Pvt) Ltd Panacea Medicals Panacea Medicals Panacea Medicals Unical Ceylon (Pvt) Ltd Inter Pharm (Pvt) Ltd M S J Industries (Ceylon) (Pvt) Ltd Navana Pharmaceuticals Ltd Y S P Industries / S P Y SDN BHD Square Pharmaceuticals Ltd (Ceylon) (Pvt) Ltd (Contd.) Ltd George Steuart Health (Pvt) Ltd Medinex (Pvt) Ltd Sonali & Sudesh Aspen Pharma Medicals Medicals Medicals (Pvt) Ltd Ltd (Ceylon) (Pvt) Ltd Co Ltd (Pvt) Ltd l(Pvt) Ltd. PharmAce (Pvt) Ltd SUSPENSION SUSPENSION SUSPENSION COA.) LOTION M S J Industries SCHEDULE - II (GROUP A) SCHEDULE - II (GROUP BELCIDADMAG ORAL ORAL GASTROGEL ORAL SHINE Vit. C 100SHINE Vit. TABLETS Lanka S P Y CARVA (EN. TABLETS CALAMINE LOTION 918MG+MAGNESIUM HYDROXIDE 300MG+ SIMETHICONE 60MG hydrox 300MG & SIMETHICONE 60MG ORAL SUSPENSION USP 500MG,MAGNESIUM TRISILICATE 240MG 500MG,MAGNESIUM TRISILICATE +MAGNESIUM HYDROXIDE 240MG IN10ML 100MG 75MG 5%+PHENOL 0.2%+SODIUM BENZOATE 0.1% 0.2%+SODIUM BENZOATE 5%+PHENOL 12 500MG ALUMINIUM HYDROXIDE B.P **** TABLETS Kamazu (Pvt) 13 ALUMINIUM HYDROXIDE GEL 14 ALUMINIUM oxide 570MG+MAGNESIUM 15 ALUMINUM HYDROXIDE DRIED GEL 16 AQUEOUS CREAM WITH GLYCERINE D-AQUA CREAM Panacea 17 AQUEOUS CREAM WITH GLYCERINE CREAM D-SOFT CREAM Panacea 18 2% AQUEOUS CREAM WITH GLYCERINE AQUARIN CREAM Panacea 19 100MG BP TABLETS ACID ASCORBIC C-TABS TABLETS Unical Ceylon 20 100MG BP TABLETS ACID ASCORBIC ***** TABLETS(Pvt) Pharm Inter 21 100MG BP TABLETS ACID ASCORBIC ***** TABLETS M S J Industries 22 250MG BP TABLETS ACID ASCORBIC CHEWCE TABLETS Darley Butler & 23 USP TABLETS AICD CHEWABLE ASCORBIC 24 BP TABLETS ASPIRIN GASTRO RESISTANT 25 BPC 4%+WITCH HAZEL CALAMINE BP 6 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 18-Aug-16 Full PAKISTAN 03-Feb-18 Full SRI LANKA 15-Feb-17SRI LANKA Full 01-Jan-17 Full INDIASRI LANKA 06-Feb-14 11-Feb-15 Full SRI LANKA Full 16-Mar-17SRI LANKA Full 01-Jan-18Years Two SRI LANKA 12-Sep-17Years Two MALAYSIA 26-Apr-18INDIA Full 08-May-15 Full THAILAND 24-Feb-14 Full INDIA 08-May-15INDIA Full 28-May-15 Full Platinum Pharmaceuticals (Pvt) Ltd Glaxo Wellcome (Ceylon) Ltd M S J Industries (Ceylon) (Pvt) Ltd ICPA Health ICPA Products Ltd Inter Pharm (Pvt) Ltd Glaxo Wellcome (Ceylon) Ltd M S J Industries (Ceylon) (Pvt) Ltd Glaxo Wellcome (Ceylon) Ltd Kotra pharma (M) Ltd Unique Pharmaceutical Labs Unique Mega Lifesciences (Pvt) Ltd Healthcare Pharmaceuticals Pharmaceutical Labs Unique Pharmaceutucal Laboratories (Contd.) PLC Glaxo Wellcome (Ceylon) Ltd (Ceylon) (Pvt) Ltd George Steuart Health (Pvt) Ltd Inter Pharm (Pvt) Ltd (Ceylon) Ltd (Ceylon) (Pvt) Ltd (Ceylon) Ltd & Co Ltd Health (Pvt) Ltd Health (Pvt) Ltd A Baur & Co A (Pvt) Ltd Imports (Pvt) Ltd Health (Pvt) Ltd MOUTH WASH- SOLUTION TUBES SOLUTION LOZENGES George Steuart SOFT GELETIN SOFT CAPSULES LOZENGES George Steuart SCHEDULE - II (GROUP A) SCHEDULE - II (GROUP CLINICA MOUTH WASH CORSODYL CIC Holdings MINT **** SOLUTION M S J Industries CHLOFENPIRITON ORAL VALMELIX SYRUP SYRUPCYTACON Glaxo Wellcome M S J Industries DEXXON SYRUP SUPERIL LOZENGES Glaxo Wellcome LOZENGES (ORANGE) Delmege Forsyth Steuart LOZENGESSUPERIL George CALCIVITA CALCIVITA FORTE ROCAL TABLETS Citihealth SUPERIL SUPERIL LOZENGES (LEMON) MOUTHWASH 0.2% W/V MOUTHWASH CETRIMIDE 15% MOUTHWASH 2ML/5ML (CHLORPHENIRAMINE) 2ML/5ML SYRUP OF 4%,LIQUID EXTRACT GLYCERRHI 0.05% COCILLANE 1% MENTHOL SYRUP 35MCG/5ML 0.25MG 0.6m+ LOZENGES (2,4)+AMYLMETACRESOL 0.6m+ LOZENGES (2,4)+AMYLMETACRESOL 1250MG 200IU(Equivalent to calcium 600mg) (2,4)+AMYLMETACRESOL 0.6m+ LOZENGES (2,4)+AMYLMETACRESOL 29 CHLORHEXIDINE DIAGLUCONATE 30 1.5% CHLORHEXIDINE GLUCONATE 31 1.0%W/W GEL CHLORHEXIDINE GLUCONATE HEXIGEL COLLAPSIBLE 28 2% CHLORHEXIDINE GLUCONATE 32 SOLUTION BP CHLORPHENAMINE ORAL 33 2MG/5ML CHLORPHENIRAMINE MALEATE 34 OF LIQUID EXTRACT CONTAINING 35 B12, (VITAMIN CYANOCOBALAMINE 36 DEQUALINIUM CHLORIDE LOZENGES 37 ALCOHOL 1.2mg DICHLOROBENZYL 38 ALCOHOL 1.2mg DICHLOROBENZYL 27 USP TABLETS CALCIUM CARBONATE 26 D3 1500MG +VIT. CALCIUM CARBONATE 39 ALCOHOL 1.2mg DICHLOROBENZYL I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 7 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 THAILAND 28-Apr-15 Full INDIA 13-Jul-18 Full INDIA 19-Nov-14 Full INDIA 03-Nov-16 Full INDIA 29-May-18 Full JORDAN 07-Aug-16 Full THAILAND 24-Mar-14 Full SRI LANKA 14-Oct-14 Full INDIA 12-Jan-18 Years Two SRI LANKA 02-Dec-17 Full Reckitt Benckser Healthcare G S Pharmabutor (Pvt) Ltd Cipla Ltd INDIASai Mirra Innopharm (Pvt) Ltd 21-Jul-18Years Two Agio Pharmaceuticals Ltd Abbott India Ltd INDIA 21-Jul-15Nem Laboretories (P) Full Ltd The United Pharmaceutica Manufacturer Mega Lifesciences Public Company (Pvt) Ltd Inter Pharm (Pvt) Ltd MMC Healthcare Ltd Glaxo Wellcome Glaxo Wellcome (Ceylon) Ltd (Contd.) Benckiser (Lanka) Ltd Co Ltd Breathe Free Lanka (Pvt) Ltd Healthcare lanka Ltd Citihealth Imports (Pvt) Ltd Sunshine Healthcare lanka Ltd Lifeline Pharmaceuticals (Pvt) Ltd (Pvt) Ltd A Baur & Co A (Pvt) Ltd Ltd (Pvt) Ltd (Ceylon) Ltd LOZENGES Reckitt SUSPENSION TABLETS CHEWABLE CHEWABLE TABLETS COATED TABLETS CAPSULES SCHEDULE - II (GROUP A) SCHEDULE - II (GROUP STREPSILS ORIGINAL DIGUSIL MPSDIGUSIL ORAL ACIFREE SUSPENSION Sunshine AGIFLUX CHEWABLE DIGENE MIXED FLAVOUR FRUIT FERIGEN XT SUGAR FEFOL CAPSULES Baur & Co A MAXX OMEGA 3MAXX OMEGA GELETIN SOFT (2,4)+AMYLMETACRESOL 0.6m+ VITAMIN C 0.6m+ VITAMIN (2,4)+AMYLMETACRESOL 100mg LOZENGES ACTIVATED+MAGNESIUM HYDROXIDE ACTIVATED+MAGNESIUM 250MG+ALUMINIUM HYDROXIDE 250MG 250MG+SIMETHICONE 50MG HYDRA 400MG+DRIED MAGNESIUM HYDROXIDE 400MG 300MG,MAGNESIUM HYDROXIDE SILICATE 300MG,MAGNESIUM HYDROXIDE SILICATE 50MG+MAGNESIUM HYDROXIDE HYDRATE 25MG, SIMETHICONE 25MG CHEWABLE TABLETS 60MG,NIACINAMIDE BP TO EQUIVALENT 50MG+PYRIDOXINE HYDROCHLORIDE BP 15MG +FOLIC BP 3MG,CYANOCABALAMINE ZINC 5 BP ACID 1MG+ZINC SULPHATE 500MCG CAPSULES 1000MG 40 ALCOHOL 1.2mg DICHLOROBENZYL 41 1% BP DICLOFENAC GEL DICLOMOL GEL Robert Hall & 42 DIMETHICONE 50MG 43 DRIED ALUM.HYDROX.GEL 250MG,MAGNE 44 DRIED ALUMINIUM HYDROXIDE 45 ALUMINIUM HYDROXIDE GEL DRIED 46 SULPHATE FERROUS GLYCINE 47ACID 150MG+FOLIC FERROUS SULPHATE 48 GELATINE SOFT CONCENTRATED FISH OIL 49 1MG BP TABLETS ACID FOLIC **** TABLETS(Pvt) Pharm Inter 50 1MG BP TABLETS ACID FOLIC F-A-One TABLETS Markss HLC 51 IRON & B COMPLEX B FERRA SYRUP Glaxo Wellcome 8 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 20-Sep-14 Full HUNGARY 28-Jan-15 Full UNITED KINGDOM INDIA 20-Oct-14 Full INDIA 29-Jul-16 Full INDIAPAKISTAN 29-Oct-14 23-Apr-14 Full PAKISTAN Full 02-Jun-15 Full PAKISTAN 23-Oct-16 Years Two Glaxo Operations UK Ltd Biolab Co Ltd THAILAND 20-Aug-18Gedeon Richter Ltd Years Two Meyer Organics (Pvt) Ltd Abbott India Ltd INDIA 23-Mar-18 Full Merck (Pvt) Ltd PAKISTAN 23-Oct-16 Tirupathi Medicare Ltd Years Two Abbott India Ltd INDIA 16-May-18 Full Apex Laboratories Ltd (Pvt ) Ltd (Pvt ) Ltd Martin Daw Pharmaceuticals Ltd (Contd.) anning (Ceylon) Ltd Health (Pvt) Ltd fl associatio (Pvt) Ltd Astron (Pvt) Ltd Astron (Pvt) Ltd SRI LANKA 09-Oct-17Years Two Sunshine Healthcare lanka Ltd (Ceylon) Ltd PLC Healthcare lanka Ltd (Pvt) Ltd Ceyoka (Pvt) Ltd Genix Pharma (Ceylon) Ltd CREAM Glaxo Wellcome ORAL ORAL SUSPENSION ORAL LIQUIDORAL Sunshine CHEWABLE CHEWABLE TABLETS SCHEDULE - II (GROUP A) SCHEDULE - II (GROUP OILATUM OILATUM CREAM CREMADIET POWDER CIC Holdings RELEEV GEL DIGENE GEL ORANGE FLAVOUR DIGENE MINT DIGENE MINT GEL FLAVOUR- ZINCOFER LIQUIDRBC-F Baur & Co A RBC Syrup SYRUPDUMASULES CAPSULES Ceyoka (Pvt) Ltd Astron (Pvt) Ltd Genix Pharma Astron (Pvt) Ltd SRI LANKA 24-Sep-16 Full PARAFFIN 15% CREAM PARAFFIN 2.5% W/W ,METHYL SALICYLATE 8.5% W/W SALICYLATE 2.5% W/W ,METHYL 4% W/W) MENTHOL 830MG ALU.HYD GEL 50MG,DRIED +CARBOXYMETHYLCELLULOSE 100MG/10ML SUSPENSION ORAL 50MG,DRIED ALU.HYD GEL 830MG ALU.HYD GEL 50MG,DRIED +CARBOXYMETHYLCELLULOSE 100MG/10ML SUSPENSION ORAL 100MG+FOLIC ACID CHEWABLE TABLETS 100MG+FOLIC ACID CHEWABLE TABLETS 0.35MG 50MG/5ML COMPLEX SYRUP COMPLEX 63 6% + WHITE SOFT LIQUID PARAFFIN LIGHT 61 0.75MGTABLETS LEVONORGESTREL 62 0.75MGTABLETS LEVONORGESTREL MADONNA TABLETS POSTINOR TABLETS George Steuart The Family 60 2.5% (KETOPROFEN GEL KETOPROFEN 64 MAGNESIUM HYDROXIDE 185 SIMETHICONE 59 3.75G/4.8G HUSK GRANULES BP ISPAGULAR FIBEREX GRANULES SMM Halcyon 65 MAGNESIUM HYDROXIDE 185 SIMETHICONE 53 IRON (III) HYDROXIDE POLYMALTOSE 54 IRON (III) HYDROXIDE POLYMALTOSE 55 B & VIT. ACID VIT.C IRON WITH FOLIC 57 B OMPLEX CAPSULES IRON+ VITAMIN 58 4.8G/5G W/W HUSK I.P ISPAGHULA SANGOBION CAPSULES Emerchemie NB 52 IRON & VITAMIN 56 B OMPLEX CAPSULES IRON+ VITAMIN SANGOBION CAPSULES Emerchemie NB I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 9 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 SRI LANKA 23-Jun-16 Full CHINA 08-Mar-14INDIA Full 08-Aug-16SRI LANKA 13-Sep-17 Full Years Two INDIASRI LANKA 20-Jun-14 27-Jun-17 Full Full JAPAN 14-Mar-14 Full INDIA 11-Feb-18 Years Two THAILAND 16-Oct-15 Full INDIA 11-Feb-18 Years Two Neon Pharmaceuticals (Pvt) Ltd Shandong Jewim Pharmaceutical Co. Ltd Indoco Remedies India Falcon Pharmaceuticals (Pvt) Ltd Bajaj Healthcare Ltd Panacea Medicals Hisamitsu Pharmaceuticals Co Inc Abbott India Ltd INDIA 23-Mar-18 Full Fourrts (India) Laboratories Ltd Pure pharma Ltd INDIA 04-Jun-16Fourrts (India) Laboratories Ltd Full Patana Co Ltd (Contd.) Pharmaceuticals (Pvt) Ltd Emerchemie NB (Ceylon) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Chemist Medicals Akbar Pharmaceuticals (Pvt) Ltd Sunshine Healthcare lanka Ltd Healthcare lanka Ltd lifeServ (Pvt) Ltd Agog Pharma Ltd INDIAKalpentyn Syndicats (Pvt) 04-May-14Ltd Full Healthcare lanka Ltd SPRAY CREAM Panacea AEROSOL SPRAY ORAL ORAL SUSPENSION SOLUTION TABLETS SCHEDULE - II (GROUP A) SCHEDULE - II (GROUP FLAMAR CREAMWINCREAM CREAM Hemas Falcon TRANSPAIN TRANSPAIN CREAM SALONPAS SPRAY DIGENE GEL DIGENE GEL MIXED FRUIT FLAVOUR ANTACIL TABLETSAGOBEN Sonali & Sudesh Thai Nakorn ORAL BPC 5%,METHYL NICOTANATE BP 1% BP NICOTANATE BPC 5%,METHYL 2%W/W CREAM USP MENTHOL 12.5% MENTHOL SALICYLATE METHYL THYMOL 2.5%,OLEORESIN CAPSICUM 0.25, 0.2% OIL 0.12% EUCALYPTUS 3%, THYMOL 10.5%,EUCALYPTUS OIL OIL 10.5%,EUCALYPTUS THYMOL 3%, 0.5%,CAPSIUM 0.5% ,CAMPHAOR 2% SIMETHICONE IP50MG,DRIED ALU.HYD GEL ALU.HYD GEL SIMETHICONE IP50MG,DRIED 100MG/10ML IP 830MG+CARBOXYMETHYL IP ALUMINIUM HYDROXIDE GEL 250MG ALUMINIUM HYDROXIDE GEL +KAOLIN 100MG/5ML 76 8% ,MEPHENESIN BP SALICYLATE METHYL 77 COMPOUND CREAM SALICYLATE METHYL 78 OINTMENT SALICYLATE METHYL RELAXON PLUS OINTMENT Neon 73 12.5%,MENTHOL SALICYLATE METHYL 74 5% 2% ,MENTHOL SALICYLATE METHYL 75 60GAEROSOL SALICYLATE METHYL 60 WINSPAY AEROSOL 66 185 MAGNESIUM HYDROXIDE IP 72 500MG U.S.P TABLETS MEBENDAZOLE ***** TABLETS Chamee 67 350+ DRIED TRISILICATE MANGESIUM 68 SUSPENSION USP MEBENDAZOLE ORAL 71 100MG U.S.P TABLETS MEBENDAZOLE MEBFIL TABLETS Sunshine 69 500MGTABLETS MEBENDAZOLE 70 100MG U.S.P TABLETS MEBENDAZOLE 500 BENHOL MEBFIL CHEWABLE TABLETS Sunshine 10 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 24-Oct-15 Full 13-Oct-14 Full 28-Jan-15 Full 20-May-14 Full 20-May-14 Full PAKISTAN 11-Mar-14 Full SRI LANKA 09-Oct-16 Full INDIA 28-Jul-15 Full Globe Pharmaceuticals Ltd CCL CCL Pharmaceuticals (Pvt) Ltd Prince Marketing Service Contract Manufacuring & Packging Services pty Ltd Contract Manufacuring & Packging Services pty Ltd U S V Ltd INDIARaptakos Brett & Company Ltd 25-Oct-15 Full Square Pharmaceuticals Ltd Catalent Australia (Pvt) Ltd (Contd.) Healthcare (Pvt) Ltd Pharmaceuticals Lanka (Pvt) Ltd Service Alaris Lanka (Pvt) Ltd Alaris Lanka (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Associates Ltd Healthcare lanka Ltd OINTMENT Prince Marketing TABLETS CAPSULES SCHEDULE - II (GROUP A) SCHEDULE - II (GROUP STANO-M CAPSULES Tabrane PRINCE WINTERGREEN VITA-KID CHEWABLE NEBANOL OINTMENT PharmAce (Pvt) CAPSULES VIT. A USP 1.5MG,VIT. D3, USP D3, USP 1.5MG,VIT. USP A CAPSULES VIT. B2,1.70MG USP,VIT B1 1.50MG,VIT. 0.4MG,VIT. 60MG,NICOTI CBP B6 2.00MG,VIT, TABLETS OINTMENT METHYL SALICYLATE MENTHOL MENTHOL SALICYLATE METHYL OINTMENT 0.12% 0.12%,THYMOL OIL 2.2% EUCALYPTUS ,CAMPHOR 1% ZINC 500IU/G OINTMENT 83TABLETS & MINERALS MULTIVITAMIN DAYA ONE TABLETS CCL 82 GELATIN & MINERALS SOFT MULTIVITAMIN 90 CAPSULES 1000MG 3 FISH OIL OMEGA SOLOMEGA GELETIN SOFT 84 CAPSULES MULTIVITAMIN 85 SYRUP MULTIVITAMIN 86 SYRUP MULTIVITAMIN MULTIFORTE CAPSULES Astron (Pvt) Ltd GROVIT Astron (Pvt) Ltd SRI LANKA 20-May-16 SYRUP HOVITE SYRUP SYRUP Full Hemas Pharma 80 & MINERALS CAPSULES MULTIVITAMIN 81 & MINERALS CHEWABLE MULTIVITAMIN MINTERRA CAPSULES Astron (Pvt) Ltd SRI LANKA 11-Feb-15 Full 79 SALUCYLATE,COMPOUND METHYL 87 SYRUP MULTIVITAMIN 88 & MINERALS CAP MULTIVITAMINS GUARDIAN VITALISE CAPSULES Sunshine SYRUP Astron (Pvt) Ltd Astron (Pvt) Ltd SRI LANKA 03-Feb-15 Full 89 5MG + BACITRACIN NEOMYCIN SULPHATE I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 11 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 27-Apr-15 Full SRI LANKA 10-Feb-16 Full PAKISTAN 14-Dec-17 Full PAKISTAN 14-Dec-17 Full PAKISTAN 30-Mar-16 Full PAKISTAN 10-Jun-16 Full INDIA 12-May-17 Years Two INDIA 05-Feb-15 Full INDIA 16-Sep-14 Full INDIA 16-Aug-16 Full INDIA 30-Apr-15 Full Contract Manufacuring & Packging Services pty Ltd Woodward Pakitan (Pvt) Ltd Woodward Woodward Pakitan (Pvt) Ltd Cipla Ltd & Well Well INDIAPharma (Pvt) Ltd 31-Jan-15 Full Woodward Woodward Pakistan (Pvt) Ltd Central drugs and Pharmaceutical Fourrts (India) Laboratories Ltd Gopaldas Visram Gopaldas Visram & Co Ltd Fourrts (India) Laboratories Ltd Bafna Pharmaceuticals Ltd Glaxo Wellcome Glaxo Wellcome (Ceylon) Ltd (Contd.) Alaris Lanka (Pvt) Ltd Markss HLC (Pvt) Ltd Markss HLC (Pvt) Ltd Lanka (Pvt) Ltd Laboratories (Pvt) Ltd Morison PLC Searle-Pakistan PAKISTAN 09-Feb-15Markss HLC Full (Pvt) Ltd Pharma Associates Sunshine Healthcare lanka Ltd Chamee Chemist Sunshine Healthcare lanka Ltd Pharma Associates (Ceylon) Ltd CAPSULES SOLUTION SOLUTION SOLUTION SOLUTION SOLUTION ORAL ORAL SOLUTION SOLUTION SOLUTION SOLUTION SCHEDULE - II (GROUP A) SCHEDULE - II (GROUP PAEDICARE ORAL HAPPY KIDSHAPPY GELETIN SOFT PAEDICARE ORAL PEDITRAL LOWPEDITRAL ORAL PEEDICARE ORAL ARCET ORAL PARACIL PARACIL SYRUP ***** ORAL PARAFIL ORAL ANODYNE-P ORAL SOLUTION ORANGE FLAVOUR 750MG SOLUTION ORANGE FLAVOUR (SODIUM CHLORIDE 2.6G,POTASIUM (SODIUM CHLORIDE 2.6G,POTASIUM ANHYDROUS CHLORIDE 1.5MG,DEXTROSE (LOW OSMOLARITY- 12.5G)PEDITRAL O.R.S) STRAWBERRY) B.P 120MG/5ML B.P SUSPENSION B.P 120MG/5ML SUSPENSION B.P SUSPENSION B.P 120MG/5ML SUSPENSION B.P SUSPENSION B.P 120MG/5ML SUSPENSION B.P SUSPENSION B.P 120MG/5ML SUSPENSION B.P 92 ELECTROLYTE REHYDRATION ORAL 91 CAPSULS GEL SOFT 3 FISH OIL OMEGA 93 ELECTROLYTE REHYDRATION ORAL 94 IP SALT REHYDRATION ORAL 95 (O.R.S) BP SALTS REHYDRATION ORAL ORSAL PROLYTE POWDER POWDER Associated Breathe Free 96 FOR SOLUTION SALTS REHYDRATION ORAL 97 SOLUTION (FLAVOUR REHYDRATION ORAL 98 SOLUTION ORAL (PAEDIATIC) PARACETAMOL 99 ORAL (PAEDRIATIC) PARACETAMOL 100 ORAL (PAEDRIATIC) PARACETAMOL 101 ORAL (PAEDRIATIC) PARACETAMOL 102 ORAL (PAEDRIATIC) PARACETAMOL 103 SYRUP 120MG/5ML PARACETAMOL CETAPYRIN SYRUP Glaxo Wellcome 12 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIA 28-Feb-18 Full INDIA 04-Jan-14 Full SRI LANKA 18-Feb-16SRI LANKA Full 06-Jun-16 Full INDIA 28-Nov-14 Full INDIA 26-Apr-18 Provisional INDIA 23-Jun-17 Full INDIA 17-Nov-17 Full INDIA 20-Oct-17 Years Two Magbro Healthcare Kausikh Therapeutics (Pvt) Ltd Scottish Pharma INDIAUnical Ceylon 28-Jun-14(Pvt) Ltd Full State Pharmaceuticals Manufacturer Corporation Astamed Healthcare (Pvt) Ltd SPMC/State Pharmaceuticals Manufacturing COP Adore Pharmaceuticals (Pvt) Ltd Bal Pharma Ltd INDIALaboratories 23-May-18(Pvt) Ltd Years Two Medopharm Ltd (PVT (Contd.) Services Pvt. Ltd Sons Pvt Ltd (Pvt) Ltd (Pvt) Ltd Pharmaceuticals Manufacturer Corporation Pharma Celyon (Pvt) Ltd Pharmaceuticals Manufacturing COP (Pvt) Ltd Ltd Pharmaceuticals (Pvt) Ltd SYRUP Astron (Pvt) Ltd SRI LANKA 03-Feb-16 Full SCHEDULE - II (GROUP A) SCHEDULE - II (GROUP SYRUP 111 500MG BP TABLETS PARACETAMOL SPMC TABLETS State 110 500MG BP TABLETS PARACETAMOL UNIMOL TABLETS Unical Ceylon 112 500MG BP TABLETS PARACETAMOL ASTAMOL TABLETS Associated 113 500MG BP TABLETS PARACETAMOL **** TABLETS SPMC/State 114 500MG BP TABLETS PARACETAMOL ZIFAM TABLETS Alaris Lanka 115 500MG BP TABLETS PARACETAMOL 116 500MG BP TABLETS PARACETAMOL REGAMOL TABLETS KELVIN Harcourts (Pvt) TABLETS Ceyoka (Pvt) Ltd Leben 117 500MG BP TABLETS PARACETAMOL MEDMOL TABLETS Akbar 105 500MG BP TABLETS PARACETAMOL PACETOL TABLETS ABC Pharma 104 120MG/5ML USP SYRUP PARACETAMOL RAPISOL 106 500MG BP TABLETS PARACETAMOL 107 500MG BP TABLETS PARACETAMOL *** **** TABLETS TABLETS Morison PLC Morison PLC Jayanetti & P SRI LANKA 16-Aug-18Years Two 108 500MG BP TABLETS PARACETAMOL 109 500MG BP TABLETS PARACETAMOL ***** 500 AZICOT TABLETS TABLETS Alaris Lanka Astron (Pvt) Ltd Astron (Pvt) Ltd SRI LANKA 08-Oct-14 Full I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 13 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 28-Feb-14 Full INDIA 23-Jul-15 Full SRI LANKA 11-Jul-14 Full MALAYSIA 24-Oct-17IRELAND Full 11-Jun-18 Years Two INDIA 13-Jul-15INDIA Full 24-Jul-15SRI LANKA 06-Apr-18 Full INDIA Full 05-Nov-17PAKISTAN 02-Jan-16 Full INDIA Full 05-Nov-17 Full SRI LANKA 07-Jun-15 Full INDIA 11-Sep-18 Years Two Globe Pharmaceuticals Ltd Navketan Research & Labo. (Pvt) Ltd Gamma Pharmaceuticals Pvt Ltd Helsinn Birex Pharmaceuticals Ltd Chemicals (Pvt) Ltd Nawketan Resarch & Laboratories Suraksa Pharma (Pvt) Ltd G S Pharmabutor (Pvt) Ltd Brookes Pharma (Pvt) Ltd G S Pharmabutor (Pvt) Ltd Hoe Pharmaceuticals SDN BHD M W L De Silva M W L & Co Glenmark Pharmaceuticals Ltd (Contd.) Healthcare (Pvt) Ltd ABC Pharma Services Pvt. Ltd maceuticals Pvt Ltd Hemas Pharmaceuticals (Pvt) Ltd ABC Pharma Services Pvt. Ltd Suraksa Pharma (Pvt) Ltd Co Ltd ceuticals (Pvt) Ltd Co Ltd Ltd & Co Healthcare lanka Ltd SOLUTION Tabrane SOLUTION ORAL ORAL SOLUTION SOLUTION Ceyoka (Pvt) Ltd Sirmaxo SCRUB CREAM SOLUTION Robert Hall & SOLUTION Robert Hall & SCHEDULE - II (GROUP A) SCHEDULE - II (GROUP APODINE Solution SANIQUAD PVP SANIQUAD PVP 7.5% KLEAN PREP POWDER NOVASEPT SURGICAL SETADINE TOPICAL BETADINE SURGICAL SCRUB PYODINE SOLUTION BETADINE SURGICAL Hemas Pharma- SCRUB GLENPER CREAM Sunshine USP USP 7.5% USP SULPHATE 5.685G SODIUM BICA SULPHATE 7.5% USP 7.5% USP 7.5% USP 7.5% USP 7.5% USP 118 PERMETHRIN CREAM 5% W/W 119 PERMETHRIN HEAD LOTION 0.5% W/V LYCINE LOTION De Silva M W L 123 SOLUTION TOPICAL POVIDONE IODINE 10% 124 POVIDONE IODINE CLEANSING SOLUTION 121 59.0G,SODIUM GLYCOL POLYETHYLENE 122 SOLUTIONTOPICAL POVIDONE IODINE 10% NOVASEPT TOPICAL 125 POVIDONE IODINE CLEANSING SOLUTION 126 POVIDONE IODINE CLEANSING SOLUTION 127 POVIDONE IODINE CLEANSING SOLUTION 128 POVIDONE IODINE CLEANSING SOLUTION 129 POVIDONE IODINE CLEANSING SOLUTION 130 5% USP POVIDONE IODINE OINTMENT SURGIDENE OINTMENT Gamma Phar- 120 PERMETHRIN LOTION 2% W/V (A-Scaba) A-SCABS LOTION Indoscan (Pvt) 14 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 03-Oct-17 Full 17-May-17 Full INDIA 18-Apr-16SRI LANKA 23-Aug-14 Full UNITED Full KINGDOM SRI LANKA 10-Sep-14 Full INDIA 08-Dec-17THAILAND Years Two 03-Dec-17 Years Two THAILAND 03-Dec-17 Years Two INDIA 06-May-17INDIA Full 12-Aug-16 Full BANGLA- DESH INDIA 19-Mar-15INDIA Full 12-Feb-14 Full Inter Pharm (Pvt) Ltd Cuxson Gerrard & Co Ltd Fourrts (India) Laboratories Ltd Coral Laboratories Ltd Man Pharma T Ltd. Man Pharma T Ltd. M S J Industries (Ceylon) (Pvt) Ltd (Pvt) Ltd Central drugs and Pharmaceutical Square Pharmaceuticals Ltd G S Pharmabutor (Pvy) Ltd for Win Medical (Pvt) Ltd Laboratories (Pvt) Ltd (Contd.) Ltd ceuticals (Pvt) Ltd Healthcare lanka Ltd Harcourts (Pvt) Ltd PharmAce (Pvt) Ltd PharmAce (Pvt) Ltd (Ceylon) (Pvt) Ltd Mamro (Pvt) Ltd Raman & Weil Associates Ltd Co Ltd SUSPENSION SUSPENSION SUSPENSION SOLUTION SCHEDULE - II (GROUP A) SCHEDULE - II (GROUP BENOFCORN CAPS SYRUP PLASTER Akbar Pharma- Inter Pharm (Pvt) CORASIL ORAL GAS-MEDGAS-MED ORAL ORAL STERILLUM ANTISEPTIC BETADINE SOLUTION Robert Hall & 2MG+GUAIPHENESIN 50MG/5ML ACID PASTE CENTRE RING CONTAING HYDROXIDE 250MG & DRIED ALUMINUM HYDROXIDE 250MG & DRIED SUSPENSION 250MG ORAL HYDROXIDE GEL 40MG/06ML DROPPERFUL 40MG/06ML DROPPERFUL 40MG/06ML 30G+MECETRONIUM ETHYLSULFATE 30G+MECETRONIUM ETHYLSULFATE 0.2G/100G SOLUTION 10% W/V 139 1MG+BROMHEXINE HCL. SALBUTAMOL 140ACID 40% W/W DRESSINGS WITH SALICYLIC 141 SIMETHICONE 50MG,MAGNESIUM 138TABLETS 125MG PAMOATE PYRANTEL COMBIFIL-125 TABLETS Sunshine 142 SUSPENSION SIMETHICONE ORAL 143 SUSPENSION SIMETHICONE ORAL 136 45G+PROPANOL-1 PROPANOL-2 137TABLETS 125MG PAMOATE PYRANTEL **** TABLETS M S J Industries 134 SOLUTION USP TOPICAL POVIDONE IODINE 135 5% POVIDONE IODINE U.S.P HEALZ OINTMENT Pharma 132 10% POVIDONE IODINE SOLUTION BP 133 10% POVIDONE IODINE SOLUTION BP HEMITADINE SOLUTION ZYLO-P Himata (Pvt) Ltd Himata (Pvt) Ltd SRI LANKA SOLUTION 17-Sep-18 Provisional Ceyoka (Pvt) Ltd Leben 131 5% USP POVIDONE IODINE OINTMENT VIODIN OINTMENT PharmAce (Pvt) I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 15 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 26-Apr-14 Full 28-Jan-18 Full 28-Jan-18 Years Two UNITED KINGDOM UNITED KINGDOM PAKISTAN 24-Sep-14 Full PAKISTAN 21-May-14 Full PAKISTAN 04-Apr-14 Full INDIA 18-Sep-15 Full INDIA 10-Oct-14 Full SRI LANKA 28-Jul-17 Full THAILAND 28-Jan-16 Full BANGLA- DESH INDIA 01-Sep-15 Full Reckitt Benckser Healthcare UK Reckitt Benckser Healthcare UK Company Ltd Alina Combine Pharmaceuticals (Pvt) Ltd Laboratories (Pvt) Ltd ICPA Health ICPA Products Ltd Laboratories (Pvt) Ltd Inter Pharm (Pvt) Ltd Mega Lifesciences Public Company (Pvt) Ltd Axon Drugs (Pvt) Ltd Globe Pharmaceuticals Ltd Sanbe FarmaT P INDONESIA 19-Aug-14 Full (Contd.) Reckitt Benckiser (Lanka) Ltd Reckitt Benckiser (Lanka) Ltd Morison PLC The Searle PharmAce (Pvt) Ltd Health (Pvt) Ltd Ltd (Pvt) Ltd Healthcare lanka Ltd Healthcare (Pvt) Ltd ceuticals (Pvt) Ltd SUSPENSION SUSPENSION ORAL SOLUTION ELECTROLY ELECTROLY SOLUTION SYRUP Ceyoka (Pvt) Ltd Leben SYRUP Lifeline Pharma- SYRUP Astron (Pvt) Ltd SRI LANKA 11-Dec-15 Full SCHEDULE - II (GROUP A) SCHEDULE - II (GROUP GAVISCON ORAL PEDITRAL LIQUID GAVISCON ORAL PEDILIN ORAL FLUORITOP MOUTH WASH George Steuart LIBITUS PLUS SYRUP **** TABLETS Inter Pharm (Pvt) NAT-C ESTERNAT-C POWDER Baur & Co A STANOVIT BSTANOVIT TABLETS Tabrane SYRUP ADULTS avine fi BICARBONATE 267MG/10ML BICARBONATE DEHYDRATE CHLORIDE 7.5MG CITRATE LIQUED 14.2G ,DEXTROSE 100MG /500ML -BUBBLE GUM FLAVOUR BICARBONATE 267MG/10ML BICARBONATE CITRATE 2.9G+POTASSIUM CHLORIDE 1.5G 2.9G+POTASSIUM CITRATE GLUCOSE 13.5G/1000ML PHOSPHATE TOPICAL SOLUTION USP TOPICAL PHOSPHATE BROMHEXINE HYDROCHLORIDE BP 4MG & BROMHEXINE HYDROCHLORIDE BP 50MG BP GUAIPHENESIN SYRUP TABLETS COMPLEX 71.45MG POWDER WITH ORANGE FLAVOUR 2mg Niacinamide 20mg BP 145 500MG+SODIUM SODIUM ALGINATE 146 SODIUM CHLORIDE 1.75MG,POTASIUM 144 500MG+SODIUM SODIUM ALGINATE 147 SODIUM CHLORIDE 2.6G+TRISODIUM 148 DROPS 0.9% SODIUM CHLORIDE NASAL NORSALINE P DROPS NASAL Morison PLC ATCO 149 SODIUM FLUORIDE AND ACIDULATED 150 1.25MG BP SULPHATE TERBUTALINE 151 THIAMINE HYDROCHLORIDE 10MG BP 152 C 1000MG PLUS,LEMON FLAVONOID VIATMIN 153 COMPLEX ,THIAMINE 5MG.Ribo VIT.B 154 B COMPLEX VITAMIN 155 B COMPLEX VITAMIN -B SANVITA **** TABLETS Sunshine 156 B COMPLEX & IRON VITAMIN FOR DUROL 16 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 13-Oct-16 Full 29-Oct-14 Full 02-Aug-14 Full PHILIP- PINES INDIA 19-Nov-17 Years Two INDIA 29-Jun-18 Full AUSTRA- LIA INDIA 02-Apr-15 Full INDIA 14-Mar-15 Full Merck Limited INDIA 09-Mar-14 Full Globe Pharmaceuticals Ltd United Laboratories Dr Reddy's Laboratories Ltd Axon Drugs (Pvt) Ltd Contract Manufacuring & Packging Services pty Ltd Axa Parenterals Ltd Triveni Triveni Formulations Ltd (Contd.) (Ceylon) Ltd Healthcare (Pvt) Ltd Health (Pvt) Ltd (Ceylon) Ltd Healthcare lanka Ltd (Pvt) Ltd Chemist (Pvt) Ltd TABLETS George Steuart SCHEDULE - II (GROUP A) SCHEDULE - II (GROUP BIZ SYRUP SYRUP Tabrane FILMCAP * TABLETS Sunshine BECOZINC CAPSULES Emerchemie NB BECOSULES SYRUP Astron (Pvt) Ltd Astron (Pvt) Ltd SRI LANKA 29-Sep-15 Full * TABLETS Morison PLC Morison PLC SRI LANKA 01-Jan-18 Provisional VITACEE TABLETS Alaris Lanka AVITONE CAPSULES Pharma Avenier SYRUP 1MG,B2 1MG & NICOTINAMIDE 10MG) C+ZINC FOLIC ACID SYRUP HCL 1MG+RIBOFLAVIN 1MG NICOTINAMIDE 1MG+RIBOFLAVIN HCL 10MG) 500MG CAPSULES 157AND IRON & ZINC B COMPLEX VITAMIN 160 B1 (VIT. TABLETS B COMPLEX VITAMIN 158 B COMPLEX FORTE+VITAMIN VITAMIN 159 B COMPLEX SYRUP VITAMIN 161 C B COMPLEX WITH VITAMIN VITAMIN POLYBION SYRUP C ENERVON Emerchemie NB 162AND B12 B COMPLEX, VITAMIN VITAMIN 163 (THIAMIN TABLETS B COMPOUND VITAMIN 164 TABLETS RELEASE C SUSTAINED VITAMIN 165 &TRACE ELEMENTS MINERAL VITAMIN 166 FOR INJECTION STERILISE WATER SWFI INJECTION Chamee I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 17 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 VIII COLUMN- VII Issue Date Reg. Type Manufactuer SWITZERLAND 16-Jul-15 Full BELGIUM 21-Feb-16 Full INDIAINDIA 22-Feb-18 Years Two INDIA 09-Oct-17 Years Two INDIA 20-Jan-16 Full INDIA 11-Apr-18INDIA Full 06-Feb-18 Years Two 19-Feb-18 Years Two Cipla LtdHospira Inc, for Cubist USA INDIAPharmaceuticals Inc USA 06-Aug-18Years Two Patheon Inc. Canada (pack & Released by Janssen Italy Cilag SPA for Janssen Pharmaceuticals N V (Pvt) Ltd Centurion Laboratories Pvt Ltd Pharmaceuticals International (Pvt) Ltd Aizant Drugs Research Solution Pvt Ltd Therdose Pharma (Pvt) Ltd Dr Reddy's Laboratories Ltd (Contd.) (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd (Ceylon) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP REOPRO INJECTION Hemas ZYTIGA TABLETS Pettah Pharmacy ABIRAGLOB 250 TABLETSN/A PharmAce (Pvt) Ltd Gobela Pharma ABIRON TABLETS TABLETSAIZERONE International Yaden Pharma Associates TABLETS BDR N/A V H Distributors A TABLETS Pharma R N Vision ABIRATREP TABLETS Emerchemie NB COLUMN-I COLUMN-II COLUMN-III COLUMN-IV COLUMN-V COLUMN-VI COLUMN- Generic Name Brand Name Dosage Form Importer Name Manufacturer Country OF 5ML 250MG 250MG 250MG 250MG 250MG 250MG USP USP 250MG USP 1 300MGTABLETS ABACAVIR 2 ABCIXIMAB INJECTION 10MG IN ABAMUNE3 TABLETS ABCIXIMAB INJECTION 2MG/ML4TM CLOTINAB TABLETS ACETATE ABIRATERONE Breathe Free Lanka INJECTIONAssociates Pharma Abxis Co Ltd ISU KOREA5 TABLETS ACETATE ABIRATERONE 16-Aug-176Years Two TABLETS ACETATE ABIRATERONE 7 TABLETS ACETATE ABIRATERONE 8 TABLETS ACETATE ABIRATERONE 9 TABLETS ACETATE ABIRATERONE 10 TABLETS ACETATE ABIRATERONE 18 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 20-Jul-14 21-Nov-16 Full INDIA Full INDIA 30-Oct-14 Full 08-May-18 Full INDIAINDIA 06-Feb-18 Years Two 08-Feb-18INDIA Years Two 09-Jan-17INDIA Full 09-Nov-17 Years Two Bayer Pharma A GA Bayer Pharma GERMANY 18-Mar-18Orchid Healthcare INDIA Full GA Bayer Pharma GERMANY 26-Feb-14 18-Mar-18Pharmaceuticals Full Full Glenmark Pharmaceuticals Ltd Micro Labs Ltd INDIAZim Laboratories Ltd Inventia 20-Feb-16Healthcare (Pvt) Ltd Full LaboratoriesIPCA INDIA Health Pell Tech Care (Pvt) Ltd 14-Jun-17Years Health Two Pell Tech Care (Pvt) Ltd Sterling Lab INDIAScences Micro Labs Ltd INDIA 09-Apr-14Laboratories (Pvt) Full Ltd 17-Jan-18Years Two (Contd.) Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Ltd (Ceylon) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd Co Ltd Ltd Ceyoka (Pvt) Ltd Leben SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP TABLETS FECK SRACHAID CAPSULES Lanka (Pvt) Tabrane ZERODOL-CR CAPSULES TABLETS Emerchemie NB ATOACE Hemas ATOACE TABLETSACENORM 100 TABLETS Salveo Pharma TABLETS Salveo Pharma Darley Butler & DOLOWIN-SR TABLETSRIHA-SR 200 SMM Halcyon (Pvt) FILM COA SR SR 200MG RELEASE TABLETS 100MG TABLETS 10MG TABLETS 100MG TABLETS 200MG RELEASE TABLETS 200MG RELEASE TABLETS 11 100MG ACARBOSE TABLETS GLUCOBAY TABLETS Hemas 12 100MGTABLETS ACARBOSE 13 50MGTABLETS ACARBOSE ACARB14 50 GLUCONAY 50MGTABLETS ACARBOSE TABLETS TABLETS15 50MG ACARBOSE TABLETS ABACUSAsian Pharma Euro Hemas 16 GLUCAR 50MGTABLETS ACARBOSE TABLETS17 ACECLOFENAC CAPSULES 200MG DIABOSE 50 TABLETSAssociates Pharma 18 The Madras ACECLOFENAC CAPSULES 200MG TABLETS Hemas 19 Micro Mega Lanka ACECLOFENAC CONTROLLED 20 ACECLOFENAC ENTERIC COATED 21 ACECLOFENAC ENTERIC COATED 22 ACECLOFENAC FILM COATED 23 1% W/W ACECLOFENAC GEL 24 ACECLOFENAC SUSTAINED ACELODON GEL GEL25 ACECLOFENAC SUSTAINED PharmAce (Pvt) Ltd Swiss Garnier Life I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 19 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 BANGLADESH 14-Jun-17 Years Two BANGLADESH 07-Jul-18 Years Two INDIAINDIA 14-Oct-18 Full 11-Mar-16 Full BANGLADESH 02-Oct-18 Years Two INDIAINDIA 10-May-18 Provisional 01-Feb-15INDIA Full INDIA 21-Oct-15BANGLADESH Full 03-May-17 23-Dec-17 Years Two Years Two INDIA 14-Oct-16 Full Chemical Industries Eskayef Bangladesh Ltd Alkem Laboratories Ltd Oasis Laboratories (Pvt) Ltd Aristopharma Ltd BANGLADESH 30-May-14Healthcare Full Pharmaceuticals Innopharm (Pvt) Ltd Zim Laboratories Ltd LaboratoriesIPCA INDIASava Healtheare Ltd 17-Feb-14Jenburkt Pharmaceuticals Ltd Full Navana Pharmaceuticals Ltd Synmedic Laboratories (Pvt) Ltd Renata Limited BANGLADESH 19-Jan-17 Full (Contd.) Healthcare lanka Ltd (Ceylon) Ltd ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Co Ltd Pharmaceuticals (Pvt) Ltd (Ceylon) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP CELOFEN TABLETS CIC Holdings PLC Advanced CECLOFEN TABLETS Emerchemie NB 100MG 100MG 28 100MG ACECLOFENAC TABLETS TUFFOX29 100MGTABLETS ACECLOFENAC MOBENAC30 TABLETS 100MGTABLETS ACECLOFENAC OSICLO TABLETS Sunshine 31 100MG ACECLOFENAC TABLETS Emerchemie NB MERVAN TABLETS32 100MGTABLETS ACECLOFENAC RS Biogenics (Pvt) TERNILLA TABLETS33 100MGTABLETS ACECLOFENAC ALFINAC Hemas TABLETS34 100MG ACECLOFENAC TABLETS Citihealth Imports FECK TABLETS35 100MGTABLETS ACECLOFENAC Harcourts (Pvt) Ltd ZERODOL36 Sai Mirra 100MGTABLETS ACECLOFENAC TABLETS ACECLODEAL37 TABLETS 100MG ACECLOFENAC TABLETS Tabrane TABLETS ZIX Emar Pharma (Pvt) 38 100MG Radiant Health Care TABLETS ACECLOFENAC ACEFLEX 10039 TABLETS100MG ACECLOFENAC TABLETS TABLETS ACEFEN Darley Butler & Hemas TABLETS Lifeline 27 BP TABLETS ACECLOFENAC 26 BP TABLETS ACECLOFENAC 20 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAPAKISTAN 18-Nov-14INDIA 14-Aug-15 Full Full INDIA 13-Oct-17 Years Two 23-Apr-14INDIA Full BANGLADESH 28-Mar-14 06-Sep-17 Years Two INDIA Full INDIA 01-Mar-18INDIA Years Two 01-Jan-14INDIA Full 09-Dec-14PAKISTAN Full 22-Mar-15 13-Sep-14 Full INDIA Full INDIA 06-Jan-16INDIA Full 11-Mar-16 Full 18-Sep-16 Full Alice Pharma Private Ltd. Pharmaceuticals S J & G Fazul Ellahie (Pvt) Ltd Ajantha Pharma Ltd Unichem Laboratories Aristopharma Ltd BANGLADESH 30-May-14G D Laboratories Full (India) Pvt Ltd The Acme Laboratories Ltd J.B.Chemicals & Pharmaceuticals Laboratories Ltd Pharmaceuticals Ltd Medizan Laboratories (Pvt) Ltd (Pvt) Ltd Oasis Laboratories (Pvt) Ltd (Contd.) ABC Pharma Services Pvt. Ltd (Pvt) Ltd Ltd Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Ltd Health (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Imports (Pvt ) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP TABLETS 40 100MGTABLETS ACECLOFENAC ACLOFEN41 100MGTABLETS ACECLOFENAC ACECLOFAR42 TABLETS 100MGTABLETS ACECLOFENAC TABLETS ACTINAC 10043Associates Pharma 100MGTABLETS ACECLOFENAC The Madras TABLETS Pharma Tropical AROFF44 100MG ACECLOFENAC TABLETS Baur & Co (Pvt) A MERVAN45 TABLETS 100MG ACECLOFENAC TABLETS CDFENAC TABLETS Baur & Co (Pvt) A 46 100MGTABLETS ACECLOFENAC Hemas TABLETS APITAC47 100MGTABLETS ACECLOFENAC Lifeline MOVIZ 10048 100MGTABLETS ACECLOFENAC TABLETS CECLOF49 TABLETS 100MGTABLETS ACECLOFENAC Mega Pharma (Pvt) ALGIC50 George Steuart 100MGTABLETS ACECLOFENAC TABLETS ACECLOFAR51Associates Ashland 100MG ACECLOFENAC TABLETS TABLETS Baader Schulz TABLETS CECLO52 Axia (Pvt) Ltd PharmAce (Pvt) Ltd 100MGTABLETS ACECLOFENAC Medley ACECLORIGHT53 MSN Laboratories TABLETS 100MGTABLETS ACECLOFENAC TABLETS OSICLO Ceyline 54 Chamee Chemist 100MGTABLETS ACECLOFENAC Alvita Pharma RUNN 100 TABLETS FILM COA Union Lanka I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 21 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 BANGLADESH 15-Mar-17 Years Two INDIAINDIA 25-Mar-15INDIA Full 16-Feb-17BANGLADESH Full 11-Dec-14 24-Nov-14 Full Full INDIAINDIA 07-Nov-14 Full 26-Sep-14INDIA Full 08-Aug-17INDIA Full INDIA 05-May-18 Full INDIA 18-Mar-17 Full 11-Apr-15 Full Laboratories (Pvt) Ltd Incepta Pharmaceuticals Ltd Scences Fredun Pharmaceuticals Ltd Pharmaceuticals Industry Ltd Umedica Laboratories (Pvt) Ltd Ltd Micro Labs Ltd INDIAZota Healthcare Ltd Micro Labs Ltd 14-Sep-17 INDIAYears Two Bliss GVS Pharma Ltd 11-May-14Galen Pharmaceuticals (Pvt) Ltd Full Centurion Laboratories Pvt Ltd (Contd.) Ceyoka (Pvt) Ltd Leben (Pvt) Ltd Health (Pvt) Ltd Pharmaceuticals Pvt Ltd Ltd (Pvt) LTD Ltd Healthcare lanka Ltd (Pvt) Ltd (Pvt) Ltd TABLETS SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP RECTOL 125RECTOL 125GALIPAR N/A Sunshine N/A Pharma Tropical TABLETS International Yaden TABLETS Kamazu (Pvt) Ltd Micro Labs Ltd INDIA 22-Aug-15 Full USP 125MG USP 125MG USP 250MG 250MG 55 100MGTABLETS ACECLOFENAC RESERVIX TABLETS Citihealth Imports 56 100MGTABLETS ACECLOFENAC RIHA57 100MGTABLETS ACECLOFENAC ACELODON 10058 100MGTABLETS ACECLOFENAC TABLETS FILM COA ACLOFRE59 PharmAce (Pvt) Ltd 100MGTABLETS Swiss Garnier Life ACECLOFENAC TABLETS PRESERVIN60 100MGTABLETS ACECLOFENAC TABLETS George Steuart RILIF 10061 Medinex (Pvt) Ltd 100MGTABLETS ACECLOFENAC The IBN SINA SUPPAINS TABLETS62 100MGTABLETS ACECLOFENAC DOLOWIN63 Gamma TABLETS 100MGTABLETS ACECLOFENAC ZOFEN 10064 Hemas Health Care TABLETSACID CREAM 20% ACELAIC Cadila Healthcare 65 TABLETS SMM Halcyon (Pvt) SUPPOSITORIES ACETAMINOPHEN AZIDERM Healthcare Trendz 66 SUPPOSITORIES ACETAMINOPHEN CREAM67 BP TABLETS ACETAZOLAMIDE Mega Pharma (Pvt) 68 BP TABLETS ACETAZOLAMIDE 22 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIA 28-Oct-15INDIA Full INDIA 10-Apr-16INDIA Full 15-Feb-18 Years Two INDIA 29-Jun-16INDIA Full 06-Feb-14 Full 12-Dec-17 Years Two CYPRUS 17-Sep-14 Full INDIAINDIA 03-Apr-15 Full PAKISTAN 16-Mar-16 23-Aug-17 Full MALAYSIA Years Two 02-Feb-17 Full B D H Industries Ltd Micro Labs Ltd INDIASG Pharma (Pvt) Ltd Ltd Science P 08-Apr-14 Full PharmaceuticalS (Pvt) Ltd SG Pharma (Pvt) Ltd Medico Remedies (Pvt) Ltd Micro Labs Ltd INDIADelobris Pharmaceuticals 01.06.18 Ltd-AT Yaden-LO42/17 16-Jul-17Hovid SDN BhdYears Two MALAYSIAAgio Pharmaceuticals 10-Jun-18Ltd Years Two Synmedic Laboratories (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals SDN BHD (Contd.) (Pvt) Ltd Ltd Pharmacy (Pvt) Ltd Pharmacy (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd Lanka (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP N/A 250ACETAMIDE TABLETSN/A TABLETS SMM Halcyon (Pvt) N/A Ravilux Company 200CIROCYST TABLETS INJECTION INJECTION The Esses MUCOTYLE Ceyoka (Pvt) Ltd Pharma Associates Ciron Drugs & Sreil-Gene Life SOLUTION The Esses 250MG 250MG 250MG 200mg/10ML 200MG 200mg/ml (2G/10ML)Sterile 69 BP TABLETS ACETAZOLAMIDE 70 IP TABLETS ACETAZOLAMIDE 71 USP TABLETS ACETAZOLAMIDE 72 ACETYLCYSTEINE INJECTION BP 73 ACETYLCYSTEINE SOLUTION USP 74 ACETYLCYSTEINE SOLUTION USP 75TABLETS ACICLOVIR 200MG BP N/A76TABLETS ACICLOVIR 200MG BP 77 HERPERAX BPTABLETS ACICLOVIR 400MG TABLETS VIRUCID TABLETS78 Akbar 5%W/W ACICLOVIR CREAM BP Micro Mega Lanka TABLETS79 VIREST 5%W/W ACICLOVIR CREAM BP Access International ACIHERPIN80 5%W/W ACICLOVIR CREAM BP CREAM CREAM ACIRAX81 5%W/W ACICLOVIR CREAM BP Hadley Bevan Citihealth Imports CYCLOZ82 CREAM 5%W/W ACICLOVIR CREAM BP DECLOVIR CREAM Lifeline CREAM Ceyoka (Pvt) Ltd Focus & Rulz Indoscan (Pvt) Ltd Hoe I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 23 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 16-Jul-16 Full INDIA 21-Feb-18 Years Two ITALY 05-Jun-14 Full 21-Mar-15PAKISTAN Full 05-Oct-17 Years Two PAKISTANINDIA 19-Apr-17 Years Two INDIA 23-Jul-15 Full INDIA 04-Aug-17 Years Two INDIA 04-Aug-17 Years Two INDIA 06-Feb-15 Full 28-Mar-14 Full Centaur Pharmaceutical (Pvt) Ltd Sunwaya Rohto Pharmaceutical Pvt Ltd Opthalmincs Glaxo Smithkiline Manufacturing SPA Micro Labs Ltd INDIARemington pharmaceutical Industries (Pvt) Ltd 20-Feb-18Sante (Private) Limited Full PharmaceuticalS (Pvt) Ltd Troikaa Pharmaceuticals Ltd Troikaa Pharmaceuticals Ltd Agio Pharmaceuticals Ltd Synmedic Laboratories (Pvt) Ltd Aristopharma Ltd BANGLADESH 02-May-14 Full (Contd.) Health (Pvt) Ltd (Pvt) Ltd Pharmaceuticlas (Pvt) Ltd (Pvt) Ltd Co Ltd (Ceylon) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP EYEVIRN/A EYE OINTMENT George Steuart LOVIR OINTMENT International Yaden OINTMENT Chamee Chemist Indiana LOVIRSANTOVIR EYE DROPS Delmege Forsyth & CIROVIR EYE OINTMENT Emerchemie NB VIR INJECTION Ceyoka (Pvt) LtdVIR Ciron Drugs & INJECTION Slim INJECTION Slim ACYVIR EYE OINTMENT Hemas W/w 3.0% 3% w/w USP 3% w/w USP INFUSION 250MG INTRAVENOUS BP TABLETS INFUSION BP INTRAVENOUS 250MG INFUSION BP INTRAVENOUS 250MG W/w STERILE 85 3% BP ACICLOVIR EYE OINTMENT 86 USP ACICLOVIR EYE OINTMENT 87 ACICLOVIR INJECTION 250MG ZOVIRAX88 5% USP ACICLOVIR OINTMENT 89 HERPERAX INJECTION ACICLOVIR OPTHALMIC OINTMENT GlaxoSmithkiline OINTMENT90 ACICLOVIR OPTHALMIC OINTMENT Micro Mega Lanka 91 ACICLOVIR SODIUM FOR 92 ACICLOVIR SODIUM FOR 93 ACICLOVIR SODIUM FOR 94 200MG BP TABLETS ACICLOVIR ACIHERPIN95 200MG BP TABLETS ACICLOVIR TABLETS ACIRAX Citihealth Imports TABLETS Lifeline 84 3% BP ACICLOVIR EYE OINTMENT 83 3% BP ACICLOVIR EYE OINTMENT 24 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 25-Nov-17 Full INDIAINDIA 06-Aug-14SPAIN/ Full 30-Nov-15AUSTRALIA Full PAKISTAN 14-Sep-17INDIA Years Two INDIA 02-May-15MALAYSIA Full 21-Jan-14 11-May-17BANGLADESH Full 21-Dec-17 Full Years Two INDIA 23-Sep-15 Full PAKISTAN 16-Aug-17GERMANY Years Two 04-Jul-14INDIA Full 17-Jan-17 Full Agio Pharmaceuticals Ltd Incepta Pharmaceuticals Ltd Kausikh Therapeutics (Pvt) Ltd XL Laboratories XL (Pvt) Ltd Cadila Healthcare Ltd Glaxo Wellcom Aranda S.A Spain /Glacosmithkline Australia Pty Ltd Brookes Pharma (Pvt) Ltd Ltd SDN BHD Pharmaceuticals (Pvt) Ltd Agio Pharmaceuticals Ltd Micro Labs Ltd INDIA 16-Dec-17 Full Denk Pharma GmbH & Co. (Contd.) (Pvt) Ltd (Pvt) Ltd Pvt Ltd Ltd Healthcare lanka Ltd Pharmaceuticlas (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP TABLETS Akbar DENK 200 96 200MG BP TABLETS ACICLOVIR OVIR97 200MG BP TABLETS ACICLOVIR CYCLOVIR98 200MG ACICLOVIR TABLETS TABLETS TABLETS ZOVIRAX SMM Halcyon (Pvt) Sunshine TABLETS GlaxoSmithkiline 99 200MG BP TABLETS ACICLOVIR CYCLOZ TABLETS Ceyoka (Pvt) Ltd Focus & Rulz 104 800MG BP TABLETS ACiCLOVIR N/A105 800MG BP TABLETS ACICLOVIR ACIHERPIN 800106 TABLETS 800MG USP TABLETS ACICLOVIR VIRLESS TABLETS107 Citihealth Imports 200MG USP TABTET ACICLOVIR Chamee Chemist SIMPLOVIR TABLETS108 Bajaj Healthcare 200MG USP TABTET ACICLOVIR TABLETS Indoscan (Pvt) Ltd 200 KAYVIR Industries / S P Y Citihealth Imports TABLETS Jayanetti & Sons P 103 800MG BP TABLETS ACICLOVIR CLOVIREX TABLETS Hemas 100 200MG BP TABLETS ACICLOVIR ACYCLOVIR- 101 400MG BP TABLETS ACICLOVIR ACIHERPIN102 400MG BP TABLETS ACICLOVIR TABLETS HERPERAX 400 TABLETS Citihealth Imports Micro Mega Lanka I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 25 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 16-Nov-18 Provisional INDIA 21-Apr-15 Full INDIA 04-Jul-18 Provisional PAKISTAN 13-Jan-16 01-Nov-17 Full BANGLADESH Years Two 08-Oct-17 Years Two FRANCE 12-Aug-15PAKISTAN Full 13-Oct-17 Years Two BANGLADESH 21-Dec-17 Years Two MALAYSIA 15-Feb-18CANADA Full 11-Dec-15 Full Cadila Healthcare Ltd Pharmaceuticals (India) Ltd Glenmark Pharmaceuticals Ltd Dupen Laboratories (Pvt) Ltd Laboratories (Pvt) Ltd Pharmaceuticals Ltd Laboratories Galderma Brookes Pharma (Pvt) Ltd Incepta Pharmaceuticals Ltd Pharmaniaga Manufacturing berhand CinnaGen Co IRAN 12-Mar-18Years Two Patheon Inc. Canada for F La Roche Hoffman ltd (Contd.) Sunshine Healthcare lanka Ltd Healthcare lanka Ltd (Pvt) Ltd Morison PLC ATCO Healthcare lanka Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd (Ceylon) Ltd Slim Pharmaceuticals (Pvt) Ltd (Ceylon) Ltd SYRINGES CREAM CREAM PharmAce (Pvt) Ltd Square INJECTION SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP EXEMPTIA PRE-FILLED CLINALIN GELDERIVA-C GEL GELCALENE GEL PharmAce (Pvt) Ltd Aurochem GEL Sunshine Pharma Tech Bio CREAM CINNORA SOLUTION FOR 40MG/0.8ML (SINGLE DOSE) 40MG/0.8ML 1% w+CLINDAMYCIN PHOSPATE w/w 10MG/G 10MG/G 40MG/0.8ML 111 ACITRETIN CAPSULES 10MG NEOTIGASON CAPSULES Emerchemie NB 113 ADALIMUMAB INJECTION 114 0.1%w/ ADAPALENE 115 1MG+CLINDAMYCIN ADAPALENE 116 1MG+CLINDAMYCIN ADAPALENE 117 CREAM 0.1% w/w ADAPALENE ADAPCO CREAM118 TOPICAL CREAM 0.1% w/w ADAPALENE 0.1% FONA 119 0.1% GEL ADAPALENE ADAFERIN GEL GEL Sunshine 110 400MG USP TABTETS ACICLOVIR N/A TABLETS112 ADALIMUMAB INJECTION Emerchemie NB 120 0.1% GEL ADAPALENE ACLENE GEL Hemas 109 200MG USP TABTET ACICLOVIR SIMPLOVIR TABLETS Citihealth Imports 26 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 06-Oct-17 Years Two 01-Jun-17 Full INDIA 25-Nov-18 Full PAKISTAN 23-Mar-14INDIA Full FRANCE 06-Jun-17 Full 12-Aug-15INDIA Full INDIA 24-Jan-18 Years Two INDIA 12-Sep-17 Years Two INDIA 16-Dec-18 Full INDIA 03-Apr-14UNITED Full KINGDOM 16-Oct-14 Full INDIAUNITED KINGDOM 02-Jul-18 Provisional PharmaceuticalS (Pvt) Ltd Galderma Laboratories Concept Pharmaceuticals Ltd Macarthys Laboratories Ltd Martindale T/A Pharmaceuticals Laboratories (Pvt) Ltd Pharmaceuticals (India) Ltd Glenmark Pharmaceuticals Ltd Glenmark Pharmaceuticals Ltd Ltd SG Pharma (Pvt) Ltd Hameln Pharmaceuticals GmbH Germany Mayne Pharma (Pvt) Ltd Kwality Pharmaceuticals Pvt Ltd (Contd.) Healthcare lanka Ltd International (Pvt) Ltd Niix Holdings (Pvt) Ltd Healthcare lanka Ltd Healthcare lanka Ltd Pharmacy (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP INJECTION AQUE GEL Sunshine N/A INJECTION Ceyoka (Pvt) Ltd Ciron Drugs & AQUEOUS GEL MsDERIVA GELAPLENE-C GELSOLADENO Sunshine N/A INJECTION Harcourts (Pvt) Ltd The Esses Parmax Labo. N/A INJECTION Akbar INJECTION International Yaden IN IML 0.1%w/w 0.1%w/w+CLINDAMYCIN 1.0% W/W GEL ML 1 IN 1000 (IMG INJECTION BP 1ML) (1,1000) 132 1MG ADRENALINE INJECTION BP 122 0.1% GEL ADAPALENE 123 0.1% GEL ADAPALENE ACNEPALE124 0.1% GEL ADAPALENE GEL ADAFERIN GEL125 GEL 0.1% BP GEL ADAPALENE DERIVA PharmAce (Pvt) Ltd126 Aurochem MICROSPHERES GEL ADAPALENE ADCEPT Sunshine 127 MICROSPHERES ADAPALENE GEL128 3MG/ ADENOSINE INJECTION USP Softcare 129 ADRENALINE (EPINEPHRINE) 130 0.1MG ADRENALINE INJECTION BP 131 1,1000 ADRENALINE INJECTION BP N/A SOLUTION FOR 121 0.1% GEL ADAPALENE ADAPCO GEL GEL Morison PLC ATCO I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 27 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 06-Oct-17 Full 06-Oct-17 Full INDIAINDIA 26-Apr-18INDIA Years Two 09-Nov-17INDIA Years Two 09-Nov-17THAILAND Years Two 18-Oct-17 26-Nov-14UNITED Full STATES Full UNITED STATES INDIAINDIA 27-Oct-17INDIA Full 14-Oct-15 Full BANGLADESH 09-Oct-17 21-Dec-17 Years Two Years Two INDIAMALAYSIA 12-Feb-14 16-Sep-15 Full PAKISTAN Full 05-Apr-17 Years Two Sciences (Pvt) Ltd Glaxo Smithkiline Pakistan Ltd Verve Human Verve Care Laboratories Human Verve Care Laboratories Pharmafabrikon Unit Atlantic Laboratories Corporation Ltd Meridian Medical In Technologies Colombia Meridian Medical In Technologies Colombia Laboratories XL (Pvt) Ltd Synmedic Laboratories (Pvt) Ltd Ankur Drugs & Pharma (Pvt) Ltd Pharmaceuticals Industry Ltd J Duncan Healthcare (Pvt) Ltd Upha (Contd.) Pharmaceuticlas (Pvt) Ltd Agency Pvt Ltd Agency Pvt Ltd (Pvt) Ltd (Pvt) Ltd Emerchemie NB (Ceylon) Ltd Emerchemie NB (Ceylon) Ltd Ltd Pharmaceuticals (Pvt) Ltd International (Pvt) Ltd Slim Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd INJECTION INJECTION SUSPENSION TABLETS Lifeline SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP N/A INJECTIONAssociates Pharma Steril Gene Life ADEVERADEVER INJECTIONN/A Leader Pharma INJECTIONN/A Leader Pharma INJECTIONEPIPEN Jr Novachem Lanka INJECTION SOLUTION FOR EPI PEN International Yaden ENDANIL SOLUTION FOR 400OLWORM TABLETS TABLETSALZEN 400 SMM Halcyon (Pvt) Lifeline TABLETS 400ESTAZOLE TABLETS Softcare LOKABEN Medinex (Pvt) Ltd The IBN SINA ORAL WORMS IN IML IN IML IN IML IN IML IN IML INJECTION 0.15MG/0.3ML AUTO INJECTION 0.15MG/0.3ML AUTO 400MG TABLETS 400MG TABLETS 400MG TABLETS 400MG USP TABLETS 200MG/5ML SUSPENSION USP 133 1MG ADRENALINE INJECTION BP 134 1MG ADRENALINE INJECTION BP 135 1MG ADRENALINE INJECTION BP 136 1MG ADRENALINE INJECTION BP 137 1MG ADRENALINE INJECTION BP 138 ADRENALINE INJECTION SYRINGE 139 ADRENALINE INJECTION SYRINGE 140 ALBENDAZOLE CHEWABLE 141 ALBENDAZOLE CHEWABLE 142 ALBENDAZOLE CHEWABLE 143 ALBENDAZOLE CHEWABLE 144 ALBENDAZOLE ORAL 145 200MG ALBENDAZOLE TABLETS CHAMPS-D 146 200MG ALBENDAZOLE TABLETS ZENTEL TABLETS GlaxoSmithkiline 28 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIABANGLADESH 11-Oct-14 12-Apr-14 Full INDIA Full INDIA 11-Oct-14 Full 18-Jul-16INDIA Full 15-Jul-14INDIA Full INDIA 08-Mar-15INDIA Full 06-Nov-16INDIA Full 28-Jan-15INDIA Full 07-Jun-14 Full 09-Aug-15 Full Globe Pharmaceuticals Ltd Oasis Laboratories (Pvt) Ltd Cadila pharmaceuticals Ltd Oasis Laboratories (Pvt) Ltd Pharmaceuticals Ltd Biolab Co Ltd THAILAND Medopharm (PVT Ltd 13-Oct-16Gepach Full International J Duncan Healthcare (Pvt) Ltd Indoco Remedies India Umedica Laboratories (Pvt) Ltd Cipla Ltd INDIA 27-Nov-17Years Two Zee Laboratories INDIA 02-Nov-17 Full (Contd.) (Pvt) Ltd Imports (Pvt ) Ltd N/AHealthcare lanka Ltd Astron (Pvt) Ltd SRI LANKA 16-Aug-16 Full ltd Health (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Ltd Pharmaceuticals (Pvt) Ltd Ltd Pharmaceuticals Pvt Ltd (Pvt) Ltd Services Pvt. Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP TABLETS DAZOLEALBEZOLE TABLETS TABLETSALKEN 400 George Steuart Akbar LOKABEN TABLETS Alaris Lanka (Pvt) TABLETSABZUBENDAZOLE Slim TABLETS TABLETS NABPACLITAX Gamma INJECTION Emar Pharma (Pvt) Breathe Free Lanka 200MG 400MG 400MG 400MG 400MG 400MG INJECTION 100MG PACLITAXEL 149 400MGTABLETS ALBENDAZOLE Al-DS150 400MGTABLETS ALBENDAZOLE OSIBEN151 TABLETS 400MG ALBENDAZOLE TABLETS ENDWORM TABLETS Healthcare Tabrane 152 400MG IP TABLETS ALBENDAZOLE ALBEN TABLETS Union Lanka 153 400MG IP TABLETS ALBENDAZOLE ANTHELAssociates Pharma Bafna CHEWABLE 154 USP ALBENDAZOLE TABLETS TABLETS155 USP ALBENDAZOLE TABLETS Sunshine 156 USP ALBENDAZOLE TABLETS 157 USP ALBENDAZOLE TABLETS 158 USP ALBENDAZOLE TABLETS 159 USP ALBENDAZOLE TABLETS 160 ALBUMIN BOUND NANOPARTICLE 148 400MGTABLETS ALBENDAZOLE OSIBEN TABLETS RS Biogenics (Pvt) 147 400MGTABLETS ALBENDAZOLE 400 ALZEL TABLETS ABC Pharma I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 29 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 SWITZERLAND 19-Oct-18 Provisional SRI LANKA 15-May-18SRI LANKA Provisional 15-May-18 Provisional PAKISTAN 09-May-18PAKISTAN Years Two INDIA 31-Jul-15 Full PAKISTAN 10-Aug-14 21-Sep-15 Full Full INDIAPAKISTAN 03-Apr-14INDIA 10-Sep-18 Full Years Two DENMARK 27-Oct-15 12-Jun-14 Full Full (Pvt) Ltd (Pvt) Ltd Sun Pharmaceutical industries Laboratories LEO France for Leo S.A Pharmaceutical ProductsLeo A/S DENMARK CSL Behring CSL GmbH Cipla LtdLaboratories (Pvt) INDIALtd S J & G Fazul Ellahie (Pvt) Ltd 07-Sep-14Cadila Healthcare Ltd Full Medisure Laboratories Pakistan (Pvt) Ltd Cipla Ltd INDIALtd 18-Jun-14Zim Laboratories Ltd Full Cipla Ltd INDIA 27-Nov-17Years Two (Contd.) N/AN/A Suraksa Pharma Suraksa Pharma Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd ABC Pharma Services Pvt. Ltd (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd SOLOTION SOLOTION INFUSION SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP ALBURX 20% SOLUTION OSTEOFOS OWBONATE TABLETS TABLETS Breathe Free Lanka 70DRATE PharmAce (Pvt) Ltd Wilshire ALDREN 70 TABLETS TABLETS Pharma Tropical BONAFIDE Hemas TABLETSOSTEOFOS Slim TABLETS Citihealth Imports OSTEOMAX 70 TABLETS Tabrane PACLITAX NABPACLITAX INJECTION Breathe Free Lanka TABLETS 70MG USP 70MG USP 70MG USP 70MG USP 70MG USP 70MG INJECTION 20% PACLITAXEL INJECTION 100MG PACLITAXEL 163 BASED HAND RUB ALCOHOL 164 BASED HAND RUB ALCOHOL N/A165 SODIUM 35MG ALENDRONATE N/A166 TABLETS SODIUM ALENDRONATE TOPICAL 167 TOPICAL TABLETS SODIUM ALENDRONATE 168 TABLETS SODIUM ALENDRONATE 169 TABLETS SODIUM ALENDRONATE 170 TABLETS SODIUM ALENDRONATE 171 70MGTABLETS ALENDRONATE 70MG RALENOST TABLETS172 70MGTABLETS ACID ALENDRONIC BONGARD 70MG TABLETS Hemas 173 USP TABLETS ACID ALENDRONIC CIC Holdings PLC PharmEvo (Pvt) 174 0.25MCG ALFACALCIDOL ALPHA ONE CAPSULES Hemas 162 ALBUMIN HUMAN SOLUTION FOR 161 ALBUMIN BOUND NANOPARTICLE 30 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 DENMARK 02-Dec-14 Full INDIAINDIA 15-Aug-15 Full PAKISTAN 12-Feb-18 Years Two 30-Jan-18INDIA Full 11-Sep-14INDIA Full INDIA 05-Mar-14 Full 12-Aug-14MALAYSIA Full 12-Nov-14 Full Laboratories LEO France for Leo S.A Pharmaceutical ProductsLeo A/S DENMARK Panacea Biotec (Pvt) Ltd Kausikh Therapeutics (Pvt) Ltd Inga Laboraories (Pvt) Ltd Hiral Labs Ltd INDIASDN BHD 02-May-18 Provisional LEO Pharma A SA LEO Pharma DENMARK 18-Nov-17Olive Healthcare INDIA Full Cipla Ltd 09-Dec-15 INDIA Full 25-Jun-14 Full Renown Pharmaceuticals Pvt Ltd Laboratories (Pvt) Ltd Sai Mirra Innopharm (Pvt) Ltd (Contd.) Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pvt Ltd Co Ltd Ltd Hemas Pharmaceuticals (Pvt) Ltd Slim Pharmaceuticals (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd Healthcare lanka Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP CAPSULES CAPSULES ONE ALPHA SOFT GELETIN CALCICURE GELETIN SOFT 0.25mcgALFACIP CAPSULES Citihealth Imports TOPBONE CAPSULES International Yaden MEGACID SUSPENSION Sunshine 0.25MCG 0.25MCG 0.25MCG HYDR.250MG,DRIED ALUMINIUM TRIS HYDR.250MG, MAGNISIUM 250MG,DIMETHICONE 125MG/15ML SUSPENSION GELATIN CAP GELATIN 186 100MG BP TABLETS ALLOPURINOL N/A TABLETS Indoscan (Pvt) Ltd Industries / S P Y 176 CAPSULES ALFACALCIDOL 177 CAPSULES ALFACALCIDOL 178 CAPSULES 0.5MCG ALFACALCIDOL ALPHA ONE CAPSULES179 Hemas CAPSULES 1.0MCG ALFACALCIDOL ALPHADOL180 CAPSULES CAPSULES BP ALFACALCIDOL Hemas 181 1MCGTABLETS ALFACALCIDOL XBONE 1MCG182 ALGINIC ACID 200MG,MAGNESIUM TABLETS PharmAce (Pvt) Ltd Wilshire 183 100MG BP TABLETS ALLOPURINOL ALLONOL184 100MG BP TABLETS ALLOPURINOL TABLETS LOGOUT185 100MG BP TABLETS ALLOPURINOL HILRIC Jayanetti & Sons P TABLETS Trading Swedish TABLETS MAPS Pharma (Pvt) 175 1MCG SOFT ALFACALCIDOL I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 31 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 BANGLADESH 02-Apr-15INDIA Full CYPRUS 14-Oct-16 26-Jul-14 Full BANGLADESH 17-Oct-14 Full IRAN Full 16-Jul-15INDIA Full INDIA 14-Jun-17INDIA Full 04-Jan-15INDIA Full 11-Feb-15 Full INDIA 14-Jun-17 Full ARGENTINA 14-Feb-18 11-Oct-18INDIA Provisional Full 18-Apr-17 Full Delobris Pharmaceuticals 01.06.18 Ltd-AT Yaden-LO42/17 Incepta Pharmaceuticals Ltd Aburaihan Pharmaceuticals Company Akums Drugs & Pharmaceuticals Ltd Pharmaceuticals Ltd MMC Healthcare Ltd Orchid Healthcare INDIAAkums Drugs & Pharmaceuticals Ltd 14-Jul-18Pharmaceuticals Full Centaur Pharmaceutical (Pvt) Ltd Akums Drugs & Pharmaceuticals Ltd Sun Pharmaceutical industries Laboratories Bago S A (Contd.) (Pvt) Ltd (Pvt) Ltd Corporation (Pvt) Ltd Plc Lanka (Pvt) Ltd (Pvt) Ltd Plc Health (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Ceylon) Ltd (Ceylon) Ltd TABLETS Emerchemie NB SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP NEUROGEN TABLETS Prime Pharma MANOREST 0.25B-REST TABLETS TABLETS Euro Asian Pharma 0.25ALPAZ Browns & Company 0.25ATREST TABLETS TABLETSAssociates Pharma 0.25B-REST The Madras George Steuart TABLETSALZOLAM Lotus TABLETS0.5 Emerchemie NB WITH MULTIVITAMIN CASULES WITH MULTIVITAMIN 0.25MG 0.25MG 0.25MG 0.25MG 0.25MG 0.25MG 187 5MGTABLETS ALLYLESTRENOL 5 GESTON TABLETS PharmAce (Pvt) Ltd Square 188ACID,COBALAMIN LIPOIC ALPHA 189 0.5MGTABLETS ALPRAZOLAM ZOLARAM 0.5190 TABLETS 0.5MGTABLETS ALPRAZOLAM ZOLIUM 0.5 Access International 191 0.5MGTABLETS ALPRAZOLAM TABLETS SEDALAM192 USP ALPRAZOLAM TABLETS Citihealth Imports TABLETS193 USP ALPRAZOLAM TABLETS Glenford 194 USP ALPRAZOLAM TABLETS 195 USP ALPRAZOLAM TABLETS 196 USP ALPRAZOLAM TABLETS 197 USP ALPRAZOLAM TABLETS 198 0.5MG USP TABLETS ALPRAZOLAM TRANQUINALS 199 0.5MG USP TABLETS ALPRAZOLAM 0.5 B-REST TABLETS Browns & Company 32 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 16-Nov-18INDIA Years Two 07-Jul-14GERMANY Full 13-Jun-17 15-Dec-15 Years Two INDIA Full 28-May-15SRI LANKA Full 16-Jul-18SRI LANKA Provisional 06-Jun-18INDIAYears Two INDIA 28-May-15 Full 25-May-15 Full INDIAINDIA 14-Feb-18 Full INDIA 20-Jun-16 Full 18-Apr-17 Full (Pvt) Ltd SG Pharma (Pvt) Ltd Sciences (Pvt) Ltd Boehringer Ingelheim Pharma gmBH & Co.Kg Laboratories (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Ltd -Sri Lanka Laboratories (Pvt) Ltd Wallace Pharmaceuticals Ltd Sun Pharmaceutical industries Centaur Pharmaceutical (Pvt) Ltd Akums Drugs & Pharmaceuticals Ltd Orchid Healthcare INDIA 21-Jul-17 Full (Contd.) Pharmacy (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Ceyoka (Pvt) Ltd Leben N/AN/A Gamma Ceyoka (Pvt) Ltd Leben Interpharm (Pvt) Ltd (Ceylon) Ltd Health (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP SUSPENSION SUSPENSION SUSPENSION SUSPENSION BIOGIANDIN INJECTIONN/A Klintas (Pvt) LtdALPOSTIN United Biotech ACTILYSE INJECTION INJECTION The Esses Pharma Associates INJECTION Samarth Life DSANTAGIT Hemas ORAL GASTRICAINE ORAL GASTRIL-MINT ORAL DSANTAGIT ORAL FORTEDIOVOL SUSPENSION Emar Pharma (Pvt) 0.5MG/ML 0.5MG/ML HUMAN TISSUE TYPE PLASMINOGEN ACTIVATOR INJECTION 20MG SUSPENSION SIMETHICONE ORAL ALUM. CONTAINS,Dried (EACH 5ML 400MG,SIMETHICONE SUP HYD BP 500MG) DOUBLE STRENGTH SUSPENSION SIMETHICONE ORAL WITH OXETACAINE SUSPENSION SIMETHICONE ORAL SUSPENSION SIMETHICONE ORAL 250MG & SIMETHICONE 40MG SUSPENSION USP ORAL 500MCG 211 ALUMINIUM +MAGNESIUM & 205 INJECTION USP ALPROSTADIL 206 INJECTION USP ALPROSTADIL 207 (RECOMBINANT ALTEPLASE 208 & , MAGNESIA ALUMINA 209 & , MAGNESIA ALUMINA 210 ALUMINIUM +MAGNESIUM & 212 ALUMINIUM 300MG+MAGNESIUM 204 INJECTION IP ALPROSTADIL 201 0.5MG USP TABLETS ALPRAZOLAM 0.5 ATREST 202 TABLETS 0.5MG USP TABLETS ALPRAZOLAM 0.5 B-REST George Steuart 203 TABLETS 0.5MG USP TABLETS ALPRAZOLAM MANOREST Lotus TABLETSAsian Pharma Euro 200 0.5MG USP TABLETS ALPRAZOLAM ALZOLAM TABLETS Emerchemie NB I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 33 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIA 12-Feb-14 Full INDIA 14-Feb-17INDIA Full 01-Mar-15 Full INDIAINDIA 07-Mar-18 Years Two INDIA 07-Mar-18 Years Two 04-May-18 Years Two INDIAINDIA 22-Mar-18 Years Two 26-Jun-15 Full Ltd Biolab Co Ltd THAILANDGeno 06-Jul-18Pharmaceuticals Years Two Pvt Ltd Pharmaceuticals Ltd Abbott India Ltd INDIAMc W Healthcare (P) Ltd 31-Oct-15Mc W Healthcare Full (P) Ltd Pharmaceuticals Pvt Ltd Biolab Co Ltd THAILAND 06-Apr-18Pvt Ltd Full Stallion Laboratories Pvt Ltd (Contd.) Harcourts (Pvt) Ltd Parmax Labo. George Steuart Health (Pvt) Ltd Mansel (Ceylon) (Pvt) Ltd Healthcare lanka Ltd Salveo Pharma (Pvt) Ltd Salveo Pharma (Pvt) Ltd George Steuart Health (Pvt) Ltd (Pvt) Ltd ORAL ORAL SUSPENSION SUSPENSION SUSPENSION SUSPENSION SUSPENSION TABLETS SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP ANACID FORTE ANACID FORTE GEL BELEID XTRA ORAL GELPEPTICA ORAL N/ADIGENE TABLETS Pharma Associates TABLETSCOOLGEL Bafna Sunshine ORAL COOLGEL ORAL ENICID SYRUP SUSPENSION PharmAce (Pvt) Ltd Enicar BELCID CHEWABLE 100COMANTREL CAPSULESELTUSS-A PharmAce (Pvt) Ltd Consern Pharma SYRUP Siba Healthcare HYD 150MG & SIMETHICONE BP HYD 150MG & SIMETHICONE BP 5MG/5ML BP 125MG+OXETACAINE HYD.306MG+MAGNESIUM HYD. 30MG USP 110MG+SIMETHICONE SUSPENSION ORAL +MANGESIUM HYDROXIDE ORAL +SIMETHICONE USP SUSPENSION BP TRISILICATE + MAGNESIUM COMPOUND 250MG CHEWABLE TABLETS 300MG+MANGESIUM SILICATE HYDR 50MG+SIMETHICONE 25MG (ORANGE) 50 AND SIMETHICONE BP 250MG SUSPENSION USP ORAL 250MG & +MAGNESIUM HYD. BP 50MG/5ML SIMETHICONE BP +MAGNESIUM HYDROXIDE + SIMETHICONE SUSPENSION 153MG+MAGNESIUM HYDROXIDE 200MG & SIMETHICONE USP USP 20MG 100MG SULPH 1.5MG 15MG+TURBUTALINE SYRUP +GUAPHENESIN 50MG/5ML 213 ALUMINIUM HYD 300+MAGNESIUM 214 ALUMINIUM 215 ALUMINIUM HYDROXIDE 216 120MG ALUMINIUM HYDROXIDE BP 217 ALUMINIUM HYDROXIDE DRIED 218 ALUMINUM 250MG,MAGNESIA 219 250MG ALUMINUM HDR. BP 220 ALUMINUM HYDROXIDE Dried 221 ALUMINUM HYDROXIDE USP 222 CAPSULES BP AMANTADINE 223 HCL AMBROXOL 34 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIA 05-Feb-15INDIA Full INDIA 15-Feb-17BANGLADESH Full 09-Jul-14 20-Sep-18 Years Two INDIA Full BANGLADESH 05-Jun-17 09-Jul-14 Years Two Full INDIAINDIA 11-Sep-14INDIA Full 28-Dec-18 Years Two INDIA 26-Jun-15 Full INDIA 30-Jul-15INDIA Full 19-Jun-16PAKISTAN Full 19-Jun-17 05-Apr-17 Full Full Specialities (Pvt) Ltd Lincolin Pharmaceuticals Pvt Ltd Eskayef Bangladesh Ltd Universal Pharmaceuticals Ltd Eskayef Bangaladesh Ltd Cipla Ltd Healthcare Vital (Pvt) Ltd INDIAMercury Laboratories Ltd Protech 31-Jul-15Biosystems (Pvt) Ltd Full Pharmaceutical Pvt Ltd Scott Edil Pharmacia Ltd Healthcare Vital (Pvt) Ltd OBS Pakistan (Pvt) Ltd (Contd.) Imports (Pvt) Ltd Healthcare lanka Ltd Ltd Healthcare lanka Ltd (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd Ltd (Pvt) Ltd (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP NORVENT SYRUPDAWACOF Pharma Associates SYRUP Indchemie Health AMBROLITE SYRUPAMBOTEN & J Pharma T SYRUP CIC Holdings PLCMUCOROL Heathcare TILL SYRUP Sunshine AMBOTEN Alaris Lanka (Pvt) SYRUPAMBROCARE SYRUPN/A Sunshine N/A Breathe Free Lanka AMPRO 100 INJECTION International Yaden INJECTION INJECTIONAMIBAC 250 Access International International Yaden INJECTIONN/A PharmAce (Pvt) Ltd Kavbir N/AMODURETIC INJECTION TABLETS C Medical (Pvt) T P INJECTION Mansel (Ceylon) International Yaden 15MG & SALBUTAMOL SULPHATE SULPHATE 15MG & SALBUTAMOL 5ML 1MG SYRUP 30MG/5ML SYRUP 15MG/5ML SYRUP 30MG/5ML SYRUP 15MG/5ML SYRUP 15MG/5ML SYRUP 250MG/2ML BP 500MG/2ML BP 100MG/2ML USP 250MG/2ML USP 500MG/2ML USP 500MG/2ML USP 5MG+HYDROCHLOROTHIAZIDE 50MG USP 15MG+TURBUTALINE SULPH BP SULPH BP 15MG+TURBUTALINE 1.25MG +GUAPHENESIN 50MG/5ML SYRUP 225 HYDROCHLORIDE AMBROXOL 226 HYDROCHLORIDE BP AMBROXOL 227 HYDROCHLORIDE AMBROXOL 228 HYDROHLORIDE BP AMBROXOL 229 HYDROHLORIDE AMBROXOL 230 HYDROHLORIDE AMBROXOL 231 INJECTION AMIKACIN SULPHATE 232 INJECTION AMIKACIN SULPHATE 233 INJECTION AMIKACIN SULPHATE 234 INJECTION AMIKACIN SULPHATE 235 INJECTION AMIKACIN SULPHATE 236 INJECTION AMIKACIN SULPHATE 237 AMILORIDE HYDROCHLORIDE USP 224 BP HCL AMBROXOL I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 35 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 18-Oct-18 Years Two INDIA 23-Sep-16 Full AUSTRIA 24-Feb-15 Full 31-Jul-17AUSTRALIA Years Two 21-Jan-14AUSTRIA Full 27-Jul-15PAKISTAN Full 24-Feb-16PAKISTAN Full 27-Feb-15INDIA Full INDIA 26-Apr-15PORTUGAL Full 10-Apr-16 20-Jan-14INDIA Full Full 11-Feb-14 Full Aculife Healthcare (Pvt) Ltd Aculife Healthcare (Pvt) Ltd Otsuka Pharmaceuticals (Pvt) Ltd Fresenius Kabi Austria Gmbh Austria Fresenius kabi Ab Sweden Fresenius Kabi Austria Gmbh Austria Fresenius kabi Ab Sweden Fresenius Kabi A.B Pharmaceuticals & Chemical Works Brookes Pharma (Pvt) Ltd Healthcare Vital (Pvt) Ltd SG Pharma (Pvt) Ltd Hikma pharmaceuticals SG Pharma (Pvt) Ltd (Contd.) Healthcare lanka Ltd Healthcare lanka Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Pharmacy (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmacy (Pvt) Ltd INJECTION Akbar SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP NIRMIN 5 INJECTION Sunshine NIRMIN PLUS INJECTION Sunshine NEPHRO AMINOVEN 10% INJECTION Hemas NEPHROSTERIL INJECTION Markss HLC (Pvt) VAMINOLACT INJECTIONAMINOLLIN Hemas SYRUP SYRUPEXALYN SYRUP Ceyoka (Pvt) Ltd ISIS VITAPHYLLINE Hemas INJECTIONN/A International Yaden N/A INJECTIONCORDASOL The Esses INJECTION INJECTION Akbar The Esses 5% W/V INJECTION W/V 10% 70g/L NUTRITION 65.3G/L INTRAVENOUS 32MG+DIPHENYDRAMINE 8MG+AMMONIUM CHLORID 30MG, 0.98MG/5ML MENTHOL 32+DIPHEHYDRAMINE 8MG+AMMONIUM CHLORIDE 30MG/5ML 25MG/ML 25MG/ML SOLUTION FOR INJECTION STERILE INJECTION 50MG/ML 238 AND SORBITIOL ACID 5% AMINO 239 10% ACID ELECTROLYTES AMINO 240ACID INJECTION 7% W/V AMINO CELEMIN 241ACID SOLUTION FOR INJ AMINO 242ACID SOLUTION FOR INJ AMINO 243ACID SOLUTION FOR AMINO 244 AMINOPHYLLIN 245 AMINOPHYLLIN PHEUR. 246 AMINOPHYLLINE INJECTION BP 247 AMINOPHYLLINE INJECTION BP 248 AMIODARONE 150MG/3ML 249 AMIODARONE CONCENTRAT 36 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 FRANCE 26-Jul-17 Years Two FRANCE 26-Jul-17 Years Two INDIA 25-Apr-18 Years Two INDIA 20-Jan-16INDIA Full 25-Sep-14 Full INDIA 22-Jan-15INDIA Full 04-Jun-16INDIA Full INDIA 27-Sep-17INDIA Full 16-Jul-17 Full 07-Feb-18 Full Winthrop Winthrop Synthelabo fi fi fi Industrie Industrie Cadila Healthcare Ltd Micro Labs Ltd INDIALtd 23-Feb-18 Provisional Cadila pharmaceuticals Ltd Medochemie Ltd CYPRUS 21-Oct-17 Full Cadila Healthcare Ltd Centurion Laboratories Pvt Ltd Micro Labs Ltd INDIA 24-Feb-17 Full Ltd Remedica limited CYPRUS Human Verve Care Laboratories 24-Nov-14Medochemie Ltd CYPRUS Full Sciences (Pvt) Ltd 21-Oct-17 Full (Contd.) Lanka Ltd Sano Lanka Ltd Sano Lanka Ltd Sano fi fi fi Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Healthcare lanka Ltd Celyon (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd Drugs (Pvt) Ltd Agency Pvt Ltd Celyon (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP TABLETS Associated Pharma TABLETS Kandana Food & CORDARONE INJECTION Sano CORDARONE INJECTION Sano CORDARONE TABLETS Sano 200 CARDILOR 200MG AMRONEN/A INJECTIONDURON Leader Pharma TABLETS INJECTION Associated Pharma Pharma Associates Samarth Life 150MG/3ML 150MG/3ML 200MG TABLETS BP 200MG BP TABLETS INJECTION 50MG/ML 200MG TABLETS 150MG/3ML BP CONCENRATE 250 INJECTION AMIODARONE HCL 251 INJECTION AMIODARONE HCL 252 IP TABLETS AMIODARONE HCL 264 100MGTABLETS AMIODORONE N/A TABLETS Chamee Chemist Bajaj Healthcare 261 200MG BP TABLETS AMIODARONE AMIODARONE 262 200MG BP TABLETS AMIODARONE ZYDARONE 200 TABLETS263 200MG BP TABLETS AMIODARONE AMIODAR-200 Hemas TABLETS Micro Mega Lanka 260 200MG BP TABLETS AMIODARONE ALDARONE TABLETS Sunshine 253 AMIODARONE HYDROCHLORIDE 254 AMIODARONE HYDROCHLORIDE 255 AMIODARONE HYDROCHLORIDE 256 AMIODARONE STERILE 257 100MG BP TABLETS AMIODARONE ZYDARONE 100 TABLETS258 100MG BP TABLETS AMIODARONE N/A Hemas 259 100MG BP TABLETS AMIODARONE AMIODAR-100 TABLETS TABLETS Micro Mega Lanka International Yaden I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 37 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 30-Jan-18 Full PAKISTAN 17-Aug-17 Years Two 28-Oct-15 Full INDIAINDIA 19-Aug-14 Full INDIA 08-Jan-18 Years Two INDIA 17-Apr-18 Years Two INDIA 20-Jan-15 Full 15-Jan-14INDIA Full INDIA 10-Jan-18 Years Two 11-May-16INDIA Full 10-Jan-18 Years Two Sun Pharmaceutical industries Sun Pharmaceutical industries OBS Pakistan (Pvt) Ltd Hiral Labs Ltd INDIALaboratories (Pvt) Ltd 22-Jun-18Laboratories (Pvt) Years Two Ltd Macleods Pharmaceuticals Ltd Cadila Healthcare Ltd Unique Pharmaceutical Labs Cipla LtdDr Reddy's Laboratories Ltd INDIAUnimax Laboratories 05-Oct-16Hovid SDN Bhd MALAYSIA Full Dr Reddy's Laboratories Ltd 24-Mar-14 Full (Contd.) (Ceylon) Ltd (Ceylon) Ltd (Pvt) Ltd Ltd (Pvt) Ltd Healthcare lanka Ltd Health (Pvt) Ltd (Pvt) Ltd (Ceylon) Ltd Pharmaceuticals (Pvt) Ltd Lanka (Pvt) Ltd (Ceylon) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP TRYPTANOL TABLETSAMITHIR 10 Mansel (Ceylon) TABLETS MAPS Pharma (Pvt) AMLOVAS TABLETSAMLODAC 10 TABLETS Pettah Pharmacy 10AMCARDA Sunshine TABLETSAMLOPRES-10 George Steuart TABLETSSTAMLO-10 Breathe Free Lanka AMLOKIND 5 TABLETS TABLETS Emerchemie NB HOVASC Hemas STAMLO-5 TABLETS TABLETS Hadley Bevan Emerchemie NB TABLETS 25MG TABLETS 10MG USP 10MG 10MG 10MG 10MG 10MG 5MG 5MG 5MG 265 200MGTABLETS AMISULPRIDE 200 SULPITAC TABLETS Emerchemie NB 266 300MGTABLETS AMISULPRIDE 300 SULPITAC 267 AMITRIPTYLINE HYDROCHLORIDE TABLETS268 AMITRIPTYLINE HYDROCHLORIDE Emerchemie NB 269 10MG BP TABLETS AMITRIPTYLINE AMILEB 10270 25MG BP TABLETS AMITRIPTYLINE TABLETS AMILEB 25271 Ceyoka (Pvt) Ltd TABLETS AMLODIPINE BESYLATE TABLETS Leben 272 Ceyoka (Pvt) Ltd TABLETS AMLODIPINE BESYLATE Leben 273 TABLETS AMLODIPINE BESYLATE 274 TABLETS AMLODIPINE BESYLATE 275 TABLETS AMLODIPINE BESYLATE 276 TABLETS AMLODIPINE BESYLATE 277 TABLETS AMLODIPINE BESYLATE 278 TABLETS AMLODIPINE BESYLATE 38 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIABANGLADESH 31-May-17 15-Mar-16INDIA Full Full INDIA 01-Dec-14 Full INDIA 01-Dec-16 Full INDIA 08-Apr-14INDIA Full 20-Dec-17 Years Two INDIA 05-Sep-14 Full INDIA 04-May-17 Full INDIA 15-Dec-17 Full INDIA 26-Sep-16INDIA Full 04-Jan-18INDIA Full 02-Jul-18 Years Two 14-Jun-17 Full Cipla LtdAkums Drugs & Pharmaceuticals INDIALtd The ACME Laboratories Ltd 05-Oct-16Aristo Pharmaceuticals Full Ltd Aristo Pharmaceuticals Ltd G D Laboratories (India) Pvt Ltd Laboratories XL (Pvt) Ltd Akums Drugs & Pharmaceuticals Ltd Synmedic Laboratories (Pvt) Ltd Sai Mirra Innopharm (Pvt) Ltd J Duncan Healthcare (Pvt) Ltd Alkem Laboratories Ltd Mercury Laboratories Ltd Akums Drugs & Pharmaceuticals Ltd (Contd.) (Pvt) Ltd Plc Ltd Co Ltd Co Ltd Pharmaceuticals (Pvt) Ltd Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Healthcare lanka Ltd Pharmaceuticals (Pvt) Ltd (Ceylon) Ltd (Pvt) Ltd Plc SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP AMLOPRES 5 TABLETS 10AMLOWEL TABLETS Breathe Free Lanka AMLORI 10 Browns & Company AMLODEP TABLETS Mega Pharma (Pvt) TABLETSAMLODEP Darley Butler & TABLETSANGIOPIN 10 TABLETS Darley Butler & 10EMLIP Lifeline VEXMLOD 10 TABLETS TABLETS 10VASCON SMM Halcyon (Pvt) Global Impex AV TABLETSAMLONORM 10 TABLETS Lifeline AMILOD Sunshine AMLOGEN TABLETSN/A TABLETS Slim 5AMLOWEL Emerchemie NB TABLETS TABLETS Browns & Company International Yaden USP 10MG USP 10MG USP 10MG USP 10MG USP 10MG USP 10MG USP 10MG USP 10MG USP 10MG USP 10MG USP 10MG USP 2.5MG USP 5MG USP 5MG 280 TABLETS AMLODIPINE BESYLATE 281 TABLETS AMLODIPINE BESYLATE 282 TABLETS AMLODIPINE BESYLATE 283 TABLETS AMLODIPINE BESYLATE 284 TABLETS AMLODIPINE BESYLATE 285 TABLETS AMLODIPINE BESYLATE 286 TABLETS AMLODIPINE BESYLATE 287 TABLETS AMLODIPINE BESYLATE 288 TABLETS AMLODIPINE BESYLATE 289 TABLETS AMLODIPINE BESYLATE 290 TABLETS AMLODIPINE BESYLATE 291 TABLETS AMLODIPINE BESYLATE 292 TABLETS AMLODIPINE BESYLATE 279 TABLETS AMLODIPINE BESYLATE I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 39 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 28-Oct-17 Years Two INDIA 24-Dec-14 Full INDIA 24-Aug-17 Full INDIA 11-Nov-15 Full INDIA 28-Mar-14 Full INDIA 08-Apr-14INDIA Full 20-Nov-15INDIA Full 20-Jun-17INDIA Full 26-Sep-16 Full INDIA 14-Jun-17 Full INDIA 28-Oct-17 Years Two GERMANY 16-Jun-16 21-Oct-14 Full Full Sun Pharmaceutical industries Denk Pharma GmbH & Co. Cadila Healthcare Ltd Unique Pharmaceutical Labs Akums Drugs & Pharmaceuticals Ltd Synmedic Laboratories (Pvt) Ltd G D Laboratories (India) Pvt Ltd Healthcare Ltd Scences J Duncan Healthcare (Pvt) Ltd Akums Drugs & Pharmaceuticals Ltd Sun Pharmaceutical industries Macleods Pharmaceuticals Ltd (Contd.) Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Healthcare lanka Ltd Health (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP AMLOSUN-5 TABLETS Hemas AMLODAC 5 TABLETS 5AMCARDIA Sunshine TABLETSVEXMLOD 5 George Steuart TABLETS 5VASCON Global Impex AV TABLETSANGIOPIN 5 Lifeline TABLETSBPCON 5 Lifeline AMLOSWIZ 5 TABLETS TABLETSAMILOD 5 Kamazu (Pvt) Ltd PharmAce (Pvt) Ltd Syncom Swiss Garnier Life TABLETS 5AMLOWEL TABLETS Slim AMLOSUN-5 Lotus TABLETSAMLOVAS Hemas TABLETS Pettah Pharmacy USP 5MG USP USP 5MG USP 5MG USP 5MG USP 5MG USP 5MG USP 5MG USP 5MG USP 5MG USP 5MG USP 5MG USP 5MG USP 293 TABLETS AMLODIPINE BESYLATE 294 TABLETS AMLODIPINE BESYLATE 295 TABLETS AMLODIPINE BESYLATE 296 TABLETS AMLODIPINE BESYLATE 297 TABLETS AMLODIPINE BESYLATE 298 TABLETS AMLODIPINE BESYLATE 299 TABLETS AMLODIPINE BESYLATE 300 TABLETS AMLODIPINE BESYLATE 301 TABLETS AMLODIPINE BESYLATE 302 TABLETS AMLODIPINE BESYLATE 303 TABLETS AMLODIPINE BESYLATE 304 TABLETS AMLODIPINE BESYLATE 305 10MGTABLETS AMLODIPINE AMLO-DENK 10 TABLETS Akbar 40 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 28-Oct-16 Full INDIAINDIA 03-Sep-15 Full 02-Mar-18 Years Two INDIA 21-Sep-15UNITED KINGDOM Full INDIA 29-Dec-16 Full BANGLADESH 12-Jun-16 Full GERMANY 13-Jul-15 Full INDIAINDIA 19-Apr-14 Full 06-Sep-16 Full (Pvt) Ltd Alkem Laboratories Ltd Sai Mirra Innopharm (Pvt) Ltd Smithkline Beecham Micro Labs Ltd INDIA 02-Dec-16 Full Ajantha Pharma Ltd Innova Captab INDIA 21-Jan-17 Full Beacon Pharmaceuticals Ltd IPCA LaboratoriesIPCA INDIA 23-Nov-17 Full Denk Pharma GmbH & Co. Ajantha Pharma Ltd Micro Labs Ltd INDIA 26-Mar-15 Full Pharmaceuticals Ltd (Contd.) CIC Lifesciences Ltd. Healthcare lanka Ltd Pharmaceuticlas (Pvt) Ltd (Pvt) Ltd Ltd Pharmaceuticals (Pvt) Ltd Co Ltd Ltd Pharmaceuticals (Pvt) Ltd Ltd (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP SUSPENSION CLAVOTECSYNERGIN TABLETS ORAL Klintas (Pvt) Ltd United Biotech BRONCOFREE SYRUPAUGMENTIN Sunshine INJECTION GlaxoSmithkiline CLAVULANATE TABLETS IP 625MG IP TABLETS CLAVULANATE POTASSIUM 125MG+CLAVULANATE 31.25MG/5ML +CLAVULANIC ACID 100MG +CLAVULANIC INJECTION 600MG 100MG+CHLORPHENIRAMINE 2MG+AMINOPHYLLINE 100MG 10ML SYRUP 311 5MG BP TABLETS AMLODIPINE N/A TABLETS Chamee Chemist Oboi Laboratories INDIA 22-May-14 Full 318 AMOXICILLIN & POTASSIUM 319 AMOXICILLIN 317 AMOXICILLIN SODIUM 500MG 316 AMMONIUM CHLORIDE 315 5MG USP TABLETS AMLODIPINE AMLONG TABLETS Micro Mega Lanka 314 5MG USP TABLETS AMLODIPINE 5 AMADAY TABLETS Baur & Co (Pvt) A 313 5MG USP TABLETS AMLODIPINE 5 AMLONOVA TABLETS Slim 312 5MG USP TABLETS AMLODIPINE AMLOWIDE TABLETS Delmege Forsyth & 310 5MGTABLETS AMLODIPINE CALCHEK 5 TABLETS Emar Pharma (Pvt) 309 5MGTABLETS AMLODIPINE AMLO-DENK 5 TABLETS Akbar 307 10MGTABLETS AMLODIPINE 308 10MGTABLETS AMLODIPINE 10 AMADAY AMLONG 10 TABLETS TABLETS Baur & Co (Pvt) A Micro Mega Lanka 306 10MGTABLETS AMLODIPINE 10 PRIMODIL TABLETS PharmAce (Pvt) Ltd Medley I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 41 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 30-Apr-18 Provisional INDIA 21-Jun-17 Years Two INDIA 17-Jun-14 Full INDIA 05-Feb-16INDIA Full 02-May-14INDIA Full 22-Mar-18 Years Two INDIA 23-Jun-17 Full INDIA 08-Apr-16 Full SRI LANKA 22-Mar-18 Years Two 05-Oct-17INDIA Full INDIA 01-Jan-14INDIA Full 22-Jun-16 Full 08-Apr-16 Full (Pvt) Ltd Sun Pharmaceutical industries Unichem Laboratories Alkem Laboratories Ltd (Pvt) Ltd Medico Remedies (Pvt) Ltd Adore Pharmaceuticals (Pvt) Ltd Adore Pharmaceuticals (Pvt) Ltd Medico Remedies (Pvt) Ltd Pharmaceuticals Manufacturer Corporation Cadila Healthcare Ltd Marksons Pharma Ltd Adore Pharmaceuticals (Pvt) Ltd (Contd.) Pharmaceuticals (Pvt) Ltd Ltd Ltd. Pharmaceuticals (Pvt) Ltd Ltd Ltd Pharmaceuticals (Pvt) Ltd Healthcare lanka Ltd Plc Ltd CAPSULES Alaris Lanka (Pvt) CAPSULES Alaris Lanka (Pvt) SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP AVAM 625AVAM TABLETSAssociates Pharma AMN Life Science ENHANCIN 625 TABLETS 625MYCLAV Hemas TABLETSSYNERGIN Baur & Co (Pvt) A TABLETSN/A CIC Lifesciences N/A CAPSULESZIFAM Chamee Chemist CAPSULES Sparah Biotech ZIFAM Akbar AMOXCILLIN CAPSULES Alaris Lanka (Pvt) N/AN/A CAPSULES Akbar MOXI CAPSULES N/AAMOXMARK 500 CAPSULES CAPSULES ZIFAM Browns & Company AMOXCILLIN Sunshine State 500MG+CLAVULANATE POTASSIUM POTASSIUM 500MG+CLAVULANATE 125MG 500MG+CLAVULANATE POTASSIUM POTASSIUM 500MG+CLAVULANATE 125MG POTASSIUM 500MG+CLAVULANATE 125MG POTASSIUM 500MG+CLAVULANATE 125MG 250MG 250MG 250MG 500MG 500MG 500MG 500MG 500MG 500MG 320 AMOXICILLIN 321 AMOXICILLIN 322 AMOXICILLIN 323 AMOXICILLIN 324 AMOXICILLIN CAPSULES B.P 325 AMOXICILLIN CAPSULES B.P 326 AMOXICILLIN CAPSULES B.P 327 AMOXICILLIN CAPSULES B.P 328 AMOXICILLIN CAPSULES B.P 329 AMOXICILLIN CAPSULES B.P 330 AMOXICILLIN CAPSULES B.P 331 AMOXICILLIN CAPSULES B.P 332 AMOXICILLIN CAPSULES B.P 42 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 14-May-15INDIA Full 07-Nov-15 Full 19-Feb-15INDIA Full INDIA 21-Mar-15 Full INDIA 18-Jun-18 Full INDIA 26-Sep-16 Full INDIA 21-Mar-15 Full INDIA 31-Dec-16 Full 12-Sep-15 Full INDIA 31-Dec-16 Full Kopran LtdLincolin INDIAPharmaceuticals Sun Pharmaceutical industries 15-Aug-15 Medopharm (PVT Full Ltd Sterling LabTheon INDIAPharmaceuticals Ltd Ankur Drugs & 30-Mar-17Pharma (Pvt) Ltd Full Health Care IVA (Pvt) Ltd Theon Pharmaceuticals Ltd Ankur Drugs & Pharma (Pvt) Ltd Health Care IVA (Pvt) Ltd Uni Medicolabs INDIASun Pharmaceutical industries 26-Mar-18Years Two (Contd.) (Pvt) Ltd Imports (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Co Ltd Pharmaceuticals (Pvt) Ltd International (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd International (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Slim Pharmaceuticals (Pvt) Ltd Hemas Pharmaceuticals (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP SUSPENSION SUSPENSION AMYN 500MOXILINK 500 CAPSULES CAPSULES 500RANOXYLL Mansel (Ceylon) & J Pharma T CAPSULESMEDOMOX-500 Hemas CAPSULES 500MOXOL Akbar THEOMOX CAPSULES Darley Butler & CAPSULES 250AMOXILET CAPSULES Slim 250IVAMOX Softcare CAPSULESTHEOMOX 500 Slim CAPSULES 500AMOXILET Slim CAPSULES 500IVAMOX Softcare CAPSULESUMOXIL-DE Slim ORAL RANOXYL ORAL 500MG 500MG 500MG 500MG 250MG 250MG 250MG 500MG 500MG 500MG 125MG/5ML SUSPENSION USP 125MG/5ML SUSPENSION USP 500MG 334 AMOXICILLIN CAPSULES B.P 335 AMOXICILLIN CAPSULES B.P 336 AMOXICILLIN CAPSULES B.P 337 AMOXICILLIN CAPSULES B.P 338 AMOXICILLIN CAPSULES USP 339 AMOXICILLIN CAPSULES USP 340 AMOXICILLIN CAPSULES USP 341 AMOXICILLIN CAPSULES USP 342 AMOXICILLIN CAPSULES USP 343 AMOXICILLIN CAPSULES USP 344 AMOXICILLIN FOR ORAL 345 AMOXICILLIN FOR ORAL 333 AMOXICILLIN CAPSULES B.P I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 43 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIABANGLADESH 08-Mar-17 31-Jul-15 Years Two INDIA Full 06-Jun-15 Full INDIAINDIA 01-Oct-17BANGLADESH 07-Jul-16 Full 01-Oct-17INDIA Full Full INDIA 09-Aug-18 Years Two INDIA 12-May-18 Full INDIA 24-Jan-18 Years Two BANGLADESH 27-Jan-15 04-Jul-16 Full INDIA Full 20-May-14 Full Medopharm (PVT Medopharm (PVT Ltd Pharmaceuticals Ltd Ankur Drugs & Pharma (Pvt) Ltd Uni Medicolabs INDIASwiss Pharma (Pvt) Ltd 14-Sep-17Swiss Pharma Years Two (Pvt) Ltd Pharmaceuticals Ltd Specialities (Pvt) Ltd Sun Pharmaceutical industries Ankur Drugs & Pharma (Pvt) Ltd Health Care IVA (Pvt) Ltd Pharmaceuticals Ltd Alkem Laboratories Ltd (Contd.) Akbar Pharmaceuticals (Pvt) Ltd PharmAce (Pvt) Ltd Square International (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd Pharma Associates Indchemie Health Hemas Pharmaceuticals (Pvt) Ltd Softcare International (Pvt) Ltd Slim Pharmaceuticals (Pvt) Ltd PharmAce (Pvt) Ltd Square Emerchemie NB (Ceylon) Ltd SUSPENSION SUSPENSION SUSPENSION FOR ORAL SUSPENSION FOR ORAL SUSPENSION POWDER FOR ORAL SUSPENSION SUSPENSION SUSPENSION SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP MEDOMOX-125 ORAL MOXACIL BAURCLAV ORAL TABLETSUMOXICLAV Softcare TABLETS 625MGCLAXY Slim TABLETS 625MGCLAXY TABLETS Pharma Avenier AMCLAV Pharma Avenier 156INDCLAV TABLETS ORAL PharmAce (Pvt) LtdENHANCIN 156.25 Square POWDER 156.25TYOLAV POWDER IVAMENTIN 156.25 AMCLAV FORTECLAVAM ORAL ORAL BP 125MG/5ML DRY SYRUP DRY 125MG/5ML BP BP 125MG/5ML DRY SYRUP DRY 125MG/5ML BP 625MG USP TABLES ACID 625MG USP TABLES ACID 625MG POTASSIUM 625MG POTASSIUM 625MG POTASSIUM SUSPENSION ORAL POTASSIUM 156.5mg SUSPENSION ORAL POTASSIUM 156.25mg/5ML USP SUSPENSION ORAL POTASSIUM 156.25mg/5ML USP SUSPENSION ORAL POTASSIUM 156.25mg/5ML USP SUSPENSION ORAL POTASSIUM 156.25mg/5ML USP SUSPENSION ORAL POTASSIUM 312.5MG/5ML USP 346 SUSPENSION AMOXICILLIN ORAL 347 SUSPENSION AMOXICILLIN ORAL 348 AMOXICILLIN & CLAVULANATE 349 AMOXICILLIN & CLAVULANATE 350 AMOXICILLIN & CLAVULANATE 351 AMOXICILLIN & CLAVULANATE 352 AMOXICILLIN & CLAVULANATE 353 AMOXICILLIN & CLAVULANATE 354 AMOXICILLIN & CLAVULANATE 355 AMOXICILLIN & CLAVULANATE 356 AMOXICILLIN & CLAVULANATE 357 AMOXICILLIN & CLAVULANATE 358 AMOXICILLIN & CLAVULANATE 44 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 11-Mar-14 Full 29-Oct-17INDIA Full INDIA 31-Dec-18INDIA Full 25-Feb-15INDIA Full 23-Jun-17INDIA Full 07-Jun-16 Full 19-Mar-15INDIA Full INDIA 18-Mar-18 Provisional INDIA 31-Dec-14 Full 09-Oct-14BANGLADESH Full 07-Jul-16 Full (Pvt) Ltd Lincolin Pharmaceuticals Sanbe FarmaT P INDONESIA 05-Jan-18Akums Drugs & Years Two Pharmaceuticals Ltd Bharat Parenterals Ltd Akums Drugs & Pharmaceuticals Ltd Galpha Laboratories Ltd Alkem Laboratories Ltd Cipla Ltd(Pvt) Ltd INDIAAkums Drugs & Pharmaceuticals Ltd 21-Jul-16Theon Pharmaceuticals Ltd Full Pharmaceuticals Ltd (Contd.) Pharma AssociatesPharma AMN Life Science Imports (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd Pharmaceuticals Ltd (Ceylon) Ltd (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP FOR ORAL FOR ORAL SUSPENSION AVAM 312AVAM POWDER MOXILINK C TABLETSCLANEKSI & J Pharma T TABLETS 375 CL VEXOXY TABLETS Lifeline BAURCLAV Global Impex AV 375JOYCLAV TABLETS TABLETS Baur Life Sciences 375CLANOXY Brown & Burk TABLETS 375CLAVAM Markss HLC (Pvt) TABLETS 375NOVACLAV TABLETS 375 Emerchemie NB AVAM Breathe Free Lanka 375 CL VEXOXY TABLETS TABLETSAssociates Pharma THEOCLAV Global Impex AV AMN Life Science TABLETSASCLAV Slim 375AMCLAV TABLETS TABLETS N/A PharmAce (Pvt) Ltd Square Astron (Pvt) Ltd SRI LANKA 19-Apr-18 Provisional POTASSIUM TABLETS BP 625MG BP TABLETS POTASSIUM 375MG USP TABLETS POTASSIUM 375MG USP POTASSIUM 375MG USP POTASSIUM 375MG USP POTASSIUM 375MG USP POTASSIUM 375MG USP POTASSIUM 375MG USP POTASSIUM 375MG USP POTASSIUM 375MG USP POTASSIUM 375MG USP POTASSIUM 375MG USP POTASSIUM POTASSIUM ORAL SUSPENSION ORAL POTASSIUM 312.5MG/5ML USP POTASSIUM USP 375MG USP POTASSIUM 360 AMOXICILLIN & CLAVULANATE 361 AMOXICILLIN & CLAVULANATE 362 AMOXICILLIN & CLAVULANATE 363 AMOXICILLIN & CLAVULANATE 364 AMOXICILLIN & CLAVULANATE 365 AMOXICILLIN & CLAVULANATE 366 AMOXICILLIN & CLAVULANATE 367 AMOXICILLIN & CLAVULANATE 368 AMOXICILLIN & CLAVULANATE 369 AMOXICILLIN & CLAVULANATE 370 AMOXICILLIN & CLAVULANATE 371 AMOXICILLIN & CLAVULANATE 359 AMOXICILLIN & CLAVULANATE 372 AMOXICILLIN & CLAVULANATE I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 45 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 25-Feb-15 Full INDIA 12-Sep-15 Full 15-Mar-17 Full INDIAINDIA 06-Jun-15INDIA Full 07-May-17INDIA Full 08-Sep-17 Full 31-Jul-15 Full INDIA 30-Mar-17 Years Two INDIAINDIA 16-Jul-17 Years Two 09-Oct-16 Full Ankur Drugs & Pharma (Pvt) Ltd IVA Health Care IVA (Pvt) Ltd Bharat Biotech International Ltd Chiros Pharma INDIAMicro Labs Ltd INDIA 12-Aug-16Bharat Parenterals Ltd Full Akums Drugs & Pharmaceuticals 07-Oct-15Ltd Full Galpha Laboratories Ltd Theon Pharmaceuticals Ltd Chiros Pharma INDIASaitech Mediccare (Pvt) Ltd 12-Aug-15Medicef Pharma INDIA Full Bharat Parenterals Ltd Healthcare 18-Sep-15Formulation (Pvt) Ltd Full (Contd.) International (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Services Pvt. Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP BAURCLAV TABLETS Softcare IVAMENTIN 375IVAMENTIN TABLETSCLAXIN 375 Slim CHIMOX-CV 375 TABLETS TABLETS Pharma Tropical 375BACTOCLAV Slim TABLETSBAURCLAV SMM Halcyon (Pvt) MOXIKIND CV 625 TABLETS TABLETS Baur Life Sciences Hemas 625CLANOXY TABLETSTHEOCLAV Markss HLC (Pvt) TABLETSCHIMOX-CV 625 TABLETS Slim NUMOLAV Slim TABLETS 625WELCLAVE TABLETS Slim CLAXIN 625 ABC Pharma 1.2CLAVOXY TABLETS INJECTION Pharma Tropical Slim POTASSIUM USP 375MG USP POTASSIUM POTASSIUM USP 375MG USP POTASSIUM 375MG USP POTASSIUM 375MG USP POTASSIUM 375MG USP POTASSIUM 625MG USP TABLETS POTASSIUM 625MG USP POTASSIUM 625MG USP POTASSIUM 625MG USP POTASSIUM 625MG USP POTASSIUM 625MG USP POTASSIUM 625MG USP POTASSIUM 625MG USP POTASSIUM FOR INJECTION BP CLAVULANATE 1.2MG 373 AMOXICILLIN & CLAVULANATE 374 AMOXICILLIN & CLAVULANATE 375 AMOXICILLIN & CLAVULANATE 376 AMOXICILLIN & CLAVULANATE 377 AMOXICILLIN & CLAVULANATE 378 AMOXICILLIN & CLAVULANATE 379 AMOXICILLIN & CLAVULANATE 380 AMOXICILLIN & CLAVULANATE 381 AMOXICILLIN & CLAVULANATE 382 AMOXICILLIN & CLAVULANATE 383 AMOXICILLIN & CLAVULANATE 384 AMOXICILLIN & CLAVULANATE 385 AMOXICILLIN & CLAVULANATE 386 AMOXICILLIN & POTASSIUM 46 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 28-Oct-16 Full 10-Mar-18 Years Two 10-Feb-18 Years Two UNITED KINGDOM INDIAUNITED KINGDOM 17-Jun-14INDIA Full INDIA 07-May-15 Full 02-Feb-18 Years Two INDIA 16-Jan-17UNITED Full KINGDOM Sandoz GmbH AUSTRALIAKopran Ltd 14-Aug-14Smithkline INDIA Full Beecham Plc Sanbe FarmaT P INDONESIA 08-Oct-15 23-Mar-18Unichem Full Years Two Laboratories Smithkline Beecham Plc Akums Drugs & Pharmaceuticals Ltd Sun Pharmaceutical industries LaboratoriesIPCA INDIA Sanbe FarmaT P INDONESIA 10-Oct-17Years Two 28-May-16 Full (Pvt) Ltd Micro Labs Ltd INDIASmithkline Beecham Limited 11-Nov-16 Full Sandoz GmbH AUSTRIA 18-May-18 Full (Contd.) A Baur & Co (Pvt) A Ltd CIC Lifesciences Ltd. GlaxoSmithkiline Pharmaceuticlas (Pvt) Ltd Lifeline Pharmaceuticals (Pvt) Ltd Ltd Pharmaceuticlas (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Lifeline Pharmaceuticals (Pvt) Ltd Ltd SMM Halcyon (Pvt) Ltd Pharmaceuticlas (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP INSUFFLATOR SUSPENSION SUSPENSION INJECTION INJECTION SUSPENSION INJECTION GlaxoSmithkiline CURAMDECAMOX POWDER AUGMENTIN ORAL ORAL CLANEKSI POWDER 375MYCLAV TABLETSAUGMENTIN TABLETS Baur & Co (Pvt) A MOXIKIND CV 375 TABLETS GlaxoSmithkiline Hemas ENHANCIN 375 TABLETSRAPICLAV Hemas TABLETSCLANEKSI Hemas POWDER FOR CURAM TABLETS Baur & Co (Pvt) A CLAVOTECBACTOCLAV TABLETS ORAL Klintas (Pvt) LtdAUGMENTIN 1.2G United Biotech ACID 200MG INJECTION SUSPENSION ORAL ACID 31.25MG/5ML SUSPENTION 200MG FOR POTASSIUM INJECTION 1.2G 125MG POTASSIUM CLAVULANATE ACID 125MG CLAVULANICN ACID 125MG USP CLAVULANICN 125MG POTASSIUM CLAVULANATE TABLETS USP POTASSIUM 250MG+CLAVULANATE 125MG ACID 100MG INJECTION ACID 125MG POTASSIUM for ORAL SUSPENSION for ORAL POTASSIUM 156.25MG /5ML USP ACID 200MG INJ. 1.2G IV CLAVULANATE TABLETS IP 375MG IP TABLETS CLAVULANATE 390 AMOXICILLIN 1000MG+CLAVULANIC 391 ORAL BP AMOXICILLIN 125MG/5ML 392 AMOXICILLIN 125MG+CLAVULANIC 393 AMOXICILLIN 1G+CLAVULANATE 394 AMOXICILLIN 250MG & 395 AMOXICILLIN 250MG + 396 AMOXICILLIN 250MG + 397AND AMOXICILLIN 250MG 398 AMOXICILLIN 399 AMOXICILLIN 500MG+CLAVULANIC 400 AMOXICILLIN 500MG+CLAVULANIC 388 AMOXICILLIN +CLAVULANATE 389 AMOXICILLIN 1000MG+CLAVULANIC 387 AMOXICILLIN & POTASSIUM I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 47 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 26-May-14 Full INDIA 19-Dec-15UNITED Full KINGDOM INDIAINDIA 19-Mar-15FRANCE Full 01-Sep-14 Full 24-Nov-17INDIA Full INDIA 28-May-15 Full 22-Jun-16INDIA Full INDIA 31-Dec-16 Full 31-Dec-15SRI LANKA Full 17-Nov-15 Full Glaxo Wellcome Glaxo Wellcome Production Marksons Pharma Ltd Sterling Lab INDIALtd Sun Pharmaceutical 17-Nov-17industries Years Two Kopran Ltd INDIAPharmaceuticals Manufacturer Corporation 11-Mar-14 Full Lark Laboratories (India) Ltd LaboratoriesIPCA INDIASmithkline Beecham 04-Oct-17Pharmaceuticals Years Two Alkem Laboratories Ltd Medispray Laboatories (Pvt) Ltd Laboratories (Pvt) Ltd Micro Labs Ltd INDIA 07-Oct-14 Full (Contd.) Pharmaceuticlas (Pvt) Ltd Plc Co Ltd Pharmaceuticals (Pvt) Ltd Ltd Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticlas (Pvt) Ltd (Ceylon) Ltd (Pvt) Ltd Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP BICIDALRAPICLAV TABLETS TABLETSAUGMENTIN Farnell Ceylon (Pvt) DROPS Hemas 625mgCLAVAM TABLETS GlaxoSmithkiline 625NOVACLAV TABLETS Emerchemie NB Breathe Free Lanka BACTOCLAV 625BACTOCLAV TABLETS SMM Halcyon (Pvt) CLAVULANATE 125MG CLAVULANATE ACID DROPS 12.5MG/ML 625MG USP TABLETS POTASSIUM 625MG USP TABLETS POTASSIUM CLAVULANATE 125MG CLAVULANATE ACID 125MG BP TABLETS ACID 125MG BP 411 250MG AMOXICILLIN CAPSULES BP MOXICOR CAPSULES Harcourts (Pvt) Ltd Coral Laboratories 414 250MG AMOXICILLIN CAPSULES BP N/A CAPSULES N/A State 403 AMOXICILLIN 500MG+POSTASSIUM 404 AMOXICILLIN 50MG+CLAVULANIC 405 AMOXICILLIN AND CLAVULANATE 406 AMOXICILLIN AND CLAVULANATE 407 AMOXICILLIN CAPSULES 500MG AMOXIL408 250MG AMOXICILLIN CAPSULES BP MOXILEB-250 CAPSULES CAPSULES409 250MG AMOXICILLIN CAPSULES BP AMOXMARK 250 GlaxoSmithkiline Ceyoka (Pvt) Ltd CAPSULES410 250MG AMOXICILLIN CAPSULES BP Leben 250 MOXOL Browns & Company CAPSULES412 250MG AMOXICILLIN CAPSULES BP Darley Butler & RANOXYL413 250MG AMOXICILLIN CAPSULES BP CAPSULES AMYN Hemas CAPSULES Alaris Lanka (Pvt) 402 AMOXICILLIN 500MG+POSTASSIUM 401 AMOXICILLIN 500MG+CLAVULANIC 48 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 16-Aug-17INDIA Years Two 10-Oct-15INDIA Full 14-May-15 Full 28-May-18FRANCE Full 21-Jun-18SRI LANKA Full 28-Oct-17 Full INDIAINDIA 28-May-15 Full 21-May-15INDIA Full 03-Jan-14 Full Blue Cross Laboratories Ltd (Pvt) Ltd Kausikh Therapeutics (Pvt) Ltd Laboratories (Pvt) Ltd Glaxo Wellcome Production Pharmaceuticals Manufacturer Corporation Micro Labs Ltd INDIAPharmaceuticals Ltd 19-Jul-16Micro Labs Ltd Full INDIA 01-Jan-14 Full Laboratories (Pvt) Ltd Pharmaceuticals Ltd (Contd.) Hayleys Consume Produsts Ltd Chamee Chemist Sparah Biotech Jayanetti & Sons P Pvt Ltd Ceyoka (Pvt) Ltd Leben Kamazu (Pvt) Ltd Micro Labs LtdGlaxoSmithkiline INDIAPharmaceuticlas (Pvt) Ltd 31-Dec-17 Full (Pvt) Ltd (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP TABLETS TABLETS SUSPENSION SUSPENSION SUSPENSION SUSPENSION AXCILBLUMOX 250 DT DISPERSIBLE CAPSULESN/A N/AKAUSIMOX 125 ORAL DISPERSIBLE MOXILEB Astron (Pvt) Ltd SRI LANKAEROX ORAL 02-Dec-17AMOXIL Full ORAL ORAL TABLETS USP 125MG USP TABLETS 125MG/5ML SUSPENSION U.S.P 125MG/5ML BP 125MG/5ML BP TABLETS 250MG TABLETS 500MG SUSPENSION 125MG/5ML 423 AMOXICILLIN DISPERSIBLE 424 AMOXICILLIN FOR ORAL 425 SUSPENSION AMOXICILLIN ORAL 426 SUSPENSION AMOXICILLIN ORAL 428 125MG USP TABLETS AMOXICILLIN N/A TABLETS N/A State 422 AMOXICILLIN DISPERSIBLE 418 250MG AMOXICILLIN CAPSULES BP NESMOX CAPSULES PharmAce (Pvt) Ltd Nestor 421 AMOXICILLIN CAPSULES USP 427 AMOXICILLIN POWDER FOR ORAL 416 250MG AMOXICILLIN CAPSULES BP MYOMOX417 250MG AMOXICILLIN CAPSULES BP 250 CAPSULES PULMOXYL CAPSULESAssociates Pharma Bafna Salveo Pharma 419 500MG AMOXICILLIN CAPSULES BP EROX-500420 500MG AMOXICILLIN CAPSULES BP 500 PULNOXYL CAPSULES CAPSULES Kamazu (Pvt) Ltd Salveo Pharma Micro Labs Ltd INDIA 31-Dec-16 Full 415 250MG AMOXICILLIN CAPSULES BP MOXILEB-250 CAPSULES Ceyoka (Pvt) Ltd Leben I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 49 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 ICELAND 16-Feb-17INDIA Full INDONESIA 28-May-17 Years Two 23-Oct-17INDIA Full INDIA 30-May-18 Provisional 11-Sep-14INDIA Full SRI LANKA 30-May-14 20-Jun-18SRI LANKA Provisional Full 01-Feb-18INDIA Provisional PAKISTAN 04-Jun-14 Full 02-Jan-17 Years Two INDIAINDIA 24-Oct-17 Full 10-Jan-19 Years Two Laboratories (Pvt) Ltd Healthcare Ltd Celon Laboratories Ltd Laboratories (Pvt) Ltd Dankos Farma T P Indonesia for PT TBK Kalbe Farma (Pvt) Ltd Healthcare Vital (Pvt) Ltd Cipla LtdBelco Pharma (Pvt) Ltd INDIAPharmaceuticals (Pvt) Ltd 28-Apr-16 Full Karnataka Antibiotic & Pharmaceuticals Ltd Zafa Pharmaceuticals Laboratories (Pvt) Ltd (Pvt) Ltd (Contd.) N/A Navana (Pvt) Ltd Ceyoka (Pvt) Ltd Leben Pharmaceuticals (Pvt) Ltd AssociatesPharma AMN Life Science (Pvt) Ltd (Pvt) Ltd Agency Pvt Ltd N/A Navesta Ltd (Pvt) Ltd INJECTION TABLETS SUSPENSION INJECTION SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP MOXILEB 500 CAPSULES Ceyoka (Pvt) Ltd Leben MOXILEB KID TABMOXILEB KID DISPERSIBLE 250CLAVAMOX TABLETS 156AVAM Hemas ORAL AMPHOVITA INJECTIONPHOTERICIN B INJECTION International Yaden N/A Breathe Free Lanka 1000AMPICIL POWDER FOR INJECTION Leader Pharma N/AZAMPICILLIN INJECTION INJECTION Baur & Co (Pvt) A International Yaden CAPSULES IP 500MG CAPSULES IP DISPERSIBLE TABLETS 125MG DISPERSIBLE TABLETS USP TABLETS CLAVULANATE 375MG SUSPENSION ACID FOR ORAL 156.25/5ML 50MG USP 50MG USP 250MG INJECTION BP 1000MG INJECTION 1G BP 500MG INJECTION BP 429 AMOXICILLIN TRIHYDRATE 430 AMOXICILLIN TRIHYDRATE 431 AMOXICILLIN WITH POTASSIUM 432 AMOXICILLIN,CLAVULANIC 433 AMPHOTERICIN B FOR INJECTION 434 AMPHOTERICIN B FOR INJECTION 435 AMPICILLIN SODIUM FOR 436 AMPICILLIN FOR INJECTION BP 437 250MG AMPICILLIN INJECTION B.P 250 AMPICIL 438 AMPICILLIN SODIUM FOR POWDER FOR 439 AMPICILLIN SODIUM FOR 440 IMGTABLETS ANASTROZOLE 441 IMG ANAGLOBTABLETS ANASTROZOLE ARMILON-1 TABLETS TABLETS PharmAce (Pvt) Ltd Globela Pharma Medmart Pharma 50 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 11-Jan-18 Full 12-Jun-15 Full 25-Jun-18 Full 28-Sep-18 Full INDIAINDIA 05-Dec-15INDIA Full 17-May-14KOREA Full 26-Jul-14 20-Aug-15 Full STATES Full UNITED STATES TAIWANINDIA 15-Mar-14INDIA Full 19-Apr-18INDIA Provisional 29-Oct-17INDIA Years Two 19-Apr-18 Provisional UNITED 17-Sep-15STATES Full SUADI ARABIA 10-Nov-14 Full STATES zer fi Vaccine Ltd Vaccine Ltd Vaccine Ltd Vaccine Corporation Baxalta US Inc UNITED Astra Zeneca Pharmaceuticals Co Ltd Biopharm TTY Co. Ltd United Biotech (Pvt) Ltd Cadila Healthcare Ltd (Pvt) Ltd (Pvt) Ltd Pharmacia & Upjohn Company for P USA Riyadh Pharma Medical &Cosmetic Products Baxalta US Inc UNITED (Contd.) international Ltd Pharmaceuticals (Pvt) Ltd (Ceylon) Ltd Health (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd J Medichem A international Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP POWDER EQUIRABREOCLONE INJECTIONTHYMOGAM INJECTION Ceyoka (Pvt) Ltd Bharat Serums & Ceyoka (Pvt) Ltd INJECTIONGREEN VIII Bharat Serums & Ceyoka (Pvt) Ltd INJECTION MHEMOFIL Bharat Serums & Ceyoka (Pvt) Ltd INJECTION Green Cross J Medichem A ERAXISPYRALVEX INJECTION Hemas SOLUTION MHEMOFIL Hemas LYOPHILIZED 1000IU IN 5ML INJECTION 300MCG EQUINE 250MG/5ML HUMAN VIII CONCENTRATED INJECTION 250IU INJECTION 220-1700IU IN 10ML 100MG ACID 1% RHUBARB 5%+SALICYLIC SOLUTION HUMAN INJECTION 220-2000IU PURIFLED MONOCLONAL VIAL NANOFILTERED 451 ANTI RABIES SERUM EQUINE 452 Anti RHO-D IMMUNOGLOBULIN 453 ANTI THYMOCYTE GLOBULIN 454 ANTIHEMOPHILIC FACTOR 455 ANTIHEMOPHILIC FACTOR 443 IMGTABLETS ANASTROZOLE 444 IMG IP ANAZOTABLETS ANASTROZOLE ANASTRAOL445 IMG IP TABLETS ANASTROZOLE TABLETS ANZUCIA TABLETS446 IMG IP TABLETS ANASTROZOLE Pharmatec (Pvt) Ltd ANASTRAOL Emerchemie NB 447 Belco Pharma IMG IP TABLETS ANASTROZOLE TABLETS TABLETS FEMISTRA George Steuart 448 ANIDULAFUNGIN FOR INJECTION PharmAce (Pvt) Ltd TABLETS Belco Pharma 449 OF ANTHRAQUINONE GLYCOSIDES Hemas 450 ANTI HEMOPHILIC FACTOR- 442 IMG ANASTROZOLE TABLETS ARIMIDEX TABLETS Hemas I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 51 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 BANGLADESH 24-Apr-14INDIA Full INDIA 04-Jul-15PAKISTAN Full 07-Nov-16 27-Dec-17INDIA Full Full INDIA 04-Jul-15 Full INDIA 06-Oct-17 Full INDIA 12-Mar-14 Full INDIA 21-Jul-15 Full PHILIPPINES 04-Jul-15 08-Apr-16 Full INDIA Full SRI LANKA 16-Feb-16 04-May-15 Full Full Alembic Pharmaceuticals Ltd Alembic Pharmaceuticals Ltd Cadila Healthcare Ltd Atoz Pharmaceuticals (Pvt) Ltd Alembic Pharmaceuticals Ltd Alembic Pharmaceuticals Ltd The Acme Laboratories Ltd Ltd Laboratories (Pvt) Ltd Amherst Laboratories Centurion Laboratories Pvt Ltd Pharmaceuticals Manufacturer Corporation Torrent Export LtdTorrent INDIA 26-Mar-14 Full (Contd.) (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd Ltd Health (Pvt) Ltd (Pvt) Ltd Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP IMNUNPED SYRUPN/A George Steuart N/A TABLETS International Yaden TABLETS N/A State SULPHATE MONOHYDRATE MONOHYDRATE SULPHATE SYRUP 27.44MG 5ML 100MG 100MG 458 10MGTABLETS ARIPIPRAZOLE 10 PIPZOL 459 10MGTABLETS ARIPIPRAZOLE TABLETS460 10 BISOZA 10MGTABLETS ARIPIPRAZOLE Citihealth Imports 10 MACTRIL TABLETS461 15MGTABLETS ARIPIPRAZOLE TABLETS Hemas Health Care 15 PIPZOL Cadila Healthcare 462 15MGTABLETS ARIPIPRAZOLE PharmAce (Pvt) Ltd Wilshire TABLETS 15 BISOZA 463 30MGTABLETS ARIPIPRAZOLE Citihealth Imports TABLETS ARIZOLE464 30MGTABLETS ARIPIPRAZOLE Hemas 30 PIPZOL TABLETS465 5MGTABLETS ARIPIPRAZOLE Asian Pharma Euro TABLETS 5 PIPZOL 466 ASCORBIC ACID 100MG+ZINC Citihealth Imports TABLETS467 ASCORBIC ACID BP TABLETS Citihealth Imports 468 ASCORBIC ACID BP TABLETS 457 10MGTABLETS ARIPIPRAZOLE 10 SIZOPRA TABLETS Mega Pharma (Pvt) 456 10MGTABLETS ARIPIPRAZOLE 10 MT ARIP TABLETS Edna Medicals (Pvt) 52 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 24-Dec-16 Full BANGLADESH 18-Oct-17 Years Two INDIAAUSTRALIA 16-Jul-15 14-Jan-18 Years Two Full INDIAINDIA 16-Mar-18 Provisional 28-Feb-19 Full MALAYSIA 05-Aug-16INDIA Full BANGLADESH 24-Feb-14 30-Jan-15BANGLADESH Full Full 27-Jul-14INDIA Full UNITED 27-Nov-15KINGDOM INDIA Full 09-Jan-14 Full Mayne Pharma (Pvt) Ltd Reckitt Benckiser Healthcare UK Ltd Cadila Healthcare Ltd Pharmaceuticals Ltd VHB Medi Sciences Ltd U S V Ltd INDIAMedibios Laboratories (Pvt) Ltd Concept 26-Jan-15Pharmaceuticals Ltd Full U S V Ltd INDIASDN BHD Medispray Laboatories (Pvt) 14-Jan-15Ltd The ACME Full Laboratories Ltd The ACME Laboratories Ltd Ratnamani Healthcare (Pvt) Ltd (Contd.) Pharmaceuticals (Pvt) Ltd (Lanka) Ltd Healthcare lanka Ltd Medmart Pharma (Pvt) Ltd Hemas Pharmaceuticals (Pvt) Ltd (Ceylon) Ltd International (Pvt) Ltd Hemas Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Ltd Ltd Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP POWDER FOR INJECTION COA.) COA.) CEEVIT 250CEEVIT TABLETSLEUCOGINASE 10000IU PharmAce (Pvt) Ltd Square ECORINXSPRIN (EN. TABLETS 75ASPICOT TABLETS TABLETS Emerchemie NB ECORIN Softcare CASPRIN 100MG (EN. TABLETS TABLETSASPIN 100 Indoscan (Pvt) Ltd Industries / S P Y TABLETSECOSPRIN Breathe Free Lanka ECOSPRIN TABLETSN/A TABLETS Mega Pharma (Pvt) Mega Pharma (Pvt) TABLETS Lanka (Pvt) Tabrane 10,000 IU 150MG USP TABLETS 75MG USP TABLETS 75MG USP TABLETS 75MG USP TABLETS 100MG USP TABLETS 100MG USP TABLETS 75MG BP TABLETS 150MG BP TABLETS 150MG BP TABLETS 250MG 470 FOR INJECTION ASPARAGINASE-L 471 ASPIRIN CAPSULES 100MG472 ASTRIX RELEASE ASPIRIN DELAYED 473 RELEASE ASPIRIN DELAYED CAPSULES Akbar 474 RELEASE ASPIRIN DELAYED 475 RELEASE ASPIRIN DELAYED 476 RELEASE ASPIRIN DELAYED 477 RELEASE ASPIRIN DELAYED 478 ASPIRIN ENTERIC COATED 479 ASPIRIN GASTRO RESISTANT 480 ASPIRIN GASTRO RESISTANT 481 75MGTABLETS ASPIRIN 482 25MG BP ATENOLOL CARDIPRIN TABLETS 25 ATENEX Reckitt Benckiser TABLETS Sunshine 469 ASCORBIC ACID BP TABLETS I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 53 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIASRI LANKA 07-Aug-17INDIA 08-Jul-18 Full Full INDIA 27-Oct-16 Full INDIA 07-Aug-17INDIA Full 27-Oct-16 Full 23-Oct-15 Full INDIAINDIA 02-Nov-14INDIA Full 03-Nov-14 Full 27-Apr-16 Full INDIAINDIA 05-Jun-14 Full 27-Oct-17 Full Agio Pharmaceuticals Ltd G D Laboratories (India) Pvt Ltd Belco Pharma (Pvt) Ltd LaboratoriesIPCA INDIA 13-Aug-16 Full G D Laboratories (India) Pvt Ltd Ltd. Laboratories (Pvt) Ltd Lark Laboratories (India) Ltd Scott Edil Pharmacia Ltd LaboratoriesIPCA INDIA 07-Feb-17 Full J.B.Chemicals & Pharmaceuticals Sunrise International LabS Ltd LaboratoriesIPCA INDIA 13-Sep-15 Full SG Pharma (Pvt) Ltd IPCA LaboratoriesIPCA INDIA 13-Sep-16 Full (Contd.) (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Agency Pvt Ltd Ltd Pharmaceuticals (Pvt) Ltd Ltd Ltd Ltd Health (Pvt) Ltd Pharmaceutical (Pvt) Ltd Ltd Pharmacy (Pvt) Ltd Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP N/A INJECTION The Esses TENORIC TABLETS Emar Pharma (Pvt) 5MG/10ML 50MG+CHLORTHALIDONE BP BP 50MG+CHLORTHALIDONE 12.5MG TABLETS 492 50MG BP TABLETS ATENOLOL 493 TENOL-50 50MG BP TABLETS ATENOLOL AGITEN494 TABLETS 50MG BP TABLETS ATENOLOL N/A ANGITEN 50495 TABLETS 50MG BP TABLETS ATENOLOL TABLETS496 Citihealth Imports 50 BETANOL 50MG BP TABLETS ATENOLOL Lifeline TABLETS CIC Lifesciences ATELEB497 50MG BP TABLETS ATENOLOL Leader Pharma 50 TENOLOL TABLETS TABLETS Ceyoka (Pvt) Ltd Leben Emar Pharma (Pvt) 491 50MG BP TABLETS ATENOLOL ANGITEN 50 TABLETS Lifeline 488 25MG BP TABLETS ATENOLOL 489 PROCOR 25 25MG BP TABLETS ATENOLOL 490 TABLETS N/A 25MG BP TABLETS ATENOLOL TENOLOL Farnell Ceylon (Pvt) TABLETS TABLETS C Medical (Pvt) T P Emar Pharma (Pvt) 487 100MG BP TABLETS ATENOLOL TENSIMIN 100 TABLETS George Steuart 485 100MG BP TABLETS ATENOLOL 100 ATERISE 486 100MG BP TABLETS ATENOLOL TABLETS TENOLOL Kent TABLETS Emar Pharma (Pvt) 484 INJECTION USP ATENOLOL 483 ATENOLOL 54 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 28-Jun-16 Full SRI LANKA 27-Apr-17 Years Two 25-Sep-18BANGLADESHYears Two 07-Jun-17 Years Two INDIAINDIA 13-Jul-15INDIA Full 13-Jan-15INDIA Full 08-Apr-18 Years Two 24-Nov-17 Full INDIA 07-Oct-17 Full Macleods Pharmaceuticals Ltd Pharmaceuticals Ltd cals Corporation Pvt Ltd Ltd Eskayef Bangaladesh Ltd Cadila Healthcare Ltd Torrent Pharmaceuticals Ltd Micro Labs Ltd INDIA 11-Dec-17 Full J.B.Chemicals & Pharmaceuticals Kopran Ltd INDIA 10-Feb-17 Full (Contd.) (Pvt) Ltd Healthcare lanka Ltd Healthcare lanka Ltd Ltd Ltd Health (Pvt) Ltd Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP LIPICON 20 TABLETS Sunshine N/A 20MODLIP TABLETS TABLETS Sunshine Edna Medicals (Pvt) TABLETS 20MG TABLETS TABLETS TABLETS 502 25MG USP TABLETS ATENOLOL NORM 25 BP 503 50MG USP TABLETS ATENOLOL TABLETS N/A504 FILM COATED ATORVASTATIN PharmAce (Pvt) Ltd Medley 505TABLETS 20MG I P ATORVASTATIN 20 STATOR TABLETS506TABLETS 20MG I P ATORVASTATIN 20 ASTORIL TABLETS N/A507 CALCIUM 20MG ATORVASTATIN TABLETS CIC Holdings PLC Abbott Healthcare 508 CALCIUM 20MG Harcourts (Pvt) Ltd ATORVASTATIN Coral Laboratories StatePharmaceuti- 501 50MG BP TABLETS ATENOLOL TENOMAC 50 TABLETS Pettah Pharmacy 500 50MG BP TABLETS ATENOLOL BETADURE-50 TABLETS SMM Halcyon (Pvt) 499 50MG BP TABLETS ATENOLOL N/A TABLETS Alaris Lanka (Pvt) 498 50MG BP TABLETS ATENOLOL TENSIMIN-50 TABLETS George Steuart I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 55 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIA 19-Feb-18 Provisional INDIA 27-Sep-17 Full INDIA 03-Nov-17 Years Two INDIA 06-Jul-16 Full INDIA 23-Oct-17 Years Two INDIAPAKISTAN 28-Oct-16 13-Oct-17 Full Years Two INDIA 07-Apr-15 Full INDIABANGLADESH 31-Jan-18 10-Apr-15 Full Full PAKISTAN 13-Oct-17 Years Two INDIA 01-Dec-17 Full Centurion Laboratories Pvt Ltd Cadila Healthcare Ltd Cadila Healthcare Ltd Torrent Torrent Pharmaceuticals Ltd Cadila Healthcare Ltd (Pvt) Ltd Zim Laboratories Ltd Renata Limited BANGLADESHHetero Drugs Ltd 27-May-17 INDIAYears Two Cadila Healthcare 01-Sep-17Ltd Years Two (Pvt) Ltd Unichem Laboratories Healthcare Pharmaceuticals Pharmaceuticals Ltd (Contd.) (Pvt) Ltd Healthcare lanka Ltd Healthcare lanka Ltd Ltd Healthcare lanka Ltd Pharmaceuticals (Pvt) Ltd (Ceylon) Ltd (Pvt) Ltd Healthcare lanka Ltd Ltd (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP N/A TABLETS International Yaden ATORVA 80ATORVA TABLETS Sunshine ATORVA TABLETS Sunshine MODLIP 10MODLIP TABLETS Edna Medicals (Pvt) LIPVAS 10LIPVAS ATORVA TABLETS Ceyoka (Pvt) Ltd TABLETS Lowitt Pharma Sunshine LIPIZIM 10 TABLETS Tabrane TAVEN 20TAVEN 10HYPOLIP TABLETS 10LIPVAS TABLETS Emerchemie NB N/A Mansel (Ceylon) TABLETS Ceyoka (Pvt) Ltd Lowitt Pharma TABLETS Sunshine XELPID TABLETS Citihealth Imports TG-TOR 20TG-TOR TABLETS Baur & Co (Pvt) A ATORIN-20 TABLETS PharmAce (Pvt) Ltd Medley IP 10MG IP 80MG 5MG 10MG 10MG 10MG 10MG 10MG 10MG TABLETS 10MG TABLETS TABLETS TABLETS 511 CALCIUM 20MG ATORVASTATIN 522 TABLETS CALCIUM ATORVASTATIN 521 TABLETS CALCIUM ATORVASTATIN 520 TABLETS CALCIUM ATORVASTATIN 519 TABLETS CALCIUM ATORVASTATIN 517 TABLETS CALCIUM ATORVASTATIN 518 TABLETS CALCIUM ATORVASTATIN 516 TABLETS CALCIUM ATORVASTATIN 513 TABLETS CALCIUM ATORVASTATIN 514 TABLETS CALCIUM ATORVASTATIN 512 CALCIUM 20MG ATORVASTATIN 515 TABLETS CALCIUM ATORVASTATIN 510 CALCIUM 20MG ATORVASTATIN 509 CALCIUM 20MG ATORVASTATIN 56 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 BANGLADESH 03-Apr-15INDIA Full PAKISTAN 01-Apr-18 14-Mar-17BANGLADESH Years Two Years Two 08-Nov-18 Full PAKISTAN 20-Nov-17INDIA Years Two INDIA 16-Nov-17 Years Two INDIA 01-Apr-18INDIA Years Two 22-Jun-16INDIA Full 31-Mar-14 Full INDIA 23-Jun-14 Full 09-Jun-14 Full INDIA 09-Mar-14 Full INDIA 11-Oct-18 Years Two INDIA 23-Nov-16 Full Ltd Pharmatec Pakistan (Pvt) Ltd Incepta Pharmaceuticals Ltd Highnoon Laboratories Ltd Cian Healthcare (Pvt) Ltd Ltd Marksons Pharma Ltd Mepro Pharmaceuticals (Pvt) Ltd Pharmaceuticals (India) Ltd Fourrts (India) Laboratories Ltd Eskayef Bangaladesh Ltd Unichem Laboratories Centurion Laboratories Pvt Ltd Pharmaceuticals Ltd (Contd.) Plc (Pvt) Ltd Healthcare lanka Ltd Pharmaceuticals (Pvt) Ltd Plc Pharmaceuticals (Pvt) Ltd Healthcare lanka Ltd Healthcare lanka Ltd Ltd (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP LIPICON 10 TABLETS Sunshine TG-TOR 10TG-TOR TABLETS Baur & Co (Pvt) A ATOCEN 20ATOCEN TABLETS International Yaden ATORIN-10 TABLETS PharmAce (Pvt) Ltd Medley TRIHYDRATE 10MG TABLETS 10MG TRIHYDRATE TRIHYDRATE 10MG TABLETS 10MG TRIHYDRATE IP 20MG IP IP 10MG IP 527 10MGTABLETS ATORVASTATIN ATOREM528 10MGTABLETS ATORVASTATIN 10 ATOSTIN 529 10MGTABLETS ATORVASTATIN TABLETS TIGIMOR TABLETS530 Axia (Pvt) Ltd 10MG TABLETS ATORVASTATIN Browns & Company LIPIREX TABLETS MSN Laboratories 531 10MGTABLETS ATORVASTATIN Citihealth Imports 10 AT-ACE TABLETS532 10MGTABLETS ATORVASTATIN TABLETS Sunshine ATOREM533 10MGTABLETS ATORVASTATIN Slim 10 ATOMARK 534 10MGTABLETS ATORVASTATIN TABLETS TABLETS 10 ATLAST 535 Axia (Pvt) Ltd 10MGTABLETS ATORVASTATIN Browns & Company TABLETS 10 APVASTIN MSN Laboratories 536 10MGTABLETS ATORVASTATIN TABLETS Akbar 10 FILSTATIN PharmAce (Pvt) Ltd Aurochem TABLETS Sunshine 526 CALCIUM ATORVASTATIN 525 CALCIUM ATORVASTATIN 524 TABLETS CALCIUM ATORVASTATIN 523 TABLETS CALCIUM ATORVASTATIN I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 57 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIA 29-Aug-15INDIA Full INDIA 22-Apr-15INDIA Full 14-Jan-14INDIA Full 27-Feb-18 Provisional INDIA 16-Nov-17 Years Two PAKISTAN 08-Nov-16 03-Jan-14 Full BANGLADESH 30-Jan-15 Full Full INDIAINDIA 12-Nov-14 Full INDIA 19-Dec-15 Full BANGLADESH 02-Apr-18 28-Jul-15 Years Two Full Lekar Pharma (Pvt) Ltd Sava Healtheare Ltd Unimax Laboratories Cian Healthcare (Pvt) Ltd Agio Pharmaceuticals Ltd CCL Pharmaceuticals (Pvt) Ltd Pharmaceuticals Ltd Akums Drugs & Pharmaceuticals Ltd Healthcare (Pvt) Ltd Sai Mirra Innopharm (Pvt) Ltd Healthcare Pharmaceuticals Windlas Biotech (Pvt) Ltd (Contd.) Health (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Pharmaceuticals Lanka (Pvt) Ltd (Pvt) Ltd Healthcare lanka Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP 538 10MGTABLETS ATORVASTATIN 539 ZASTOVA 10MGTABLETS ATORVASTATIN 10 ATROLAR 540 10MGTABLETS ATORVASTATIN TABLETS TABLETS 10 BIOSTAT 541 10MGTABLETS ATORVASTATIN N/A George Steuart LIPIKIND 10 TABLETS542 10MGTABLETS ATORVASTATIN TABLETS Radiant Health Care 10 AT-ACE 543 Astron (Pvt) Ltd 10MGTABLETS ATORVASTATIN Hemas SRI LANKA TABLETS CHOLTROL544 10MG TABLETS 24-Jun-16 ATORVASTATIN Slim TABLETS PRO-STATIN Full 545 10MGTABLETS ATORVASTATIN Citihealth Imports TABLETS 10 ANZITOR 546 10MGTABLETS CCL ATORVASTATIN TABLETS VEXTRO 10547 10MGTABLETS ATORVASTATIN PharmAce (Pvt) Ltd Square TABLETS 10 TINOLIP 548 10MG TABLETS ATORVASTATIN Global Impex AV TABLETS ATSTAT549 10MGTABLETS ATORVASTATIN Ceyoka (Pvt) Ltd XELPID Global Pharma TABLETS Sunshine TABLETS Citihealth Imports 537 10MGTABLETS ATORVASTATIN 10 AVAST TABLETS Lifeline 58 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 BANGLADESH 13-Jan-16 Full INDIAINDIA 11-Nov-15INDIA Full 04-Jan-17 Full 14-May-15 Full INDIAPAKISTAN 04-Oct-17 Years Two 14-Jun-15INDIA Full 24-Mar-15 Full INDIAGERMANY 25-Oct-16 06-Jul-15 Full Full zer fi IVA Health Care IVA (Pvt) Ltd Lark Laboratories (India) Ltd Lincolin Pharmaceuticals Innova Captab INDIAMicro Labs Ltd INDIA 20-Aug-16Sun Pharmaceutical industries Full 22-Nov-16Getz Pharma (Pvt) Ltd Full Emcure Pharmaceuticals Ltd IntermedKopran Ltd INDIARenata Limited INDIA BANGLADESHUnique 27-Jun-16 02-Sep-15Pharmaceutical Labs 25-Jun-14 Full Full P Manufacturing Full Deutschland GmbH Globe Pharmaceuticals Ltd (Contd.) Pharmaceuticals (Pvt) Ltd Ltd Imports (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd (Ceylon) Ltd Pharmaceuticals (Pvt) Ltd (Ceylon) Ltd (Pvt) Ltd Ltd (Ceylon) Ltd Health (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP 551 10MGTABLETS ATORVASTATIN 40 LITORIP 552 10MGTABLETS ATORVASTATIN TABLETS 10 ATROLAR 553 10MGTABLETS ATORVASTATIN Slim TABLETS 10 VAST 554 10MG TABLETS ATORVASTATIN Farnell Ceylon (Pvt) ATORNOVA555 TABLETS 10MGTABLETS ATORVASTATIN TABLETS 10 ASTAT 556 10MGTABLETS & J Pharma T ATORVASTATIN Slim 10 STORVAS TABLETS557 10MG TABLETS ATORVASTATIN TABLETS LIPIGET Micro Mega Lanka 558 10MGTABLETS Emerchemie NB ATORVASTATIN ATOREC TABLETS559 10MGTABLETS ATORVASTATIN Hemas ATORMED560 TABLETS 10MGTABLETS ATORVASTATIN ATOSTAT561 10MG Emerchemie NB TABLETS TABLETS ATORVASTATIN TAVEN562 10MGTABLETS Salveo Pharma ATORVASTATIN TABLETS 10 VASOLIP Alaris Lanka (Pvt) 563 10MG TABLETS ATORVASTATIN TABLETS TABLETS LIPITOR Emerchemie NB George Steuart TABLETS Hemas 550 10MGTABLETS ATORVASTATIN LIPLO 10 TABLETS Healthcare Tabrane I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 59 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 02-Mar-18 Years Two INDIA 18-Oct-17 Years Two INDIA 14-Feb-17 Full 31-Aug-17INDIA Full INDIA 31-Dec-16 Full PAKISTAN 24-Apr-18 Years Two 20-Nov-17INDIA Years Two INDIA 25-Oct-17 Full BANGLADESH 29-Nov-17 30-Jan-15 Years Two Full INDIAINDIA 07-Feb-14 Full 12-Jun-14 Full Pharmaceuticals Sun Pharmaceutical industries Dr Reddy's Laboratories Ltd Zee Laboratories INDIAAtoz Pharmaceuticals (Pvt) Ltd 23-Dec-17Agio Pharmaceuticals Full Ltd Highnoon Laboratories Ltd Unique Pharmaceutical Labs Umedica Laboratories (Pvt) Ltd Pharmaceuticals Ltd Sava Healtheare Ltd Fourrts (India) Laboratories Ltd Macleods Pharmaceuticals Ltd (Contd.) Pharmaceuticals (Pvt) Ltd (Ceylon) Ltd Services Pvt. Ltd (Pvt) Ltd (Pvt) Ltd Healthcare lanka Ltd Health (Pvt) Ltd Pharmaceuticals Pvt Ltd (Pvt) Ltd Healthcare lanka Ltd (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP 565 10MGTABLETS ATORVASTATIN 10 ATORFIT 566 10MG TABLETS ATORVASTATIN AZTOR TABLETS567 10MGTABLETS ATORVASTATIN Associates Pharma 10 ATOCOR The Madras 568 10MGTABLETS ATORVASTATIN TABLETS ATV-10 TABLETS569 10MGTABLETS ATORVASTATIN Hemas OPTILIP-10 Emerchemie NB 570 20MGTABLETS ATORVASTATIN TABLETS TABLETS CHOLTROL571 ABC Pharma 20MG TABLETS ATORVASTATIN Asian Pharma Euro TABLETS LIPIREX572 20MGTABLETS ATORVASTATIN Citihealth Imports 20 VASOLIP TABLETS573 20MGTABLETS ATORVASTATIN TABLETS Sunshine 20 UMESTATIN 574 20MGTABLETS TABLETS ATORVASTATIN George Steuart 20 ANZITOR Gamma 575 20MGTABLETS ATORVASTATIN TABLETS 20 BIOSTAT 576 20MGTABLETS ATORVASTATIN PharmAce (Pvt) Ltd 20 Square FILSTATIN TABLETS TABLETS Radiant Health Care Sunshine 564 10MGTABLETS ATORVASTATIN ATORMAC TABLETS Pettah Pharmacy 60 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 23-Jun-14INDIA Full 22-Jun-16INDIA Full 28-Oct-16 Full PAKISTAN 29-Aug-14 10-Apr-14 Full PAKISTAN Full 11-Mar-14INDIA Full INDIA 03-Mar-16 Full INDIA 28-Jan-18 Years Two INDIA 11-Mar-14 Full INDIA 25-Oct-17 Full BANGLADESH 31-Oct-17 14-Dec-16 Full Full Marksons Pharma Ltd Zim Laboratories Ltd Windlas Biotech (Pvt) Ltd Zafa Pharmaceuticals Laboratories (Pvt) Ltd CCL Pharmaceuticals (Pvt) Ltd Akums Drugs & Pharmaceuticals Ltd Theon Pharmaceuticals Ltd Unimax Laboratories Unique Pharmaceutical Labs Genpharma Intetnational (Pvt ) Ltd Incepta Pharmaceuticals Ltd Pharmaceuticals (India) Ltd (Contd.) Plc Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Pharmaceuticals Lanka (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Health (Pvt) Ltd Ltd (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP 578 20MGTABLETS ATORVASTATIN 20 ATOMARK 579 20MGTABLETS ATORVASTATIN TABLETS LIPIZIM 20580 20MGTABLETS ATORVASTATIN Browns & Company TABLETS 20 AVAST 581 20MGTABLETS ATORVASTATIN Tabrane TABLETS COLEZAF582 20MG TABLETS ATORVASTATIN Lifeline TABLETS PRO-STATIN583 20MGTABLETS ATORVASTATIN International Yaden TABLETS VEXTRO 20584 20MGTABLETS CCL ATORVASTATIN TABLETS 20 THEOSTAT 585 20MGTABLETS ATORVASTATIN TABLETS Global Impex AV LIPIKIND 20586 Slim 20MGTABLETS ATORVASTATIN TABLETS 20 VASOLIP 587 20MGTABLETS ATORVASTATIN Hemas TABLETS 20 GRASALIP 588 20MGTABLETS ATORVASTATIN George Steuart TABLETS TIGINOR 20 Evo Pharma (Pvt) TABLETS Citihealth Imports 577 20MGTABLETS ATORVASTATIN 20 APVASTIN TABLETS PharmAce (Pvt) Ltd Aurochem I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 61 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIABANGLADESH 13-Nov-15 13-Jan-16 Full Full INDIAPAKISTAN 14-Feb-17 14-Jun-15 Full INDIA Full INDIA 02-Oct-17 Years Two INDIA 18-Oct-14INDIA Full 29-Nov-16 Full 22-Apr-15GERMANY Full 06-Jul-15 Full INDIA 13-Jan-15 Full zer fi Globe Pharmaceuticals Ltd Micro Labs Ltd INDIASun Pharmaceutical industries 22-Nov-17Getz Pharma Pakistan (Pvt) Ltd Full Sun Pharmaceutical industries Pharmaceuticals Atoz Pharmaceuticals (Pvt) Ltd Lekar Pharma (Pvt) Ltd Kopran LtdP INDIAManufacturing Deutschland GmbH Intermed 23-Jun-17Years Two Emcure Pharmaceuticals INDIALtd 02-Sep-15 Full IVA Health Care IVA (Pvt) Ltd (Contd.) (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Ceylon) Ltd (Pvt) Ltd Health (Pvt) Ltd Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd (Ceylon) Ltd Pharmaceuticals (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP 590 20MGTABLETS ATORVASTATIN LIPLO 20591 20MGTABLETS ATORVASTATIN 20 ASTAT 592 TABLETS 20MG TABLETS ATORVASTATIN AZTOR Healthcare Tabrane TABLETS593 20MG TABLETS ATORVASTATIN LIPIGET Micro Mega Lanka TABLETS594 20MGTABLETS ATORVASTATIN STORVAS-20 Hemas TABLETS595 20MGTABLETS ATORVASTATIN TABLETS Hemas 20 ATORFIT 596 20MGTABLETS ATORVASTATIN Emerchemie NB OPTILIP-20 TABLETS597 20MGTABLETS ATORVASTATIN Associates Pharma TABLETS N/A The Madras 598 20MGTABLETS ATORVASTATIN Asian Pharma Euro ATOSTAT599 20MG TABLETS ATORVASTATIN LIPITOR TABLETS TABLETS600 20MGTABLETS ATORVASTATIN George Steuart Alaris Lanka (Pvt) TABLETS ATORMED601 20MGTABLETS ATORVASTATIN Hemas ATOREC TABLETS Salveo Pharma TABLETS Emerchemie NB 589 20MGTABLETS ATORVASTATIN 20 LITORIP TABLETS Slim 62 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 11-Nov-16 Full INDIA 17-Aug-17 Full INDIA 13-Nov-15 Full INDIA 26-Nov-16 Full SRI LANKA 28-Jan-17 08-Jul-17SRI LANKA Full Years Two 08-Jul-18INDIAYears Two INDIA 30-Sep-14INDIA Full 13-Jul-15 29-Nov-17 Full Years Two SRI LANKA 16-Jan-16INDIA Full 29-Nov-17 Years Two Cadila Healthcare Ltd Health Care IVA (Pvt) Ltd Akums Drugs & Pharmaceuticals Ltd Zim Laboratories Ltd Ltd. Ltd. Pharmaceuticals (Pvt) ltd Pvt Ltd Umedica Laboratories (Pvt) Ltd Pharma Fabrikon INDIAHetero Labs Ltd INDIA 14-Feb-18Ltd Full Umedica 09-Dec-14Laboratories (Pvt) Ltd Full Akums Drugs & Pharmaceuticals Ltd (Contd.) Healthcare lanka Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd N/A CIC Lifesciences Pharmaceuticals Pvt Ltd (Pvt) Ltd (Ceylon) Ltd Pharmaceuticals Pvt Ltd (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP TABLETS 611 10MG IP TABLETS ATORVASTATIN 10 UMESTATIN TABLETS Gamma 603 40MG TABLETS ATORVASTATIN ATORVA604 40MGTABLETS ATORVASTATIN 40 LITORIP TABLETS605 5MGTABLETS ATORVASTATIN TABLETS Sunshine VEXTRO 5606 5MGTABLETS ATORVASTATIN Slim TABLETS LIPIZIM 05607 10MG BP TABLETS ATORVASTATIN LOLIP Global Impex AV 608 TABLETS 10MG IP TABLETS ATORVASTATIN 10 LOLIP 609 Tabrane 10MG IP TABLETS ATORVASTATIN TABLETS 10 ATOSTAR FILM COA 610 N/A 10MG IP TABLETSTABLETS ATORVASTATIN 10 STATOR Algarash (Pvt) Ltd Surien TABLETS612 CIC Lifesciences 10MG IP TABLETS ATORVASTATIN CIC Holdings PLC 10 LDL Abbott Healthcare 613 10MG IP TABLETS ATORVASTATIN LILO-10614 10MG IP TABLETS ATORVASTATIN TABLETS N/A615 20MG IP TABLETS TABLETS ATORVASTATIN Novachem Lanka 20 UMESTATIN TABLETS Glaxo Wellcome TABLETS Gamma N/A Inter Pharm (Pvt) 602 40MGTABLETS ATORVASTATIN VEXTRO 40 TABLETS Global Impex AV I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 63 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAGERMANY 14-Aug-17 Years Two 01-Jun-14 Full INDIAINDIA 20-Apr-15 Full 05-Jan-14 Full GERMANY 01-Jun-14 Full INDIA 17-May-18 Years Two ITALY 03-Mar-18 Years Two SRI LANKA 30-Aug-18INDIA Provisional INDIA 26-Jul-18 Years Two INDIA 02-Mar-18 Years Two 27-Apr-17 Years Two Hameln Pharmaceuticals GmbH/Germany Hospira Australia (Pvt) Ltd Troikaa Troikaa Pharmaceuticals Ltd PharmaceuticalS (Pvt) Ltd Gland Pharma (Pvt) Ltd Hameln Pharmaceuticals GmbH/Germany Hospira Australia (Pvt) Ltd Vital Healthcare Vital (Pvt) Ltd Glaxo Smithkiline Manufacturing SPA (Pvt) Ltd Cadila Healthcare Ltd Macleods Pharmaceuticals Ltd Ltd Hetero Labs Ltd INDIACipla Ltd 09-Dec-14 INDIA Full 05-Dec-17Years Two (Contd.) Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Services Pvt. Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Healthcare lanka Ltd (Pvt) Ltd (Ceylon) Ltd (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP N/ATRYOCURIUM INJECTION INJECTION Slim Ceyoka (Pvt) Ltd Ciron Drugs & ACRIS INJECTION ABC Pharma Atracurium Hameln INJECTION Akbar ATRAVITA INJECTION International Yaden TRACRIUM INJECTION Hemas INJECTION USP 10MG/ML INJECTION USP 10MG/ML INJECTION USP INJECTION USP 10MG/ML INJECTION USP INJECTION 10MG/ML ,2.5ML INJECTION 10MG/ML INJECTION 10MG/ML ,1ml INJECTION 10MG/ML INJECTION 25MG/2.5ML 628 INJECTION 10MG/ML ATRACURIUM Atracurium Hameln INJECTION Akbar 626 BESYLATE ATRACURIUM 627 BESYLATE ATRACURIUM 625 BESYLATE ATRACURIUM 624 BESYLATE ATRACURIUM 623 BESYLATE ATRACURIUM 617 20MG IP TABLETS ATORVASTATIN 20 ATORVA 618 20MG IP TABLETS ATORVASTATIN TABLETS ATORMAC619 Sunshine 20MG IP TABLETS ATORVASTATIN TABLETS ATOREM620 20MG IP TABLETS ATORVASTATIN Pettah Pharmacy LILO-20621 TABLETS 5MG IP TABLETS ATORVASTATIN 5 ATORILP 622 Axia (Pvt) Ltd TABLETS BESYLATE ATRACURIUM TABLETS MSN Laboratories Glaxo Wellcome Breathe Free Lanka 616 20MG IP TABLETS ATORVASTATIN 20 ATOGEN TABLETS N/A Celogen Lanka 64 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 03-Feb-17 Full INDIAINDIA 28-Jul-18 Full 09-Mar-17 Years Two INDIAINDIA 30-Oct-18INDIA Full 20-May-14 Full 07-Feb-16 Full INDIAINDIA 17-Sep-15 Full 29-Apr-14 Full INDIA 28-Mar-15 Full UNITED KINGDOM INDIA 29-Jun-18 Provisional INDIA 24-Dec-18 Years Two INDIAINDIA 28-Jul-18INDIA Full 09-Jul-17 Years Two 30-Nov-14 Full (Pvt) Ltd Sava Healtheare Ltd Ltd Stallion Laboratories Pvt Ltd Shilpa Medicar Ltd INDIAGetwell Pharmaceuticals 02-Aug-18 Provisional PharmaceuticalS (Pvt) Ltd Harson Laborstories Pharmafabrikon Unit Martindale Pharmaceuticals Kwality Pharmaceuticals Pvt Ltd Mercury Laboratories Ltd Neon Laboratories Ltd Pharmaceuticals Ltd Sunway Rohto Pharmaceutical Pvt Ltd (Contd.) (Ceylon) Ltd (Pvt) Ltd Slim Pharmaceuticals (Pvt) Ltd The Esses Pharmacy (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd Ltd (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP POW INJECTION INJECTION AZZ-AIR SPRAY NASAL Emerchemie NB CIRATRO 0.6CIRATRO INJECTIONAZAC Ceyoka (Pvt) Ltd Ciron Drugs & AZACITE 100 LYOPHILIZED POWDER / N/A INJECTION Citihealth Imports N/A INJECTION Novachem Lanka N/AN/A INJECTION Niix Holdings (Pvt) INJECTION International Yaden ATROPAN/A INJECTION Pharmacare Ltd Troikaa INJECTION International Yaden NASAL SPRAY 0.1% W/W SPRAY NASAL 100MG / VIAL P.0.6MG/ML 100MG / VIAL BP 0.6MG/ML BP BP 0.6MG/ML BP B.P. 1MG/1ML B.P. 600MCG/ML ML- 25ML VIAL ML- 25ML 15MG/25ML 643 250MGTABLETS AZITHROMYCIN AZINAM 250 TABLETSAssociates Pharma AMN Life Science 640TABLETS 50MG BP AZATHIOPRINE N/A641 50MG BP TABLETS AZATHIOPRINE AZOSTAL642 AZELASTINE HYDROCHLORIDE TABLETS TABLETS Chamee Chemist Siba Healthcare Bajaj Healthcare 639 AZACITIDINE FOR INJECTION 637 INJECTION I SULPHATE ATROPINE 638 AZACITIDINE FOR INJECTION 636 INJECTION SULPHATE ATROPINE 635 INJECTION SULPHATE ATROPINE 634 INJECTION SULPHATE ATROPINE 633 INJECTION SULPHATE ATROPINE 630 0.6MG/ML INJECTION BP ATROPINE TROPINE631 0.6MG/ INJECTION BP ATROPINE INJECTION632 INJECTION BP ATROPINE Ravilux Company 629 EYE DROPS 1% W/V ATROPINE ATROSUN EYE DROPS International Yaden I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 65 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 31-Dec-14 Full 17-Apr-18 Years Two INDIA 12-Sep-15 Full INDIAINDIA 19-Aug-14 Full 28-Jun-17 Full INDIAINDIA 09-Dec-17 Years Two 23-Aug-14 Full INDIA 02-Nov-17 Years Two INDIAINDIA 07-Jul-18 Full 28-Jun-18 Full INDIA 04-Oct-16 Full Macleods Pharmaceuticals Ltd Renata Limited BANGLADESH 08-Jan-16(Pvt) Ltd Full IVA Health Care IVA (Pvt) Ltd Scences Synmedic Laboratories (Pvt) Ltd Pharmaceuticals Ltd Unique Pharmaceutical Labs Rhydburg Pharmaceuticals Ltd Scences Cian Healthcare (Pvt) Ltd Indoco Remedies India (Contd.) (Pvt) Ltd (Ceylon) Ltd Pharmaceuticals (Pvt) Ltd Health (Pvt) Ltd Health (Pvt) Ltd Pharmaceutical (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Hemas Pharmaceuticals (Pvt) Ltd SUSPENSION SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP ZINTHRIN CAPSULES Emerchemie NB SWILLIDE 500 TABLETS 500AZEEVA PharmAce (Pvt) Ltd TABLETS Swiss Garnier Life Slim AZM 500AZSYNIR 500 TABLETS TABLETS Chamee Chemist Synokem George Steuart ODAZYTH 500PUZUCIL TABLETS TABLETS CIC Holdings PLC C I Ltd A George Steuart BANGLADESH 31-Dec-15 Full SWILLIDE 500 TABLETS 500RHYDIZT PharmAce (Pvt) Ltd TABLETS Swiss Garnier Life Kent AZIO 500 TABLETS Slim ATM 200ATM ORAL 500MG 500MG 500MG 500MG 500MG 500MG 500MG 500MG 500MG 500MG 200MG/5ML 657TABLET AZITHROMYCIN 250MG AZICURE TABLETS Pettah Pharmacy 656TABLETS AZITHROMYCIN 250MG IP AZITEC 250 TABLETS Klintas (Pvt) Ltd United Biotech 655 USP TABLETS AZITHROMYCIN 653 USP TABLETS AZITHROMYCIN 654 USP TABLETS AZITHROMYCIN 651 USP TABLETS AZITHROMYCIN 652 USP TABLETS AZITHROMYCIN 650 USP TABLETS AZITHROMYCIN 649 USP TABLETS AZITHROMYCIN 647 USP TABLETS AZITHROMYCIN 648 USP TABLETS AZITHROMYCIN 646 USP TABLETS AZITHROMYCIN 644 AZITHROMYCIN CAPSULES 250MG ZITHROCINE645 AZITHROMYCIN SUSPENSION CAPSULES N/A Astron (Pvt) Ltd SRI LANKA 22-Mar-17 Full 66 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIA 07-Aug-18 Full BANGLADESH 17-Feb-17 Full BANGLADESH 03-Jun-18 Years Two INDIA 29-Jan-14 Full BANGLADESH 03-Jun-16 Full PAKISTAN 31-Dec-14BANGLADESH 17-Dec-14 Full Full BANGLADESH 10-Jan-17 Full INDIAINDIA 26-Jun-17INDIA Years Two 09-Mar-16 Full 17-Apr-18 Years Two Zim Laboratories Ltd Navana Pharmaceuticals Ltd Laboratories (Pvt) Ltd Beximco Pharmaceuticals Ltd Kopran Ltd INDIABeximco Pharmaceuticals 08-Sep-14Ltd Full Pharmaceuticals Ltd Chemical Industries CCL CCL Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Macleods Pharmaceuticals Ltd Cipla Ltd INDIA 26-Jun-14 Full Cipla LtdAjantha Pharma Ltd INDIA 17-Jun-14 Full (Contd.) Tabrane Tabrane Pharmaceuticals (Pvt) Ltd Co Ltd (Ceylon) Ltd Ltd (Ceylon) Ltd Pharmaceuticals Lanka (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP SUSPENSION ZITO ORAL AZILEB 500 TABLETSAZIROX 500 Ceyoka (Pvt) Ltd TABLETS Leben Darley Butler & AZITHROCIN TABLETS Emerchemie NB ZIMAXAZ-1 CAPSULESODAZYTH PharmAce (Pvt) Ltd Square CAPSULES CAPSULESAZITHROCIN Alaris Lanka (Pvt) CIC Holdings PLC CAPSULES Advanced Emerchemie NB ACASIA 250ACASIA CAPSULES CCL SUSPENSION USP 200MG/5ML SUSPENSION USP 500MG 500MG USP TABLETS 500MG 250MG 250MG 250MG 250MG 250MG 671 AZITHROMYCIN FOR ORAL 669 USP AZITHROMYCIN TABLETS 670 AZITHROMYCIN DIHYDRATE 668 USP AZITHROMYCIN TABLETS 666 AZITHROMYCIN CAPSULES USP 664 AZITHROMYCIN CAPSULES USP 665 AZITHROMYCIN CAPSULES USP 667 AZITHROMYCIN CAPSULES USP 660TABLET AZITHROMYCIN 500MG AZINAM 500661TABLET AZITHROMYCIN 500MG AZICURE 500 TABLETS662TABLET AZITHROMYCIN 500MG TABLETSAssociates Pharma AZEE 500663 AMN Life Science AZITHROMYCIN CAPSULES USP Pettah Pharmacy TABLETS Breathe Free Lanka 658TABLET AZITHROMYCIN 250MG N/A TABLETS Breathe Free Lanka 659TABLET AZITHROMYCIN 250MG 250 ZAHA TABLETS Baur & Co (Pvt) A I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 67 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIA 20-Mar-14 Full INDIA 13-May-14 Full BANGLADESH 01-Mar-15 Full BANGLADESH 07-Feb-14 Full INDIA 03-Apr-14 Full BANGLADESH 23-Nov-17 Full PAKISTAN 21-Feb-14 Full BANGLADESH 20-Apr-18 Full BANGLADESH 24-Feb-15 Full BANGLADESH 13-Jul-18 Years Two INDIA 11-May-16 Full BANGLADESH 23-Feb-17 Full Ajantha Pharma Ltd Renata Limited BANGLADESH 27-Nov-14(Pvt) Ltd Full Novartis Bangladesh Ltd. for Sandoz GmbH Eskayef Bangaladesh Ltd Fredun Pharmaceuticals Ltd Healthcare Pharmaceuticals CCL CCL Pharmaceuticals (Pvt) Ltd Cipla LtdNavana Pharmaceuticals INDIALtd 17-Sep-14 Full Medicon Pharmaceuticals Ltd Beximco Pharmaceuticals Ltd Alembic Pharmaceuticals Ltd Pharmaceuticals Ltd (Contd.) A Baur & Co (Pvt) A Ltd Emerchemie NB (Ceylon) Ltd AssociatesPharma AMN Life Science A Baur & Co (Pvt) A Ltd Sunshine Healthcare lanka Ltd George Steuart Health (Pvt) Ltd (Pvt) Ltd CCL CCL Pharmaceuticals Lanka (Pvt) Ltd Breathe Free Lanka (Pvt) Ltd Darley Butler & Co Ltd (Pvt) Ltd Emerchemie NB (Ceylon) Ltd Citihealth Imports (Pvt) Ltd PharmAce (Pvt) Ltd Square SUSPENSION SUSPENSION SUSPENSION SUSPENSION SUSPENSION SUSPENSION ORAL ORAL SUSPENSION SUSPENSION SUSPENSION SUSPENSION ORAL ORAL SUSPENSION SUSPENSION SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP ZAHA LIQUID 200ZAHA ORAL ZITHRINAZINAM 250 ORAL POWDER DRY BINOZYT ORAL ZITHROX POWDER AZIFRED DS ORAL ROZITH SUSPENSION Citihealth Imports ACASIA ACASIA SUSPENTION AZEEAZIROX ORAL ORAL ZITREX SYRUP DRY Act Enterpriese AZITHROCIN ORAL ALEMBIC AZITHRAL- LIQUIED ZIMAX POWDER FOR SUSPENSION 200MG/5ML SUSPENSION USP 200MG/5ML SUSPENSION USP SUSPENSION USP 200MG/5ML SUSPENSION USP SUSPENSION USP 200MG/5ML SUSPENSION USP SUSPENSION USP 200MG/5ML SUSPENSION USP SUSPENSION USP 200MG/5ML SUSPENSION USP SUSPENSION USP 200MG/5ML SUSPENSION USP SUSPENSION USP 200MG/5ML SUSPENSION USP SUSPENSION USP 200MG/5ML SUSPENSION USP SUSPENSION USP 200MG/5ML SUSPENSION USP SUSPENSION USP 200MG/5ML SUSPENSION USP SUSPENSION USP 200MG/5ML SUSPENSION USP SUSPENSION USP 40mg/ml SUSPENSION USP SUSPENSION USP 200MG/5ML SUSPENSION USP 684 AZITHROMYCIN ORAL 683 AZITHROMYCIN ORAL 682 AZITHROMYCIN FOR ORAL 681 AZITHROMYCIN FOR ORAL 680 AZITHROMYCIN FOR ORAL 679 AZITHROMYCIN FOR ORAL 678 AZITHROMYCIN FOR ORAL 677 AZITHROMYCIN FOR ORAL 676 AZITHROMYCIN FOR ORAL 675 AZITHROMYCIN FOR ORAL 674 AZITHROMYCIN FOR ORAL 673 AZITHROMYCIN FOR ORAL 672 AZITHROMYCIN FOR ORAL 685 AZITHROMYCIN ORAL 68 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 27-Jan-15 Full 26-Jan-15INDIA Full 30-May-17 Years Two INDIABANGLADESH 28-Oct-15 31-Jan-14SRI LANKA Full Full 11-Oct-18INDIA Provisional 22-Sep-17 Years Two INDIA 27-Dec-17 Years Two INDIA 20-Aug-14 Full INDIA 22-Jun-15 Full BANGLADESH 16-Nov-18 Years Two PAKISTAN 29-Jun-15 Full MMC Healthcare Ltd Micro Labs Ltd INDIAAjantha Pharma Ltd LaboratoriesIPCA INDIA 30-Jun-16 Full Laboratories (Pvt) 08-Jun-17Ltd Healthcare Full Pharmaceuticals Ltd. Cadila Healthcare Ltd IVA Health Care IVA (Pvt) Ltd Centurion Laboratories Pvt Ltd Synmedic Laboratories (Pvt) Ltd Theon Pharmaceuticals Ltd Incepta Pharmaceuticals Ltd Getz Pharma Pakistan (Pvt) Ltd (Contd.) Ltd Ltd Ltd Pharmaceuticals (Pvt) Ltd Citihealth Imports (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Health (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Hemas Pharmaceuticals (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP TABLETS SUSPENSION AZEEVA 250AZEEVA TABLETS Slim N/A TABLETS International Yaden AZSYNIR 250 TABLETS George Steuart AZITHRIN 250 TABLETS Slim TRIDOSIL 250TRIDOSIL TABLETS Citihealth Imports ZETRO ORAL 250MG 250MG 250MG 250MG 250MG FOR ORAL SUSPENSION USP SUSPENSION USP FOR ORAL 200MG/5ML 692 250MGTABLETS AZITHROMYCIN AZITHROTAB693 250MGTABLETS AZITHROMYCIN TABLETS AZILIDE694 500MGTABLETS AZITHROMYCIN Markss HLC (Pvt) 500 ZAHA 695 500MGTABLETS AZITHROMYCIN TABLETS AZIFAST TABLETS696 SMM Halcyon (Pvt) 250MG IP TABLETS AZITHROMYCIN AZILEB 250 Baur & Co (Pvt) A TABLETS697 TABLETS 250MGTABLETS AZITHROMYCIN Hemas ROZITH698 Ceyoka (Pvt) Ltd 250MGTABLETS AZITHROMYCIN AZIM 250 Leben 699 250MGTABLETS AZITHROMYCIN FILM COA ZYDZITH 250 TABLETS TABLETS N/A Hemas CIC Lifesciences 691 USP AZITHROMYCIN TABLET 690 USP AZITHROMYCIN TABLET 689 USP AZITHROMYCIN TABLET 688 USP AZITHROMYCIN TABLET 687 USP AZITHROMYCIN TABLET 686 AZITHROMYCIN POWDER I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 69 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIA 31-Dec-16 Full INDIASRI LANKA 31-Dec-16 28-Sep-18 Full Years Two INDIA 05-Jan-18 Full INDIA 16-Mar-15 Full INDIABANGLADESH 17-Feb-14 31-Jan-14 Full Full INDIABANGLADESH 15-Feb-18 31-Dec-14 Full Full INDIA 28-Oct-15 Full Oasis Laboratories (Pvt) Ltd Ltd. Oasis Laboratories (Pvt) Ltd Zim Laboratories Ltd Aristopharma Ltd BANGLADESH 23-Jun-18Years Two G D Laboratories (India) Pvt Ltd Healthcare Pharmaceuticals LaboratoriesIPCA INDIA(Pvt) Ltd 24-Apr-17Years Two Pharmaceuticals Ltd Micro Labs Ltd INDIALaboratories (Pvt) Ltd 01-Jun-18Years Two Stallion Laboratories Pvt Ltd (Contd.) Imports (Pvt ) Ltd ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Citihealth Imports (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Ltd (Pvt) Ltd TABLETS SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP OSI AZ 500OSI TABLETS Union Lanka AZIM TABLETS N/A CIC Lifesciences OSI AZ 500OSI TABLETS RS Biogenics (Pvt) ZITO 250ZITO TABLETS Tabrane AZILEB 250 TABLETSAZ 250 Ceyoka (Pvt) LtdAZIBAC 250 Leben TABLETS TABLETS Hemas Lifeline 500MG 500MG 500MG 250MG 250MG 250MG 250MG 711 USP AZITHROMYCIN TABLETS 712 USP AZITHROMYCIN TABLETS 710 USP AZITHROMYCIN TABLETS 709 USP AZITHROMYCIN TABLETS 708 USP AZITHROMYCIN TABLETS 701 250MGTABLETS AZITHROMYCIN ROZITH702 250MGTABLETS AZITHROMYCIN 250 AZIFAST 703 FILM COA 500MGTABLETS AZITHROMYCIN TABLETS AZITEC 500704 500MGTABLETS AZITHROMYCIN Hemas ZIMAX TABLETS705 500MG IP TABLETS AZITHROMYCIN AZILIDE Klintas (Pvt) Ltd706 USP TABLETS AZITHROMYCIN TABLETS United Biotech TABLETS PharmAce (Pvt) Ltd707 Square USP AZITHROMYCIN TABLETS SMM Halcyon (Pvt) 700 250MGTABLETS AZITHROMYCIN 250 AZAL TABLETS Siba Healthcare 70 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIA 01-Oct-15 Full BANGLADESH 08-Jun-18 Years Two INDIA 29-Oct-17 Full PAKISTAN 27-Jun-17 Full INDIA 20-Nov-15 Full BANGLADESH 29-May-14 Full INDIA 04-Jun-16 Full INDIA 05-Jan-18 Full Pharma Fabrikon INDIAAristopharma Ltd BANGLADESH 12-Jan-18 24-Jan-19 Provisional Orion pharma Ltd BANGLADESH Full 05-Dec-17Years Two Formulation Ltd Serum Institute of India (Pvt) Ltd Aristopharma Ltd BANGLADESH 23-Jun-17 Full Lincolin Pharmaceuticals Healthcare Ltd Getz Pharma (Pvt) Ltd Globe Pharmaceuticals Ltd Theon Pharmaceuticals Ltd Zim Laboratories Ltd (Contd.) (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Co Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Imports (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP BEROCIN-NF CAPSULES Kamazu (Pvt) Ltd Micro Labs LtdBCG INDIA INJECTION 05-Mar-16 Citihealth Imports Full AZ 500 500NIMZA TABLETSAZILIN TABLETS Hemas Kamazu (Pvt) Ltd TABLETS Syncom & J Pharma T ZETRO TABLETS Hemas AZIGLO TABLETS Healthcare Tabrane AZITHRIN 500 TABLETS Slim ZITO 500ZITO TABLETS Tabrane (BCG) VACCINE, LIVE ATTENUATED ATTENUATED LIVE (BCG) VACCINE, 20 DOSES INJECTION WITH VITAMIN C,E,& ZINC WITH VITAMIN BP BP10MG,RIBOFLVI (THIAMIN NIT 3MG, BP 10MG,PYRIDOXINE HCL NICOTINAMIDE ACID 50MG,CAL. PANTOTHENAT 500MG 500MG 500MG 500MG 500MG 500MG 500MG 722 10MG BP TABLET BACLOFEN 723 10MG BP TABLET BACLOFEN BACLON 10 BECLOVAN724 TABLETS 10MG BP TABLET BACLOFEN 725 TABLETS Novachem Lanka 10MG BP TABLET BACLOFEN FENBACK Hemas FLEXILAX 10 TABLETS TABLETS Darley Butler & PharmAce (Pvt) Ltd Square 721 BACILLUS CALMETTE GUERIN 720 CAPSULES B COMPLEX FORTE 718 USP AZITHROMYCIN TABLETS 717 USP AZITHROMYCIN TABLETS 719 USP AZITHROMYCIN TABLETS 716 USP AZITHROMYCIN TABLETS 715 USP AZITHROMYCIN TABLETS 714 USP AZITHROMYCIN TABLETS 713 USP AZITHROMYCIN TABLETS I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 71 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 BANGLADESH 27-Mar-14 Full BANGLADESH 20-Nov-18 Full BANGLADESH 24-Jan-14 Full BANGLADESH 27-Oct-17 Years Two BANGLADESH 24-Mar-17 Full BANGLADESH 08-May-18 Years Two INDIABANGLADESH 26-Sep-14 12-Jan-18SWITZERLAND Years Two Full 31-May-15INDIA Full PAKISTAN 01-Mar-18 03-Aug-14 Full INDIA Full INDIA 08-May-15MALAYSIA Full 10-Apr-16 09-Mar-16 Full Full Chemical Industries Eskayef Bangaladesh Ltd Pharmaceuticals Ltd Globe Pharmaceuticals Ltd Formulation Ltd Pharmafabrikon Unit Healthcare Pharmaceuticals Novartis Pharma A G Atoz Pharmaceuticals (Pvt) Ltd Genome Pharmceuticals (Pvt) Ltd Ratnamani Healthcare (Pvt) Ltd SG Pharma (Pvt) Ltd Ain Medicare Sdn Bhd Beacon Pharmaceuticals Ltd (Contd.) Healthcare lanka Ltd (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd Ltd (Pvt) Ltd Ltd Ltd Pharmacy (Pvt) Ltd Syndicate Medical Ltd Co Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP BUTEROL SYRUP CIC Holdings PLC Advanced DILATOR TABLETS Sunshine ORAL SOLUTION 5MG/5ML ORAL 10MG 739 HYDROCHLORIDE BAMBUTEROL 727 10MG BP TABLET BACLOFEN RESTOBAC728 10MG BP TABLET BACLOFEN TABLETS SPINAFEN 10729 5MG BP TABLET BACLOFEN Harcourts (Pvt) Ltd TABLETS730 General 5MG BP TABLET BACLOFEN FLEXILAX 5 Healthcare Tabrane 731 10MGTABLETS BACLOFEN BACLON 5 TABLETS732 10MGTABLETS BACLOFEN MYOREL PharmAce (Pvt) Ltd TABLETS Square 733 10MG USP TABLETS BACLOFEN LIORESAL Novachem Lanka BACOFEN 10 TABLETS734 10MG USP TABLETS BACLOFEN TABLETS TABLETS Citihealth Imports BACLIN735Asian Pharma Euro 10MG USP Baur & Co (Pvt) A TABLETS BACLOFEN N/A TABLETS736 5MG USP TABLETS BACLOFEN Lanka (Pvt) Tabrane 737 N/A SOLUTION BALANCED SALT TABLETS738 RINS BS HYDROCHLORIDE BAMBUTEROL Lanka (Pvt) Tabrane TABLETS SOLUTION The Esses Commercial 726 10MG BP TABLET BACLOFEN FLEXIBAC TABLETS Delmege Forsyth & 72 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIA 06-Aug-17 Years Two INDIA 26-Jul-17 Full INDIA 26-Jul-17 Years Two INDIA 10-Mar-16 Full INDIAINDIA 10-Feb-15 Full INDIA 30-Apr-15INDIA Full 04-Jan-18 Years Two 28-May-14 Full INDIA 08-Oct-15 Full INDIA 10-Feb-15 Full INDIA 29-Jun-15 Full INDIA 29-Jun-16 Full West Coast West Pharmaceurical works Ltd West Coast West Pharmaceurical works Ltd West Coast West Pharmaceurical works Ltd Emcure Pharmaceuticals Ltd Pharmaceuticals (India) Ltd (Pvt) Ltd Laboratories (Pvt) Ltd Eskay Fine Chemicals (Pvt) Ltd Eskay Fine Chemicals (Pvt) Ltd Eskay Fine Chemicals (Pvt) Ltd Eskay Fine Chemicals (Pvt) Ltd Eskay Fine Chemicals (Pvt) Ltd (Contd.) (Pvt) Ltd (Pvt) Ltd AV Global Impex AV (Pvt) Ltd (Ceylon) Ltd Cee Geez Associates Associates Associates Cee Geez Associates Cee Geez Associates SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP INHALATION SUSPENSION ENEMA Cee Geez ENEMA Cee Geez POWDER SUSPENSION ORAL ORAL SUSPENSION CLOMVEX 400 CAPSULES DPI Global Impex AV CLOMVEX 200 CAPSULES DPI Global Impex AV CLOMVEX 100 POWDER FOR BECLOTOS CREAMBECLOGNTA-C CREAMBECLOMIN PharmAce (Pvt) Ltd Aurochem Pharmatec (Pvt) Ltd Pharma Yash LOTIONBECLASONE-N CREAM Ceyoka (Pvt) Ltd Leben Emerchemie NB MICROBAR GAS ORAL MICROBAR FOR ENEMA MICROBAR FOR ENEMA MICROBAR POWDER MICROBAR- PASTE DIPROPIONATE DPI CAPSULES DIPROPIONATE 400MCG DIPROPIONATE DPI CAPSULES DIPROPIONATE 200MCG DIPROPIONATE 100MCG DIPROPIONATE 0.025% CREAM DIPROPIONATE 0.025% + DIPROPIONATE 2.00% MICONAZOLE NITRATE LOTION 0.025% NEOMYCIN DIPROPIONATE 0.5% CREAM SUSPENSION WITH ACID BASE SUSPENSION WITH 95G/100G 4G BP PACK SUSPENSION BP 92G100G SUSPENSION BP SUSPENSION BP 92G100G SUSPENSION BP SUSPENSION BP 92G100G SUSPENSION BP SUSPENSION BP 100G/100ml SUSPENSION BP 751 BECLOMETHASONE 750 BECLOMETHASONE 749 BECLOMETHASONE 745 BECLOMETHASONE CREAM BP 746 BECLOMETHASONE 747 BECLOMETHASONE 748 BECLOMETHASONE 744 FOR BARIUM SULPHATE 743 FOR BARIUM SULPHATE 742 FOR BARIUM SULPHATE 741 FOR BARIUM SULPHATE 740 FOR BARIUM SULPHATE I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 73 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 07-Aug-17 Full SRI LANKA 04-Jan-18 Years Two 27-Jan-15 Full CHINA 06-Jun-14 Full CHINA 22-May-15 Full SRI LANKA 27-Jan-16 Full SRI LANKA 31-Jul-16 Full ITALY 24-Feb-15 Full Cipla Ltd INDIA 06-Feb-14 Full (Pvt) Ltd Sciences (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Shandong Jewim Pharmaceutical Co. Ltd Cipla Ltd INDIA 06-Feb-18 Full Shandong Jewim Pharmaceutical Co. Ltd Manufacturing Akbar (Pvt) Ltd for Pharmaceuticals (Pvt) Ltd Pharmaceuticals Cipla LtdCipla Ltd INDIASciences (Pvt) Ltd INDIA 06-Feb-14 Full 27-Jul-18Years Two (Contd.) (Pvt) Ltd Healthcey (Pvt) Ltd Biodeal (Ceylon) Ltd (Pvt) Ltd (Ceylon) Ltd (Pvt) Ltd (Pvt) Ltd N/A Emergen Life NASAL SPRAYNASAL Breathe Free Lanka CAPSULES NASAL SPRAYNASAL Emerchemie NB FOR INHALATION SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP BECLOGENTA-N CREAMBECLOHALE 400 Pharmatec (Pvt) Ltd INHALATION Pharma Yash N/ABECLAE AQUANASE Emergen Life BIOTASONE RESPIRATOR BECLOMATE NS BECLOMATE 50 BECLATE-200 CAPSULES 400BECLOVENT Breathe Free Lanka POWDER DRY N/ARINO CLENIL SPRAY NASAL Lina Burhani EnterprisesBCLOTIS 50 Chiesi SPRAY NASAL Emerchemie NB BECLATE-100 CAPSULES Breathe Free Lanka BECLATE 400BECLATE CAPSULESBECLOHALE 200 POWDER DRY Breathe Free Lanka DIPROPIONATE,CLOTRIMASOLE & DIPROPIONATE,CLOTRIMASOLE NEOMYCIN CREAM CAPSULES 400MCG INHALATION SOLUTION 50MCG SPRAY NASAL PER DOSE DIPROPIONATE REPIRATORY REPIRATORY DIPROPIONATE 200MCG CAPSULES BP DIPROPIONATE NASAL SPRAY BP BP SPRAY NASAL DIPROPIONATE 50MCG DIPROPIONATE DRY POWDER DRY DIPROPIONATE 400MCG INHALA DIPROPIONATE DRY POWDER DRY DIPROPIONATE 200MCG INHALA SPRAY NASAL DIPROPIONATE 100MCG SPRAY NASAL DIPROPIONATE 50MCG/DOSE DIPROPIONATE B.P CAPSULES B.P DIPROPIONATE 100MCG INHALATION DIPROPIONATE CAPSULES 400MG DIPROPIONATE POWDER DRY DIPROPIONATE 200MCG INHALA 761 BECLOMETHASONE 762 POWDER BECLOMETHASONE DRY 763 BECLOMETHASONE INTERNASAL 760 BECLOMETHASONE 759 BECLOMETHASONE 756 BECLOMETHASONE 755 BECLOMETHASONE 757 BECLOMETHASONE 758 BECLOMETHASONE 752 BECLOMETHASONE 753 BECLOMETHASONE 754 BECLOMETHASONE 74 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 CHINA 30-Jun-15 Full INDIA 29-Aug-14 Full INDIA 12-Jun-14 Full CHINA 30-Jun-14 Full INDIA 18-Jun-16 Full INDIA 18-Jun-15 Full BANGLADESH 02-Jun-18 Full INDIA 21-Sep-17 Years Two INDIA 21-Sep-17 Years Two CHINA 01-Jul-17 Years Two BANGLADESH 29-Apr-16 Full Shandong Jewim Pharmaceutical Co. Ltd Glenmark Pharmaceuticals Ltd Glenmark Pharmaceuticals Ltd Cipla LtdShandong Jewim INDIAPharmaceutical Co. Ltd 11-Nov-14 Full Glenmark Pharmaceuticals Ltd Glenmark Pharmaceuticals Ltd Beximco Pharmaceuticals Ltd Concept Pharmaceuticals Ltd Concept Pharmaceuticals Ltd Shandong Jewim Pharmaceutical Co. Ltd Beximco Pharmaceuticals Ltd (Contd.) (Ceylon) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd (Ceylon) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Ceylon) Ltd International (Pvt) Ltd Softcare International (Pvt) Ltd (Ceylon) Ltd (Ceylon) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP INHALATION Breathe Free Lanka DRY POWDERDRY Softcare DRY POWDER DRY FOR INHALATION CAPSULES Emerchemie NB BCLOTICS INHALATION Emerchemie NB IBICAR 250 INHALER Hemas IBICAR 50 INHALATION Hemas BECLATE 250 HFA 250 HFA BECLATE INHALER BCLOTIS 250 INHALATION Emerchemie NB IBICAR 200 INHALATION Hemas IBICAR 100 INHALATION Hemas DECOMIT 100DECOMIT INHALATION Emerchemie NB BECLOLET DPI BECLOLET 400MG BECIATE DPI BECIATE 200MCG BECLOMATE 200 BECLOMATE MCG FLOWCAPS DECOMIT SPRAY NASAL Emerchemie NB INHALATIONs BP 100MCG/Dose BP INHALATIONs INHALATION BP250MCG INHALATION ACTUATION INHALATION BP 50MCG HFA BP INHALATION INHALATION BP 250MCG HFA 250MCG HFA BP INHALATION INHALER INHALATION BP 250MCG HFA 250MCG HFA BP INHALATION INHALER INHALATION BP 200MCG/Actuation BP INHALATION INHALATION BP 100MCG ACTUTION 100MCG BP INHALATION INHALATION BP 100MCG ACTUTION 100MCG BP INHALATION INHALATION CAPSULE 400MCG INHALATION INHALATION 200MCG CAPSULES INHALATION INHALATION 200MCG CAPSULES INHALATION BP 50MCG BP 775 BECLOMETHASONE PRESSURISED 774 BECLOMETHASONE PRESSURISED 773 BECLOMETHASONE PRESSURISED 772 BECLOMETHASONE PRESSURISED 771 BECLOMETHASONE PRESSURISED 770 BECLOMETHASONE PRESSURISED 769 BECLOMETHASONE PRESSURISED 768 BECLOMETHASONE PRESSURISED 767 BECLOMETHASONE POWDER FOR 766 BECLOMETHASONE POWDER FOR 765 BECLOMETHASONE POWDER FOR 764 SPRAY BECLOMETHASONE NASAL I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 75 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 07-Oct-14 Full INDIAUNITED KINGDOM 27-Jul-17 Years Two INDIAINDIA 06-May-16INDIA Full 26-Dec-16 Full 24-Aug-16 Full INDIASRI LANKA 25-Jul-18 Years Two 27-Sep-16INDIA Full 04-Apr-16BANGLADESH 07-Feb-14 Full Full INDIA 01-Dec-14 Full INDIA 18-Nov-17 Years Two INDIA 16-May-18 Full BANGLADESH 01-Mar-18 Years Two Glaxo Operations UK Ltd Torrent Pharmaceuticals Ltd Centaur Pharmaceutical (Pvt) Ltd Divine Laboratories (Pvt) Ltd Indi Pharma (Pvt) Ltd Pharmaceuticals Manufacturer Corporation Health ICPA Products Ltd Wings Biotech INDIAPharmaceuticals Ltd 21-Aug-17(india) (Pvt) Ltd Years Two Getwell Pharmaceuticals Panacea Biotec (Pvt) Ltd Wallace Wallace Pharmaceuticals Ltd Pharmaceuticals Ltd (Contd.) (Ceylon) Ltd Ltd Health (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Ltd Health (Pvt) Ltd (Pvt) Ltd Pharmacy (Pvt) Ltd Ltd Ltd PharmAce (Pvt) Ltd Square DENTAL GELDENTAL PharmAce (Pvt) Ltd Square INHALTION SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP OROGEL DENTAL DENTAL OROGEL GEL N/AN/A OINTMENT Ceyoka (Pvt) Ltd INJECTION Galentic Pharma Slim BENDAWEL INJECTION The Esses BEMUSTIN INJECTION Markss HLC (Pvt) WALACORT TABLETS Emar Pharma (Pvt) BECLOMIN 100 PRESSURIZED W/W OINTMENT 1MG/ML INJECTION USP LYOPHILIZED FOR INJECTION LYOPHILIZED 100MG VIAL FOR INJECTION 100MG VIAL 0.5MG INHALATIONs BP 100MCG/Dose BP INHALATIONs 786 PEROXIDE 4% BENZOYL BREVOXYL788 5ANE GEL PEROXIDE 5% BENZOYL ENZOXID CREAM789 2.5% BP PEROXIDE GEL BENZOYL GEL BENZOX Glaxo Wellcome GEL Mega Pharma (Pvt) George Steuart 787 PEROXIDE 5% BENZOYL AC 5 GEL PERSOL GEL TOPICAL Emar Pharma (Pvt) 780 2MG BP TAB BENZHEXOL 781 N/A 20% USP BENZOCAINE GEL 782 20% USP BENZOCAINE GEL MUCOPAIN783 20% USP GEL BENZOCAINE ORAL TABLETS N/A GEL784 N/A BENZOIC ACID COMPOUND George Steuart 785 BENZOTROPINE MESYLATE GEL State International Yaden 779 BENDAMUSTIN HYDROCHLORIDE 778 BENDAMUSTIN HYDROCHLORIDE 777 IP BECLOMETHASONE TABLETS 776 BECLOMETHASONE PRESSURISED 76 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 07-Apr-16 Full STATES INDIA 19-Nov-16 Full INDIA 04-Jul-14 Full SRI LANKA 15-Dec-17 Full INDIA 27-Jul-17 Years Two INDIA 29-Aug-15 Full INDIAINDIA 04-Apr-14 Full INDIA 24-Nov-17 Years Two INDIA 16-Feb-18 Full INDIA 04-Apr-14 Full INDIA 16-Jan-18 Provisional 13-Oct-17 Full INDIA 04-May-16 Full Abb Vie IncAbb Vie UNITED Geno Pharmaceuticals Pvt Ltd Karnataka Antibiotic & Pharmaceuticals Ltd Pharmaceuticals (Pvt) Ltd Divine Laboratories (Pvt) Ltd SG Pharma (Pvt) Ltd Encube Ethicals (Pvt) Ltd Centaur Pharmaceutical (Pvt) Ltd Aurochem Pharmaceuticals (India) Ltd Centaur Pharmaceutical (Pvt) Ltd Encube Ethicals (Pvt) Ltd Aurochem Pharmaceuticals (India) Ltd Indi Pharma (Pvt) Ltd (Contd.) Healthcare lanka Ltd (Pvt) Ltd Ltd N/A Navesta Pharmaceuticals (Pvt) Ltd Pharmacy (Pvt) Ltd Healthcare lanka Ltd Health (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Health (Pvt) Ltd Healthcare lanka Ltd Pharmaceuticals (Pvt) Ltd Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP INJECTION GEL Hemas SURVANTABETAHIST TABLETS Sunshine Mansel (Ceylon) N/A INJECTION Baur & Co (Pvt) A PENZID POWDER FOR FLAGENTIN INJECTION Slim BENCOGEN INJECTION The Esses 2.5% 16MG SUSPENSION 200mg in 8ml 300MG (500,000 Units) INJECTION BP 600MG 1,000,000 Unit INJECTION BP INJECTION USP 1MG/1ML INJECTION USP INJECTION USP 1MG/1ML INJECTION USP 802 DIHYDROCHLORIDE BETAHISTINE 801 INTRATRACHEAL BERACTANT 800 PENICILLIN INJECTION BP BENZYL 799 PENICILLIN FOR BENZYL 798 BENZTROPINE MESYLATE 792 2.5% BP PEROXIDE GEL BENZOYL AC 2.5% BENZAN GEL793 2.5% BP PEROXIDE GEL BENZOYL AC 2.5% PERNEX GEL Sunshine 794 5% BP PEROXIDE GEL BENZOYL 5% BP ACNESTAR GEL George Steuart 795 5% BP PEROXIDE GEL BENZOYL AC 5% PERNEX GEL796 Hemas 5% IP PEROXIDE GEL BENZOYL AC BENZAC 797 BENZTROPINE MESYLATE George Steuart GEL Sunshine 791 2.5% BP PEROXIDE GEL BENZOYL BP ACNESTAR 790 2.5% BP PEROXIDE GEL BENZOYL AC 2.5 PERSOL GEL Emar Pharma (Pvt) I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 77 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 BANGLADESH 06-Dec-17 Years Two BANGLADESH 06-Dec-17 Years Two PAKISTAN 13-Feb-17 Full CYPRUS 23-Oct-14 Full INDIAINDIA 11-Nov-14 Full 30-Sep-17 Full INDIAFRANCE 11-Nov-14 Full 13-Aug-16 Full INDIAFRANCE 29-Aug-16 Full 30-Mar-16 Full INDIA 08-Jan-14 Full FRANCE 20-Mar-16 Full Incepta Pharmaceuticals Ltd Incepta Pharmaceuticals Ltd Remington pharmaceutical Industries (Pvt) Ltd Farmaceutisch Analytisch Laboratories Theon Pharmaceuticals Ltd Pulse Pharmaceuticals (Pvt) Ltd Laboratories Ltd Medochemie Ltd CYPRUSTheon 14-Mar-18Pharmaceuticals Years Ltd Two Laboratories Ltd Windlas Biotech (Pvt) Ltd Geno Pharmaceuticals Pvt Ltd Laboratories Ltd (Contd.) (Pvt) Ltd (Pvt) Ltd Co Ltd Laboratories (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Health (Pvt) Ltd Laboratories (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP MENARIL TABLETS Citihealth Imports MENARIL TABLETS Citihealth Imports D-VERT TABLETS Delmege Forsyth & LAFINOR 24 TABLETS Associated HISTAVERT 24HISTAVERT TABLETS George Steuart BETASERC 24THEOHIST TABLETS TABLETS CIC Holdings PLC Mylan Slim BETASERC 8BETASERC TABLETSALFINOR 8MG TABLETS CIC Holdings PLC 8THEOHIST Mylan Associated TABLETS Slim B HIST 8B HIST TABLETS Lifeline BETAHIST TABLETS Mansel (Ceylon) BETASERC TABLETS CIC Holdings PLC Mylan TABLETS 16MG TABLETS TABLETS 16MG TABLETS TABLETS BP 24MG BP TABLETS TABLETS BP 24MG BP TABLETS TABLETS BP 24MG BP TABLETS TABLETS 24MG TABLETS 24MG TABLETS 8MG 8MG 8MG 8MG 8MG 16MG 811 DIHYDROCHLORIDE BETAHISTINE 815 DIHYDROCHLORIDE BETAHISTINE 814 DIHYDROCHLORIDE BETAHISTINE 813 DIHYDROCHLORIDE BETAHISTINE 812 DIHYDROCHLORIDE BETAHISTINE 809 DIHYDROCHLORIDE BETAHISTINE 810 DIHYDROCHLORIDE BETAHISTINE 808 DIHYDROCHLORIDE BETAHISTINE 806 DIHYDROCHLORIDE BETAHISTINE 807 DIHYDROCHLORIDE BETAHISTINE 805 DIHYDROCHLORIDE BETAHISTINE 804 DIHYDROCHLORIDE BETAHISTINE 803 DIHYDROCHLORIDE BETAHISTINE 78 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 PHILIPPINES 11-Apr-15INDIA Full 30-Sep-15PAKISTAN Full 01-Jun-15 Full INDIA 17-Jun-18 Years Two INDIA 08-Nov-17 Years Two BANGLADESH 30-Aug-18 Full CYPRUS 23-Oct-14 Full INDIA 17-May-18 Years Two INDIA 30-Sep-17 Full INDIA 28-Apr-18 Provisional INDIA 26-Apr-18 Provisional INDIA 12-Jan-18 Full Pulse Pharmaceuticals (Pvt) Ltd Micro Labs Ltd INDIALaboratories (Pvt) Ltd 26-May-15 Full LLOYD Laboratories Inc Aurobindo Pharam Ltd Synmedic Laboratories (Pvt) Ltd Incepta Pharmaceuticals Ltd Farmaceutisch Analytisch Laboratories Aurobindo Pharam Ltd Pulse Pharmaceuticals (Pvt) Ltd Centurion Laboratories Pvt Ltd Centurion Remedies Pvt Ltd Windlas Biotech (Pvt) Ltd (Contd.) Health (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Ltd Health (Pvt) Ltd (Pvt) Ltd Laboratories (Pvt) Ltd Ltd Health (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP BETAGENIC CREAM Morison PLC ATCO VERT TABLETS Slim BE-STEDY 8BE-STEDY TABLETS Alaris Lanka (Pvt) VERISYN TABLETS George Steuart MENARIL TABLETS Citihealth Imports ALFINOR 16MG TABLETS Associated BE-STEDY 8BE-STEDY TABLETS Alaris Lanka (Pvt) HISTAVERT 16HISTAVERT TABLETS George Steuart CENVERT 16CENVERT TABLETS International Yaden CENVERT 8CENVERT TABLETS International Yaden B-HIST-16 TABLETS Lifeline DIPROPIONATE) 0.05%+ DIPROPIONATE) 0.1% (AS SULPHATE) GENTAMICIN W/W CREAM TABLETS 16MG TABLETS TABLETS BP 8MG BP TABLETS TABLETS BP 8MG BP TABLETS TABLETS BP 8MG BP TABLETS TABLETS BP 16MG BP TABLETS TABLETS BP 16MG BP TABLETS TABLETS BP 16MG BP TABLETS TABLETS BP 16MG BP TABLETS TABLETS BP 16MG BP TABLETS TABLETS BP 16MG BP TABLETS 826 8MG BP TABLETS BETAHISTINE 8 HISTAVERT 827 8MG BP TABLETS BETAHISTINE TABLETS 8 NURONIST 828 (AS BETAMETHASONE George Steuart TABLETS Salveo Pharma 825 HYDROCHLORIDE BETAHISTINE 824 DIHYDROCHLORIDE BETAHISTINE 823 DIHYDROCHLORIDE BETAHISTINE 822 DIHYDROCHLORIDE BETAHISTINE 821 DIHYDROCHLORIDE BETAHISTINE 820 DIHYDROCHLORIDE BETAHISTINE 819 DIHYDROCHLORIDE BETAHISTINE 818 DIHYDROCHLORIDE BETAHISTINE 817 DIHYDROCHLORIDE BETAHISTINE 816 DIHYDROCHLORIDE BETAHISTINE I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 79 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 08-Aug-17 Years Two INDIAINDIA 10-Mar-17 Full 15-May-14 Full INDIA 10-Mar-17 Full MALAYSIA 19-Jun-14 Full PAKISTAN 10-Feb-18INDIA Years Two INDIA 21-Apr-15 Full 08-Nov-14 Full INDIA 24-Oct-17 Full INDIA 03-Dec-17 Years Two INDIA 17-Feb-14 Full INDIA 17-Oct-17 Years Two INDIA 21-Oct-14 Full UNITED KINGDOM (india) (Pvt) Ltd Agio Pharmaceuticals Ltd Agio Pharmaceuticals Ltd Pharmaniaga Manufacturing berhand Pharmaceuticals (India) Ltd (india) (Pvt) Ltd Laboratories (Pvt) Ltd Glaxo Smithkiline Pharmaceuticlas PharmaceuticalS (Pvt) Ltd Pharmaceutical (Pvt) Ltd Glaxo Smithkiline Pharmaceuticlas Aurochem Pharmaceuticals (India) Ltd Glaxo Operations UK Ltd (Contd.) (Pvt) Ltd (Pvt) Ltd (Ceylon) Ltd Morison PLC ATCO Beecham (Pvt) Ltd Ceyoka (Pvt) Ltd Ciron Drugs & PharmAce (Pvt) Ltd DCI Pharmaceuticlas (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticlas (Pvt) Ltd NASAL DROPS NASAL DROPS DROPS SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP DERMOSONE CREAM Ceyoka (Pvt) Ltd Galentic Pharma BETA-D CREAM Citihealth Imports BETA-D CREAM Citihealth Imports BEPROCOAT-G CREAMPYLOCAIN PharmAce (Pvt) Ltd Aurochem OINTMENTDERMASOLE Ceyoka (Pvt) Ltd CREAM Galentic Pharma Emerchemie NB PROBETA-N EYE,EAR & BETNOVATE CBETNOVATE CREAM Glaxo Smith Kline BETNEW EYE & EAR BETNOR EYE & EAR BETNOVATE- SBETNOVATE- OINTMENT GlaxoSmithkiline NUFORCE- G CREAM Hemas BETNOVATE CBETNOVATE CREAM GlaxoSmithkiline CREAM USP 0.05% W/W CREAM USP CREAM USP 0.05% W/W CREAM USP CREAM USP 0.05% W/W CREAM USP GENTAMICIN IMG W/W CREAM GENTAMICIN 0.5MG+PHENYLEPHRINE 1MG+LIDOCAINE 25MG/G W/W 0.1%+NEOMYCIN 0.5% W/V DROPS FOR EYE,EAR & NOSE 0.1%+CLIOQUINOL 3% CREAM 0.1%+CLIOQUINOL NEOMYCIN 0.5% W/W +NEOMYCIN 0.5% W/W +SALICYLIC ACID 3% OINTMENT +SALICYLIC +CLOTRIMAZOLE 10MG & 1MG CREAM GENTAMICIN CLIOQUINOL 3% W/W CLIOQUINOL 841 DIPROPIONAE BETAMETHASONE 840 DIPROPIONAE BETAMETHASONE 839 DIPROPIONAE BETAMETHASONE 836 0.5MG WITH BETAMETHASONE 837 BETAMETHASONE 838 CREAM 0.1% BETAMETHASONE 835 BETAMETHASONE 834 BETAMETHASONE 833 0.1%+ BETAMETHASONE 832 0.1% BETAMETHASONE 831 0.1% BETAMETHASONE 830 0.064% BETAMETHASONE 829 0 0.1% BETAMETHASONE 80 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIA 18-Apr-17 Full INDIA 02-Oct-16 Full INDIAINDIA 15-Dec-16 Full 12-Mar-16INDIA Full 05-Mar-14 Full INDIABANGLADESH 28-May-16 24-Aug-17 Years Two Full MALAYSIA 17-Jun-17 Full INDIABANGLADESH 14-Dec-16 18-Apr-18 Full Full INDIA 04-May-18 Years Two S Kant Healthcare Ltd Merck Limited INDIA 10-Apr-18Merck LimitedYears Two INDIASun Pharmaceutical industries 10-Apr-17 Full & Co Ltd Laboratories (Pvt) Ltd Agio Pharmaceuticals Ltd Pharmaceuticals Ltd Pharmaceuticals SDN BHD S Kant Healthcare Ltd Pharmaceuticals Ltd S Kant Healthcare Ltd Agio Pharmaceuticals Ltd (Contd.) Ltd. (Ceylon) Ltd (Ceylon) Ltd (Ceylon) Ltd (Pvt) Ltd Pharmaceuticals Ltd Co Ltd (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP BETAPRO C+GBETAPRO CREAM CIC Lifesciences GV BET CREAMGV BET CREAM MBETAMIL Chamee Chemist CREAM Gopaldas Visram BECLOMIN Emerchemie NB OINTMENT -NBETAMIL Ceyoka (Pvt) Ltd CREAM Leben -NDIPROVATE CREAM Emerchemie NB Emerchemie NB DIPROBET OINTMENTBEPROSONE PharmAce (Pvt) Ltd OINTMENT Square BETACYLIC Indoscan (Pvt) Ltd Hoe OINTMENT Citihealth Imports DIPROBET CREAMBETAD PharmAce (Pvt) Ltd Square CREAM Mediccon BETAPRO CREAM Delmege Forsyth & BETA-D OINTMENT Citihealth Imports 0.05%+CLOTRIMAZOLE Sulph 0.1% w/w 1%+GENTAMICIN 0.05% MICONAZOLE NITRATE 2% 0.05% MICONAZOLE NITRATE W/W 0.5% 0.05% NEOMYCIN SULPHATE W/W 0.05% W/W 2% 0.05% MICONAZOLE NITRATE W/W 0.5% 0.05% NEOMYCIN SULPHATE W/W OINTMENT USP 0.05% W/W USP OINTMENT 0.05% W/W USP OINTMENT ACID 3% 0.5% & SALYCYLIC W/W OINTMET CREAM USP 0.05% W/W CREAM USP 0.05% W/W CREAM USP CREAM USP 0.05% W/W CREAM USP CREAM USP 0.05% W/W CREAM USP 854 DIPROPIONATE BETAMETHASONE 851 DIPROPIONATE BETAMETHASONE 853 DIPROPIONATE BETAMETHASONE 849 DIPROPIONATE BETAMETHASONE 850 DIPROPIONATE BETAMETHASONE 852 DIPROPIONATE BETAMETHASONE 846 DIPROPIONAE BETAMETHASONE 847 DIPROPIONAE BETAMETHASONE 848 DIPROPIONATE BETAMETHASONE 844 DIPROPIONAE BETAMETHASONE 845 DIPROPIONAE BETAMETHASONE 843 DIPROPIONAE BETAMETHASONE 842 DIPROPIONAE BETAMETHASONE I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 81 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 PAKISTAN 03-Feb-18 Full INDIA 13-Feb-14 Full INDIAMALAYSIA 29-Jun-17 Years Two 01-Sep-18MALAYSIA Full 07-Jun-15INDIA Full MALAYSIA 27-Apr-15 02-Aug-16 Full MALAYSIA Full 09-Aug-16 Full INDIA 12-Mar-16 Full MBL PharmaMBL PAKISTAN 27-Sep-18Years Two MBL PharmaMBL PAKISTANLaboratories (Pvt) 27-Sep-18Ltd Full S Kant Healthcare Ltd Pharmaceuticals SDN BHD Pharmaceuticals SDN BHD Pharmaceuticals (India) Ltd Pharmaceuticals SDN BHD Pharmaceuticals SDN BHD & Co Ltd S Kant Healthcare Ltd (Contd.) Markss HLC (Pvt) Ltd Markss HLC (Pvt) Ltd Morison PLC ATCO Co Ltd Pharmaceuticals Ltd DROPS DROPS DROPS NASAL OINTMENT Chamee Chemist Gopaldas Visram SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP BETASOL-N EYE & EAR BETASOL EYE & EAR PROBETA EYE,EAR & BEPROGEL SOLUTIONBEPROSALIC Indoscan (Pvt) Ltd CREAM Hoe BEPROCORT Indoscan (Pvt) Ltd CREAM Hoe BEPROSONE PharmAce (Pvt) Ltd CREAM Aurochem BE PROSALIC LOTION Indoscan (Pvt) Ltd Hoe Indoscan (Pvt) Ltd - N GV BET CREAM Hoe CGDELBETA CREAM Delmege Forsyth & DIPGEN CREAM Mediccon PHOSPHATE 0.1%+NEOMYCIN 0.5% PHOSPHATE EYE/EAR DROPS W/V PHOSPHATE DROPS FOR EYE/EAR PHOSPHATE or NOSE 0.1% W/V PHOSPHATE DROPS FOR EYE/EAR DROPS FOR EYE/EAR PHOSPHATE 0.1% W/V 0.064% W/V ACID 3% W/W 0.064%+SALICYLIC 0.064% W/W CREAM USP 0.064% W/W CREAM USP 0.05%V+ USP DIPROPIONATE BP SULPHATE GENTAMICIN 0.1%+CLOTRIMAZOLE 1% CREAM W/V 0.1%+NEOMYCIN SULPHATE USP 0.5% CREAM 1% W/W TO EQUIVALENT USP 0.05%W/ BETAMETHASONE W+CLOTRIMAZOLE BP SULPHATE 1%+GENTAMICIN GENTAMYCIN TO EQUIVLANT 0.1 SULPHATE,GENTA 0.064MG/G AND GENTAMICIN AND GENTAMICIN 0.064MG/G 1MG/G W/W CREAM 865 SODIUM BETAMETHASONE 864 SODIUM BETAMETHASONE 863 SODIUM BETAMETHASONE 856 DIPROPIONATE BETAMETHASONE 857 DIPROPIONATE BETAMETHASONE 858 DIPROPIONATE BETAMETHASONE 859 DIPROPIONATE BETAMETHASONE 860 BETAMETHASONE 861 DIPROPIONATE BETAMETHASONE 862 DIPROPIONATE BETAMETHASONE 855 DIPROPIONATE BETAMETHASONE 82 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIA 20-Oct-16 Full PAKISTAN 17-Jul-17INDIA Years Two INDIA 11-Nov-17 Years Two INDIA 13-Mar-18 Full 29-Jun-18 Full PAKISTAN 17-Jul-14 Full PAKISTAN 17-Jul-18PAKISTAN Years Two 16-Oct-17PAKISTAN Years Two 16-Oct-17 Years Two INDIAPAKISTAN 26-Jun-17 Years Two 11-Nov-17 Years Two PAKISTAN 28-Feb-14INDONESIA Full 06-Sep-17 Years Two Belco Pharma (Pvt) Ltd Laboratories (Pvt) Ltd House Co Ltd Laboratories (Pvt) Ltd Glaxo Smithkiline Pakistan Ltd Glaxo Smithkiline Pakistan Ltd Laboratories (Pvt) Ltd Laboratories (Pvt) Ltd Glaxo Smithkiline Pakistan Ltd Laboratories (Pvt) Ltd Glaxo Smithkiline Pharmaceuticlas Remington pharmaceutical Industries (Pvt) Ltd T Schering- P Plough Indonesia Tbk (Contd.) Agency Pvt Ltd Pharmaceuticlas (Pvt) Ltd Pharmaceuticlas (Pvt) Ltd Pharmaceuticlas (Pvt) Ltd Pharmaceuticlas (Pvt) Ltd Delmege Forsyth & Co Ltd Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP NASAL DROPS NASAL BETADERM-N OINTMENTBETAMET-N Morison PLCBETALEB CREAM ATCO Pharma AssociatesBETANONE OINTMENT General Drugs Ceyoka (Pvt) Ltd CREAM Leben Leader Pharma BETNOVATE-N OINTMENT GlaxoSmithkiline BETADERM-N CREAMBETADERM-N Morison PLC CREAMBETNOVATE-N ATCO CREAM Morison PLC ATCO GlaxoSmithkiline BETADERM CREAMBETNOVATE CREAM Morison PLC ATCO GlaxoSmithkiline BETNELAN TABLETS GlaxoSmithkiline BETADROP-N EYE,EAR & + NEOMYCIN 0.5% SKIN OINTMENT + NEOMYCIN 0.5% W/W CREAM W/W B P W/W B P + NEOMYCIN 0.5% SKIN OINTMENT + NEOMYCIN 0.1% W/W + NEOMYCIN 0.1% W/W 0.1% + NEOMYCIN 0.5%W/W SKIN OINTMENT 0.1% W/W CREAM 0.1% W/W 0.5MG PHOSPHATE 0.1%+NEOPMYCIN PHOSPHATE EYE/EAR / 0.5% BP SULPHATE NOSE DROPS 875 0.1% VALERATE BETAMETHASONE 876 0.1% VALERATE BETAMETHASONE 877 0.1% VALERATE BETAMETHASONE 878 0.1% VALERATE BETAMETHASONE 874 0.1% VALERATE BETAMETHASONE 871 0.1% VALERATE BETAMETHASONE 872 0.1% VALERATE BETAMETHASONE 873 VALERATE BETAMETHASONE 869 CREAM USP BETAMETHASONE 870 VALERATE BETAMETHASONE 867 0.5MGTABLETS BETAMETHASONE CELESTONE868 TABLETS IP TABLETS BETAMETHASONE Baur & Co (Pvt) A 866 SODIUM BETAMETHASONE I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 83 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 CHINARUSSIA 26-Oct-17 12-Aug-18 Full Years Two INDIASRI LANKA 20-Oct-16 18-May-18INDIAYears Two Full PAKISTAN 05-Jun-14 16-Oct-17BELGIUM Full Full 04-Oct-15 Full INDIA 06-Oct-16 Full INDIA 24-Jan-14 Full INDIA 31-Oct-15 Full PAKISTAN 17-Jul-14INDIA Full 20-Oct-18 Full INDIA 04-Oct-18 Full joint Stock Company Ashford Laboratories Ltd (India) (Pvt) Ltd & Co Ltd Laboratories (Pvt) Ltd N V Belco Pharma (Pvt) Ltd Yash Medicare Yash (Pvt) Ltd Agio Pharmaceuticals Ltd Hovid SDN Bhd MALAYSIAB D H Industries 31-May-16Ltd Full Pharmaceutical Glaxo Wellcome Glaxo Wellcome Pakistan Ltd Laboratories (Pvt) Ltd (Contd.) Ltd Agency Pvt Ltd Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Pharmaceuticlas (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP AVEGRA SOLUTION PharmAce (Pvt) Ltd BIOCAD Closed N/AN/ABETADERM OINTMENT N/A OINTMENT CREAMBETOPIC-S Morison PLCACCULOL EYE DROPS Chamee Chemist ATCO Gopaldas Visram Morison PLC Astra Lifecare EYE DROPS Alocon Couvreur Ceylon (Pvt) Teastar BETANONE OINTMENT Leader Pharma BETAVIN OINTMENT Himan Group (Pvt) BETA-V CREAMBETA-V CREAM Citihealth Imports N/ABETASONE CREAM CREAMN/A Thorn Associates Pharma Central drugs and CREAM Ravilux Company BETNOVATE OINTMENT GlaxoSmithkiline BETALEB CREAM Ceyoka (Pvt) Ltd Leben SOLUTION FOR INFUSION 25MG/4ML OINTMENT USP 0.1% W/W USP OINTMENT 0.1% W/W USP OINTMENT 0.1% W/W USP OINTMENT DROPS 0.25% 0.5% SOLUTION USP OINTMENT B.P 0.1% W/W B.P OINTMENT OINTMENT B.P 0.1% W/W B.P OINTMENT CREAM USP 0.1% W/W CREAM USP CREAM BP 0.1% CREAM BP CREAM B.P 0.1% W/W CREAM B.P 1% W/W CREAM B.P 0.1 % W/W 0.1 % W/W 892 CONCENTRATE BEVACIZUMAB 887 VALERATE BETAMETHASONE 888 VALERATE BETAMETHASONE 889 VALERATE BETAMETHASONE 890 HYDROCHLORIDE EYE BETAXOLOL 891 OPHTHALMIC BETAXOLOL 886 VALERATE BETAMETHASONE 885 VALERATE BETAMETHASONE 884 VALERATE BETAMETHASONE 883 VALERATE BETAMETHASONE 881 VALERATE BETAMETHASONE 882 VALERATE BETAMETHASONE 880 B.P VALERATE BETAMETHASONE 879 B.P VALERATE BETAMETHASONE 84 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 IRELAND 02-Sep-18 Full MALAYSIA 08-Mar-16 Full INDIA 10-Jan-19 Years Two INDIAINDIA 10-Jan-19 Years Two ARGENTINA 26-Sep-18 Years Two 29-Jan-16INDIA Full 11-Oct-17 Full SWITZERLAND 30-Mar-14 Full GERMANY 13-Jul-14GERMANY Full 14-Jun-14 Full SWITZERLAND 06-Mar-14 Full Allergan Pharmaceuticals Ain Medicare Sdn Bhd Cipla LtdJodas Expoim Pvt Ltd INDIACadila Healthcare Ltd 06-Aug-18Years Two Bioprofarma SA Terrada (Pvt) Ltd Jodas Expoim Pvt Ltd Corden Pharma GmbH ,Germany for Astrazeneca UK Ltd Corden Pharma GmbH ,Germany for Astrazeneca UK Ltd Roche Diagnostics GmbH, Germany, La /F Hoffman Roche Ltd F Hoffman-La F Hoffman-La Roche Ltd Biocon Limited INDIA 28-Dec-18 Provisional (Contd.) Pharmaceuticals (Pvt) Ltd Syndicate Medical Ltd (Pvt) Ltd International (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Ceylon) Ltd International (Pvt) Ltd Hemas Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Ltd Ltd Medmart Pharma (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP TABLETS INFUSION GANFORT EYE DROPS Hemas RENACID KIS SOLUTION Commercial BICAL 150BICAL TABLETS Softcare AVASTIN INJECTION Baur & Co (Pvt) A AVASTIN INJECTION Baur & Co (Pvt) A KRABEVA 100KRABEVA INTRA ML+TIMOLOL 5MG/ML EYE/DROPS 5MG/ML ML+TIMOLOL SOLUTION ACIDIC COMPONENT SOLUTION ACIDIC COMPONENT 150MG INJECTION 100MG/4ML INJECTION 100MG/4ML Origin ) 100mg/4ml CONCENTRATE Origin ) 100mg/4ml CONCENTRATE SOLUTION FOR INFUSION 905 300MCG/ BIMATOPROST 899 50MG USP TABLETS BICALUTAMIDE CALUTIDE 50900 TABLETS 50MG USP TABLETS BICALUTAMIDE 50 BICAL Breathe Free Lanka 901 50MG USP TABLETS BICALUTAMIDE 50 ZYLUT TABLETS902 Softcare 50MG USP TABLETS BICALUTAMIDE BIDROSTAT TABLETS903 50MG USP TABLETS BICALUTAMIDE PROSTAGLOB TABLETS Hemas 904 TABLETS HAEMODIALYSIS BICARBONATE Emerchemie NB PharmAce (Pvt) Ltd Globela Pharma 896 150MGTABLETS BICALUTAMIDE CASODEX897 50MG TABLETS BICALUTAMIDE FILM COA CASODEX898 USP TABLETS BICALUTAMIDE TABLETS Hemas 895 SOLUTION FOR BEVACIZUMAB 894 SOLUTION FOR BEVACIZUMAB 893 INJECTION (r-DNA BEVACIZUMAB I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 85 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 08-Mar-15 Full UNITED STATES INDIA 20-Jun-15 Full INDIA 20-Oct-17 Years Two IRELAND 02-Mar-18 Full BANGLADESH 06-Feb-18 Full INDIA 07-Dec-17 Full GERMANY 08-Dec-15 Full Aventis Aventis fi Novo Nordisk DENMARKNovo Nordisk 05-May-14 DENMARK Full LtdWockhardt 05-May-14 INDIA Full 16-Aug-17Years Two Allergan Sales LLC Sun Pharmaceutical industries Ajantha Pharma Ltd Allergan Pharmaceuticals Popular Pharmaceuticals Ltd Novo Nordisk DENMARKGalen Pharmaceuticals 23-May-14(Pvt) Ltd Full Deutschland Gmbh (Contd.) Lanka Ltd Sano fi Healthcare lanka Ltd Healthcare lanka Ltd (Ceylon) Ltd Hemas Pharmaceuticals (Pvt) Ltd Hemas Pharmaceuticals (Pvt) Ltd A Baur & Co (Pvt) A Ltd Pharmaceuticals (Pvt) Ltd Services Pvt. Ltd Morison PLC Biocon Limited INDIAHealthcare lanka Ltd 31-Aug-18(Pvt) Ltd Provisional INJECTION Sunshine INJECTION Sano SUSPENSION SOLUTION SUSPENSION FOR INJECTION INJECTION Sunshine SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP MIXTARD 30 MIXTARD PENNFILL 30MIXTARD INJECTIONWOSULIN 30/70 Sunshine INJECTIONINSUMAN COMB Emerchemie NB 25 LUMIGAN OPHTHALMIC CAREPROST OPHTHALMIC BIMAT OPHTHALMIC LUMIGAN EYE DROPS Hemas INSUGEN 30/70 SUSPENSION 50 MIXTARD PENNFILL STIMULAX Pharma Tropical 30/70 BIOSYNTHETICE HUMAN INSULIN INJ. 1000IU/1ML Origin) 100IU/ML(Recombi DNA 25% HUMAN CONTAINING INSULIN & 75% CRY DISSOLVED INSULIN PROTAMINE TALLINE ORIGIN R-DNA INJECTION 100IU/ML 30/70 BIOSYNTHETICE HUMAN INSULIN INJ. 1000IU/1ML SOLUTION 0.03% w/v 0.3mg in 1ml SOLUTION 0.03% w/v 0.3mg in 1ml SOLUTION 0.03% w/v 0.3mg in 1ml SOLUTION 0.1MG/ 1ml HUMAN rDNA INJECTION 100IU/ML HUMAN rDNA 10MG HUMAN OF RECOMBINANT DNA DNA HUMAN OF RECOMBINANT Origin (30% SOLUBLE INSULIN & 70% ISOPHANE INSULIN) 100 IU SUSPENTION FOR INJECTION /1ML 911 BIPHASIC ISOPHANE INSULIN 912 BIPHASIC ISOPHANE INSULIN 913 BIPHASIC ISOPHANE INSULIN BP 914 BIPHASIC ISOPHANE INSULIN 910 OPHTHALMIC BIMATOPROST 909 OPHTHALMIC BIMATOPROST 908 OPHTHALMIC BIMATOPROST 907 EYE DROPS BIMATOPROST 906 EYE DROPS 0.03% BIMATOPROST BIMAPROST EYE DROPS ABC Pharma 916 BIPHASIC ISOPHANE INSULIN 917 BP SUPPOSITORIES BISACODYL 915 BIPHASIC ISOPHANE INSULIN 86 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIA 24-May-18 Provisional INDIAINDIA 28-Feb-16 Full 28-Oct-15 Full INDIAINDIA 18-Mar-15 Full INDIA 04-Nov-16 Full INDIA 16-Jul-18 Years Two INDIA 16-Jun-18 Provisional 23-Feb-16 Full INDIA 25-Apr-15 Full INDIA 28-Feb-14 Full INDIA 28-Feb-16 Full INDIA 18-Mar-16 Full INDIA 28-Apr-15 Full Cadila Healthcare Ltd Cadila Healthcare Ltd Stallion Laboratories Pvt Ltd Centurion Laboratories Pvt Ltd Healthy Life Pharma (Pvt) Ltd Ltd Centurion Laboratories Pvt Ltd Bliss GVS Pharma Ltd Cadila Healthcare Ltd Fredun Pharmaceuticals Ltd Stallion Laboratories Pvt Ltd Bliss GVS Pharma Ltd Cadila Healthcare Ltd (Contd.) Healthcare lanka Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Healthcare lanka Ltd Pharmaceuticals (Pvt) Ltd Health (Pvt) Ltd (Pvt) Ltd Healthcare lanka Ltd Pharmaceuticals (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP TABLETS Sunshine BISOLOL H BISOLOL 10/6.25 CAMUOLAX TABLETS Siba Healthcare CONLAX 5 Sunshine ZYCOLAX 10 Hemas LAXAFRED TABLETS George Steuart CAMUOLAX TABLETS Siba Healthcare CONLAX 10 Sunshine ZYCOLAX 5 Hemas +HYDROCHLOROTHIAZIDE TABLET +HYDROCHLOROTHIAZIDE TABLET 6.25MG USP GASTRO RESISTANT 5MG 10MG 5MG TABLETS BP 5MG BP TABLETS 10MG 5MG 929 5MG IP TABLETS BISACODYL ZYCOLAX 5930 10MG FUMARATE BISOPROLOL TABLETS Hemas 924 10MG BP TABLETS BISACODYL N/A925 5MG BP TABLETS BISACODYL BISLAX926 5MG BP TABLETS BISACODYL TABLETS927 METALAX 5MG BP TABLETS BISACODYL TABLETS International Yaden N/A928 TABLETS 5MG BP TABLETS Slim BISACODYL Kamazu (Pvt) Ltd B D H Industries TABLETS International Yaden 923 USP SUPPOSITORIES BISACODYL 922 IP SUPPOSITORIES BISACODYL 921 BP SUPPOSITORIES BISACODYL 920 GASTRO RESISTANT BISACODYL 919 USP SUPPOSITORIES BISACODYL 918 IP SUPPOSITORIES BISACODYL I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 87 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIA 05-Jan-18 Full INDIA 18-Jun-16 Full INDIABANGLADESH 11-Jun-17 15-Jun-16 Years Two Full INDIABANGLADESH 16-Mar-17 24-Mar-15 Full Full INDIA 18-Jun-16 Full INDIA 26-Apr-18 Provisional BANGLADESH 28-Feb-17 Full J Duncan Healthcare (Pvt) Ltd Fredun Pharmaceuticals Ltd Pharmaceuticals Ltd Centurion Laboratories Pvt Ltd Pharmaceuticals Ltd U S V Ltd INDIAMerck Limited INDIAUnichem Laboratories 25-May-15 28-Feb-18 Full Years Two U S V Ltd INDIAFredun 25-May-15Pharmaceuticals Ltd Full Pharmaceuticals Ltd Merck (Pvt) Ltd INDIACadila Healthcare Ltd 04-Mar-16 Full (Contd.) Pharmaceuticals (Pvt) Ltd Health (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Ceylon) Ltd Ltd Pharmaceuticals (Pvt) Ltd Health (Pvt) Ltd (Ceylon) Ltd Healthcare lanka Ltd TABLETS Emerchemie NB SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP PROBIS 5 TABLETS Slim BISOCOR 5 TABLETS 5BRISOTOL PharmAce (Pvt) Ltd TABLETS Square George Steuart BISOCOR 2.5 TABLETSN/A PharmAce (Pvt) Ltd Square TABLETS International Yaden ZABESTA 2.5ZABESTA CAPSULESCONCOR-COR Hemas 2 .5 CORBLOC 2.5 TABLETS Baur & Co (Pvt) A ZABESTA 5ZABESTA TABLETSBISOCOR 10 Hemas TABLETS 10BRISOTOL PharmAce (Pvt) Ltd TABLETS Square George Steuart LODOZ-5 TABLETS Emerchemie NB BISOLOL H 5/6.25BISOLOL TABLETS Sunshine USP 5MG USP USP 5MG USP 5MG USP USP 2.5MG USP 5MG USP USP 2.5MG USP 2.5MG USP USP 2.5MG USP USP 10MG USP 5MG 10MG USP +HYDROCHLOROTHIAZIDE TABLET +HYDROCHLOROTHIAZIDE TABLET 6.25MG USP +HYDROCHLOROTHIAZIDE TABLET +HYDROCHLOROTHIAZIDE TABLET 6.25MG USP 943 TABLETS FUMARATE BISOPROLOL 941 TABLETS FUMARATE BISOPROLOL 942 TABLETS FUMARATE BISOPROLOL 939 TABLETS FUMARATE BISOPROLOL 940 TABLETS FUMARATE BISOPROLOL 937 TABLETS FUMARATE BISOPROLOL 938 TABLETS FUMARATE BISOPROLOL 936 TABLETS FUMARATE BISOPROLOL 934 TABLETS FUMARATE BISOPROLOL 933 TABLETS FUMARATE BISOPROLOL 935 TABLETS FUMARATE BISOPROLOL 931 5MG FUMARATE BISOPROLOL 932 5MG FUMARATE BISOPROLOL 88 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIA 31-Oct-18 Years Two ITALY 17-Jun-16 Full INDIA 25-Jul-18 Years Two INDIA 16-Jul-17 Full INDIA 28-Feb-18 Years Two INDIA 25-May-18 Years Two INDIA 28-May-18 Years Two INDIAINDIA 25-Jul-18INDIA Years Two 12-Oct-18 Full 18-Apr-14 Full INDIA 09-Nov-17 Years Two FRANCE 16-Nov-17 Full Pasteur fi Merck Limited INDIA 04-Mar-18 Full Cipla Ltd INDIA 10-Sep-18Years Two Sun Pharmaceutical industries BSP BSP Pharmaceuticals SRL Dr Reddy's Laboratories Ltd BDR Pharmaceuticals Sun Pharmaceutical industries Getwell Pharmaceuticals Natco Pharma Ltd INDIAGetwell Pharmaceuticals 27-Mar-18 Full Laboratories Ltd United Biotech (Pvt) Ltd Getwell Pharmaceuticals United Biotech (Pvt) Ltd S A (Contd.) Lanka Ltd Sano fi (Ceylon) Ltd Sano (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Emerchemie NB (Ceylon) Ltd Ltd Hemas Pharmaceuticals (Pvt) Ltd The Esses Pharmacy (Pvt) Ltd Healthcare lanka Ltd The Esses Pharmacy (Pvt) Ltd Health (Pvt) Ltd The Esses Pharmacy (Pvt) Ltd Health (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP SUSPENSION INJECTION POWDER POWDER INJECTION POWDER / INJECTION CONCOR TABLETS Emerchemie NB N/A ORAL PROART TABLETS Hemas VELCADE SOLUTION Pettah Pharmacy MYBORTE 3.5MYBORTE POWDER FOR DOTREX 2 INJECTIONAgencies Pharma BORTESUN LYOPHILIZED NEOMIB-3.5 LYOPHILIZED BORTENAT 2GBORTENAT INJECTIONNEOMIB-3.5 Sunshine POWDER FOR BLEOWEL-15 UNIT LYOBLE 15LYOBLE INJECTION George Steuart USP 5MG USP VIRUS (BOPV) TYPELI & 3 LIVE VIRUS (BOPV) VACCINE ATTENUATED TABLETS 62.5MG TABLETS SOLUTION INJECTION IMG INJECTION 3.5MG POWDER FOR INJECTION 2MG/VIAL 3.5MG /VIAL 3.5MG /VIAL VIAL VIAL 15 UNIT 15 UNIT 944 TABLETS FUMARATE BISOPROLOL 945 POLINYELITIS ORAL BIVALENT 958 125MGTABLETS BOSENTAN BOSENTAS TABLETS Breathe Free Lanka 957 MONOHYDRATE BOSENTAN 956 POWDER FOR BORTEZOMIB 955 POWDER FOR BORTEZOMIB 954 LYOPHILIZED BORTEZOMIB 953 FOR INJECTION BORTEZOMIB 952 FOR INJECTION BORTEZOMIB 951 FOR INJECTION 2MG BORTEZOMIB 948 INJECTION 2MG BORTEZOMIB 949 MIBOR INJECTION 2MG BORTEZOMIB 950 EGYBORT FOR INJECTION 2MG BORTEZOMIB INJECTION INJECTIONAssociates Pharma Celon George Steuart 947 BLEOMYCIN FOR INJECTION USP 946 BLEOMYCIN FOR INJECTION USP I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 89 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 01-Sep-16 Full UNITED STATES TURKEY 27-Feb-18 Years Two TURKEY 01-Mar-17 Full INDIA 11-Dec-14 Full PAKISTAN 05-Jul-18 Years Two IRELAND 04-Jul-18 Years Two IRELAND 13-Oct-17 Years Two CHINA 07-Dec-14 Full INDIAINDIA 06-Jun-18INDIA Years Two 24-Aug-18 Years Two 08-Apr-19INDIA Full 08-Apr-14 Full Allergan Sales LLC World Medicine World Ilac san ve World Medicine World Ilac san ve Indoco Remedies India Remington pharmaceutical Industries (Pvt) Ltd Allergan Pharmaceuticals Allergan Pharmaceuticals Lanzhou Instite of Biological Products Ltd Ltd Zim Laboratories Ltd Cipla LtdZim Laboratories Ltd INDIA 09-Apr-15 Full (Contd.) Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Co Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pvt Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP ALPHAGAN-P EYE DROPS Hemas RIMONAL EYE DROPS Slim RIMONAL EYE DROPS Slim BRIMOCHEK-T EYE DROPS Hemas BRYTIM EYE DROPS Delmege Forsyth & COMBIGAN EYE DROPS Hemas BOTOX INJECTION Hemas BTXA INJECTION Scientia Healthcare SOLUTION 0.15% EYE DROPS DROPS 0.2% DROPS 0.2% & TIMOLOL 5MG EYE DROPS TIMOLOL & SOLUTION TIMOLOL 0.5% EYE DROPS TIMOLOL EYE DROPS /50U UNITS 971 BRIMONIDINE TARTRATE 970 EYE BRIMONIDINE TARTRATE 969 EYE BRIMONIDINE TARTRATE 968 2MG BRIMONIDINE TARTRATE 967 0.2% + TARTRATE BRIMONIDINE 966 0.5% BRIMONIDINE 0.2%+TIMOLOL 965 100U A TYPE BOTULINUM TOXIN 960 62.5MGTABLETS BOSENTAN 961 62.5MG TABLETS BOSENTAN PULMOFIRST TABLETS BOSENCARD962 62.5MGTABLETS BOSENTAN TABLETS Axia (Pvt) Ltd963 62.5MGTABLETS BOSENTAN BOSENTAS Tabrane MSN Laboratories 964 100 / A TYPE BOTULINUM TOXIN BOSENCARD TABLETS TABLETS Breathe Free Lanka Lanka (Pvt) Tabrane 959 125MGTABLETS BOSENTAN PULMOJAJ TABLETS Chamee Chemist Bajaj Healthcare 90 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 05-Jun-18 Full 05-Mar-17 Full 05-Mar-17 Full BELGIUMITALY 09-Mar-18 Full SWITZERLAND 15-Nov-16 15-Nov-16 Full Full BANGLADESH 06-Feb-18 Years Two TURKEY 01-Mar-18 Full UNITED STATES INDIA 13-Dec-17 Years Two TURKEY 21-Mar-18STATES Full INDIA 13-Dec-17 Years Two INDIA 24-Dec-18 Years Two UNITED KINGDOM Merck Limited INDIA 30-Dec-17Years Two Roche SpA, for La F Hoffmann Roche Ltd Roche SpA, for La F Hoffmann Roche Ltd S A Alcon- S A Couvreur N V Popular Pharmaceuticals Ltd World Medicine World Ilac san ve Alcon Research Ltd Sunwaya Rohto Pharmaceutical Pvt Ltd World Medicine World Ilac san ve Sunway Rohto Pharmaceutical Pvt Ltd N V Mercury Laboratories Ltd (Contd.) (Ceylon) Ltd Ltd Ltd Ltd ABC Pharma Services Pvt. Ltd Slim Pharmaceuticals (Pvt) Ltd A Baur & Co (Pvt) A Ltd International Yaden (Pvt) Ltd Pharmaceuticals (Pvt) Ltd International Yaden (Pvt) Ltd (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP SYRUP Emerchemie NB SUSPENSION OPHTHALIMIC SOLUTION SUSPENSION SUSPENSION EYE DROPS Morison PLCSUSPENSION ALCon Couvreur COSOME EXPECTORANT AZARGA EYE DROPS Baur & Co (Pvt) A BENOZOL OPHTHALMIC BRITIL STERILE AZOPTBRIO OPHTHALMIC OPHTHALMIC BRITOSOPT EYE DROPS Slim EYE SIMBRINZA DROP BRIO OPHTHALMIC N/A EYE DROPS International Yaden 4MG,PHENYLEPHRINE Hcl 5MG,CHLORPHENIRAMINE SOLUOTION 2MG ORAL MALEATE DROPS 10mg+5mg /ml SUSPENSION USP 1% SUSPENSION USP SUSPENSION USP 1% SUSPENSION USP SUSPENSION USP 1% SUSPENSION USP SUSPENSION USP 1% SUSPENSION USP BRIMONIDINE 2MG PER 1ML BRIMONIDINE 2MG PER 1ML SUSPENSION 1% SUSPENSION USP 0.5% EYE DROPS 0.5% EYE DROPS 982 1.5MG BROMAZEPAM 983 3MGTABLETS BROMAZEPAM LEXOTANIL LEXOTANIL984 BROMHEXINE Hcl TABLETS TABLETS Baur & Co (Pvt) A Baur & Co (Pvt) A 981 EYE BRINZOLAMIDE+TIMOLOL 980 BRINZOLAMIDE OPHTHALMIC 979 BRINZOLAMIDE OPHTHALMIC 978 BRINZOLAMIDE OPHTHALMIC 974 BRINZOLAMIDE 1% EYE DROPS AZOPT EYE DROPS Morison PLC977 BRINZOLAMIDE OPHTHALMIC Laboratories Alcon UNITED 975AND BRINZOLAMIDE 10MG 976 BRINZOLAMIDE OPHTHALMIC 973 TIMOLOL BRINZOLAMIDE 1% & 972 TIMOLOL BRINZOLAMIDE 1% & I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 91 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 PAKISTAN 11-Oct-18 Full BANGLADESH 03-May-18 Full INDIA 22-Feb-18 Provisional SWEDEN 10-Jan-15 Full NETHERLANDS 19-Aug-14 Full INDIA 25-Nov-14 Full INDIAINDIA 11-Feb-16 Full 28-Dec-17 Years Two INDIA 28-Apr-17INDIA Full 06-Apr-16 Full Getz Pharma (Pvt) Ltd Incepta Pharmaceuticals Ltd Cadila Healthcare Ltd Astra Zeneca AB Astra Zeneca ,Sweden Medochemie Ltd CYPRUSPharmachemie 19-May-14BV Full Inga Laboraories (Pvt) Ltd Ltd IPCA LaboratoriesIPCA INDIA 13-Sep-16 Full SG Pharma (Pvt) Ltd Company Ltd IPCA LaboratoriesIPCA INDIACadila Healthcare Ltd 13-Sep-17Years Two (Contd.) Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Sunshine Healthcare lanka Ltd Pharmaceuticals (Pvt) Ltd Laboratories (Pvt) Ltd (Ceylon) Ltd Co Ltd Ltd Pharmacy (Pvt) Ltd Ltd Pharmaceuticals (Pvt) Ltd INHALER Hemas POWDER SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP FORTIDE FORTIDE INHALER BUDEMET POWDER DRY Citihealth Imports N/A CAPSULES SYMBICORT INHALATION Hemas MEDOCRIPTINE CAPSULES Associated CYCORTIDE CAPSULES Emerchemie NB BROMYLATE TABLETSBROM Chamee Chemist Bajaj Healthcare TABLETS Swedish Trading SOLVIN EXPPLEMNIL TABLETS EXPECTORANTAssociates Pharma Raptakos Brett & Emar Pharma (Pvt) N/A TABLETS The Esses SOLVIN ELIXIR Emar Pharma (Pvt) ZOLVAN TABLETS Hemas 200MCG+FORMOTEROL FUMARATE FUMARATE 200MCG+FORMOTEROL 6MCG METERED DOSE DIHYDRATE INHALER 200MCG+FORMETEROL FUMARAT FUMARAT 200MCG+FORMETEROL POWDER INHALER 6MCG DRY CAPSULES 200MCG+FORMETEROL FUMARAT FUMARAT 200MCG+FORMETEROL POWDER INHALER 6MCG DRY CAPSULES 160MCG+FORMOTEROL FUMARATE FUMARATE 160MCG+FORMOTEROL TURBUHALER 4.5MCG/ DOSE INHALATION 400MCG INHALATION 2.5MG 2..5MG TABLETS 2.5MG BP +PHENYLEPHRINE BP HYDROCHLORIDE BP +GUAIPHENESIN BP TABLETS BP 8MG BP TABLETS 2..5MG TABLETS BP 4MG/5ML ELIXIR 4MG/5ML BP IP 8MG IP 997 BUDESONIDE 996 BUDESONIDE 995 BUDESONIDE 994 BUDESONIDE 993 BUDESONIDE CAPSULES FOR 992 BP BROMOCRIPTINE TABLETS 990 USP BROMOCRIPTINE MESYLATE 991 BP BROMOCRIPTINE TABLETS 988 BROMHEXINE HYROCHLORIDE 987 BROMHEXINE HYDROCHLORIDE 989 USP BROMOCRIPTINE MESYLATE 985 BROMHEXINE HYDROCHLORIDE 986 BROMHEXINE HYDROCHLORIDE 92 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 BANGLADESH 03-May-18 Full SWEDEN 22-Feb-14INDIA Full 12-Sep-17 Years Two INDIABANGLADESH 12-Sep-17 28-Sep-17 Years Two Years Two CHINAINDIA 29-Sep-14 Full SWEDEN 10-Apr-19 05-Dec-15 Full Full SWEDEN 17-Mar-18 Full INDIA 22-Jul-16 Full Astra Zeneca AB Astra Zeneca ,Sweden AB Astra Zeneca ,Sweden Astra Zeneca SWEDENAB Astra Zeneca ,Sweden 15-Jul-17Years Two Incepta Pharmaceuticals Ltd Concept Pharmaceuticals Ltd Cipla LtdConcept Pharmaceuticals INDIALtd Incepta Pharmaceuticals Ltd 03-Apr-18Shandong Jewim Full Pharmaceutical Co. Ltd Medispray Laboatories (Pvt) Ltd Cadila Healthcare Ltd (Contd.) Hemas Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Hemas Pharmaceuticals (Pvt) Ltd Hemas Pharmaceuticals (Pvt) Ltd Citihealth Imports (Pvt) Ltd International (Pvt) Ltd (Pvt) Ltd International (Pvt) Ltd (Pvt) Ltd (Ceylon) Ltd (Pvt) Ltd Healthcare lanka Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP POWDER CAPUSES SPRAYNASAL Hemas SOLUTION POWDER INHALER FOR INHALATION SYMBICORT INHALATION BUDOLET SPRAY NASAL BUDENASE QA Softcare SPRAY NASAL Breathe Free Lanka BUDICORT SPRAY NASAL NS 64BUDEMATE Citihealth Imports SPRAY NASAL Emerchemie NB 200BUDECORT INHALATION Breathe Free Lanka RHINOCORT AQUA PULMICORT NEBULIZING PULMICOR TURBUHALAER BUDEMET POWDER DRY BUDOLET SPRAY NASAL Softcare 80MCG+FORMOTEROL FURATE FURATE 80MCG+FORMOTEROL 4.5MCG DOSE 100MCG BP SPRAY 100MCG BP SPRAY 100MCG BP SPRAY 64MCG BP SPRAY METERED DOSE INHALER 64MCG/DOSE SOLUTION 0.25MG/ML 100MCG PER DOSE INHALATION SPRAY BP 100MCG BP SPRAY 400MCG+FORMETEROL FUMARATE FUMARATE 400MCG+FORMETEROL POWDER INHALER 12MCG DRY CAPSULES 999 BUDESONIDE 998 BUDESONIDE 400MCG CAP DERINIDE CAPSULES Sunshine 1000 BUDESONIDE 1001 BUDESONIDE AQUEOUS NASAL 1002 BUDESONIDE AQUEOUS NASAL 1004 BUDESONIDE AQUEOUS NASAL 1005 BUDESONIDE AQUEOUS NASAL 1006 BUDESONIDE INHALER 200MCG 1007 SPRAY BUDESONIDE NASAL 1008 BUDESONIDE NEBULISING 1009 BUDESONIDE POWDER FOR 1003 BUDESONIDE AQUEOUS NASAL I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 93 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 SWEDEN 04-Dec-17INDIA Years Two INDIA 12-Feb-15 Full INDIA 23-Jul-14 Full 16-Mar-16INDIA Full INDIA 26-Jun-14 Full INDIA 03-Aug-15 Full BANGLADESH 25-May-16 05-Oct-17 Full INDIA Full FRANCE 06-May-15 Full 20-Jul-17 Full INDIA 29-Apr-14 Full Cadila Healthcare Ltd Ltd Cipla LtdPharmaceuticalS INDIA(Pvt) Ltd 03-Nov-14 Full Pharmaceuticals Ltd Cenexi 52 Rue Marcel Et Jacques Gaucher Astra Zeneca AB Astra Zeneca ,Sweden Glenmark Pharmaceuticals Ltd Claris Lifescience Ltd Claris Injectables Ltd Harson Laborstories ABAstra Zeneca SWEDENNeon Laboratories 01-Oct-18Ltd Full (Contd.) Healthcare lanka Ltd Chamee Chemist Axa Parenterals Breathe Free Lanka (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Hemas Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd RESPIRATOR RESPIRATOR SUSPENTION SOLUTION INJECTION Hemas POWDER INHALER SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP BUDEXA BUDEXA RESPULES BUDECORTN/A RESPIRATOR BUPICAN INJECTIONBUPICAN HEAVY INJECTION INJECTION Ceyoka (Pvt) Ltd Akbar Ciron Drugs & Akbar ANESPINE INJECTIONN/A PharmAce (Pvt) Ltd Square MARCAIN SPINAL 0.5% HEAVY INJECTIONMARCAIN Citihealth Imports INJECTION Hemas PULMICORT PULMICORT TURBUHALER BUDESMA INHALER Hemas ANAWIN INJECTION Ravilux Company SUSPENSION 0.5MG IN 2ML SUSPENSION 0.5MG IN 2ML 0.5%+DEXTROSE 8% INJECtion 0.5% BP 0.5% DEXTROSE INJEC. USP 5MG & DEXTROSE INJETION USP 80MG/4ml 5MG & DEXTROSE INJETION USP 80MG/ml INJECTION 5ML/ML 50MG/10ML INHALATION 200MCG INHALATION INHALATION 200MCG INHALATION 100MG/20ML 1011 BUDESONIDE PRESURISED 1012 200MCG BUDESONIDE RESPICAP DERINIDE1013 BUDESONIDE RESPIRATORY CAPSULES1014 BUDESONIDE RESPIRATORY Sunshine 1015 HYDROCHLORIDE BUPIVACAINE 1016 HYDROCHLORIDE BUPIVACAINE 1017 HYDROCHLORIDE IN BUPIVACAINE 1018 HYDROCHLORIDE IN BUPIVACAINE 1019 HYDROCHLORIDE IN BUPIVACAINE 1020 HYDROCHLORIDE BUPIVACAINE 1021 INJECTION 0.5% BUPIVACAINE 1010 BUDESONIDE POWDER 1022 INJECTION E BP BUPIVACAINE 94 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 26-May-14PAKISTAN Full 28-May-15 01-Mar-14INDIA Full Full SWEDEN 12-Jan-18 Years Two SWEDEN 23-Apr-15 Full 23-Apr-15FRANCE Full 23-Jul-14INDIA Full IRELAND 06-Sep-18 Years Two 16-Jun-18IRELAND Full 17-Feb-17INDIA Full INDIA 27-Oct-17 Years Two GERMANY 26-Jan-17 05-Sep-14 Full Full PharmaceuticalS (Pvt) Ltd Sun Pharmaceutical industries Medical Ltd Chemical Ab Sweden smith & Nephew Medical UK Delpharm S A Huningue S Pharmaceutical Catalent German Eberbach Gmbh Vital Healthcare Vital (Pvt) Ltd S J & G Fazul Ellahie (Pvt) Ltd Leo Laboratories Ltd Leo Laboratories Ltd Renown Pharmaceuticals Pvt Ltd Glenmark Generics Ltd (Contd.) Pharmaceuticals (Pvt) Ltd Ltd AssociatesPharma Central drugs and Ltd (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Healthcare lanka Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP NASAL SPRAYNASAL Baur & Co (Pvt) A OINTMEN BECAINE 5 INJECTIONBUSRON Ceyoka (Pvt) Ltd Ciron Drugs & TABLETSIODOSORB V H Distributors A IODOSORB OINTMENT CIC Holdings PLC POWDER Smith & Nephew MIACALCIC CIC Holdings PLCNASAL Speciality Perstrop CALCIBETDAIVOBET TOPICAL OINTMENTDAIVOBET Hemas GEL TOPICAL CALTROX Hemas CAPSULESDIPSOTREX International Yaden OINTMENT Sunshine BUPIVIT INJECTION International Yaden 5MG/ML 20MG USP TABLETS IODINE 0.9% IODINE 0.09% 200IU SALMON CALCITONIC ACTUATION OINTMENT BETAMETHASONE 0.5MG/G BETAMETHASONE 0.5MG/G BETAMETHASONE 0.25MCG W/W 5MMCG/G 5MG/ML 1024 INJECTION E BP BUPIVACAINE 1025 BUSPIRONE HYDROCHLORIDE 1026 0.5MGTABLETS CABERGOLINE CABERLIN 0.51027 WITH CADEXOMER OINTMENT TABLETS1028 CADEXOMER POWDER WITH Hemas 1029 SPRAY NASAL CALCATONIN 1030 & CALCIPOTRIOL 1031 50MCG+ CALCIPOTRIOL 1032 50MCG+ CALCIPOTRIOL 1033 CAPSULES BP CALCIPOTRIOL 1034 0.005% OINTMENT CALCIPOTRIOL 1035 CAPSULES 0.25MCG CALCITRIOL ROCALTROL CAPSULES Baur & Co (Pvt) A 1023 INJECTION E BP BUPIVACAINE I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 95 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 THAILAND 29-Oct-17INDIA Full 11-Jun-15INDIA Full INDIA 10-Jun-15 Full INDIA 02-Jun-15INDIA Full 28-May-15 Full 02-Jun-15INDIA Full BANGLADESH 08-Jun-15 04-Aug-18 Full Full INDIASRI LANKA 13-Feb-18 11-May-16 Years Two AUSTRALIA Full 04-Apr-14INDIA Full 27-Mar-14 Full Care (Pvt) Ltd Pharmaceuticals (India) Ltd Pharmaceuticals Pvt Ltd Contract Manufacuring Mega Lifesciences Public Company (Pvt) Ltd Olive Healthcare INDIACadila Healthcare Ltd 03-Nov-16 Full MMC Healthcare Ltd Stallion Laboratories Pvt Ltd Biolab Co Ltd THAILANDCadila Healthcare Ltd 27-May-14Eskayef Full Bangladesh Ltd Meyer Healthcare (Pvt) Ltd Fredun Pharmaceuticals Ltd (Contd.) Pharma Associates Softgel Health Alaris Lanka (Pvt) Ltd A Baur & Co (Pvt) A Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Ltd (Pvt) Ltd Health (Pvt) Ltd Hemas Pharmaceuticals (Pvt) Ltd Healthcare lanka Ltd Ltd Health (Pvt) Ltd CAPSULES CAPSULES CAPSULES TABLETS SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP N/AN/A GELETIN SOFT CAPSULES Slim CALCINASIBACAL TABLETS DCALTAMIN TABLETS Markss HLC (Pvt) TABLETS Siba Healthcare George Steuart OSTOCAL-D TABLETSOSTEOCARE Sunshine LIQUID ORAL KACO D SMM Halcyon (Pvt) MOMCAL TABLETS 250FREDCAL N/A GELETIN SOFT TABLETS George Steuart Gamma CALCIT SGCALCIT EMULSION Hemas KALZANA CHEWABLE 0.25MCG 0.25MCG (400MG+400IU) BP TABLETS TABLETS 600MG CALCIUM USP FILM COATED CARBANETE 250MG D3 200IU/5ML 25,ZINC 2MG & VIT 200IU CHOLECALCIFEROL IP CHEWBLE TABLETS CAPSULES GELATIN IU SOFT TABLETS D3 125IU 110MG+VITAMIN 0.25MCG (500MG/400IU) TABLES 1037 CAPSULES BP CALCITRIOL 1038 CAPSULES BP CALCITRIOL 1040 50MCG/G OINTMENT CALCITRIOL CALCIROX1041 CALCIUM & CHOLECALCIFEROL OINTMENT1042 CHEWABLE CALCIUM & VITAMIN PharmAce (Pvt) Ltd Aurochem 1043 USP TABLES D CALCIUM & VITAMIN 1045 D3 CALCIUM & VITAMIN 1046 CALCIUM 150MG MAGNESIUM 1047 CALCIUM 200MG & 1048 D3 400 CALCIUM 250mg & VITAMIN 1049 CALCIUM 250MG+PHOSPHATE 1036 CAPSULES 0.25MCG CALCITRIOL MEDITROL GELETIN SOFT 1039 CAPSULES BP CALCITRIOL 1044 D3 CHEWABLE CALCIUM & VITAMIN 96 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIABANGLADESH 30-Aug-16 15-Feb-17 Full Full INDIAINDIA 27-Mar-14 Full INDIA 14-Aug-15 Full 09-Oct-14INDIA Full THAILAND 13-Aug-16 Full 19-Feb-14 Full INDIA 13-Feb-18 Years Two Bal Pharma Ltd INDIASunrise International LabS 13-Nov-16Ltd Full The Acme Laboratories Ltd Sterling Lab INDIAFredun Pharmaceuticals Ltd Cian Healthcare 12-May-15(Pvt) Ltd Full Meyer Organics (Pvt) Ltd Cadila pharmaceuticals Ltd Mega Lifesciences (Pvt) Ltd Meyer Healthcare (Pvt) Ltd (Contd.) Pharmaceuticals (Pvt) Ltd Pharmaceutical (Pvt) Ltd Ltd Co Ltd Health (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Ltd Healthcare lanka Ltd Baur & Co (Pvt) A Ltd Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP CAPSULES OCIUM FORTE TABLETS Lotus SEACAL 500SEACAL TABLETSCALPEROS-D Kent TABLETS 500STERCAL Mega Pharma (Pvt) TABLETSFREDCAL Darley Butler & TABLETSCIANCAL George Steuart TABLETSCASTRACID LIQUID ORAL Slim SMM Halcyon (Pvt) CALSOF- D CAPSULESCALCIVITA Sunshine GELETIN SOFT OSTEOCARE TABLETS SMM Halcyon (Pvt) 150MG+ZINC 5MG+ VIT.D3 100IU 150MG+ZINC 5MG+ VIT.D3 TABLETS IU TABLETS IU TABLETS TABLETS 400IU COLECALCIFEROL BP 250+ZINC 90MG+VIT.D3 TABLETS D3 250IU 220MG+VITAMIN TABLETS D3 VITAMIN 400MG+MAGNESIUM HYDROXIDE 120MG+MAGNESIUM TRISILICATE 50MG + SIMETHICONE 30% EMULSION 83MG Per 5ML D3 200IU 500MG+VITAMIN CAPSULES 50MG+Dibasic CALCIUM 2500 IU. 150MG+ VIT.A PHOSPHATE 400IU VIT.D3 1051 D3 250 CALCIUM 500mg & VITAMIN 1052 D3 250 CALCIUM 500mg & VITAMIN 1053AND CALCIUM 500MG 1054 CALCIUM 500MG+MAGNESIUM 1055 CALCIUM 500MG+PHOSPHORUS 1056 1250MG & CALCIUM CARBONATE 1057 CALCIUM CARBONATE 1058 CALCIUM CARBONATE 1059 CALCIUM CARBONATE 1050 CALCIUM 400MG+MAGNESIUM I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 97 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 AUSTRALIA 13-Feb-16 Full INDIAINDIA 14-Jul-16 Full INDIA 27-Nov-15 Full SRI LANKA 24-Sep-14 14-Feb-18Years Two Full BANGLADESH 11-Sep-16 Full Delta Pharma Ltd BANGLADESH 20-Feb-14 Full Centurion Laboratories Pvt Ltd Ratnamani Healthcare (Pvt) Ltd Ltd Priivate Limited Biolab Co Ltd THAILANDHealthcare 28-Aug-14Pharmaceuticals Full Contract Manufacuring & Packging Services pty Ltd (Contd.) Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Ltd Health (Pvt) Ltd (Pvt) Ltd Alaris Lanka (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP CAPSULES ASCAL TABLETSBONI-D N/AN/A TABLETS Hyena N/A Astron (Pvt) Ltd SRI LANKA TABLETSCALJAJ 14-Dec-14 International Yaden TABLETS Full ZECARB TABLETS Lanka (Pvt) Tabrane TABLETS Chamee ChemistN/A Bajaj Healthcare N/A 600CALTAMIN TABLETS TABLETS Celogen Lanka D VITA N/AROCAL George Steuart TABLETS Citihealth Imports Astron (Pvt) Ltd SRI LANKA 18-Jun-18Years Two THERACAL GELETIN SOFT 450MG,VITAMIN C (ASCORBIC 450MG,VITAMIN D 3 40MG & VITAMIN ACID ) BP 200 IU ) BP (CHOLECALCIFEROL TABLETS CHEWABLE USP 500MG+CHOLECALCIFEROL D3) 200IU (VITAMIN 1250MG CHEWABLE 1.25g USP 1.25g USP 1.25g USP 1250MG USP 1500MG USP D3 400IU 600MG & VITAMIN TABLETS EFERVESCERAT VITAMIN D3 400IU SOFT CAPSULES D3 400IU SOFT VITAMIN 1061 BP CALCIUM CARBONATE 1062 BP CALCIUM CARBONATE 1063 BP TABLETS CALCIUM CARBONATE 1064 TABLETS CALCIUM CARBONATE 1065 TABLETS CALCIUM CARBONATE 1066 TABLETS CALCIUM CARBONATE 1067 TABLETS CALCIUM CARBONATE 1068 TABLETS CALCIUM CARBONATE 1069 USP CALCIUM CARBONATE 1060 625MG + CALCIUM CARBONATE 98 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 14-Oct-15 Full INDIA 12-Jan-18 Years Two INDIA 26-Aug-16 Full 31-Aug-18INDIA Full 26-Jan-15 Full INDIAINDIA 20-Jan-17 Years Two 20-Jan-17GERMANY Years Two 28-Dec-16 Full INDIA 08-Aug-17 Full MMC Healthcare Ltd Amol Pharmaceuticals (Pvt) Ltd Sciences Pvt Ltd MMC Healthcare Ltd Jenburkt Pharmaceuticals Ltd Merck Limited INDIACentaur Pharmaceutical 15-Aug-14(Pvt) Ltd Full Centaur Pharmaceutical (Pvt) Ltd Hameln Pharmaceuticals GmbH Germany Mayne Pharma (Pvt) Ltd Healthcare Vital (Pvt) Ltd (Contd.) Lanka (Pvt) Ltd (Pvt) Ltd Ltd Pharmaceuticals (Pvt) Ltd (Ceylon) Ltd Health (Pvt) Ltd Health (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP TABLETS Harcourts (Pvt) Ltd Bioplus Life PRIMECAL TABLETS Prime Pharma SUPRACAL SUPRACAL ULTRABONE FORMULA CALCIPLUS TABLETSTOPCAL-M Markss HLC (Pvt) TABLETSBONATE Hemas TABLETSBONIUM Emerchemie NB TABLETSBONIUM George Steuart TABLETSN/A George Steuart CALCIVIT INJECTION Akbar INJECTION International Yaden VITAMIN D3, MINARALS TABLETS D3, MINARALS VITAMIN 1000MG+MAGNESIUM HYDROXIDE D3 200IU 100MG+ZINC 4mg VIT 1000MG+MAGNESIUM HYDROXIDE , VIT 11MG 100MG+ZINC SULPHATE D3 200MG USP 200IU+MAGNESIUM HYDROXIDE 100MG+ZINC SULPHATE4MG TABLETS 250MG OF TO EQUIVALENT D3 CALCIUM+ VIT- ELEMENTAL 200IU +MAGNESIUM HYDROXIDE +ZINC TABLETS SULPHATE D3 200IU +MAGNESIUM HYDROXIDE100MG +ZINC TABLETS 4MG SULPHATE INJECTION B.P 100mg/ml B.P 1070 WITH CALCIUM CARBONATE 1071TABLETS D +VIT CALCIUM CITRATE KELZER1072 CALCIUM CITRATE TABLETS Pharma Avenier 1073 CALCIUM CITRATE 1074 D3 1G+VIT CALCIUM CITRATE 1075 MALATE CALCIUM CITRATE 1076 D3 CALCIUM CITRATE+VIT 1077 100MG+VIT CALCIUM CITRATE 1078 1G/ 10ML CALCIUM GLUCONATE 1079 INJECTION CALCIUM GLUCONATE I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 99 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 CHINA 18-Mar-18BANGLADESH Provisional 08-May-14 Full INDIAINDIA 16-Mar-16 Full INDIA 05-Jun-15 Full INDIA 19-Feb-16 Full INDIA 06-Apr-18 Years Two INDIA 08-Apr-18 Years Two 30-Jul-14 Full Hebei Tiancheng Hebei Tiancheng Pharmaceuticals Co Ltd Beacon Pharmaceuticals Ltd Ltd Pharmaceuticals Ltd Medopharm (PVT Ltd United Biotech (Pvt) Ltd United Biotech (Pvt) Ltd Pondchy Pharmaceuticals Biolab Co Ltd THAILAND 27-May-14 Full (Contd.) Pharmaceuticals (Pvt) Ltd (Ceylon) Ltd Pharmaceuticals (Pvt) Ltd Health (Pvt) Ltd Health (Pvt) Ltd Neon Pharmaceuticals (Pvt) Ltd Health (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP SUSPENSION N/A INJECTION Slim FOLINEX 50 INJECTIONAGOCAL Emerchemie NB TABLETSN/A lifeServ (Pvt) Ltd Agog Pharma LtdN/A INDIA TABLETS Chamee ChemistEMLACTATE 31-Mar-14 Bajaj Healthcare TABLETS TABLETS Full Pharma AssociatesK-STRYN Bafna Akbar POWDER ORAL George Steuart K-STRYN POWDER ORAL George Steuart CAL-BIND ORAL PLUSCALTAMIN TABLETS George Steuart BP 10% W/V BP BP 50MG BP 300MG 300MG 300MG 300MG POWDER 15G SULPHONATE SACHETS POWDER 15G SULPHONATE SACHETS POWDER ORAL SULPHONATE SUSPENSION (600MG,D3 TABLES D & MINERAL 200MG,40MG 1080 INJECTION CALCIUM GLUCONATE 1081 INJECTION CALCIUM GLUCONATE 1082 BP TABLETS CALCIUM LACTATE 1083 BP TABLETS CALCIUM LACTATE 1084 BP TABLETS CALCIUM LACTATE 1085 USP TABLETS CALCIUM LACTATE 1086 CALCIUM POLYSTYRENE 1087 CALCIUM POLYSTYRENE 1088 CALCIUM POLYSTYRENE 1089 CALCIUM SUPPLEMENT+ VITAMIN 100 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAITALY 08-Oct-14 Full SWEDEN 22-Oct-18 Provisional 12-Oct-17PAKISTAN Full 17-Mar-18 Years Two PAKISTAN 27-Jun-18INDIA Full PAKISTAN 01-Dec-15 Full 27-Jun-18INDIA Full INDIA 20-Oct-15 Full 28-Feb-18 Years Two Janssen Cilag Pharmaceutica Lda NV Belgium AB Astra Zeneca ,Sweden Ltd Getz Pharma (Pvt) Ltd Ajantha Pharma Ltd Getz Pharma (Pvt) Ltd Ajantha Pharma Ltd Macleods Pharmaceuticals Ltd Astra Zeneca SWEDEN 15-Jul-18 Full Acme Formulation (Pvt) Ltd-india for Abbott India Ltd

(Contd.) (Ceylon) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Ltd Pharmaceuticals (Pvt) Ltd Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP ATACAND PLUSATACAND TABLETS Hemas TREATAN TABLETSADVANT CIC Holdings PLC PharmEvo (Pvt) TABLETSADERAN Hemas TABLETSADVANT Baur & Co (Pvt) A TABLETSADERAN Hemas TABLETSCANDESARMAC TABLETS Baur & Co (Pvt) A Pettah Pharmacy ATACAND TABLETS Hemas SANDOCAL 500SANDOCAL TABLETS Smithkline Beecham HYDROCHLOROTHIAZIDE TABLETS HYDROCHLOROTHIAZIDE TABLETS 12.5MG TABLETS TABLETS TABLETS TABLETS TABLET 16MG 4MG TABLES (CALCIUM 500MG, TABLES 250IU CHOLECACIFEROL 1091 100MGTABLETS CANAGLIFLOZIN 100 INVOKANA TABLETS1092 16MG & CILEXETIL CANDESARTAN Emerchemie NB 1093 16MG CILEXETIL CANDESARTAN 1094 16MG CILEXETIL CANDESARTAN 1095 16MG CILEXETIL CANDESARTAN 1096 16MG CILEXETIL CANDESARTAN 1097 32MG CILEXETIL CANDESARTAN 1098 TABLETS CILEXETIL CANDESARTAN 1099 TABLETS CILEXETIL CANDESARTAN 1090 D3 CALCIUM WITH VITAMIN I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 101 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 03-Jun-17 Years Two SWEDEN 15-Jul-18PAKISTAN Full 11-Aug-15PAKISTAN Full 26-Jun-16INDIA Full INDIA 28-Feb-18 Years Two SWITZERLAND/ 01-Dec-15MEXICO Full ARGENTINA 26-Dec-18 Years Two INDIAINDIA 24-Aug-16 Full 02-Jan-19 Years Two Astra Zeneca AB Astra Zeneca ,Sweden Ltd Getz Pharma (Pvt) Ltd Macleods Pharmaceuticals Ltd Ajantha Pharma Ltd Drugs LtdTechno BANGLADESH 20-May-16 Full Laboratorio A S Varifarma Getwell Pharmaceuticals Products Roche Mexico for A S F Hoffman-La Roche Ltd. Switzerland Sun Pharmaceutical industries (Contd.) Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Ltd Pharmaceticals (Ceylon) Ltd Pharmacy (Pvt) Ltd Ltd Pharmaceuticals (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP ATACAND TABLETSTREATAN Hemas TABLETSADVANT CIC Holdings PLC PharmEvo (Pvt) TABLETSCANDESARMAC TABLETS Hemas Pettah Pharmacy ADERAN TABLETS Baur & Co (Pvt) A CAPTABINE TABLETS S P L 500CABITA TABLETS The Esses 8MG 8MG 8MG 8MG 8MG 500MG USP TABLETS 500MG 1107 500MGTABLETS CAPECITABINE BAGOCAP TABLETS Emerchemie NB 1100 TABLETS CILEXETIL CANDESARTAN 1101 TABLETS CILEXETIL CANDESARTAN 1102 TABLETS CILEXETIL CANDESARTAN 1103 TABLETS CILEXETIL CANDESARTAN 1104 TABLETS CILEXETIL CANDESARTAN 1105 500MG CAPECITABINE 1106 XELODA HYDROCHLORIDE CAPECITABINE TABLETS Baur & Co (Pvt) A 1108 500MGTABLETS CAPECITABINE 500 CAXETA 1109 TABLETS USP TABLETS CAPECITABINE Hemas 102 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 16-Aug-18 Provisional INDIA 20-Sep-17 Full BANGLADESH 30-Aug-15 24-Oct-15 Full Full INDIAINDIA 24-Oct-17 Full INDIA 30-Jun-17 Years Two INDIA 08-Feb-17 Full INDIA 19-Jun-14 Full 03-Dec-14 Full Reliance Life Sciences (Pvt) Ltd Celon Laboratories Ltd United Biotech (Pvt) Ltd Beacon Pharmaceuticals Ltd Cipla Ltd INDIA(Pvt) Ltd 23-Aug-14 Full Stallion Laboratories Pvt Ltd Lark Laboratories (India) Ltd Ltd Medicamen Biotech Ltd (Contd.) Services Pvt. Ltd (Pvt) Ltd Health (Pvt) Ltd (Ceylon) Ltd (Pvt) Ltd (Pvt) Ltd Ltd Pharmaceuticals (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP GLOCAPX TABLETS PharmAce (Pvt) Ltd Globela Pharma RELICTABINE 500RELICTABINE TABLETS ABC Pharma 500XELOCEL TABLETSCITABIN Medmart Pharma TABLETSXITABIN George Steuart TABLETSCAPEGARD 500 TABLETS Emerchemie NB Breathe Free Lanka 500MG CAPECITABINE TABLETS USP TABLETS CAPECITABINE 500MG 500MG 500MG 500MG 500MG 1111 1115 USP TABLETS CAPECITABINE 1110 USP TABLETS CAPECITABINE 1112 USP TABLETS CAPECITABINE 1113 USP TABLETS CAPECITABINE 1114 USP TABLETS CAPECITABINE 1116 25MG B.P TABLETS CAPTOPRIL 25 CAPORIL 1117 25MG B.P TABLETS CAPTOPRIL TABLETS CAPTOLAR Siba Healthcare 1118 25MG B.P TABLETS CAPTOPRIL TABLETS N/A Farnell Ceylon (Pvt) 1119 25MG B.P TABLETS CAPTOPRIL N/A TABLETS Chamee Chemist Bajaj Healthcare TABLETS Slim I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 103 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 12-Apr-16 Full INDIA 25-Jun-18 Years Two INDIA 08-Jul-18 Provisional PAKISTAN 29-Dec-16 Full 16-May-14PAKISTAN Full 20-Oct-15MALAYSIA Full 28-May-14SWITZERLAND Full 10-Apr-15 Full INDIAINDIA 25-Oct-14 Full 13-Jun-18 Years Two Novartis Pharma Italy SPA Crescent Therapeutics Ltd Mercury Laboratories Ltd Pharmaceuticals Ltd Treffer Pharmaceuticals Torrent Pharmaceuticals Ltd (Pvt) Ltd Maple Pharmaceuticals (Pvt) Ltd Glaxo Smithkiline Pakistan Ltd SDN BHD (Contd.) A Baur & Co (Pvt) A Ltd (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd Ltd Ltd Pharmaceuticlas (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP RELEASE TABLETS TEGRETOL 200TEGRETOL CONTROLLED CR 200ZIGMA TABLETSN/AAsian Pharma Euro SUSPENSION International Yaden RELEASE TABLETS 200mg RELEASE TABLETS 200MG USP TABLETS RELEASE 100MG/5ML SUSPENSION USP 1120 25MG B.P TABLETS CAPTOPRIL 25 ACEPRIL TABLETSAssociates Pharma Bafna 1121 12.5MG USP TABLETS CAPTOPRIL N/A1122 25MG USP TABLETS CAPTOPRIL 25 ANGIOPRIL TABLETS TABLETS1123 25MG USP TABLETS CAPTOPRIL International Yaden N/A Edna Medicals (Pvt) 1124 25MG USP TABLETS CAPTOPRIL CAPRIL TABLETS1125 25MG USP TABLETS CAPTOPRIL PharmAce (Pvt) Ltd TABLETS CAPOTEN Swiss Pharma 1126 25MG USP TABLETS CAPTOPRIL Markss HLC (Pvt) TABLETS APUZIN GlaxoSmithkiline 1127 CARBAMAZEPINE CONTROLLED TABLETS1128 CARBAMAZEPINE CONTROLLED Indoscan (Pvt) Ltd Industries / S P Y 1129 CARBAMAZEPINE ORAL 104 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 FRANCE 07-Aug-15SWITZERLAND 22-Apr-15 Full Full INDIAINDIA 26-Nov-18 Provisional INDIA 27-Mar-18 Full INDIA 27-Mar-18 Full INDIA 01-Aug-18 Provisional INDIA 23-Aug-15 Full 28-May-15INDIA Full INDIA 30-Jun-15 Full 03-Nov-17 Full Delpharm S A Huningue S Corona Remedics (Pvt) Ltd Pharmafabrikon Unit Pharmafabrikon Unit Akriti pharmaceuticals Pvt Ltd Torrent Pharmaceuticals Ltd SG Pharma (Pvt) Ltd Novartis Pharma S.P.A. Sava Healtheare Ltd (Pvt) Ltd (Contd.) Ltd Healthcare lanka Ltd (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Ltd Pharmacy (Pvt) Ltd Ltd (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP TEGRETOL SYRUP Baur & Co (Pvt) A NOSTRA TABLETSN/A Sunshine N/A TABLETS 200 Novachem Lanka CABATIC TABLETS TABLETS Novachem Lanka CARBATOL Slim TABLETSN/A Edna Medicals (Pvt) TABLETS The Esses 100MG/5ML 100MG 100MG 100MG 200MG 200MG 110MG USP 1131 200MGTABLETS CARBAMAZEPINE 200 TEGRETOL TABLETS1132 BP CARBAMAZEPINE TABLETS Baur & Co (Pvt) A 1133 BP CARBAMAZEPINE TABLETS 1134 BP CARBAMAZEPINE TABLETS 1135 BP CARBAMAZEPINE TABLETS 1136 BP CARBAMAZEPINE TABLETS 1137 TABLES & LEVODPA CARBIDOPA 1138 B.PTABLET CARBIMAZOLE 5MG N/A1139 B.PTABLET CARBIMAZOLE 5MG N/A TABLETS Radiant Health Care TABLETS Chamee Chemist Alvita Pharma 1130 CARBAMAZEPINE SYRUP I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 105 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 04-Jun-18 Provisional INDIA 31-Aug-18 Years Two PHILIPPINES 22-Jan-14 28-Sep-14 Full Full INDIA 21-May-17INDIA Full PHILIPPINES 19-Mar-15 28-Aug-14 Full Full PHILIPPINES 28-Sep-15 Full BELGIUM 31-Jul-16INDIA Full 14-Oct-16 Full Pharmaceuticals (Pvt) Ltd United Biotech (Pvt) Ltd Amherst Laboratories Amherst Laboratories Inc Unilab Pharma Cabpus Alcon- S A Couvreur N V MMC Healthcare Ltd Treffer Treffer Pharmaceuticals (Pvt) Ltd Abbott Biological BV United Laboratories (Contd.) Health (Pvt) Ltd George Steuart Health (Pvt) Ltd Health (Pvt) Ltd Baur & Co (Pvt) A Ltd Lanka (Pvt) Ltd (Pvt) Ltd Healthcare lanka Ltd Health (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP SUSPENSION GEL CARBOL INJECTIONUNICARB 450 Ceyoka (Pvt) Ltd INJECTION VED George Steuart SOLMUX FORTE ORAL SOLMUX SYRUPLACRYEISC OPHTHALMIC George Steuart FEROTAB CAPSULES Prime Pharma 450MG/45ML 450MG/45ML SUSPENSION 500MG/5ML 200MG/5ML PAEDIATRIC 1G GEL MINERALS CAPSULES 1140 10MG B.P TABLET CARBIMAZOLE N/A TABLETS International Yaden 1141 10MG I.P TABLET CARBIMAZOLE 10 CARBRIGHT TABLETS1142 20MG IP TABLET CARBIMAZOLE Chamee Chemist THYROCAB Alvita Pharma 1143 CARBOCISTEINE CAPSULES 500MG TABLETS SOLMUX Sunshine 1144 CAPSULES CARBOCISTEINE INJECTION BP George Steuart 1145 CARBOCISTEINE INJECTION BP 1146 CARBOCISTEINE ORAL 1147 CARBOCISTEINE SYRUP 1148 CARBOMER 3MG IN OPHTHALMIC 1149 & IRON , VITAMIN CARBONYL 106 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAGERMANY 02-Jun-17 Full 27-Jun-18GERMANY Full 09-Apr-18INDIA Full 16-May-18INDIA Full 16-May-17BANGLADESH 08-May-18 Years Two Full INDIAINDIA 19-Mar-15 Full INDIA 15-Mar-15 Full 16-May-17INDIA Full 16-May-15 Full Naprod Life Scienc (Pvt) Ltd Oncotec Pharma Produktion Oncotec Pharma Produktion Laboratories Ltd Fresenius Kabi Oncology Ltd Beacon Pharmaceuticals Ltd United Biotech (Pvt) Ltd Getwell Pharmaceuticals Fresenius Kabi Oncology Ltd Fresenius Kabi Oncology Ltd (Contd.) (Pvt) Ltd S J Enterprises (Pvt) Ltd S J Enterprises (Pvt) Ltd Ltd (Ceylon) Ltd Health (Pvt) Ltd Pharmacy (Pvt) Ltd Ltd Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP INFUSION SOLUTION INFUSION INJECTION Emerchemie NB NAPROPLAT INJECTIONN/A Ravilux Company MEDAC CARBOPLATIN SOLUTION WOMASTIN INJECTIONKEMOCARB Ceyoka (Pvt) Ltd Khandelwal INJECTION 150 CARBOPLAT Markss HLC (Pvt) / 450 UNICARB 150 INJECTION George Steuart CARBOTIN 450 INJECTION The Esses KEMOCARB INJECTIONKEMOCARB Markss HLC (Pvt) INJECTION Markss HLC (Pvt) INJECTION SOLUTION FOR INFUSION 10MG/ML SOLUTION FOR INFUSION 10MG/ML 10MG/1ML 10MG/1ML & 450MG/45ML IN15ML 150MG/15ML (450MG/45ML) 10MG/ML ,45ML 10MG/ML 150MG/15ML 1151 FOR CONCENTRATE CARBOPLATIN 1152 FOR CONCENTRATE CARBOPLATIN 1153 INJECTION CARBOPLATIN 1154 INJECTION CARBOPLATIN 1155 INJECTION 150MG CARBOPLATIN 1156 INJECTION CARBOPLATIN 1157 INJECTION BP CARBOPLATIN 1158 INJECTION BP CARBOPLATIN 1159 INJECTION BP CARBOPLATIN 1150 450MG/45ML CARBOPLATIN I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 107 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 22-Jun-15 Full 15-Aug-14 Full 25-May-16 Full INDIAINDIA 03-Jun-17 Full INDIA 31-Aug-15 Full 09-Apr-14 Full INDIAUNITED 06-Sep-17STATES Years Two UNITED STATES UNITED STATES INDIA 20-Jun-14 Full Pharmaceutical Pvt Ltd Laboratories Ltd Parenteral Drugs Ltd INDIA Drugs LtdTechno BANGLADESH 04-Jun-16 Full Cipla Ltd INDIA Ltd Vaccine 23-Mar-16Allergan Sales LLC Full Allergan Sales LLC Allergan Sales LLC Amanta Healthcare Ltd (Contd.) (Pvt) Ltd Pharmaceticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Citihealth Imports (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP OPHTHALMIC SOLUTION CARBOL SOLUTIONCELCARB 450 Ceyoka (Pvt) Ltd INJECTION Kavbir Associates Pharma 450WOMAPLAT Celon INJECTION Omacx Healthcare CARBOTIN 450 INJECTION S P L CYFTOCARB INJECTIONENDOPROST Breathe Free Lanka INJECTIONREFRESH Ceyoka (Pvt) Ltd Bharat Serums & EYE DROPSOPTIVE Hemas EYE DROPSREFRESH Hemas EYE DROPSALEMBIC Hemas VELDROP 450MG/45ML 250MCG/ML INJECTION USP 150MG/15ML 450MG/45ML 450MG/45ml 450MG/45ML SODIUM 0.5% W/V 0.9% SODIUM 0.5% W/V+GLYCERIN EYE DROPS LUBRICANT SODIUM EYE DROPS 1% W/V 0.5% W/V SODIUM EYE DROPS BP 1164 INJECTION BP CARBOPLATIN 1165 TROMETHAMINE CARBOPROST 1160 INJECTION BP CARBOPLATIN 1161 INJECTION BP CARBOPLATIN 1162 INJECTION BP CARBOPLATIN 1163 INJECTION BP CARBOPLATIN 1166 CARBOXYMETHYLCELLULOSE 1167 CARBOXYMETHYLCELLULOSE 1168 CARBOXYMETHYLCELLULOSE 1169 CARBOXYMETHYLCELLULOSE 108 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIA 20-Jun-14 Full INDIA 12-Oct-18 Full INDIABANGLADESH 23-Feb-18 Provisional 30-Jul-14 Full INDIAINDIA 01-Jun-18 Provisional INDIA 27-Mar-16 Full INDIA 01-Jun-18 Provisional 25-Feb-17 Full Amanta Healthcare Ltd Aristopharma Ltd BANGLADESH 09-Nov-18Years Two Sun Pharmaceutical industries IPCA LaboratoriesIPCA INDIACadila Healthcare 08-Feb-15Ltd Full Beximco Pharmaceuticals Ltd Pharmaceuticals Ltd Macleods Pharmaceuticals Ltd Pharmaceuticals Ltd Cadila Healthcare Ltd (Contd.) Citihealth Imports (Pvt) Ltd Hemas Pharmaceuticals (Pvt) Ltd Hemas Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Healthcare lanka Ltd (Ceylon) Ltd (Pvt) Ltd Healthcare lanka Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP OPHTHALMIC SOLUTION SOLUTION SUSPENSION ALEMBIC GEL VELDROP DRYLIEF OPHTHALMIC TEARS DROPS OPHTHALMIC SODIUM OPTHALMIC SOLUTION 0.5% W/V SODIUM LUBRICANT EYE DROPS SODIUM LUBRICANT 1% W/V SODIUM OPTHALMIC SOLUTION 0.5% W/V 1172 CARBOXYMETHYLCELLULOSE 1171 CARBOXYMETHYLCELLULOSE 1173 6.25MGTABLETS CARVEDILOL CARDOZ 6.251174 TABLETS 6.25MGTABLETS CARVEDILOL CARVIL Hemas 1175 6.25MGTABLETS CARVEDILOL TABLETS DILAPRESS 6.25 TABLETS1176 6.25MGTABLETS CARVEDILOL Sunshine Emerchemie NB 6.25 CARVAS 1177 6.25MG TABLETSTABLETS CARVEDILOL CANDALOL PharmAce (Pvt) Ltd Medley 1178 12.5MGTABLETS CARVEDILOL TABLETS 12.5 CARVAS Pettah Pharmacy 1179 12.5MG TABLETS CARVEDILOL TABLETS CARVIL PharmAce (Pvt) Ltd Medley TABLETS Sunshine 1170 CARBOXYMETHYLCELLULOSE I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 109 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 ARGENTINA 16-Nov-17 Years Two INDIAINDIA 23-Feb-18 Years Two INDIA 25-Feb-17 Full INDIA 29-Apr-15 Full INDIA 08-Apr-18 Years Two 30-Nov-17 Full INDIA 13-Sep-18 Years Two Sun Pharmaceutical industries IPCA LaboratoriesIPCA INDIALaboratoires Bago 08-Feb-15S. A Full Cadila Healthcare Ltd Cadila Healthcare Ltd Centurion Laboratories Pvt Ltd Centurion Laboratories Pvt Ltd Remedica limited CYPRUS 10-Nov-14Sterling Lab Full INDIAPharmaceuticals (Pvt) ltd 18-Jan-18 Full (Contd.) Hemas Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Ceylon) Ltd Healthcare lanka Ltd Healthcare lanka Ltd International Yaden (Pvt) Ltd (Pvt) Ltd Drugs (Pvt) Ltd Co Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP SUSPENSION TABLETS KEFLOR ORAL SUSPENSION USP 125MG/5ML SUSPENSION USP 1180 25MGTABLETS CARVEDILOL CARDOZ 25 TABLETS Hemas 1181 25MGTABLETS CARVEDILOL 25 CARVEDIL 1182 3.125MG TABLETS CARVEDILOL TABLETS CARVIL Emerchemie NB 1183 12.5MG USP TABLETS CARVEDILOL CARVIL TABLETS1184 12.5MG USP TABLETS CARVEDILOL Sunshine TABLETS N/A Sunshine 1185 6.25MG USP TABLETS CARVEDILOL N/A FILM COA 1186 FOR ORAL CEFACLOR TABLETS1187 500MG CAPSULES B.P CEFALEXIN International Yaden FELEXIN 500 CAPSULES1188 500MG CAPSULES B.P CEFALEXIN 500 CEPHAST Kandana Food & CAPSULES1189 500MG CAPSULES B.P CEFALEXIN Darley Butler & CILCEF 500 CAPSULES Algarash (Pvt) Ltd Surien 110 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 03-Mar-17 Years Two INDIA 27-Mar-15 Full BANGLADESH 27-Apr-15 12-Nov-18 Years Two Full INDIAINDIA 15-Nov-15 Full INDIA 21-Dec-17 Years Two INDIA 29-Jan-17 Years Two 17-Sep-14 Full Alkem Laboratories Ltd Formulation Yeluri (Pvt) Ltd United Biotech (Pvt) Ltd Incepta Pharmaceuticals Ltd Sterling Lab INDIA 12-Oct-17Years Two Alkem Laboratories Ltd Medico Remedies (Pvt) Ltd Medico Remedies (Pvt) Ltd Medispray Laboatories (Pvt) Ltd (Contd.) Emerchemie NB (Ceylon) Ltd Healthcare lanka Ltd George Steuart Health (Pvt) Ltd (Pvt) Ltd Co Ltd Kamazu (Pvt) Ltd Micro Labs Ltd INDIA 02-May-16 Full Ltd. Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP INJECTION INJECTION SUSPENSION CEPHAST SYRUPLECEF 125 Darley Butler & ORAL 125MG/5ML 125MG/5ML 1197 CEFEPIME FOR INJECTION 1G USP SHERPIME INJECTION1198 1.G CEFEPIME INJECTION IP Sunshine EPIME1199 CEFIXIME CAPSULES 200MG EMIXEF POWDER FOR CAPSULES Citihealth Imports 1195 SUSPENSION B.P ORAL CEFALEXIN 1196 CEFEPIME FOR INJECTION 1G USP MEGAPIME POWDER 1191 250MG CAPSULES BP CEFALEXIN N/A1192 250MG CAPSULES BP CEFALEXIN N/A CAPSULES1193 500MG CAPSULES I.P CEFALEXIN Akbar CEPHADEX 500 CAPSULES CAPSULES1194 SUSPENSION B.P ORAL CEFALEXIN Breathe Free Lanka Akbar 1190 500MG CAPSULES B.P CEFALEXIN DECACEF CAPSULES CIC Lifesciences I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 111 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 PAKISTAN 18-Jun-18 Years Two BANGLADESH 13-Aug-17 Full BANGLADESH 17-Nov-17 Years Two BANGLADESH 08-Oct-16 Full BANGLADESH 05-Oct-17 Full BANGLADESH 23-Dec-16 Full INDONESIA 21-Mar-14INDIA Full INDIA 24-Jan-18 Full 26-Nov-18 Full Laboratories (Pvt) Ltd Navana Pharmaceuticals Ltd Aristopharma Ltd BANGLADESH 08-May-17 Full Healthcare Pharmaceuticals Pharmaceuticals Ltd Pharmaceuticals Ltd Medicon Pharmaceuticals Ltd Dankos Farma T P Indonesia for PT TBK Kalbe Farma SRS Pharmaceuticals (Pvt) Ltd Unimax Laboratories (Contd.) Co Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Lifeline Pharmaceuticals (Pvt) Ltd Hemas Pharmaceuticals (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP TABLETS TABLETS SAVECEF CHEWABLE MAHACEF 100 DISPERSIBLE 200MG 100MG 1200 CEFIXIME CAPSULES 200MG SECURE 200 CAPSULES PharmAce (Pvt) Ltd Wilshire 1201 CEFIXIME CAPSULES 200MG DURACEF1202 CEFIXIME CAPSULES 200MG CAPSULES AFIX1203 Darley Butler & CEFIXIME CAPSULES 200MG 200 DENVAR 1204 CAPSULES CEFIXIME CAPSULES 200MG CAPSULES Hemas CEF 3 Citihealth Imports 1205 CEFIXIME CAPSULES 400MG CEF 3 CAPSULES1206 200MG CEFIXIME CAPSULES BP PharmAce (Pvt) Ltd PROFIX Square CAPSULES1207 200MG CEFIXIME CAPSULES USP TRIFIX PharmAce (Pvt) Ltd CAPSULES Square Act Enterpriese 1208 TABLETS CEFIXIME CHEWABLE TABLETS1209 TABLETS CEFIXIME DISPERSIBLE Hemas 112 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 18-Mar-14 Full 21-Mar-14 Full INDIAINDIA 23-Mar-17 Full INDIA 27-Jan-15 Full 18-Mar-14 Full PAKISTAN 10-May-18 Years Two INDIA 17-Mar-18 Years Two Theon Pharmaceuticals Ltd Sterling Lab INDIAAlkem Laboratories Ltd 16-Oct-17 Health Care IVA Full (Pvt) Ltd (Pvt) Ltd Sterling Lab INDIA Kalbe FarmaT P INDONESIA 12-Aug-15 24-Feb-14 Full Laboratories (Pvt) Full Ltd Lark Laboratories (India) Ltd (Pvt) Ltd (Contd.) Slim Pharmaceuticals (Pvt) Ltd Darley Butler & Co Ltd Emerchemie NB (Ceylon) Ltd Slim Pharmaceuticals (Pvt) Ltd Co Ltd Pharmaceuticals (Pvt) Ltd PharmAce (Pvt) Ltd Wilshire Farnell Ceylon (Pvt) Ltd Pharma AssociatesPharma AMN Life Science SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP TABLETS TABLETS TABLETS TABLETS FOR ORAL SUSPENSION FOR ORAL SOLUTION TABLETS CHEOFIX 100 DT DISPERSIBLE 100 DT CIFATAZE DISPERSIBLE DTTAXIM-O DISPERSIBLE 100 DTIVAFIXIM DISPERSIBLE AMZIF 200 TABLETS 200 DT CIFATAZE TABLETSAssociates Pharma AMN Life Science Darley Butler & SECURE POWDER LORAXIM POWDER AMZIF 100 DISPERSIBLE 100MG 100MG 100MG 200MG 200MG 100MG/5ML USP 100MG/5ML USP 100MG 100MG 1211 TABLETS CEFIXIME DISPERSIBLE 1212 TABLETS CEFIXIME DISPERSIBLE 1213 TABLETS CEFIXIME DISPERSIBLE 1214 TABLETS CEFIXIME DISPERSIBLE 1215 TABLETS CEFIXIME DISPERSIBLE 1216 TABLETS CEFIXIME DISPERSIBLE 1217 1G CEFIXIME FOR INJECTION USP VIPIME1218 SUSPENSION CEFIXIME FOR ORAL INJECTION Hemas 1219 SUSPENSION CEFIXIME FOR ORAL 1210 TABLETS CEFIXIME DISPERSIBLE I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 113 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 PAKISTAN 27-Sep-18 Full IRAN 12-Feb-16 Full INDIABANGLADESH 06-Apr-18 24-Oct-17 Provisional Full INDIAPAKISTAN 16-Jul-16 24-Oct-14 Full BANGLADESH Full 05-Apr-16 Full INDONESIA 24-Feb-18 Full Exir Pharmaceuticals Company (Pvt) Ltd Pharmaceuticals Ltd Zim Laboratories Ltd Ltd Navana Healthcare Ltd T Dankos P Farma S J & G Fazul Ellahie (Pvt) Ltd (Contd.) Glenford Corporation (Pvt) Ltd AssociatesPharma AMN Life Science PharmAce (Pvt) Ltd Square Tabrane Pharmaceuticals (Pvt) Ltd Darley Butler & Co Ltd Hemas Pharmaceuticals (Pvt) Ltd A V H Distributors A (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP SUSPENSION SYRUP Kamazu (Pvt) Ltd Micro Labs LtdSUSPENSION INDIASUSPENSION 25-Jan-18Years Two SUSPENSION SUSPENSION SOLUTION SUSPENSION RITE-O-CEF SYRUPLOPRAX 100 Kamazu (Pvt) Ltd ORAL Micro Labs Ltd RITE-O CEF DRY INDIASYRUP SUNCEXIM 100 25-Jan-18 ORAL Years Two CEF 3ZEFLET ORAL POWDER ORAL EVOFIX SUSPENSIONDURACEF CIC Holdings PLC PharmEvo (Pvt) ORAL TRIFIX POWDER ORAL MAGNETT POWDER FOR USP 100MG/5ML USP 100MG/5ML USP 100MG/5ML USP 100MG/5ML USP 100MG/5ML USP 100MG/5ML USP 100MG/5ML 100MG/5ML 100MG/5ML USP 100MG/5ML USP 1221 SUSPENSION CEFIXIME FOR ORAL 1222 SUSPENSION CEFIXIME FOR ORAL 1223 SUSPENSION CEFIXIME FOR ORAL 1224 SUSPENSION CEFIXIME FOR ORAL 1225 SUSPENSION CEFIXIME FOR ORAL 1226 SUSPENSION CEFIXIME FOR ORAL 1227 SUSPENSION USP CEFIXIME ORAL 1228 SUSPENSION USP CEFIXIME ORAL 1229 SUSPENSION USP CEFIXIME ORAL 1220 SUSPENSION CEFIXIME FOR ORAL 114 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAPAKISTAN 09-Mar-18 Years Two 01-Sep-17 Years Two INDIA 31-May-16PAKISTAN Full 27-Sep-18INDIA Full INDIA 05-Aug-17 Full INDIA 04-Jun-15 Full 08-May-15INDIA Full INDIA 31-Dec-18 Full INDIA 24-Jan-18 Years Two 16-Jul-15 Full Tabros Pharma Tabros (Pvt) Ltd (Pvt) Ltd S J & G Fazul Ellahie (Pvt) Ltd (Pvt) Ltd Lanark Laboratores (Pvt) Ltd Zim Laboratories Ltd Zim Laboratories Ltd Unimax Laboratories Marksons Pharma Ltd Alkem Laboratories Ltd (Contd.) Associated Laboratories (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Plc Emerchemie NB (Ceylon) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP SUSPENSION SUSPENSION FIXITILAMZIF ORAL SUSPENSIONAssociates Pharma AMN Life Science TAXIMO FORTSTAXIMO POWDER FOR 100MG/5ML 50MG/5ML 100MG/5ML 1231 SUSPENSION USP CEFIXIME ORAL 1232 SUSPENSION USP CEFIXIME ORAL 1233 200MGTABLETS CEFIXIME MAGNETT1234 200MG IP TABLETS CEFIXIME TABLETS U-FIXIM 2001235 100MG USP TABLETS CEFIXIME V H Distributors TABLETS A EXIM 1001236 Klintas (Pvt) Ltd 100MG USP TABLETS CEFIXIME TABLETS United Biotech 100 ZEFLET 1237 Pharma Avenier 200MG USP TABLETS CEFIXIME TABLETS 200 ZEFLET Tabrane 1238 200MG USP TABLETS CEFIXIME TABLETS MAHACEF 200 Tabrane TABLETS1239 200MG USP TABLETS CEFIXIME C-MARK 200 Hemas TABLETS Browns & Company 1230 SUSPENSION USP CEFIXIME ORAL I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 115 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 PAKISTAN 23-Mar-16INDIA Full INDIA 21-Mar-15 Full 29-Sep-15 Full INDIAINDIA 27-Mar-17 Full INDIA 05-Aug-14 Full 03-May-15 Full INDIA 28-Jun-14INDIA Full 30-Oct-16 Full Tabros Pharma Tabros (Pvt) Ltd Theon Pharmaceuticals Ltd Health Care IVA (Pvt) Ltd Chiros Pharma INDIALark Laboratories (India) Ltd 13-Oct-16 Full Alkem Laboratories Ltd Emcure Pharmaceuticals Ltd Delta Pharma Ltd BANGLADESH 21-Dec-18 Provisional GMH Organics india for Vexxa Life ciences (Pvt) Ltd India Advance Scott Edil Research Laboratories (Contd.) Laboratories (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Ltd (Ceylon) Ltd (Ceylon) Ltd Accorria Pharmaceuticals (Pvt) Ltd C Medical (Pvt) T P Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP SUSPENSION INJECTION OFEXVEXOP-S 1000 POWDER INJECTION Global Impex AV N/A POWDER FOR SUSPENSION USP 100MG/5ML SUSPENSION USP FOR INJECTION 1G/VIAL FOR INJECTION 1G/VIAL 1240 200MG USP TABLETS CEFIXIME FIXITIL-T CREAM Associated 1241 200MG USP TABLETS CEFIXIME THEOFIX1242 200MG USP TABLETS CEFIXIME TABLETS 200 IVAFIXIM 1243 Slim TABLETS 200MG USP TABLETS CEFIXIME CHIFIX 200 Slim 1244 200MG USP TABLETS CEFIXIME TABLETS LORAXIM 200 Slim 1245 TABLETS 200MG USP TABLETS CEFIXIME TAXIM-O Farnell Ceylon (Pvt) 1246 200MG USP TABLETS CEFIXIME TABLETST C-TAX 1247 Emerchemie NB CEFIXME POWDER FOR ORAL TABLETS1248 CEFOPERZONE & SULBACTRUM Emerchemie NB 1249 CEFOPERZONE & SULBACTRUM 116 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 27-Apr-15 Full INDIA 22-Mar-18 Years Two 28-Jun-14INDIA Full INDIA 29-Jan-15 Full 28-Jun-15INDIA Full 25-May-16INDIA Full 28-Jun-14INDIA Full 28-Jun-14PAKISTAN Full 09-Feb-18 Years Two PAKISTAN 17-Aug-18 Provisional Pharmaceutical Pvt Ltd Maan Pharmaceuticals Ltd GMH Organics india for Vexxa Life ciences (Pvt) Ltd India (Pvt) Ltd GMH Organics india for Vexxa Life ciences (Pvt) Ltd India Shamshree Lifesciences Ltd GMH Organics india for Vexxa Life ciences (Pvt) Ltd India GMH Organics india for Vexxa Life ciences (Pvt) Ltd India Ltd Zafa Pharmaceuticals Laboratories (Pvt) Ltd (Contd.) P T C Medical (Pvt) T P Ltd Global Impex AV (Pvt) Ltd Global Impex AV (Pvt) Ltd (Pvt) Ltd Global Impex AV (Pvt) Ltd (Pvt) Ltd International Yaden (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP INJECTION INJECTION INJECTION INJECTION INJECTION PRAZONE-S INJECTION Ceyoka (Pvt) Ltd Kavbir SULBACZONE 1 POWDER FOR VEXOP-S 1500 POWDER AMICEF-S INJECTIONVEXOP-S 2000Associates Pharma POWDER AMN Life Science CEFSULASH 100 INJECTION Omacx Healthcare 2000VEXOP POWDER 1000VEXOP INJECTIONEVOTAXIME Global Impex AV INJECTIONZAFIXIME CIC Holdings PLC PharmEvo (Pvt) POWDER / FOR INJECTION 1G/VIAL FOR INJECTION USP 1G/VIAL FOR INJECTION USP FOR INJECTION 1500MG VIAL FOR INJECTION 1500MG VIAL & FOR INJECTION 2000MG/VIAL VIAL FOR INJECTION 20ML WATER 1000MG FOR INJECTION USP 2000MG/VIAL FOR INJECTION USP FOR INJECTION & WATER 1000MG VIAL USP 500MG 500MG 1250 CEFOPERZONE & SULBACTRUM 1251 CEFOPERZONE & SULBACTRUM 1252 CEFOPERZONE & SULBACTRUM 1253 CEFOPERZONE & SULBACTRUM 1254 CEFOPERZONE & SULBACTRUM 1255 CEFOPERZONE & SULBACTRUM 1256 CEFOPERZONE & SULBACTRUM 1257 CEFOPERZONE FOR INJECTION 1258 FOR INJECTION U.S.P CEFOTAXIME 1259 FOR INJECTION U.S.P CEFOTAXIME I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 117 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 PAKISTAN 10-May-14 Full PAKISTAN 18-Jun-18 Provisional INDONESIA 01-Jan-18 Provisional INDIAINDIA 14-Nov-14 Full INDIA 07-Jan-15 Full CHINA 26-Jun-14 Full 15-Oct-14PAKISTAN Full 18-Aug-17 Years Two INDONESIA 01-Jan-18 Provisional PAKISTAN 10-May-18 Years Two Surge Laboratories (Pvt) Ltd, Pakistan for Nabiqasin Indu,s Pvt Ltd Laboratories (Pvt) Ltd Dankos Farma T P Indonesia for PT TBK Kalbe Farma Alkem Laboratories Ltd Medispray Laboatories (Pvt) Ltd Protech Biosystems (Pvt) Ltd North China Pharmacuticals Co Pharma Tabros (Pvt) Ltd Dankos Farma T P Indonesia for PT TBK Kalbe Farma Laboratories (Pvt) Ltd (Contd.) Health (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Ceylon) Ltd (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd Laboratories (Pvt) Ltd Pharmaceuticals (Pvt) Ltd PharmAce (Pvt) Ltd Wilshire SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP INJECTION Breathe Free Lanka INJECTION NGN Enterprises SOLUTION BAXIM INJECTION George Steuart SWIFTAX 1GSWIFTAX INJECTIONKALFOXIM IG PharmAce (Pvt) Ltd Wilshire INJECTIONTAXIM Hemas NOVATAX INJECTION Emerchemie NB PROTATOXIME 1000 N/ACEFON INJECTION Dowell International KALFOXIM IG INJECTION INJECTION Associated 250SWIFTAX Hemas INJECTABLE 500MG 1G 1G 1G 1G 1G 1G 1G 1G 250MG 1260 FOR INJECTION U.S.P CEFOTAXIME 1261 FOR INJECTION USP CEFOTAXIME 1262 FOR INJECTION USP CEFOTAXIME 1263 FOR INJECTION USP CEFOTAXIME 1264 FOR INJECTION USP CEFOTAXIME 1265 FOR INJECTION USP CEFOTAXIME 1266 FOR INJECTION USP CEFOTAXIME 1267 FOR INJECTION USP CEFOTAXIME 1268 FOR INJECTION USP CEFOTAXIME 1269 FOR INJECTION USP CEFOTAXIME 118 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 29-Apr-16 Full 12-Nov-14 Full INDIA 10-May-18INDIA Years Two INDIA 15-Jul-14 Full 14-May-18INDIA Years Two INDIA 24-Feb-15 Full INDIA 15-Dec-14 Full 23-Nov-15 Full Nitin Lifesciences Ltd Cadila Laboratories Ltd Sanbe FarmaT P INDONESIA 16-Nov-14 Dexa MedicaT P Full INDONESIA 30-Jan-14Zim Laboratories Ltd Full Laboratories (Pvt) Ltd Zim Laboratories Ltd Formulation Yeluri (Pvt) Ltd Ltd Theon Pharmaceuticals Ltd (Contd.) Pharmaceuticals (Pvt) Ltd Healthcare lanka Ltd Pharmaceuticals (Pvt) Ltd Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Healthcare lanka Ltd Pharmaceuticals (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP NITAXIM INJECTION Slim ORITAXIM-1000 INJECTION Sunshine CEFDOZIM 100 TABLETS 50 CEFWAR Tabrane POWDER DRY Ceyoka (Pvt) LtdCEFDOZIM 100 Leben TABLETS ELZID 1000MG Tabrane INJECTION Sunshine K-ZIDIME INJECTIONTHEOZIDE 1000 INJECTION Ceyoka (Pvt) Ltd Akorn India (Pvt) Slim 250MG USP 1G USP 100MG USP 50MG/5ML SUSPENSION USP ORAL 200MG TABLETS 1000MG 1000MG 1000MG 1270 FOR INJECTION USP CEFOTAXIME 1271 SODIUM INJECTION CEFOTAXIME 1272 CEFPIROME FOR INJECTION 1G BACTIROM1273 CEFPIROME INJECTION 1G INJECTION Lifeline CEFRIN 1 G1274 TABLETS CEFPODOXIME PROXETIL INJECTION1275 Baur & Co (Pvt) A CEFPODOXIME PROXETILE FOR 1276 CEFPODOXIME PROXETILE USP 1277 FOR INJECTION USP CEFTAZIDIME 1278 FOR INJECTION USP CEFTAZIDIME 1279 FOR INJECTION USP CEFTAZIDIME I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 119 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 21-Oct-16 Full BANGLADESH 20-Jan-17 25-Feb-18 Years Two Full MALAYSIA 13-May-14INDIA Full INDIA 05-Oct-15 Full INDIA 10-Nov-16 Full BANGLADESH 18-Apr-14 27-May-15 Full Full INDONESIA 31-Jan-18 Years Two INDIA 27-Apr-16 Full Swiss Paranterals (Pvt) Ltd Pharmaceuticals Ltd Kotra pharma (M) Ltd Swiss Paranterals (Pvt) Ltd Shamshree Lifesciences Ltd Swiss Paranterals (Pvt) Ltd Pharmaceuticals Ltd T Dankos P Laboratories Tbk Kalbe T for P Farma Injectcare Parenterals (Pvt) Ltd Nitin Lifesciences Ltd (Contd.) Ltd Co Ltd C Medical (Pvt) T P Ltd (Pvt) Ltd Ltd Pharmaceuticals (Pvt) Ltd International Yaden (Pvt) Ltd Slim Pharmaceuticals (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP INJECTION INJECTION SUSPENSION N/ACEFTAZID INJECTION INJECTION Kay Pharma (Pvt) VAXCEL PharmAce (Pvt) Ltd Square INJECTIONN/A Delmege Forsyth & CEFTRASH POWDER FOR INJECTIONN/A Omacx Healthcare CEFTRON INJECTION INJECTION C Medical (Pvt) T P BROADCED PharmAce (Pvt) Ltd Square INJECTIONN/A Hemas POWDER FOR NECEFT 1000NECEFT POWDER DRY 1G 1G 1G 500mg Sterile 1000MG USP 1G USP 1G USP 1G USP 250MG USP 1000MG 1281 FOR INJECTION USP CEFTAZIDIME 1282 FOR INJECTION USP CEFTAZIDIME 1283 FOR INJECTION USP CEFTAZIDIME 1284 FOR INJECTION USP CEFTAZIDIME 1285 CEFTRIAXONE FOR INJECTION 1286 CEFTRIAXONE FOR INJECTION 1287 CEFTRIAXONE FOR INJECTION 1288 CEFTRIAXONE FOR INJECTION 1289 CEFTRIAXONE FOR INJECTION 1280 FOR INJECTION USP CEFTAZIDIME 120 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 21-Apr-14 Full BANGLADESH 27-May-17 Full INDIA 21-May-17BANGLADESH Years Two 27-May-15 Full SWITZERLAND 01-Jan-14 Full INDIAINDIA 26-Dec-14 Full 26-Jun-15 Full CHINA 15-Mar-14INDIA Full UNITED 13-Mar-15KINGDOM Full Pharmaceuticals Ltd Injectcare Parenterals (Pvt) Ltd Pharmaceuticals Ltd F Hoffman-La Roche Ltd Ltd Protech Biosystems (Pvt) Ltd Drugs LtdTechno BANGLADESH 20-May-16 Full North China Pharmacuticals Co Ltd Glaxo Wellcome UK Ltd (Contd.) Yaden International Yaden (Pvt) Ltd Ltd (Pvt) Ltd Pharmaceticals (Pvt) Ltd Pharmaceuticlas (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP INJECTION INJECTION NGN Enterprises CEFTRON INJECTION PharmAce (Pvt) Ltd Square N/ACEFTRON POWDER FOR POWDER DRY PharmAce (Pvt) Ltd Square ALCEF 250 INJECTIONCEFTRIAXONE PROTECH PharmAce (Pvt) Ltd Alpa Laboratories CEFIZON INJECTIONN/A S P L ALCEF 1000 INJECTION INJECTION Dowell International PharmAce (Pvt) Ltd Alpa Laboratories USP 250MG USP USP 500MG USP 500MG USP 250MG INJETION BP 1000MG( 1G) INJETION USP 1000MG( 1G) INJETION USP 1G INJECCTION USP 1G (1000MG) 1290 CEFTRIAXONE FOR INJECTION 1291 CEFTRIAXONE FOR INJECTION 1292 CEFTRIAXONE FOR INJECTION 1293 CEFTRIAXONE SODIUM IG IV ROCEPHIN1294 CEFTRIAXONE SODIUM FOR INJECTION Baur & Co (Pvt) A 1295 CEFTRIAXONE SODIUM FOR 1296 CEFTRIAXONE SODIUM FOR 1297 CEFTRIAXONE SODIUM 1298 CEFTRIAXONE SODIUM STERILE 1299 CEFUROXIME AXETIL 125MG ZINNAT TABLETS GlaxoSmithkiline I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 121 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 04-Apr-16 Full INDIAINDIA 31-Mar-18 Full BANGLADESH 21-Feb-14 11-Jun-18 Full Years Two INDIAINDIA 18-Apr-15 Full INDIA 28-Feb-14 Full UNITED 09-Jul-15KINGDOM Full INDIA 22-Jun-18 Years Two INDIA 31-Dec-18 Full Alkem Laboratories Ltd Healthcare Formulation (Pvt) Ltd Samce Laboratories (Pvt) Ltd Pharmaceuticals Zim Laboratories Ltd Glaxo Operations UK Ltd (Pvt) Ltd (Pvt) Ltd Orion pharma Ltd BANGLADESH 02-Nov-17Years Two Akums Drugs & Pharmaceuticals Ltd (Contd.) Emerchemie NB (Ceylon) Ltd Citihealth Imports (Pvt) Ltd International (Pvt) Ltd Tabrane Pharmaceuticals (Pvt) Ltd GlaxoSmithkiline Pharmaceuticlas (Pvt) Ltd Pharma AssociatesPharma AMN Life Science Co Ltd (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP SUSPENSION SUSPENSION SUSPENSION SUSPENSION SUSPENSION ZOCEFFUROTIL ORAL POWDER BETFUR-OS 125 SYRUP DRY Tabrane MILCEF 125 SYRUPCEFEROAssociates Pharma The Madras ORAL ZINNAT ORAL SUNCETIN 125 ORAL SUNCETIN 500 TABLETS 500AXET Associates Pharma AMN Life Science TABLETSVEXURO 500 Darley Butler & TABLETS Global Impex AV SUSPENSION USP 125MG/5ML SUSPENSION USP 125MG/5ML SUSPENSION USP 125MG/5ML SUSPENSION USP 125MG/5ML SUSPENSION USP 125MG/5ML 125MG/5ML SUSPENSION USP 125MG/5ML SUSPENSION USP 500MG 500MG 500MG 1301 FOR ORAL AXETIL CEFUROXIME 1302 FOR ORAL AXETIL CEFUROXIME 1303 FOR ORAL AXETIL CEFUROXIME 1304 FOR ORAL AXETIL CEFUROXIME 1305 CEFUROXIME AXETIL SUSPENSION 1306 CEFUROXIME AXETIL SUSPENSION 1300 FOR ORAL AXETIL CEFUROXIME 1307 USP TABLET AXETIL CEFUROXIME 1308 USP TABLET AXETIL CEFUROXIME 1309 USP TABLET AXETIL CEFUROXIME 122 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIA 15-May-19INDIA Full 21-Apr-18INDIA Full INDIA 28-Sep-15 Full INDIA 30-Jul-15 Full INDIA 01-Feb-14 Full INDIA 26-Dec-17 Full INDIA 26-Apr-14 Full INDIA 31-Dec-14 Full INDIA 09-Mar-18 Years Two 15-May-14 Full Zim Laboratories Ltd Maxim Pharmaceuticals India for Glenmark Pharmaceuticals Ltd Synmedic Laboratories (Pvt) Ltd Marksons Pharma Ltd Pharmaceuticals Ltd SRS Pharmaceuticals (Pvt) Ltd Unimax Laboratories Akums Drugs & Pharmaceuticals Ltd Innova Captab (Pvt) Ltd Zim Laboratories Ltd (Contd.) Pharmaceuticals (Pvt) Ltd Healthcare lanka Ltd Pharmaceuticals (Pvt) Ltd Plc Drugs (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP CEFERO 500 TABLETS Tabrane ALTACEF TABLETSCEFUROX Sunshine TABLETSFUROMARK 500 TABLETS Lifeline Browns & Company CEUROX 500 TABLETSFIRESIN PharmAce (Pvt) Ltd Medley TABLETSCEFAKIND Kandana Food & TABLETSVEXURO 500 Hemas TABLETS 500AUXTOCEF Global Impex AV TABLETS Slim CEFERO 500 TABLETS Lanka (Pvt) Tabrane 500MG 500MG 500MG 500MG 500MG 500MG 500MG 500MG 500MG 500MG 1311 USP TABLET AXETIL CEFUROXIME 1310 USP TABLET AXETIL CEFUROXIME 1312 USP TABLET AXETIL CEFUROXIME 1313 USP TABLET AXETIL CEFUROXIME 1314 USP TABLET AXETIL CEFUROXIME 1315 USP TABLET AXETIL CEFUROXIME 1316 USP TABLET AXETIL CEFUROXIME 1317 USP TABLET AXETIL CEFUROXIME 1318 USP TABLET AXETIL CEFUROXIME 1319 USP TABLET AXETIL CEFUROXIME I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 123 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIA 05-Jun-14 Full INDIAINDIA 04-Mar-15 Full INDIA 31-Dec-18 Full INDIA 30-Jul-15 Full INDIA 12-Jan-16 Full INDIA 15-Sep-15 Full INDIA 28-Sep-15 Full 26-Apr-14 Full Orion pharma Ltd BANGLADESH 02-Nov-17Years Two Emcure Pharmaceuticals Ltd Aristo Pharmaceuticals Ltd Zim Laboratories Ltd Marksons Pharma Ltd Pharmaceuticals Ltd SRS Pharmaceuticals (Pvt) Ltd Synmedic Laboratories (Pvt) Ltd Unimax Laboratories (Contd.) Co Ltd (Ceylon) Ltd Co Ltd Pharmaceuticals (Pvt) Ltd Plc Drugs (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP AXET 500AXET TABLETS Darley Butler & C-TRI T-500 TABLETSRITIL Emerchemie NB FORCEF TABLETS Kamazu (Pvt) Ltd TABLETSCEFRRO 250 Micro Labs Ltd TABLETS Darley Butler & INDIAFUROMARK 250 Tabrane TABLETS 05-Apr-18 Browns & Company CEUROX 250 Full TABLETSFIRESIN PharmAce (Pvt) Ltd Medley TABLETSCEFUROX 250 TABLETS Kandana Food & CEFAKIND Lifeline TABLETS Hemas 500MG 500MG 500MG 500MG 250MG 250MG 250MG 250MG 250MG 250MG 1320 USP TABLET AXETIL CEFUROXIME 1321 USP TABLET AXETIL CEFUROXIME 1322 USP TABLET AXETIL CEFUROXIME 1323 USP TABLET AXETIL CEFUROXIME 1324 USP CEFUROXIME AXETIL TABLET 1325 USP CEFUROXIME AXETIL TABLET 1326 USP CEFUROXIME AXETIL TABLET 1327 USP CEFUROXIME AXETIL TABLET 1328 USP CEFUROXIME AXETIL TABLET 1329 USP CEFUROXIME AXETIL TABLET 124 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 28-Jan-14 Full INDIA 29-Jan-14 Full INDIA 15-Mar-17 Full INDIABANGLADESH 15-Jul-14 25-Feb-15 Full Full UNITED KINGDOM INDIABANGLADESH 10-Jul-18 22-Mar-18 Years Two Full PAKISTAN 03-Jan-14 Full Medispray Laboatories (Pvt) Ltd Sterling Lab INDIABharat Parenterals Ltd 08-Oct-15 Full Pharmaceuticals Healthcare Pharmaceuticals Glaxo Operations UK Ltd Fist Twenty Century Pharmaceutical Pvt Ltd Pharmaceuticals Ltd CCL Pharmaceuticals (Pvt) Ltd (Contd.) (Pvt) Ltd Co Ltd (Pvt) Ltd (Pvt) Ltd Pharmaceuticlas (Pvt) Ltd Ltd Pharmaceuticals Lanka (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP CEFASYN 250CEFASYN TABLETS Breathe Free Lanka CEFTIL 250CEFTIL TABLETSOXIME 250 Darley Butler & TABLETSRITIL Pharma Tropical MILCEF 500 TABLETS TABLETS Kamazu (Pvt) LtdFUROTIL Micro Labs LtdAssociates Pharma The Madras INDIA TABLETSZINNAT Citihealth Imports 05-Apr-17Years Two 250 TABLETSTRYOXIM TABLETS GlaxoSmithkiline 250CEFOTIL Alaris Lanka (Pvt) TABLETSKEFROX 250 PharmAce (Pvt) Ltd Square TABLETS CCL 250MG 250MG 250MG 250MG 500MG 500MG 500MG 250MG 250MG 250MG 1330 USP CEFUROXIME AXETIL TABLET 1331 USP CEFUROXIME AXETIL TABLET 1332 USP CEFUROXIME AXETIL TABLET 1333 USP CEFUROXIME AXETIL TABLET 1334 CEFUROXIME AXETIL TABLETS 1335 CEFUROXIME AXETIL TABLETS 1336 CEFUROXIME AXETIL TABLETS 1337 BP CEFUROXIME AXETIL TABLETS 1338 BP CEFUROXIME AXETIL TABLETS 1339 BP CEFUROXIME AXETIL TABLETS I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 125 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIABANGLADESH 28-Dec-16 26-Jun-14 Full Full BANGLADESH 22-Mar-18 Years Two PAKISTAN 11-Mar-14INDIA Full 26-Jan-14 Full INDIAINDIA 27-Nov-17 Years Two INDIA 27-Nov-17 Years Two INDIA 15-Jan-15 Full 22-Nov-17 Years Two Alkem Laboratories Ltd Globe Pharmaceuticals Ltd Pharmaceuticals Ltd CCL Pharmaceuticals (Pvt) Ltd Laboratories XL (Pvt) Ltd Delta Pharma Ltd BANGLADESH 14-Oct-16Ankur Drugs & Full Pharma (Pvt) Ltd Ankur Drugs & Pharma (Pvt) Ltd (Pvt) Ltd Ankur Drugs & Pharma (Pvt) Ltd (Contd.) (Ceylon) Ltd (Pvt) Ltd Pharmaceuticals Lanka (Pvt) Ltd SMM Halcyon (Pvt) Ltd Drugs (Pvt) Ltd International (Pvt) Ltd International (Pvt) Ltd International (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP TABLETS ZOCEF TABLETS Emerchemie NB XIMETIL 500XIMETIL TABLETS 500CEFOTIL Healthcare Tabrane TABLETSKEFROX PharmAce (Pvt) Ltd Square TABLETSTEIKEDEN 500 FILM COA CCL 500STAXIM TABLETS 250CEFATIL Kandana Food & TABLETS 250CEFATIL Softcare TABLETSCEFOPRIM Softcare TABLETS 500CEFATIL Klintas (Pvt) Ltd TABLETS United Biotech Softcare 250MG 500MG 500MG 500MG 500MG 500MG 250MG 250MG 500MG 500MG 1340 BP CEFUROXIME AXETIL TABLETS 1341 BP CEFUROXIME AXETIL TABLETS 1342 BP CEFUROXIME AXETIL TABLETS 1343 BP CEFUROXIME AXETIL TABLETS 1344 BP CEFUROXIME AXETIL TABLETS 1345 BP CEFUROXIME AXETIL TABLETS 1346 IP CEFUROXIME AXETIL TABLETS 1347 IP CEFUROXIME AXETIL TABLETS 1348 IP CEFUROXIME AXETIL TABLETS 1349 IP CEFUROXIME AXETIL TABLETS 126 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIA 06-Dec-16 Full BANGLADESH 29-Sep-16 Full INDIA 26-Sep-14 Full INDIACHINA 18-Jul-14 Full 27-Aug-17INDIA Years Two INDIA 31-Dec-14 Full INDIA 31-Dec-15 Full 12-Sep-15 Full Medispray Laboatories (Pvt) Ltd Sterling Lab INDIAHealthcare Pharmaceuticals 21-May-15Zim Laboratories Full Ltd Micro Labs Ltd INDIAPharmaceuticals 04-Nov-14 Full Shenzhen Zhijun Pharmaceutical Co Ltd Akums Drugs & Pharmaceuticals Ltd Umedica Laboratories (Pvt) Ltd Health Care IVA (Pvt) Ltd (Contd.) (Pvt) Ltd Co Ltd (Pvt) Ltd Ltd Ltd Ltd (Pvt) Ltd Pharmaceuticals Pvt Ltd Pharmaceuticals (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP CEFASYN 125CEFASYN TABLETS Breathe Free Lanka STERITIL 125STERITIL TABLETSFUROTIL Darley Butler & TABLETSCEFERO Citihealth Imports TABLETSPULMOCEF Lanka (Pvt) Tabrane TABLETSMILCEF 125 SMM Halcyon (Pvt) TABLETSDALIROXIMAssociates Pharma The Madras TABLETSVEXURO 250 Farnell Ceylon (Pvt) TABLETSUROXIME 250 Global Impex AV TABLETSZINAXIN 250 Gamma TABLETS Slim 125MG 125MG 125MG 125MG 125MG 125MG 250MG 250MG 250MG 250MG 1350 USP CEFUROXIME AXETIL TABLETS 1351 USP CEFUROXIME AXETIL TABLETS 1352 USP CEFUROXIME AXETIL TABLETS 1353 USP CEFUROXIME AXETIL TABLETS 1354 USP CEFUROXIME AXETIL TABLETS 1355 USP CEFUROXIME AXETIL TABLETS 1356 USP CEFUROXIME AXETIL TABLETS 1357 USP CEFUROXIME AXETIL TABLETS 1358 USP CEFUROXIME AXETIL TABLETS 1359 USP CEFUROXIME AXETIL TABLETS I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 127 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIA 18-Jul-16 Full INDIAINDIA 25-Feb-15 Full BANGLADESH 17-Jun-17 11-Jun-18 Years Two Full INDIA 31-Dec-15 Full INDIA 12-Sep-15 Full Zee Laboratories INDIAPharmaceuticals 27-Jul-16 Full Micro Labs Ltd INDIAAristo Pharmaceuticals 28-Aug-16Ltd Full Sun Pharmaceutical industries Incepta Pharmaceuticals Ltd Umedica Laboratories (Pvt) Ltd Sterling Lab INDIAChiros Pharma INDIA 28-Aug-16 Health Care IVA Full (Pvt) Ltd 12-Aug-15 Full (Contd.) Services Pvt. Ltd Ltd Co Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Pharmaceuticals Pvt Ltd Co Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP CEFZIM TABLETS ABC Pharma MILCEF 250 TABLETSPULMOCEFAssociates Pharma The Madras TABLETSFORCEF 250 SMM Halcyon (Pvt) TABLETSCEROXIM Darley Butler & TABLETSKILBAC 500 Hemas TABLETSUROXIME Citihealth Imports TABLETS 500CEFTIL Gamma TABLETSCHIFUROX 500 Darley Butler & TABLETSZINAXIN 500 Slim TABLETS Slim 250MG 250MG 250MG 250MG 250MG 500MG 500MG 500MG 500MG 500MG 1360 USP CEFUROXIME AXETIL TABLETS 1361 USP CEFUROXIME AXETIL TABLETS 1362 USP CEFUROXIME AXETIL TABLETS 1363 USP CEFUROXIME AXETIL TABLETS 1364 USP CEFUROXIME AXETIL TABLETS 1365 USP CEFUROXIME AXETIL TABLETS 1366 USP CEFUROXIME AXETIL TABLETS 1367 USP CEFUROXIME AXETIL TABLETS 1368 USP CEFUROXIME AXETIL TABLETS 1369 USP CEFUROXIME AXETIL TABLETS 128 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIACHINA 17-Jun-15 Full 24-Apr-18INDIA Full INDIA 30-Nov-14 Full CHINA 15-Sep-14 Full 04-Jul-15INDIA Full INDIA 27-Sep-17 Full INDIA 23-Sep-17 Full INDIA 03-Jul-15 Full 19-Apr-14 Full Micro Labs Ltd INDIASun Pharmaceutical 28-Aug-15industries Full Youcare Pharmaceutical Group Co Ltd Swiss Paranterals (Pvt) Ltd Cooper Pharma Ltd Pharmaceuticals Co. Ltd Injectcare Parenterals (Pvt) Ltd Sciences (Pvt) Ltd Marksons Pharma Ltd (Pvt) Ltd (Contd.) Ltd Pharmaceuticals (Pvt) Ltd Ino-Life Healthcare (Pvt) Ltd Ltd (Pvt) Ltd International Yaden (Pvt) Ltd Browns & Company Plc SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP INJECTION INJECTION INJECTION PULMOCEF TABLETS SMM Halcyon (Pvt) CEROXIM TABLETSMINGKEXIN Hemas POWDER / N/ABIXIM INJECTION C Medical (Pvt) T P N/A INJECTION BMEC Lifestyle N/A INJECTION Pharma AssociatesN/A Reyoung POWDER FOR FUROMARK 750 POWDER FOR INJECTIONAssociates Pharma CEFOROX Steril Gene Life INJECTION Pharmatec (Pvt) Ltd Belco Pharma 500MG 500MG 0.75G 750MG 750MG 750MG 750MG 750MG 750MG 750MG 1370 USP CEFUROXIME AXETIL TABLETS 1371 USP CEFUROXIME AXETIL TABLETS 1372 CEFUROXIME FOR INJECTION USP 1373 CEFUROXIME FOR INJECTION USP 1374 CEFUROXIME FOR INJECTION USP 1375 CEFUROXIME FOR INJECTION USP 1376 CEFUROXIME FOR INJECTION USP 1377 CEFUROXIME FOR INJECTION USP 1378 CEFUROXIME FOR INJECTION USP 1379 CEFUROXIME FOR INJECTION USP I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 129 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 28-Jul-17 Full INDIA 01-Apr-16 Full 31-Aug-15 Full INDIA 22-Mar-18INDIA Provisional ITALY 09-Oct-16 Full 03-Mar-14ITALY Full 03-Mar-14PAKISTAN Full 12-Feb-15CHINA Full 27-Aug-14 Full Cadila pharmaceuticals Ltd Alkem Laboratories Ltd Delta Pharma Ltd BANGLADESH 14-Oct-14 Fist Twenty Full Century Pharmaceutical Pvt Ltd Nitin Lifesciences Ltd Glaxo Smithkiline Manufacturing SPA Glaxo Smithkiline Manufacturing SPA CCL Pharmaceuticals (Pvt) Ltd Shenzhen Zhijun Pharmaceutical Co Ltd (Pvt) Ltd (Contd.) Healthcare lanka Ltd (Ceylon) Ltd Kandana Food & Drugs (Pvt) Ltd Alaris Lanka (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticlas (Pvt) Ltd Pharmaceuticlas (Pvt) Ltd CCL Pharmaceuticals Lanka (Pvt) Ltd Farnell Ceylon (Pvt) Ltd Klintas (Pvt) Ltd United Biotech SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP SUSPENSION SUSPENSION INJECTION INJECTION INJECTION CEFOGEN 750 INJECTION Sunshine ZOCEFSTAXIM INJECTION Emerchemie NB POWDER ORAL 125TRYOXIM POWDER NEROXIM 750 POWDER DRY Slim ZINACEF INJECTIONZINACEF GlaxoSmithkiline INJECTIONKEFROX GlaxoSmithkiline POWDER DALIROXIM POWDER CEFOPRIT 750CEFOPRIT POWDER FOR 750MG 750MG 125MG/5ML BP 125MG/5ML BP SOLUTION FOR INJECTION USP 750MG INJECTION 1.5G INJECTION 250MG 750MG VIALS INJECTION BP 1.5G INJECTION USP 750MG 1381 CEFUROXIME FOR INJECTION USP 1382 CEFUROXIME FOR INJECTION USP 1383 SUSPENSION CEFUROXIME ORAL 1384 SUSPENSION CEFUROXIME ORAL 1385 CEFUROXIME POWDER FOR 1386 CEFUROXIME SODIUM FOR 1387 CEFUROXIME SODIUM FOR 1388 CEFUROXIME SODIUM FOR 1389 CEFUROXIME SODIUM FOR 1380 CEFUROXIME FOR INJECTION IP 130 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 MALAYSIA 10-Aug-16INDIA Full ITALY 11-Dec-15 Full 03-Mar-14CHINA Full 03-Sep-14INDIA Full 03-Jun-14 Full INDIAINDIA 05-Mar-18 Years Two BANGLADESH 11-Jul-17 16-Aug-18 Years Two Full Kotra pharma (M) Ltd Shamshree Lifesciences Ltd Glaxo Smithkiline Manufacturing SPA Shenzhen Zhijun Pharmaceutical Co Ltd Pharmaceuticals Ltd Medochemie Ltd CYPRUS 03-Nov-14Medochemie Ltd CYPRUS Full 05-Nov-14Pharmaceuticals Full Akums Drugs & Pharmaceuticals Ltd Incepta Pharmaceuticals Ltd (Contd.) Co Ltd (Pvt) Ltd Pharmaceuticlas (Pvt) Ltd Ltd Celyon (Pvt) Ltd Associated Laboratories (Pvt) Ltd Plc (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP TABLETS VAXCEL INJECTION Delmege Forsyth & SHAMOEF 750 INJECTION Omacx Healthcare ZINACEF 750 INJECTIONDALIROXIM GlaxoSmithkiline INJECTIONN/A Farnell Ceylon (Pvt) INJECTION Harcourts (Pvt) Ltd Flamingo INJECTION USP 1.5G INJECTION USP INJECTION USP 750MG VIAL INJECTION USP 750MG VIAL INJECTION USP 750MG VIALS INJECTION USP 750MG VIALS INJECTION USP 1390 CEFUROXIME SODIUM FOR 1391 CEFUROXIME SODIUM FOR 1392 CEFUROXIME SODIUM FOR 1393 CEFUROXIME SODIUM FOR 1394 CEFUROXIME SODIUM FOR 1395 250MG BP TABLETS CEFUROXIME AXETINE 250MG TABLETS1396 500MG BP TABLETS CEFUROXIME Associated Pharma AXETINE 500 FILM COA 1397 CELECOXIB CAPSULES 100MG 100 NIMERAL 1398 CELECOXIB CAPSULES 100MG CAPSULESAssociates Pharma PLENCOXIB 100 The Madras CAPSULES1399 CELECOXIB CAPSULES 100MG Browns & Company 100 CELENTA CAPSULES Citihealth Imports I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 131 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 28-Sep-17 Years Two INDIA 26-Apr-15 Full INDIA 04-Jun-15 Full INDIA 20-Feb-18 Full INDIA 13-Oct-17 Full 11-Jul-17 Full PAKISTAN 28-Nov-17 Full Kopran Ltd INDIASynmedic Laboratories (Pvt) Ltd 27-Aug-18Years Two Unichem Laboratories Zim Laboratories Ltd Scences Laboratories XL (Pvt) Ltd Akums Drugs & Pharmaceuticals Ltd Renata Limited BANGLADESH 23-Aug-14 LaboratoriesIPCA INDIA Full Getz Pharma (Pvt) 25-Feb-18Ltd Full (Contd.) Ltd Pharmaceuticals (Pvt) Ltd Ltd Pharmaceuticals (Pvt) Ltd Ltd Pharmaceuticals (Pvt) Ltd (Ceylon) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP 1400 CELECOXIB CAPSULES 100MG 100 CELEKOP CAPSULES Alaris Lanka (Pvt) 1401 CELECOXIB CAPSULES 100MG CELIX1402 CELECOXIB CAPSULES 100MG N/A CAPSULES1403 CELECOXIB CAPSULES 100MG Lifeline COLCIBID 100 CAPSULES1404 CAPSULES CELECOXIB CAPSULES 100MG Baur & Co (Pvt) A Tabrane SWIZCOX 1001405 CAPSULES CELECOXIB CAPSULES 100MG PharmAce (Pvt) Ltd CELECAP Swiss Garnier Life 1406 CELECOXIB CAPSULES 100MG CAPSULES PLENCOXIB 100 CAPSULES SMM Halcyon (Pvt) 1407 CELECOXIB CAPSULES 100MG Lotus CELOX- R 1001408 CAPSULES CELECOXIB CAPSULES 100MG Emerchemie NB 100 CELEDOL 1409 CAPSULES CELECOXIB CAPSULES 100MG Hemas CELCOXX CAPSULES Hemas 132 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 13-Feb-17 Full INDIA 25-Oct-17 Full BANGLADESH 09-Feb-18 Years Two 27-Oct-17 Full INDIA 23-Jun-17 Full INDIAINDIA 19-Nov-17 Full INDIA 26-Apr-15 Full 04-Jun-15 Full Pharmaceuticals Incepta Pharmaceuticals Ltd Kopran Ltd INDIAAkums Drugs & Pharmaceuticals Ltd 27-Aug-18Years Two LaboratoriesIPCA INDIASynmedic 25-Feb-18Laboratories (Pvt) Ltd Full Unichem Laboratories Zim Laboratories Ltd Cadila Healthcare Ltd Sun Pharmaceutical industries (Contd.) (Pvt) Ltd Ltd Plc Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Ltd Pharmaceuticals (Pvt) Ltd Healthcare lanka Ltd Pharmaceuticals (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP 1411 CELECOXIB CAPSULES 100MG 100 COLCIBRA CAPSULES Hemas 1412 CELECOXIB CAPSULES 200MG 200 NIMERAL 1413 CELECOXIB CAPSULES 200MG CAPSULES 200Associates Pharma CELENTA The Madras 1414 CAPSULES CELECOXIB CAPSULES 200MG Citihealth Imports 200 CELEKOP 1415 CAPSULES CELECOXIB CAPSULES 200MG Alaris Lanka (Pvt) PLENCOXIB 200 CAPSULES1416 CELECOXIB CAPSULES 200MG Browns & Company 200 CELEDOL 1417 CAPSULES CELECOXIB CAPSULES 200MG Hemas CELLX 2001418 CELECOXIB CAPSULES 200MG CAPSULES N/A Lifeline 1419 CELECOXIB CAPSULES 200MG COLCIBID 200 CAPSULES CAPSULES Baur & Co (Pvt) A Tabrane 1410 CELECOXIB CAPSULES 100MG 100 ZYCEL CAPSULES Sunshine I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 133 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 31-Mar-18 Full INDIA 23-Jun-17 Full INDIA 25-Feb-18 Full 16-Mar-18 Full INDIAINDIA 27-Feb-18 Full INDIA 23-Oct-17 Full INDIA 28-Feb-18 Full INDIA 08-Dec-14 Full 01-Oct-14 Full Alice Pharma Private Ltd. Akums Drugs & Pharmaceuticals Ltd Laboratories XL (Pvt) Ltd Scences Renata Limited BANGLADESH 23-Aug-14Cadila Healthcare Full Ltd Sun Pharmaceutical industries Unicure Ramadies (Pvt) Ltd Pharmaceuticals Ltd Medispray Laboatories (Pvt) Ltd (Contd.) Services Pvt. Ltd Pharmaceuticals (Pvt) Ltd Ltd (Ceylon) Ltd Healthcare lanka Ltd Pharmaceuticals (Pvt) Ltd Ltd (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP 1420 CELECOXIB CAPSULES 200MG CECOX 200 CAPSULES ABC Pharma 1421 CELECOXIB CAPSULES 200MG PLENCOXIB 200 CAPSULES1422 CELECOXIB CAPSULES 200MG Lotus 200 SELECAP 1423 CAPSULES CELECOXIB CAPSULES 200MG SMM Halcyon (Pvt) SWIZCOX 2001424 CAPSULES CELECOXIB CAPSULES 200MG PharmAce (Pvt) Ltd CELOX R-200 Swiss Garnier Life 1425 CELECOXIB CAPSULES 200MG CAPSULES 200 Emerchemie NB ZYCEL 1426 CELECOXIB CAPSULES 200MG CAPSULES 200 COLCIBRA Sunshine CAPSULES1427 200MGTABLETS CELECOXIB Hemas CELEC 2001428 CEPHALEXIN 250MG BP TABLETS1429 250mg CEPHALEXIN CAPSULES IP Emar Pharma (Pvt) N/A CEPHADEX 250 CAPSULES Breathe Free Lanka CAPSULESAssociates Pharma Bafna 134 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIA 17-May-18 Years Two INDIA 01-Feb-14 Full INDIAINDIA 28-Jan-17 Full INDIA 01-Feb-14 Full INDIA 04-Mar-15 Full INDIA 26-Sep-17 Full INDIA 02-Apr-18 Years Two 03-May-17 Full Bharat Parenterals Ltd Cadila Healthcare Ltd Sterling Lab INDIASun Pharmaceutical industries 12-Sep-14Cadila Healthcare Full Ltd Pharmaceuticals Ltd Sun Pharmaceutical industries Bharat Parenterals Ltd Akums Drugs & Pharmaceuticals Ltd (Contd.) (Pvt) Ltd Healthcare lanka Ltd Co Ltd Pharmaceuticals (Pvt) Ltd Healthcare lanka Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Plc SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP KEPHALEX B CAPSULES Baur Life Sciences KEPHALEX- B 250 CAPSULES Baur Life Sciences CORFEX 250 CAPSULES Browns & Company 500MG 250MG 250MG 1430 CEPHALEXIN CAPSULES USP 1431 250MG CEPHALEXIN CAPSULES BP LECEF-250 CAPSULES1432 250MG CEPHALEXIN CAPSULES BP ORIPHEX 250 Kamazu (Pvt) Ltd CAPSULES Micro Labs Ltd1433 250MG CEPHALEXIN CAPSULES BP INDIA Sunshine 250 CEPHAST CAPSULES1434 250MG CEPHALEXIN CAPSULES BP 10-Nov-17 Darley Butler & SPORIDEXYears Two CAPSULES1435 500MG CEPHALEXIN CAPSULES BP ORIPHEX 500 Hemas CAPSULES1436 500MG CEPHALEXIN CAPSULES BP Sunshine N/A1437 500MG CEPHALEXIN CAPSULES BP SPORIDEX CAPSULES CAPSULES1438Associates Pharma CEPHALEXIN CAPSULES USP Bafna Hemas 1439 CEPHALEXIN CAPSULES USP I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 135 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 MALAYSIA 11-Jul-16INDIA Full 03-May-17INDIA Full SRI LANKA 18-Jun-18 01-Sep-17 Full Years Two INDIAINDIA 14-Oct-15 Full MALAYSIA 05-Jul-17 Full 14-Jul-18 Years Two INDIA 31-Dec-16 Full INDIA 10-Dec-16 Full Kotra pharma (M) Ltd Akums Drugs & Pharmaceuticals Ltd Ankur Drugs & Pharma (Pvt) Ltd Ltd Plethico Pharmaceuticals Ltd Akums Drugs & Pharmaceuticals Ltd Kotra pharma (M) Ltd Ankur Drugs & Pharma (Pvt) Ltd Ltd (Contd.) Co Ltd Pharmaceuticals (Pvt) Ltd International (Pvt) Ltd Health (Pvt) Ltd Plc Co Ltd International (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP AXCEL CAPSULES Delmege Forsyth & CORFEX 250 CAPSULES 250CEFAMAX Lotus CAPSULES Softcare N/APLECEF 250 CAPSULES CAPSULES N/ACORFEX 500 George Steuart CAPSULESAXCEL Browns & Company Inter Pharm (Pvt) 500CEFAMAX CAPSULES CAPSULES Delmege Forsyth & Softcare TABLECEF KID TABLETS Kamazu (Pvt) LtdSAFEXIN 125 Micro Labs Ltd SYRUP DRY INDIA Burhani Enterprises Saga laboratories 31-Dec-17 Full 250MG 250MG 250MG 250MG 250MG 500MG 500MG 500MG 125MG TABLETS 125MG/5ML SUSPENSION BP 1440 CEPHALEXIN CAPSULES USP 1441 CEPHALEXIN CAPSULES USP 1442 CEPHALEXIN CAPSULES USP 1443 CEPHALEXIN CAPSULES USP 1444 CEPHALEXIN CAPSULES USP 1445 CEPHALEXIN CAPSULES USP 1446 CEPHALEXIN CAPSULES USP 1447 CEPHALEXIN CAPSULES USP 1448 CEPHALEXIN DISPERSIBLE 1449 CEPHALEXIN FOR ORAL 136 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 04-Dec-15 Full INDIA 28-Jan-16 Full BANGLADESH 11-Dec-17 Years 06-Aug-16 Two Full PAKISTAN 20-Oct-14BANGLADESH Full 14-Jul-15 Full BANGLADESH 06-Aug-15 Full SWITZERLAND 27-Apr-18 Years Two SWITZERLAND 24-Apr-18 Years Two INDIA 16-Feb-16 Full Ranbaxy laboratories Ltd Blue Cross Laboratories Ltd Chemical Industries Glaxo Smithkiline Pakistan Ltd Chemical Industries Chemical Industries Novartis Pharma Stein .AG Novartis Pharma Stein .AG MMC Healthcare Ltd Alkem Laboratories Ltd (Contd.) Hemas Pharmaceuticals (Pvt) Ltd Produsts Ltd CIC Holdings PLC Advanced Pharmaceuticlas (Pvt) Ltd Ltd Ltd Ltd CIC Lifesciences Ltd. SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP SUSPENSION SUSPENSION SUSPENSION SPORIDEX ORAL BLUCEF 250 DT TABLETS Hayleys Consume CEFFRIN POWDER CEFFRIN 250 CAPSULESALOCEF CIC Holdings PLC Advanced SYRUP CIC Holdings PLC Advanced CITRI SYRUP SYRUP Markss HLC (Pvt) DECACEF ORAL BP 125MG/5ML BP 250MG SUSPENSION USP 125MG/5ML SUSPENSION USP 250MG 125MG/5ML 5MG/5ML SUSPENSION BP 125MG/5ML SUSPENSION BP 1451 SUSPENSION CEPHALEXIN ORAL 1452 FOR ORAL TABLETS CEPHALEXIN 1453 CEPHRADINE FOR ORAL 1454 CEPHRADINE CAPSULES 250MG VELOSEF1455 CEPHRADINE CAPSULES USP CAPSULES GlaxoSmithkiline 1456 USP CEPHRADINE SYRUP 1457 CERITINIB CAPSULES 150MG SPEXIB1458 CERITINIB CAPSULES 150MG CAPSULES SPEXIB1459 CETIRIZINE DIHYDROCHLORIDE Baur & Co (Pvt) A CAPSULES Baur & Co (Pvt) A 1450 CEPHALEXIN FOR ORAL I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 137 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 BANGLADESH 08-Jun-17 Years Two BANGLADESH 03-Sep-16 Full BANGLADESH 27-Mar-14 Full INDIA 10-Aug-14 Full MALAYSIA 11-May-17MALAYSIA Full 06-Apr-18 Years Two INDIA 23-Jan-14 Full Medicon Pharmaceuticals Ltd Sterling Lab INDIAChemical Industries 24-Mar-18 Provisional Globe Pharmaceuticals Ltd Indoco Remedies India Cipla Ltd INDIADelta Pharma Ltd BANGLADESH 25-Mar-15 07-Oct-17 Full Years Two SDN BHD Kotra pharma (M) Ltd Akums Drugs & Pharmaceuticals Ltd (Contd.) (Pvt) Ltd Co Ltd (Pvt) Ltd Ltd (Pvt) Ltd Pharmaceuticals Co Ltd Hemas Pharmaceuticals (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP SOLUTION CEZIN SYRUP Act Enterpriese HISTER SYRUP SYRUPACITRIN Darley Butler & SYRUPTRIN CIC Holdings PLCTRIZ Advanced SYRUPALARID Healthcare Tabrane SYRUP SYRUPCTZ 10 Emar Pharma (Pvt) Breathe Free Lanka CERITEC TABLETS Accorria TABLETS CETIRIZINEAXEL TABLETS Indoscan (Pvt) Ltd Industries / S P Y Delmege Forsyth & COPE ORAL 5MG/5ML 5MG/5ML SYRUP 5MG/5ML SYRUP 5MG/5ML SYRUP 5MG/5ML SYRUP 5MG/5ML SYRUP 5MG/5ML 10MG TABLETS 10MG TABLETS 10MG TABLETS 5MG/5ML SUSPENSION USP ORAL 1460 CETIRIZINE DIHYDROCHLORIDE 1461 CETIRIZINE DIHYDROCHLORIDE 1462 CETIRIZINE DIHYDROCHLORIDE 1463 CETIRIZINE DIHYDROCHLORIDE 1464 CETIRIZINE DIHYDROCHLORIDE 1465 CETIRIZINE DIHYDROCHLORIDE 1466 CETIRIZINE DIHYDROCHLORIDE BP 1467 CETIRIZINE DIHYDROCHLORIDE BP 1468 CETIRIZINE DIHYDROCHLORIDE BP 1469 CETIRIZINE DIHYDROCHLORIDE 138 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 PAKISTAN 04-Sep-15INDIA Full 23-Jun-17 Years Two INDIAINDIA 16-Feb-17 Full INDIA 17-Sep-17 Years Two INDIA 04-Mar-14 Full PAKISTAN 17-Aug-17 Years Two 17-Jun-14PAKISTAN Full 03-May-18 Years Two SRI LANKA 06-Feb-18Years Two Tabros Pharma Tabros (Pvt) Ltd Unichem Laboratories Medochemie Ltd CYPRUS 01-Sep-17Pharmaceuticals Years Two Ltd Sun Pharmaceutical industries Blue Cross Laboratories Ltd Dr Reddy's Laboratories Ltd Hilton Pharma (Pvt) Ltd Pharma Tabros (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Contd.) Laboratories (Pvt) Ltd Baur & Co (Pvt) A Ltd Laboratories (Pvt) Ltd (Ceylon) Ltd Produsts Ltd (Ceylon) Ltd Healthcare lanka Ltd Laboratories (Pvt) Ltd N/A Gamma SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP TABLETS SUSPENSION ARIX SYRUP Associated ZYNCET FILM COA TEMELIN TABLETSTAB ONCET Associated TABLETSCETRIZET PharmAce (Pvt) Ltd Medley TABLETSEKON-D.T Emerchemie NB TABLETSCETRINE Hayleys Consume TABLETSRONEX Emerchemie NB ARIX TABLETS Sunshine N/A TABLETS Associated ORAL SYRUP 1MG in 1ML SYRUP TABLET 10MG TABLET 10MG TABLET 10MG TABLET 10MG TABLET 10MG TABLET 10MG TABLET 10MG TABLET 10MG TABLET 5MG/5ML SOLUTION BP ORAL 1470 CETIRIZINE DIHYDROCHLORIDE 1471 CETIRIZINE DIHYDROCHLORIDE 1472 CETIRIZINE DIHYDROCHLORIDE 1473 CETIRIZINE DIHYDROCHLORIDE 1474 CETIRIZINE DIHYDROCHLORIDE 1475 CETIRIZINE DIHYDROCHLORIDE 1476 CETIRIZINE DIHYDROCHLORIDE 1477 CETIRIZINE DIHYDROCHLORIDE 1478 CETIRIZINE DIHYDROCHLORIDE 1479 CETIRIZINE HYDROCHLORIDE I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 139 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIABANGLADESH 28-Apr-18 15-Jan-14 Years Two Full INDIAINDIA 30-Jul-14 Full 22-May-15INDIA Full INDIA 15-Sep-14 Full INDIA 16-Mar-18 Full INDIA 13-Feb-14 Full INDIA 25-Jun-17 Full 22-May-15INDIA Full 13-Jul-14 Full Pharmaceuticals Ltd Agio Pharmaceuticals Ltd Ankur Drugs & Pharma (Pvt) Ltd Astamed Healthcare (Pvt) Ltd Medibios Laboratories (Pvt) Ltd Healthcare Ltd Agio Pharmaceuticals Ltd Ankur Drugs & Pharma (Pvt) Ltd Indoco Remedies India Pharmaceuticals (Pvt) ltd (Contd.) (Pvt) Ltd International (Pvt) Ltd Celyon (Pvt) Ltd (Ceylon) Ltd (Pvt) Ltd International (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Algarash (Pvt) Ltd Surien SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP SOLUTION ALATROL SYRUPCETZAC PharmAce (Pvt) Ltd Square SYRUPCETRILET Citihealth Imports SYRUPCETIC SYRUP SYRUP Softcare CETRICON Associated Pharma TABLETSN/A Emerchemie NB CETZAC 10 TABLETS TABLETS Kamazu (Pvt) LtdCETRILET Citihealth Imports Syncom TABLETSTRIZ Softcare TABLETS Hemas GENRIZINE ORAL SYRUP 100MG/100ML SYRUP 5MG/5ML SYRUP 5MG/5ML SYRUP 5MG/5ML SYRUP 10MG TABLET 10MG TABLET 10MG TABLET 10MG TABLET 10MG TABLET ORAL SOLUTION USP 5MG/5ML SOLUTION USP ORAL 1481 CETIRIZINE HYDROCHLORIDE 1482 CETIRIZINE HYDROCHLORIDE 1483 CETIRIZINE HYDROCHLORIDE 1484 CETIRIZINE HYDROCHLORIDE 1485 CETIRIZINE HYDROCHLORIDE 1486 CETIRIZINE HYDROCHLORIDE 1487 CETIRIZINE HYDROCHLORIDE 1488 CETIRIZINE HYDROCHLORIDE 1489 CETIRIZINE HYDROCHLORIDE 1480 CETIRIZINE HYDROCHLORIDE 140 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIABANGLADESH 12-Jul-17 23-Jan-17 Full Full INDIAINDIA 04-Dec-18 Years Two 07-Aug-15 Full INDIAMALAYSIA 02-Apr-16 Full 27-Oct-15 Full Cipla Ltd INDIAPharmaceuticals (India) Ltd 14-Feb-15Pharmaceuticals Full Ltd Sterling Lab INDIAMicro Labs Ltd INDIA 05-Jun-15Bharat Parenterals Full Ltd 02-Dec-16 Full G D Laboratories (India) Pvt Ltd Aristopharma Ltd BANGLADESH 01-Jun-18Years Two Laboratories XL (Pvt) Ltd Kotra pharma (M) Ltd (Contd.) (Pvt) Ltd Co Ltd Ltd (Pvt) Ltd Lifeline Pharmaceuticals (Pvt) Ltd Hemas Pharmaceuticals (Pvt) Ltd SMM Halcyon (Pvt) Ltd Delmege Forsyth & Co Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP SOLUTION SOLUTION SOLUTION ORAL SOLUTION ALERID TABLETS Breathe Free Lanka AUROZINE TABLETS 10ALATROL PharmAce (Pvt) Ltd Aurochem TABLETSHISTER PharmAce (Pvt) Ltd Square TABLETSALLERCET Darley Butler & TABLETSBETRAZ SMM Halcyon (Pvt) TABLETSCETZED Baur Life Sciences ORAL LIQUIDRHINIL ORAL ALESOF 10 ORAL AXCEL CETIRIZINE TABLET 10MG TABLET TABLET BP 10MG BP TABLET 10MG BP TABLET 10MG BP TABLET 10MG BP TABLET 5MG/5ML 5MG/5ML 5MG/5ML 5MG/5ML 5MG/5ML 1490 CETIRIZINE HYDROCHLORIDE 1491 CETIRIZINE HYDROCHLORIDE 1492 CETIRIZINE HYDROCHLORIDE 1493 CETIRIZINE HYDROCHLORIDE 1494 CETIRIZINE HYDROCHLORIDE 1495 SOLUTION BP CETIRIZINE ORAL 1496 SOLUTION BP CETIRIZINE ORAL 1497 SOLUTION BP CETIRIZINE ORAL 1498 SOLUTION BP CETIRIZINE ORAL 1499 SOLUTION BP CETIRIZINE ORAL I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 141 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIASRI LANKA 02-Apr-18 31-Oct-18 Full Provisional INDIAINDIA 26-Apr-18 Full INDIA 07-Aug-15 Full SRI LANKA 29-Nov-15 Full 23-Feb-18 Provisional INDIAINDIA 19-Jun-16 Full 26-Nov-15 Full INDIA 24-Mar-14 Full Centurion Laboratories Pvt Ltd Pharmaceuticals Manufacturer Corporation Pharmaceuticals G D Laboratories (India) Pvt Ltd Akriti pharmaceuticals Pvt Ltd (Ceylon) (Pvt) Ltd Baader Schulz Laboratories Corona Remedics (Pvt) Ltd Zee Laboratories INDIAUmedica Laboratories (Pvt) 15-Jul-15Ltd Full (Contd.) (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Ltd (Pvt) Ltd International Services Pvt. Ltd Pharmaceuticals Pvt Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP 1500 10MG BP TABLETS CETIRIZINE IRIZINE 10 TABLETS International Yaden 1501 10MG BP TABLETS CETIRIZINE N/A1502 10MG BP TABLETS CETIRIZINE ZIN TABLETS1503 10MG BP TABLETS CETIRIZINE N/A CETZED TABLETS1504 10MG BP TABLETS CETIRIZINE TABLETSAssociates 10 SET Pharma Laborate State 1505 10MG BP TABLETS CETIRIZINE Lifeline N/A TABLETS1506 10MG BP TABLETS CETIRIZINE Alaris Lanka (Pvt) CETBARD TABLETS1507 10MG BP TABLETS CETIRIZINE TABLETS N/A CETCOR1508 Radiant Health Care 10MG BP TABLETS CETIRIZINE TABLETS 10 ZECET 1509 M S J Industries 10MG BP TABLETS CETIRIZINE Sethma TABLETS ALLERTIN ABC Pharma TABLETS Gamma 142 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIA 19-Jan-15 Full GERMANY 07-Feb-16 Full INDIAINDIA 19-Jul-15 Full INDIA 12-Oct-18 Provisional INDIA 26-Jun-18 Years Two 05-Jan-17 Full Merck KGaA GERMANY 30-Aug-16 Full Natco Pharma Ltd INDIAExcella GmbH 24-Jan-16Germany for Glaxo Smith Kline GmbH Full Natco Pharma Ltd INDIASG Pharma (Pvt) 15-Feb-14Ltd Full Pharmaceuticals Belco Pharma (Pvt) Ltd (india) (Pvt) Ltd Pharmaceuticals Ltd (Contd.) (Ceylon) Ltd Healthcare lanka Ltd Pharmaceuticlas (Pvt) Ltd Healthcare lanka Ltd Pharmacy (Pvt) Ltd Agency Pvt Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP ERBITUX INJECTIONORALEEZ Emerchemie NB GEL N/A Astron (Pvt) Ltd SRI LANKA 27-Aug-15 Full N/ACHLOROWIN EYE DROPS EAR DROPSAssociates Pharma Laborate Leader Pharma KLORAXIN EYE OINTMENT Ceyoka (Pvt) Ltd Galentic Pharma CETALKONIUM CHLORIDE 0.01% CETALKONIUM GEL DROPS DROPS OINTMENT INJECTION 5MG/ML 1511 CETUXIMAB SOLUTION FOR 1512 8.714% & CHELINE SALICYLATE 1513 2MG BP TABLETS CHLORAMBUCIL CLOKERAN 2 TABLETS1514 2MG BP TABLETS CHLORAMBUCIL LEUKERAN Sunshine TABLETS1515 5MG BP TABLETS CHLORAMBUCIL CLOKERAN 5 GlaxoSmithkiline TABLETS1516 2MG USP TABLETS CHLORAMBUCIL N/A Sunshine 1517 0.5% EYE CHLORAMPHENICOL TABLETS1518 0.5% EYE CHLORAMPHENICOL The Esses 1519 1% EYE CHLORAMPHENICOL 1510 10MG BP TABLETS CETIRIZINE CROSZINE TABLETSAssociates Pharma Bafna I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 143 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 07-Jul-16 Full 01-Jan-14 Full INDIAINDIA 17-Feb-15 Full PAKISTAN 21-Oct-14 Full 11-Mar-16INDIA Full PAKISTAN 06-Aug-14 Full 25-Aug-16 Full Centaur Pharmaceutical (Pvt) Ltd Ambala Sarabhal Enterprises Pharmaceuticals B D H Industries Ltd Pliva Pakistan (Pvt) Ltd Pharmaceutical (Pvt) Ltd Pliva Pakistan (Pvt) Ltd (Contd.) Health (Pvt) Ltd Co Ltd (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP OCUMYCIN EYE OINTMENT George Steuart ASCLOR EYE OINTMENTAGOPHENOL Trading Swedish CAPSULESN/A lifeServ (Pvt) Ltd Agog Pharma Ltd INDIAAGOPHENOL CAPSULES CAPSULES 27-Oct-17 Kamazu (Pvt) LtdN/A lifeServ (Pvt) Ltd Full Micro Labs Ltd Agog Pharma Ltd INDIA INDIAMETAMYCIN EAR DROPS EAR DROPS 30-Jun-17 27-Oct-17Associates Pharma Years Two Laborate Ravilux Company ROCOPHEN Full EAR DROPSDICINYCIN Citihealth Imports EAR DROPSROGOPHEN PharmAce (Pvt) Ltd DCI EYE DROPS Citihealth Imports OINTMENT OINTMENT 250MG 250MG 250MG 5% BP 5% BP 5% BP 5% BP 5% BP 1520 1% EYE CHLORAMPHENICOL 1521 1% EYE CHLORAMPHENICOL 1522 CAPSULES BP CHLORAMPHENICOL 1523 CAPSULES BP CHLORAMPHENICOL 1524 CAPSULES BP CHLORAMPHENICOL 1525 EAR DROPS CHLORAMPHENICOL 1526 EAR DROPS CHLORAMPHENICOL 1527 EAR DROPS CHLORAMPHENICOL 1528 EAR DROPS CHLORAMPHENICOL 1529 EAR DROPS CHLORAMPHENICOL 144 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 PAKISTAN 19-Nov-16 Full INDIAINDIA 24-Aug-17 Full INDIA 07-Feb-15 Full CHINA 06-Apr-16 Full 05-Jun-14INDIA Full 21-Oct-14INDIA Full 25-May-18INDIA Years Two 26-May-14SWITZERLAND 11-Jan-17 Full Full Nabiqasim Industries (Pvt) Ltd for Surge Laboratories PharmaMBL PAKISTANDivine 12-Mar-17Laboratories (Pvt) Ltd Full B D H Industries Ltd Megasys Biotek (Pvt) Ltd Ashford Laboratories Ltd Karnataka Antibiotic & Pharmaceuticals Ltd Kwality Pharmaceuticals Pvt Ltd Neon Laboratories Ltd ICN Polfa Rzesow SA,Poland for Valeant Pharmaceuticals Switzerland (Contd.) Health (Pvt) Ltd Ltd Pharmaceuticals (Pvt) Ltd Akbar Pharmaceuticals (Pvt) Ltd Leader Pharma Agency Pvt Ltd Ltd Baur & Co (Pvt) A Ltd International Yaden (Pvt) Ltd (Pvt) Ltd Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP EYE DROPS Markss HLC (Pvt) OINTMENT DROPS INJECTION INJECTION COMYCETIN EYE DROPS George Steuart MB-CHLOR EYE DROPS N/AMETAMYCIN EYE DROPS OPHTHALMIC Slim CLOZEOPTOMYCIN EYE & EAR EYE DROPS Ceylon (Pvt) Teastar N/AN/A POWDER TYPE-S POWDER FOR INJECTIONLIBRAX Ravilux Company TABLETS Baur & Co (Pvt) A BP 0.5% BP BP 0.5% BP 0.5% BP 1% W/W USP OINTMENT 0.5% EYE DROPS SOLUTION USP 0.5% EYE DROPS SOLUTION USP 1G INJECTION BP 500MG INJECTIO BP SUCCINATE INJECTION 1G SUCCINATE CLIDINIUM BROMIDE 2.5MG 1530 EYE DROPS CHLORAMPHENICOL 1531 EYE DROPS CHLORAMPHENICOL 1532 EYE DROPS CHLORAMPHENICOL 1533 OPHTHALMIC CHLORAMPHENICOL 1534 OPHTHALMIC CHLORAMPHENICOL 1535 OPHTHALMIC CHLORAMPHENICOL 1536 SODIUM FOR CHLORAMPHENICOL 1537 SODIUM CHLORAMPHENICOL 1538 SODIUM CHLORAMPHENICOL 1539 CHLORDIAZEPOXIDE 5MG, I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 145 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 05-Jun-18 Provisional INDIA 08-Feb-18 Years Two INDIA 06-Feb-18 Years Two BANGLADESH 23-Jul-14 18-Jan-15 Full Full BANGLADESH 01-Oct-15 Full PAKISTAN 13-Dec-17PAKISTAN Full 13-Dec-17BANGLADESH Full 18-Jan-15 Full BANGLADESH 18-Jan-17 Full Kwality Pharmaceuticals Pvt Ltd Kwality Pharmaceuticals Pvt Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Chemical Industries Chemical Industries Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Chemical Industries Chemical Industries (Contd.) (Pvt) Ltd (Pvt) Ltd CIC Holdings PLC Advanced SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP GELMOUTH WASH CIC Holdings PLC CIC Holdings PLC Advanced Advanced SOLOTION N/A TABLETS International Yaden N/AN/A TABLETS Healthcare Tabrane SCRUBBACTO TABLETS SOLUTION Mamro (Pvt) Ltd Healthcey (Pvt) LtdORALON DENTAL Biodeal GEL Raman & Weil RINSE GELCLINICA GEL ORAL GELCLINICA CIC Holdings PLC Platinum GEL ORAL SEPTEX CIC Holdings PLC Platinum CREAMSEPTEX CIC Holdings PLC TOPICAL Advanced

10MG GLUCONATE 4% W/V GLUCONATE 5MG 5MG eq to CHLORHEXIDINE SOLUTION IP GEL DENTAL BP 0.2%W/V 0.2%W/V 0.3% & CETRIMIDE 3% SOLUTION +CHLOROHEXIDINE 0.1% CREAM HYDROCHLORIDE BP W/V & CETRIMIDE 3% 1540 USP CHLORDIAZEPOXIDE TABLETS 1541 USP CHLORDIAZEPOXIDE TABLETS 1542 USP CHLORDIAZEPOXIDE TABLETS 1543 CHLORHEXIDINE GLUCONATE 1544 20% CHLORHEXIDINE GLUCONATE 1545 0.2% CHLORHEXIDINE GLUCONATE ORALON MOUTH 1546 CHLORHEXIDINE GLUCONATE 1547 CHLORHEXIDINE GLUCONATE 1548 CHLORHEXIDINE GLUCONATE 1549 0.3% CHLORHEXIDINE GLUCONATE 146 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 04-Sep-14 Full 23-Jul-15INDIA Full INDIA 28-Apr-18 Provisional INDIA 09-Jul-18 Full INDIA 02-Mar-18 Full INDIA 11-Oct-18 Full 26-Dec-17SRI LANKA Full 16-Feb-18Years Two SRI LANKA 11-Feb-15 Full Chemicals Pvt Ltd (Pvt) Ltd Indoco Remedies India Health ICPA Products Ltd Centurion Laboratories Pvt Ltd PharmaceuticalS (Pvt) Ltd Belco Pharma (Pvt) Ltd Ltd Pharmaceuticals (Pvt) Ltd (Contd.) Pharmaceuticals (Pvt) Ltd Health (Pvt) Ltd (Pvt) Ltd Agency Pvt Ltd N/AN/A Inter Pharm (Pvt) Gamma SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP SOLUTION SOLUTION SANIQUAD M20 SOLUTION Ceyoka (Pvt) Ltd Sirmaxo BACTO RUBBACTO SOLUTION Mamro (Pvt) LtdREXIDIN Raman & Weil MOUTH WASHHEXIDINE Hemas MOUTH WASHN/A George Steuart N/A TABLETSN/A International Yaden INJECTIONCOREX-D Ceyoka (Pvt) Ltd INJECTION Ciron Drugs & SYRUPN/A Leader Pharma N/ACHLOFEN ORAL ORAL Astron (Pvt) Ltd SRI LANKA 01-Jan-17 Full 4% SURGICAL SCRUB BP 20% V/V SCRUB BP 4% SURGICAL SOLUTION GLUCONATE SOLUTION IP SOLUTION IP GLUCONATE 2.5%V/V,CHLORHEXIDINE Alcohol IP 0.5%,Ethyl GLUCONATE 70% with emollent and moisture 0.2% W/V 0.2% W/V 250MG BP TABLETS 10MG/ML 10MG/ML 2MG & DEXTROMETHORPHAN SYRUP HYDROBROMIDE 5MG/ 5ML 2ML/5ML SOLUTION BP (CHLORPHENIRAMINE) 2ML/5ML SOLUTION BP (CHLORPHENIRAMINE) 1550 CHLORHEXIDINE GLUCONATE 1551 CHLORHEXIDINE 1552 BP CHLORHEXIDINE MOUTHWASH 1553 BP CHLORHEXIDINE MOUTHWASH 1554 CHLOROQUINE PHOSPHATE 1555 CHLORPHENAMINE INJECTION BP 1556 CHLORPHENAMINE INJECTION BP 1557 CHLORPHENAMINE MALEATE 1558 CHLORPHENAMINE ORAL 1559 CHLORPHENAMINE ORAL I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 147 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIA 02-Aug-18SRI LANKA Years Two 01-Jan-18INDIAYears Two INDIA 23-Mar-15 Full 02-Mar-18 Provisional INDIAINDIA 18-Feb-15 Full 18-Feb-15 Full SRI LANKA 08-Jul-14BANGLADESH Full 24-Apr-18 Full Laboratories (Pvt) Ltd (Ceylon) Ltd Harson Laborstories Fourrts (India) Laboratories Ltd (Pvt) Ltd Belco Pharma (Pvt) Ltd (Ceylon) Ltd Glaxo Smithkiline Bangaladesh Ltd (Contd.) (Pvt) Ltd Healthcare lanka Ltd Agency Pvt Ltd Pharmaceuticlas SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP SYRUP N/ASYRUP Glaxo Wellcome Sunshine N/AELOUF SYRUP SYRUP N/A Ceyoka (Pvt) Ltd Leben Astron (Pvt) Ltd SRI LANKA 27-Feb-17Years Two PIRITON PIRITON EXPECTORANT N/AFILOCOF EXPECTORANT INJECTIONBRONCODEX Citihealth Imports SYRUPN/A N/AN/A SYRUP Astron (Pvt) LtdALLERMINE Pharmatec (Pvt) Ltd SRI LANKA Belco Pharma SYRUP SYRUP 27-May-17Years DM Two PIRITON Leader Pharma N/A SYRUPPIRITON N/A Astron (Pvt) Ltd TABLETS SRI LANKA Glaxo Smithkiline 27-Feb-17 Glaxo Wellcome Years Two BP 2.5MG+AMMONIUM CHLORIDE BP BP 125MG+SODIUM CITRAT SYRUP 55MG/5ML 2ML/5ML (CHLORPHENIRAMINE) 2ML/5ML 2MG +AMMONIUM CHLORIDE BP 2MG +AMMONIUM CHLORIDE BP 100MG/5ML+SODIUM 10MG/1ML BP 2.5MG AMMONIUM CHLORIDE 125MG 2MG & DEXTROMETHORPHAN BROMIDE 10MG/ML USP SYRUP 2MG/5ML USP SYRUP 2MG/5ML USP SYRUP 2MG/5ML 2MG+DEXTROMETHORPHAN 10MG SYRUP 5ML 4MG 1561 CHLORPHENIRAMINE MALEATE 1560 USP CHLORPHENAMINE SYRUP 1562 BP CHLORPHENIRAMINE MALEATE 1563 CHLORPHENIRAMINE INJECTION 1564 CHLORPHENIRAMINE MALEATE 1565 CHLORPHENIRAMINE MALEATE 1566 CHLORPHENIRAMINE MALEATE 1567 CHLORPHENIRAMINE MALEATE 1568 CHLORPHENIRAMINE MALEATE 1569 CHLORPHENIRAMINE MALEATE 1570 CHLORPHENIRAMINE MALEATE 148 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIA 07-May-14 Full INDIAINDIA 30-Aug-16 Full INDIA 24-Jul-18 Years Two INDIA 05-Jan-14 Full 10-Aug-14 Full INDIAINDIA 11-Dec-14 Full 18-Nov-17 Years Two Vital Healthcare Vital (Pvt) Ltd Wings Biotech INDIA(Pvt) Ltd 23-Jun-18Years Two Laboratories (Pvt) Ltd PharmaceuticalS (Pvt) Ltd Medopharm (PVT Ltd Astra Lifecare (India) (Pvt) Ltd Laboratories (Pvt) Ltd (Contd.) (Pvt) Ltd (Pvt) Ltd Ceyoka (Pvt) Ltd Leben Ceyoka (Pvt) Ltd Ciron Drugs & Pharmaceuticals (Pvt) Ltd Health (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP SYRUP Harcourts (Pvt) Ltd Pharm Products SOLUTION SOLUTION COREXALLERVIT SYRUP INJECTION N/A International Yaden Astron (Pvt) Ltd SRI LANKA 07-Feb-17Years Two WINAVIL TABLETSTUSHIN COUGH SYRUP International Yaden CIPIUM SOLUION ORAL N/AN/A ORAL N/A TABLETS Akbar ASPI-M TABLETS Chamee ChemistCIPIUM TABLETS Oboi Laboratories INDIA George Steuart TABLETS 26-Apr-14 Ceyoka (Pvt) Ltd Leben Full INJECTION BP 10MG/1ML INJECTION BP 4MG+CODEINE PHOSPHATE USP USP 4MG+CODEINE PHOSPHATE 10MG/5ML TABLETS USP 4MG USP TABLETS 2MG+AMMONIUM CHLORIDE 137.5MG/5ML 2MG/5ML BP 2MG/5ML BP 4MG 4MG 4MG 4MG 1572 CHLORPHENIRAMINE MALEATE 1571 CHLORPHENIRAMINE MALEATE 1573 CHLORPHENIRAMINE MALEATE 1574 CHLORPHENIRAMINE MALIATE 1575 CHLORPHENIRAMINE SOLUTION 1576 CHLORPHENIRAMINE SOLUTION 1577 BP CHLORPHENIRAMINE TABLETS 1578 BP CHLORPHENIRAMINE TABLETS 1579 BP CHLORPHENIRAMINE TABLETS 1580 BP CHLORPHENIRAMINE TABLETS I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 149 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIA 29-Jun-17 Full SRI LANKA 01-Jan-18 Provisional INDIAINDIA 18-Mar-17 Full INDIA 18-Mar-16 Full INDIA 12-Jun-16 Full PAKISTAN 15-Aug-16 Full 29-Jan-15PAKISTAN Full 28-Jan-15AUSTRALIA Full 06-Mar-18 Full Axon Drugs (Pvt) Ltd (Ceylon) (Pvt) Ltd Laboratories (Pvt) Ltd Laboratories (Pvt) Ltd Centurion Laboratories Pvt Ltd Pharmaceuticals (Pvt ) Ltd (Pvt ) Ltd Contract Manufacuring & Packging Services pty Ltd (Contd.) Healthcare lanka Ltd (Pvt) Ltd Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP N/A TABLETS Sunshine N/AN/A TABLETS 50 Kamazu (Pvt) LtdZINECTIL Micro Labs Ltd TABLETS TABLETS INDIA N/AN/A Ceyoka (Pvt) Ltd Leben 06-Feb-14N/A Full TABLETS M S J Industries Ceyoka (Pvt) LtdC-DONE TABLETS Leben TABLETS International Yaden D4U Pharma Associates Madras D4U INJECTION Ceyoka (Pvt) LtdN/A Genix Pharma DROPS ORAL Ceyoka (Pvt) Ltd Genix Pharma CAPSULES Alaris Lanka (Pvt) 4MG 4MG 4MG HYDROCHLORIDE 50MG 25MG 50MG 6.25MG INJECTION INJECTION CAPSULES 25MCG (1000 D) 1581 BP CHLORPHENIRAMINE TABLETS 1582 BP CHLORPHENIRAMINE TABLETS 1583 BP CHLORPHENIRAMINE TABLETS 1584 CHLORPROMAZINE 1585 BP CHLORPROMAZINE TABLETS 1586 BP CHLORPROMAZINE TABLETS 1587 USP CHLOTHALIDONE TABLETS 1588 200,000 IU/ML CHOLECALCIFEROL 1589 200,000 IU/ML CHOLECALCIFEROL 1590 GELATIN SOFT CHOLECALCIFEROL 150 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 SPAIN 28-Feb-18INDIA Provisional 23-Jan-15 Full ITALY 28-Feb-17INDIA Full 24-Feb-14 Full CHINA 06-Jun-14 Full Indoco Remedies India Wings Biotech INDIAMerck Serono S P A 21-Aug-17Years Two Cadila Healthcare Ltd N.V.Organon NETHERLANDS 15-Jun-14Cipla Ltd Full INDIACipla Ltd INDIA 07-Sep-15Shandong Jewim Pharmaceutical Full Co. Ltd 19-Mar-15Micro Labs Ltd INDIA Full 24-May-18Years Two Laboratoires Rubio S.A (Contd.) Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Ltd Pharmaceuticals (Pvt) Ltd Ltd (Pvt) Ltd (Pvt) Ltd (Ceylon) Ltd (Pvt) Ltd Slim Pharmaceuticals (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP NASAL SPRAYNASAL Emerchemie NB POWDER FOR ORAL SOLUTION DENTOGEL GEL ORAL ORASORE Hemas GELOVIDREL International Yaden INJECTIONOVIDAC 5K Baur & Co (Pvt) A INJECTIONPREGNYL Hemas INJECTION 160CICLOCIP Baur & Co (Pvt) A INHALATION Breathe Free Lanka 80CICLOCIP INHALER NS CICLOMATE 50 Breathe Free Lanka OLAMIN CREAM Micro Mega Lanka 8.7%+BENZALKONIUM CHLORIDE 2.0% W//W 0.01%,LIGNOCAINE HCL COMBINATION) 8.7%+LIGNOCAINE HYDROCHLORIDE 2.0%W/W= INJECTION 250MCG/0.5ML 5000 IU POWDER FOR INJECTION (HUMAN) 5000 IU POWDER FOR INJECTION DOSE DOSE 50MCG/DOSE 1% ORAL SUSPENSION 4G ORAL 1592 CHOLINE SALICYLATE 1593 CHOLINE SALICYLATE 1594 CHORIOGONADOTROPIN ALFA 1595 IP CHORIONIC GONADATROPHIN 1596 CHORIONIC GONADOTROPHIN 1597 CICLESONIDE INHALER 160 MCG/ 1598 CICLESONIDE INHALER 80MCG/ 1599 SPRAY CICLESONIDE NASAL 1600 CICLOPIROX OLAMINE CREAM USP 1591 CHOLESTYRAMINE POWDER FOR I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 151 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 IRANIRAN 08-Oct-15 Full INDIA 08-Oct-16 Full SWITZERLAND 17-Dec-18 25-Jun-18 Years Two Years Two GERMANY 12-Dec-16 Full BANGLADESH 26-Dec-18 Years Two INDIAINDIA 15-Aug-18 Provisional INDONESIA 15-Aug-18 Provisional 19-Oct-17 Years Two PAKISTAN 16-Dec-17 Full Zahravi Pharmaceutical Company Iran Zahravi Pharmaceutical Company Iran Mercury Laboratories Ltd Delpharm S A Huningue S Catalent Germany Eberbach Gmbh,Germany for Cheplapharm Arineimittel Gmbh Germany The Acme Laboratories Ltd Unique Pharmaceutical Labs Unique Pharmaceutical Labs T Dankos P Laboratories Laboratories (Pvt) Ltd (Contd.) Corporation (Pvt) Ltd Corporation (Pvt) Ltd International Yaden (Pvt) Ltd Baur & Co (Pvt) A Ltd Ltd Ltd Health (Pvt) Ltd Health (Pvt) Ltd Pharmaceuticals (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP SOLUTION ORAL SOLUTION CAPSULES Baur & Co (Pvt) A IMINORAL 25IMINORAL CAPSULES Glenford IMINORAL 50IMINORAL CAPSULES Glenford SADIMMUN NEORAL SANDIMMUN NEORAL 25MG 50MG 100MG/ML CAPSULES 100MG 1601 CICLOSPORIN CAPSULES USP 1602 CICLOSPORIN CAPSULES USP 1603 0.1% CICLOSPORIN EYE DROPS BP N/A1604 SOLUTION CICLOSPORIN ORAL OPHTHALMIC 1605 CICLOSPORIN SOFTGEL 1606 10MGTABLET CILNIDIPINE DUOCARD 101607 10MGTABLET CILNIDIPINE TABLETS CILACAR 101608 5MGTABLET CILNIDIPINE Mega Pharma (Pvt) TABLETS1609 CILACAR 5 100MGTABLETS CILOSTAZOL George Steuart 100 CITAZ TABLETS1610 100MG USP TABLETS CILOSTAZOL 100 LABISTA George Steuart TABLETS TABLETS Hemas PharmAce (Pvt) Ltd Wilshire 152 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIASRI LANKA 09-Mar-17 Full 20-Nov-15INDIA Full INDIA 27-Jan-14 Full 01-Jan-14 Full INDIAINDIA 16-Feb-15 Full INDIA 20-Aug-18 Provisional BANGLADESH 07-Jul-18 04-Jun-16 Full Full (Ceylon) (Pvt) Ltd Medopharm (PVT) Ltd Geno Pharmaceuticals Pvt Ltd Biolab Co Ltd THAILANDAgio 23-Feb-16Pharmaceuticals Ltd Full Centaur Pharmaceutical (Pvt) Ltd (Pvt) Ltd Incepta Pharmaceuticals Ltd F D C Limited INDIA 16-Aug-18 Full Glenmark Pharmaceuticals Ltd (Contd.) Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Health (Pvt) Ltd (Pvt) Ltd George Steuart Health (Pvt) Ltd Pharmatec (Pvt) Ltd Megasys Biotek (Pvt) Ltd Healthcare lanka Ltd Pharmaceuticals (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP DROPS DROPS QUINOCIP 500QUINOCIP TABLETSCIPRO CENT Citihealth Imports EYE & EAR CIPROCIDAL EYE & EAR BEUFLOX EYE DROPSZOXAN Citihealth Imports EYE DROPS Sunshine BP 0.3% w/v 0.3% w/v 0.3% w/v 0.3% USP 1611 50MG USP TABLETS CILOSTAZOL STILOZ 50 TABLETS Hemas 1612 200MG BP TABLETS CIMETIDINE N/A1613 200MG USP TABLETS CIMETIDINE N/A TABLETS1614 25MGTABLETS CINNARIZINE N/A TABLETS 25 VERTIGON 1615 25MGTABLETS CINNARIZINE TABLETS Akbar CELENID Mansel (Ceylon) M S J Industries 1616 TABLETS CIPROFLOXACIN 500MG TABLETS1617 CIPROFLOXACIN EYE/EAR DROPS George Steuart 1618 CIPROFLOXACIN EYE/EAR DROPS 1619 CIPROFLOXACIN EYE/EAR DROPS 1620 CIPROFLOXACIN EYE/EAR DROPS I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 153 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 05-Nov-14 Full INDIA 11-Apr-16 Full INDIABANGLADESH 06-Apr-14 08-Apr-18 Years Two Full STATES PAKISTAN 12-Jan-18 Years Two INDIA 16-Mar-16 Full MBL PharmaMBL PAKISTANRainbow Life 28-Sep-14Science (Pvt) Ltd Full Beximco Pharmaceuticals Ltd Cipla Ltd INDIAAlcon Laboratories UNITED 11-Mar-15Sterling Lab Full INDIASterling Lab INDIA 08-Aug-15 Full (Pvt ) Ltd 08-Aug-15 Full Pharmaceuticals (Pvt) Ltd Indoco Remedies India (Contd.) Ltd Radiant Health Care (Pvt) Ltd Emerchemie NB (Ceylon) Ltd (Pvt) Ltd Ltd Co Ltd Co Ltd Hemas Pharmaceuticals (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP EYE DROPS Markss HLC (Pvt) SOLUTION DROPS DROPS CIPRO EYE DROPS CIPOXIN OPHTHALMIC NEOFLOXIN EYE,EAR CIPLOX - 500 TABLETSCILOXAN Breathe Free Lanka EYE DROPS 250CIPROST Baur & Co (Pvt) A TABLETS 500CIPROST Darley Butler & TABLETSEFECIP Darley Butler & INFUSIONAXACIP Ceyoka (Pvt) Ltd Genix Pharma INJECTION Chamee Chemist Axa Lanka CEPROLEN EYE & EAR EYE DROPS USP 3MG/ML EYE DROPS USP EYE/EAR DROPS 0.3% EYE/EAR DROPS 0.3% 500MG IP OPTHALMIC SOLUTION EYE 0.3% DROPS USP 250MG BP TABLETS 500MG BP TABLETS 200MG/100ML 200MG/100ML EYE DROPS USP 0.3% EYE DROPS USP 1622 CIPROFLOXACIN HYDROCHLORIDE 1623 CIPROFLOXACIN HYDROCHLORIDE 1624 CIPROFLOXACIN HYDROCHLORIDE 1625 CIPROFLOXACIN HYDROCHLORIDE 1626 CIPROFLOXACIN HYDROCHLORIDE 1627 CIPROFLOXACIN HYDROCHLORIDE 1628 CIPROFLOXACIN HYDROCHLORIDE 1629 CIPROFLOXACIN INFUSION BP 1630 CIPROFLOXACIN INJECTION 1621 CIPROFLOXACIN HYDROCHLORIDE 154 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 08-Jun-18 Provisional BANGLADESH 04-Mar-17 20-Apr-18 Full Years Two BANGLADESH 15-Dec-16 Full INDIAINDIA 05-Jun-14 Full INDIA 18-Mar-16 Full INDIA 20-Nov-15 Full INDIA 20-Jan-15 Full SRI LANKA 27-Jul-17 Years Two 10-Oct-18 Provisional Unique Pharmaceutical Labs Fresenius Kabi India Pvt Ltd Pharmaceuticals Ltd Pharmaceuticals Ltd Opthalmincs Pharmaceuticals (Pvt) Ltd Healthcare Ltd Laboratories (Pvt) Ltd Laboratories (Pvt) Ltd Ltd. (Contd.) Health (Pvt) Ltd Pharmaceuticals (Pvt) Ltd PharmAce (Pvt) Ltd Square Chamee Chemist Indiana Chamee Chemist Axa Lanka SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP DROPS SOLUTION SOLUTION IFICIPRO INJECTION George Steuart N/ACIPROCIN 200 INJECTION IV INFUSION PharmAce (Pvt) Ltd Hemas Square CIPROCIN 0.3% EYE & EAR CIPROCON OPHTHALMIC I CIPCUBE 250 OPHTHALMIC TABLETSCIPROLEB 250 TABLETS Kamazu (Pvt) Ltd Syncom CIPROLEB 500 Ceyoka (Pvt) Ltd TABLETS Leben CIPRODEX Ceyoka (Pvt) Ltd Leben TABLETS N/A CIC Lifesciences 0.2% 200MG 200MG/100ML INFUSION 200MG 0.3% EYE SOLUTION USP 0.3% EYE SOLUTION USP 0.3% EYE SOLUTION USP 250MG 250MG 500MG 500MG 1631 CIPROFLOXACIN INJECTION USP 1632 CIPROFLOXACIN INJECTION USP 1633 CIPROFLOXACIN INTRAVENOUS 1634 CIPROFLOXACIN OPHTHALMIC 1635 CIPROFLOXACIN OPHTHALMIC 1636 CIPROFLOXACIN OPHTHALMIC 1637 BP CIPROFLOXACIN TABLETS 1638 BP CIPROFLOXACIN TABLETS 1639 BP CIPROFLOXACIN TABLETS 1640 USP TABLETS CIPROFLOXACIN I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 155 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 22-Jun-16 Full SRI LANKA 24-Feb-17 Years Two 10-Oct-18 Provisional INDIAPAKISTAN 24-Sep-14 Full 01-Apr-14INDIA Full 15-Jun-16 Full INDIAINDIA 18-Oct-16 Full INDIA 28-Apr-18 Full 08-Feb-14 Full Marksons Pharma Ltd Macleods Pharmaceuticals Ltd Ltd. Ltd CCL Pharmaceuticals (Pvt) Ltd Fredun Pharmaceuticals Ltd Cipla Ltd INDIAUnique Pharmaceutical Labs 11-Mar-15 Medopharm (PVT Ltd Full Cadila Healthcare Ltd (Contd.) Plc (Pvt) Ltd Pharmaceuticals Lanka (Pvt) Ltd Health (Pvt) Ltd (Pvt) Ltd Health (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Healthcare lanka Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP CIPROCIN 500 TABLETS Browns & Company COFLOX 500 TABLETSCIPRO CENT Pettah Pharmacy TABLETSN/A N/ACIPROMEN TABLETS CIC Lifesciences TABLETS Chamee ChemistCIPROFED 250 CCL Bajaj Healthcare TABLETSCIPLOX 250 George Steuart TABLETSIFICIPRO 250 Breathe Free Lanka TABLETSN/A George Steuart CIPROBID 250 TABLETS TABLETS Akbar Sunshine 500MG 500MG 250MG 250MG 250MG 250MG 250MG 250MG 250MG 250MG 1641 USP TABLETS CIPROFLOXACIN 1642 USP TABLETS CIPROFLOXACIN 1643 USP CIPROFLOXACIN TABLETS 1644 USP CIPROFLOXACIN TABLETS 1645 USP CIPROFLOXACIN TABLETS 1646 USP CIPROFLOXACIN TABLETS 1647 USP CIPROFLOXACIN TABLETS 1648 USP CIPROFLOXACIN TABLETS 1649 USP CIPROFLOXACIN TABLETS 1650 USP CIPROFLOXACIN TABLETS 156 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 PAKISTAN 01-Apr-14INDIA Full IRAN 17-Feb-14 Full INDIA 12-Feb-16 Full INDIA 08-Feb-18 Full INDIA 19-Jan-15 Full 11-Dec-16 Full INDIAINDIA 19-Jul-17 Full 30-May-15INDIA Full 23-Jun-16 Full CCL CCL Pharmaceuticals (Pvt) Ltd Fredun Pharmaceuticals Ltd Exir Pharmaceuticals Company Cadila Healthcare Ltd S Kant Healthcare Ltd Sun Pharmaceutical industries Drugs LtdTechno BANGLADESH 20-May-16 Full Getwell Pharmaceuticals Pharma (Pvt) Ltd United Biotech (Pvt) Ltd (Contd.) Pharmaceuticals Lanka (Pvt) Ltd Health (Pvt) Ltd Corporation (Pvt) Ltd Healthcare lanka Ltd Pharmaceuticals Ltd Pharmaceuticals (Pvt) Ltd L S P Pharmaceticals Pharmacy (Pvt) Ltd Health (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP INJECTION CIPROMEN TABLETS CCL CIPROFRED 500 TABLETS George Steuart CIPROXIR 500 TABLETSCIPROBID 500 Glenford TABLETSCIPROKANT Sunshine TABLETSCIFRAN Mediccon TABLETSCESALIN Hemas POWDER FOR 10PLATICIN INJECTIONPLATIONCO The Esses INJECTION 10UNIPLATIN Pharma Associates Chandra Bhagat INJECTION George Steuart 500MG 500MG 500MG 500MG 500MG 500MG POWDER FOR LYOPHILIZED INJECTION 10ML 10ML 10MG/20ML 1651 USP CIPROFLOXACIN TABLETS 1652 USP CIPROFLOXACIN TABLETS 1653 USP CIPROFLOXACIN TABLETS 1654 USP CIPROFLOXACIN TABLETS 1655 USP CIPROFLOXACIN TABLETS 1656 USP CIPROFLOXACIN TABLETS 1657 INJECTION 10MG CISPLATIN 1658 10MG IN INJECTION BP CISPLATIN 1659 10MG IN INJECTION BP CISPLATIN 1660 INJECTION BP CISPLATIN I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 157 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 14-Jul-17INDIA Years Two 23-Jun-16INDIA Full 30-May-15INDIA Full 26-Jan-16 Full INDIA 22-Dec-15 Full CYPRUS 21-Jun-18 16-May-14 Full INDIA Full PAKISTAN 25-Jun-15 06-Oct-17PAKISTAN Years Two Full 31-Dec-14PAKISTAN Full 02-Jan-14PAKISTAN Full 15-Sep-17 Full INDIA 12-Feb-18 Full Getwell Pharmaceuticals United Biotech (Pvt) Ltd Pharma (Pvt) Ltd Torrent Pharmaceuticals Ltd Sun Pharmaceutical industries Sun Pharmaceutical industries Delobris Pharmaceuticals Ltd United Biotech (Pvt) Ltd Abbott Laboratories Martin Daw Marker Ltd (Pvt ) Ltd Abbott Laboratories Merck (Pvt) Ltd PAKISTANMedibios Laboratories (Pvt) 31-Dec-14 Full Ltd (Contd.) Pharmacy (Pvt) Ltd Health (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Ceylon) Ltd (Ceylon) Ltd (Pvt) Ltd (Pte) Ltd Healthcare lanka Ltd Emerchemie NB (Ceylon) Ltd Ceyoka (Pvt) Ltd Genix Pharma Sunshine Healthcare lanka Ltd Emerchemie NB (Ceylon) Ltd Emerchemie NB (Ceylon) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP SUSPENSION SUSPENSION SUSPENSION SUSPENSION ORAL SUSPENSION PLATICIN 50PLATICIN INJECTION 50UNIPLATIN INJECTION The Esses PLATIONCO George Steuart INJECTIONFELIZ 20 Pharma Associates Chandra Bhagat CITOPAM TABLETS Hemas TABLETS Emerchemie NB CLERON 250 TABLETSCLARIMIN Access International KLARICID I V POWDER INJECTION R & D Intertrades KLARIBACT Sunshine LARITH ORAL KLARICID ORAL ORAL KLARIBACT CLARIMATE ORAL 125/5ML 50MG/50ML 50MG/50ML 20MG USP TABLETS 20MG USP TABLETS 250MG TABLETS 500MG 500MG SUSPENSION 125MG/5ML SUSPENSION 125MG/5ML SUSPENSION 125MG/5ML SUSPENSION 125MG/5ML 125MG/5ML SUSPENSION USP 50MG/50ML 1662 INJECTION BP CISPLATIN 1663 INJECTION BP CISPLATIN 1664 HYDROBROMIDE CITALOPRAM 1665 HYDROBROMIDE CITALOPRAM 1666 10MG USP TABLETS CITALOPRAM CITOPAM1667 CLARITHROMYCIN FILM COATED TABLETS1668 CLARITHROMYCIN INJECTION Emerchemie NB 1669 CLARITHROMYCIN INJECTION 1670 CLARITHROMYCIN ORAL 1671 CLARITHROMYCIN ORAL 1672 CLARITHROMYCIN ORAL 1673 CLARITHROMYCIN ORAL 1674 CLARITHROMYCIN ORAL 1661 INJECTION BP CISPLATIN 158 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 PAKISTAN 16-Oct-17INDIA Years Two PAKISTAN 12-Feb-18 26-Apr-18 Full PAKISTAN Years Two 31-Dec-15INDIA Full INDONESIA 15-Feb-17 05-Jan-16 Full Full PAKISTAN 07-Apr-17 Full PAKISTAN 10-Oct-17INDIA Years Two PAKISTAN 07-Feb-14 24-Nov-17 Full PAKISTAN Years Two 02-Feb-18 Provisional Pharmaceuticals Pvt Ltd Medibios Laboratories (Pvt) Ltd Laboratories (Pvt) Ltd Ferozsons Laboratories Ltd Zim Laboratories Ltd Caprifaminda PT Laboratories Indonesia for Farma P.T.Sanbe Kopran Ltd INDIA Pharma Tabros (Pvt) Ltd Micro Labs Ltd 10-Sep-14 INDIA Full Nabiqasim Industries (Pvt) Ltd 18-Apr-15Intas Pharmaceuticals Ltd Full Abbott Laboratories Martin Daw Marker Ltd (Contd.) eld fi Klintas (Pvt) Ltd Hansel Emerchemie NB (Ceylon) Ltd PharmAce (Pvt) Ltd Wilshire Emerchemie NB (Ceylon) Ltd Tabrane Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Laboratories (Pvt) Ltd Ltd Health (Pvt) Ltd Co Ltd Healthcare lanka Ltd (Ceylon) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP GRANULES ORAL SUSPENSION ORAL SUSPENSION SUSPENSION SOLUTION SUSPENSION KLARISEF 125/5ML CLARIMATE 125/5ML RANKERCLARION ORAL CLARILET ORAL ORAL BICROLID TABLETS 250CLARIBEST TABLETS Lifeline Somer E-CLARCLARIWIN 250 TABLETS TABLETSCLARITHRO 250 Associated TABLETS SMM Halcyon (Pvt) 250CLARYTAS George Steuart TABLETSKLARICID Darley Butler & TABLETSKLARIBACT Sunshine TABLETS Emerchemie NB SUSPENSION USP 125MG/5ML SUSPENSION USP 125MG/5ML SUSPENSION USP 125MG/5ML SUSPENSION USP 125MG/5ML SUSPENSION USP 250MG 250MG SUSPENSION USP 125MG/5ML SUSPENSION USP 250MG 250MG 250MG 250MG 250MG 250MG 1676 CLARITHROMYCIN ORAL 1677 CLARITHROMYCIN ORAL 1678 CLARITHROMYCIN ORAL 1679 CLARITHROMYCIN ORAL 1680 USP CLARITHROMYCIN TABLET 1681 USP CLARITHROMYCIN TABLET 1675 CLARITHROMYCIN ORAL 1682 USP CLARITHROMYCIN TABLET 1683 USP CLARITHROMYCIN TABLET 1684 USP CLARITHROMYCIN TABLET 1685 USP CLARITHROMYCIN TABLET 1686 USP CLARITHROMYCIN TABLET 1687 USP CLARITHROMYCIN TABLET I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 159 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 12-Sep-15INDIA Full 02-Aug-17INDONESIA Full 02-Aug-17 15-Nov-17 Full Full PAKISTAN 11-Mar-14PAKISTAN Full 02-Jan-14 Full INDIA 23-Jun-16PAKISTAN Full 12-Jun-15INDIA Full MALAYSIA 31-Dec-14 09-Aug-18 Full PAKISTAN Years Two 10-Jul-18 Years Two Pharmaniaga Manufacturing berhand Zim Laboratories Ltd (Pvt) Ltd (Pvt) Ltd T Hexpharm P Jaya - Indonesia Remedica limited CYPRUS CCL Pharmaceuticals 06-May-15(Pvt) Ltd Full (Pvt ) Ltd Fredun Pharmaceuticals Ltd Cipla LtdGetz Pharma (Pvt) Ltd INDIAPlethico Pharmaceuticals Ltd 11-Aug-17Years Two Laboratories (Pvt) Ltd (Contd.) (Ceylon) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Drugs (Pvt) Ltd Pharmaceuticals Lanka (Pvt) Ltd Health (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Health (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP TABLETS Emerchemie NB CLARIMINCLARIMIN TABLETSKLARID TABLETS Klintas (Pvt) Ltd United Biotech Klintas (Pvt) LtdCLAREM 250 TABLETS United Biotech TABLETSNEOKLAR Hemas Kandana Food & TABLETSLARITH CCL CLARIMAX TABLETSKLATRIL TABLETS Ceyoka (Pvt) Ltd N/A Genix Pharma SYNCLAR 250 TABLETS TABLETSCLARITEK 250 George Steuart TABLETS Breathe Free Lanka Astron (Pvt) LtdPLECLAR 250 Hemas SRI LANKA TABLETS 23-Mar-17Years Two George Steuart RANKER 500 TABLETS PharmAce (Pvt) Ltd Wilshire 250MG 250MG 250MG 250MG 250MG 250MG 250MG 250MG 250MG 250MG 250MG 500MG 500MG 1688 250MGTABLETS CLARITHROMYCIN 250 CLARILET TABLETS Tabrane 1689 IP CLARITHROMYCIN TABLETS 1690 IP CLARITHROMYCIN TABLETS 1691 USP CLARITHROMYCIN TABLETS 1692 USP CLARITHROMYCIN TABLETS 1693 USP CLARITHROMYCIN TABLETS 1694 USP CLARITHROMYCIN TABLETS 1695 USP CLARITHROMYCIN TABLETS 1696 USP CLARITHROMYCIN TABLETS 1697 USP CLARITHROMYCIN TABLETS 1698 USP CLARITHROMYCIN TABLETS 1699 USP CLARITHROMYCIN TABLETS 1700 USP CLARITHROMYCIN TABLETS 1701 USP CLARITHROMYCIN TABLETS 160 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 13-Oct-17 Years Two PAKISTAN 21-May-18PAKISTAN Full 22-Feb-14PAKISTAN Full 14-Feb-14INDIA Full INDIA 15-Jun-18 Years Two 23-Jun-16INDIA Full MALAYSIA 11-Oct-14 24-Jun-18PAKISTAN Full Full 11-Aug-14INDIA Full PAKISTAN 13-Oct-14 28-Feb-16 Full PAKISTAN Full 23-Mar-17UNITED KINGDOM Full BANGLADESH 26-Sep-18 Years Two Synmedic Laboratories (Pvt) Ltd Tabros Pharma Tabros (Pvt) Ltd Ferozsons Laboratories Ltd (Pvt ) Ltd Fredun Pharmaceuticals Ltd Zim Laboratories Ltd Micro Labs Ltd INDIAAjantha Pharma Ltd Pharmaniaga 06-Jun-17Manufacturing berhand Full Ferozsons Laboratories Ltd Getz Pharma (Pvt) Ltd Pharma Tabros (Pvt) Ltd Glaxo Operations UK Ltd Navana Pharmaceuticals Ltd (Contd.) Health (Pvt) Ltd Laboratories (Pvt) Ltd (Ceylon) Ltd Ceyoka (Pvt) Ltd Genix Pharma Health (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Ltd Ltd (Ceylon) Ltd (Ceylon) Ltd Hemas Pharmaceuticals (Pvt) Ltd Associated Laboratories (Pvt) Ltd Pharmaceuticlas (Pvt) Ltd Co Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP TABLETS SUSPENSION ORAL SUSPENSION GELTOPICAL GlaxoSmithkiline E-CLARCLARION TABLETSLARITH Associated TABLETSKLATRIL Emerchemie NB FILM COA 500CLARILET TABLETS TABLETS George Steuart CLARIWIN 500 Tabrane TABLETS 500CLARANTA TABLETS SMM Halcyon (Pvt) Baur & Co (Pvt) A CLARITEK ORAL E-CLARDUAC ONCE GRANULES GEL DAILY 500MG 500MG 500MG 500MG 500MG 500MG GRANULES FOR ORAL /5ML SUSPENSION 125MG /5ML SUSPENSION USP PEROXIDE 5% W/W GEL 500MG 1711 250MG CLARITHROMYCIN USP CLARIMYCIN 250 TABLETS George Steuart 1703 USP CLARITHROMYCIN TABLETS 1704 USP CLARITHROMYCIN TABLETS 1705 USP CLARITHROMYCIN TABLETS 1706 USP CLARITHROMYCIN TABLETS 1707 USP CLARITHROMYCIN TABLETS 1708 USP CLARITHROMYCIN TABLETS 1709 250MG CLARITHROMYCIN USP 1710 250MG CLARITHROMYCIN USP CLARION TABLETS1712 TABLETS CLARITHTROMYCIN 125MG Emerchemie NB Emerchemie NB 1713 CLARITHTROMYCIN FOR ORAL 1714 CLINDAMYCIN 1% W/W & BENZOYL 1715 CLINDAMYCIN CAPSULES 300MG CLINDAMIX 300 CAPSULES Darley Butler & 1702 USP CLARITHROMYCIN TABLETS I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 161 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 FRANCE 21-Aug-15BANGLADESH 26-Sep-18 Full Years Two PAKISTAN 16-May-14SRI LANKA Full 28-Nov-18MALAYSIAYears Two 31-Dec-14SRI LANKA Full 26-Nov-18Years Two FRANCE 21-Aug-17BANGLADESH 18-Feb-18 Full Full BELGIUM 06-Jan-14INDIA Full INDIA 11-Oct-17 Full 11-Oct-17 Full zer fi Fareva Amboise Zone Industrielle Navana Pharmaceuticals Ltd Orion pharma Ltd BANGLADESH 08-Apr-18Caraway Years Two Pharmaceuticals Ltd SDN BHD Ltd -Sri Lanka Micro Labs Ltd INDIAFareva Amboise Zone Industrielle 16-Aug-18Years Two Cephalosporins Ltd Orion pharma Ltd BANGLADESH 06-Apr-18P Years Two Manufacturing NV/SA Divine Laboratories (Pvt) Ltd Divine Laboratories (Pvt) Ltd (Contd.) Pharmaceuticals (Pvt) Ltd Co Ltd Co Ltd Health (Pvt) Ltd SMM Halcyon (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Co Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP GELATINE GELATINE CAPSULES CLIDAMIX 150 CAPSULESXINDAL Darley Butler & CAPSULESN/A Darley Butler & CAPTIDACT CAPSULESN/A CAPSULES Indoscan (Pvt) Ltd N/AN/A Industries / S P Y CAPSULESDALACIN C N/A HARD Inter Pharm (Pvt) CAPSULESCLIMYCIN 150 Hemas CAPSULES 150XINDAL PharmAce (Pvt) Ltd Interpharm (Pvt) Square DALACIN-C CAPSULES Darley Butler & INJECTION 150CLINDABACT INJECTION Hemas Slim 150CLINDABACT INJECTION Slim 150MG 300MG 150MG 150MG 300MG CAPSULES USP 300MG CAPSULES USP 150MG USP 150MG USP 150MG USP ML 150MG/2ML 150MG/2ML 1716 CLINDAMYCIN CAPSULES 300MG DALACIN C CAPSULES Hemas 1717 CLINDAMYCIN CAPSULES BP 1718 CLINDAMYCIN CAPSULES USP 1719 CLINDAMYCIN CREAM 2% W/W CLINDEX1720 CAPSULES USP CLINDAMYCIN HCL 1721 CAPSULES USP CLINDAMYCIN HCL CREAM1722 CLINDAMYCIN HYDROCHLORIDE George Steuart 1723 CLINDAMYCIN HYDROCHLORIDE 1724 CLINDAMYCIN HYDROCHLORIDE 1725 CLINDAMYCIN HYDROCHLORIDE 1726 CLINDAMYCIN HYDROCHLORIDE 1727 CLINDAMYCIN INJECTION 150MG/ 1728 CLINDAMYCIN INJECTION BP 1729 CLINDAMYCIN INJECTION BP 162 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 09-Sep-14INDIA Full 20-Nov-14 Full 20-Jul-18INDIA Full INDIA 21-Jul-18MALAYSIA Full 15-Feb-16 02-Jan-18 Full MALAYSIA Full 20-Jul-15GERMANY Full 25-Jan-18 Years Two BANGLADESH 07-May-16 Full PAKISTAN 24-Oct-17INDIA Full 31-Jan-18 Full PharmaceuticalS (Pvt) Ltd Magna Labortories (Guiarat) (Pvt) Ltd Ltd Health Biotech Ltd INDIALtd 27-Nov-15Indi Pharma (Pvt) Ltd , for Wallace Full Pharmaceuticala Pharmaceuticals SDN BHD Pharmaceuticals SDN BHD Slegfred Hameln GmbH Kalbe FarmaT P INDONESIA 01-Feb-15Pharmaceuticals Ltd Full Nabiqasim Industries (Pvt) Ltd Cadila pharmaceuticals Ltd (Contd.) (Pvt) Ltd Ltd Ltd Pharmaceuticals (Pvt) Ltd Hemas Pharmaceuticals (Pvt) Ltd Health (Pvt) Ltd Healthcare lanka Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP INJECTION Akbar SOLUTION N/AN/A INJECTIONCLIM Ceyoka (Pvt) LtdN/A INJECTION Ciron Drugs & INJECTION International CLIM Yaden PharmAce (Pvt) LtdCLINCIN GEL Alpa Laboratories INJECTION GEL INJECTION New Arumed (Pvt) T3-MYCIN GEL PharmAce (Pvt) Ltd GEL Alpa Laboratories Emar Pharma (Pvt) T3-MYCIN Indoscan (Pvt) Ltd LOTIONCLINDAMYCIN Hoe HAMELN Indoscan (Pvt) LtdALBIOTIN ACNE Hoe TOPICAL GELCLINFACE GELVAGIBACT PharmAce (Pvt) Ltd CREAM Square DEXAQUIN OINTMENT George Steuart Sunshine 30MG/ML 300MG/2ML 300MG/2ML 300MG/2ML USP GEL GEL LOTION 1.2% 150MG/ML INJECTION BP 10MG/ML SOLUTION USP TOPICAL 0.025% GEL 1.2% +TRETINOIN USP 2% CREAM USP VAGINAL 0.05/ DEXAMETHASONE USP OINTMENT SODIUM PHOSPHATE 150MG/ML 1731 CLINDAMYCIN INJECTION BP 1732 CLINDAMYCIN INJECTION USP 1733 CLINDAMYCIN INJECTION USP 1734 CLINDAMYCIN INJECTION USP 1735 1 % CLINDAMYCIN PHOSPHATE 1736 1.20 % CLINDAMYCIN PHOSPHATE 1737 BP CLINDAMYCIN PHOSPHATE 1738 CLINDAMYCIN PHOSPHATE 1739 CLINDAMYCIN PHOSPHATE 1740 USP CLINDAMYCIN PHOSPHATE 1741 CLINDAMYCIN PHOSPHATE 1742 3% & BP CLIOGUINOL 1730 CLINDAMYCIN INJECTION BP I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 163 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 BANGLADESH 08-Sep-17 Years Two INDIA 15-Jun-16INDIA Full INDIA 24-Jun-18PAKISTAN Full 24-May-18 05-Sep-17 Years Two INDIA Full INDIA 16-Oct-17 Years Two PAKISTAN 16-Oct-17 Years Two INDIA 04-Oct-17 Years Two BANGLADESH 17-Oct-18 11-Sep-16 Full Full INDIA 07-Jun-16 Full INDIA 16-Jan-17 Full India Ltd INDIA 26-Sep-17Years Two fi Beximco Pharmaceuticals Ltd Human Verve Care Laboratories Pharmaceuticals Human Verve Care Laboratories Laboratories (Pvt) Ltd Concept Pharmaceuticals Ltd Concept Pharmaceuticals Ltd MASS Pharma Pvt Ltd Nem Laboretories (P) Ltd Pharmaceuticals Ltd Unijules Life Sciences Ltd Medochemie Ltd CYPRUSOaknet Healthcare 30-Oct-17Pvt Ltd Years Two (Contd.) Lanka Ltd Sano fi (Ceylon) Ltd Agency Pvt Ltd Agency Pvt Ltd International (Pvt) Ltd International (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Laboratories (Pvt) Ltd Health (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP CREAM Softcare CREAM Softcare CLOBEDERM-NN OINTMENT Morison PLCDERMOCON PLUS ATCO DERMOCON PLUS 0.5%W/W+ NEOMYCIN SULPHATE 0.5%W/W+ NEOMYCIN SULPHATE 100,000 0.05%W/W +NYSTATIN UNITS OINTMENT 0.05% CREAM 0.05% CREAM 1743 10MG BP TABLETS CLOBAZAM KEOLAX TABLETS Emerchemie NB 1744 10MG BP TABLETS CLOBAZAM 1745 VERCLOB 10MG BP TABLETS CLOBAZAM 1746 5MG BP TABLETS CLOBAZAM FRISIUM TABLETS1747 5MG BP TABLETS CLOBAZAM CLOBAS 5 Leader Pharma TABLETS1748 PROPIONATE CLOBETASOL VERCLOB TABLETS Sano TABLETSAssociates Pharma 1749 The Madras 0.5% & NEOMYCIN CLOBETASOL Leader Pharma 1750 0.5% & NEOMYCIN CLOBETASOL 1751 CREAM 0.05% 15G CLOBETASOL CLOBETREX1752 0.05% CREAM BP CLOBETASOL CREAM CLOBIT1753 0.05% CREAM BP CLOBETASOL V H Distributors A CREAM CLONATE CREAM CREAM1754 0.05% CREAM BP CLOBETASOL N/A PharmAce (Pvt) Ltd Lifeline Square 1755 0.05% CREAM BP CLOBETASOL MEDQDERMONE CREAM1756 0.05% CREAM BP CLOBETASOL CREAM COSVATE Associated Lifeline CREAM George Steuart 164 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 MALAYSIA 02-Aug-16MALAYSIA Full 23-Feb-17PAKISTAN Full 04-Oct-17 Years Two BANGLADESH 11-Sep-15 Full INDIA 17-Feb-18 Full BANGLADESH 11-Sep-15 Full INDIAINDIA 01-Sep-18 Provisional INDIA 28-Dec-17 Full INDIA 13-Oct-17 Years Two INDIA 13-Oct-17 Years Two INDIA 12-Oct-17 Years Two PAKISTAN 06-Jan-14 09-Jan-17 Full Full Pharmaceuticals SDN BHD Kotra pharma (M) Ltd MASS Pharma Pvt Ltd Pharmaceuticals Ltd Unijules Life Sciences Ltd Pharmaceuticals Ltd PharmaceuticalS (Pvt) Ltd Glenmark Pharmaceuticals Ltd Oaknet Healthcare Pvt Ltd Oaknet Healthcare Pvt Ltd Oaknet Healthcare Pvt Ltd Laboratories (Pvt) Ltd Glaxo Smithkiline Pakistan Ltd (Contd.) Co Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Healthcare lanka Ltd Health (Pvt) Ltd Health (Pvt) Ltd Health (Pvt) Ltd Pharmaceuticlas (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP CREAM Delmege Forsyth & OINTMENT PharmAce (Pvt) Ltd Square OINTMENT PharmAce (Pvt) Ltd Square AXCEL AXCEL CLOSBETASOL CLOBETREX OINTMENTOINTMENT V H Distributors A OINTMENT CIROSOLPOWERCORT CREAM CREAM Ceyoka (Pvt) LtdCOSVATE-G Ciron Drugs & Sunshine CREAMCOSVATE-G George Steuart CREAMCOSVATE George Steuart CREAMENDERM-GM CREAM George Steuart DERMOVATE Ceyoka (Pvt) Ltd OINTMENT Leben GlaxoSmithkiline W/W W/W CREAM BP 0.05% CREAM BP 0.05% CREAM BP 0.1% SULPHATE & GENTAMICIN CREAM 0.1% SULPHATE & GENTAMICIN CREAM 0.1% SULPHATE + GENTAMICIN 2% CREAM +MICONAZOLE NITRATE 0.1% SULPHATE + GENTAMICIN 2% CREAM +MICONAZOLE NITRATE B.P OINTMENT 1758 0.05% CREAM USP CLOBETASOL 1759 0.05% OINTMENT CLOBETASOL 1760 0.05% BP OINTMENT CLOBETASOL CLONATE 1757 0.05% CREAM BP CLOBETASOL CLODERM OINTMENT Indoscan (Pvt) Ltd Hoe 1761 0.05% BP OINTMENT CLOBETASOL CB-SOL1762 0.05% BP OINTMENT CLOBETASOL CLONATE OINTMENT Lifeline 1763 PROPIONATE CLOBETASOL 1764 PROPIONATE CLOBETASOL 1765 0.05% PROPIONATE CLOBETASOL 1766 0.05% PROPIONATE CLOBETASOL 1767 0.05% PROPIONATE CLOBETASOL 1768 0.05% PROPIONATE CLOBETASOL 1769 0.05% PROPIONATE CLOBETASOL I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 165 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAPAKISTAN 24-May-17 Years Two 10-Sep-17INDIA Years Two INDIA 19-Apr-18 Years Two MALAYSIA 23-Apr-18 Years Two 02-Feb-17INDIA Full KOREA 28-Sep-17 Years Two INDIA 13-Feb-14 Full 14-Sep-14PAKISTAN Full 09-Jan-18INDIA Years Two 29-May-18 Full KOREAINDIA 13-Feb-14 Full 07-Aug-18 Years Two Korean Drugs Co Ltd Blue Cross Laboratories Ltd Laboratories (Pvt) Ltd Agio Pharmaceuticals Ltd Agio Pharmaceuticals Ltd Pharmaceuticals SDN BHD Brassica Pharma Pvt Ltd Laboratories (Pvt) Ltd Micro Labs Ltd INDIAGlaxo Smithkiline Pakistan Ltd 01-Jan-18Agio Pharmaceuticals Ltd Full Korean Drugs Co Ltd Laboratories (Pvt) Ltd (Contd.) Pharmaceuticals Ltd Produsts Ltd (Pvt) Ltd (Pvt) Ltd International (Pvt) Ltd (Pvt) Ltd Pharmaceuticlas (Pvt) Ltd (Pvt) Ltd Mediccon Pharmaceuticals Ltd OPICAL OPICAL SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP OINTMENT Mediccon SOLUTION TAVATE TAVATE T SONADERM GM CREAMCLOBEDERM-S Hayleys Consume LOTIONAGICLOB CREAM CREAM Morison PLCAGICLOB CREAM Citihealth Imports ATCO OINTMENT Citihealth Imports CLODERM CREAMSICACORT-CP CREAM Indoscan (Pvt) LtdCLO-BE Hoe Softcare ENDERMSTERIDERM-S CREAM CREAMDERMOVATE Ceyoka (Pvt) Ltd CREAM Micro Mega Lanka Leben AGICLOB-GM GlaxoSmithkiline CREAMCLO-BE Citihealth Imports ENDERM OINTMENT Ceyoka (Pvt) Ltd Leben 0.05%+ MICONAZOLE Nitrate 2% Sulphate 0.1% CREAM GENTAMICIN 0.525G+SALICYLIC ACID 2G/100ML 0.05% W/W BP 0.05% W/W BP 0.05% W/W BP 0.05% USP 0.05% USP 0.05% USP 0.05% USP 0.05% USP 0.05%+GENTAMICIN CREAM USP 0.2%+MICONAZOLE BP SUPPHATE 2% USP NITRATE SOLUTION 0.05% TOPICAL USP OINTMENT USP 0.05% w/w USP OINTMENT 1770 PROPIONATE CLOBETASOL 1771 PROPIONATE CLOBETASOL 1772 CREAM PROPIONATE CLOBETASOL 1773 CREAM PROPIONATE CLOBETASOL 1774 CREAM PROPIONATE CLOBETASOL 1775 CREAM PROPIONATE CLOBETASOL 1776 CREAM PROPIONATE CLOBETASOL 1777 CREAM PROPIONATE CLOBETASOL 1778 CREAM PROPIONATE CLOBETASOL 1779 CREAM PROPIONATE CLOBETASOL 1780 PROPIONATE CLOBETASOL 1781 LIQ PROPIONATE CLOBETASOL 1782 PROPIONATE CLOBETASOL 166 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 19-Apr-18 Years Two INDIA 07-Aug-17 Full INDIA 19-Apr-18 Years Two KOREA 09-Oct-15INDIA 13-Nov-15 Full Full 11-Jan-18 Years Two PAKISTAN 16-Mar-18PAKISTAN Years Two 25-Feb-15INDIA Full PAKISTAN 18-Dec-18 Years Two 14-Jun-16INDIA Full 07-Jul-14 Full Korean Drugs Co Ltd Agio Pharmaceuticals Ltd Torrent Pharmaceuticals Ltd Agio Pharmaceuticals Ltd Medicare Yash (Pvt) Ltd (Pvt) Ltd Micro Labs Ltd INDIARenata Limited BANGLADESHNabiqasim 29-Apr-14 13-Feb-18Industries (Pvt) Ltd Full Full Fynk Pharmaceuticals Jodas Expoim Pvt Ltd OBS Pakistan (Pvt) Ltd SG Pharma (Pvt) Ltd (Contd.) Pharmaceuticals Ltd (Pvt) Ltd Ltd (Pvt) Ltd Himan Group (Pvt) Ltd (Pvt) Ltd (Ceylon) Ltd Health (Pvt) Ltd Pharmaceuticals (Pvt) Ltd International (Pvt) Ltd (Ceylon) Ltd Pharmacy (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP OINTMENT Mediccon OINTMENT Citihealth Imports OINTMENT Citihealth Imports OINTMEN TAVATE AGICLOB OINTMENT QUACEAGICLOB OINTMENTOINTMENT Mega Pharma (Pvt) CLOBETVIN CLO-BE TOPICAL MICLOGENTA CREAMSTERISONE Pharmatec (Pvt) Ltd Pharma Yash CREAMOVULETCLOMITAB Micro Mega Lanka TABLETS TABLETSNICLOFENC 50 Emerchemie NB TABLETS George Steuart JOTRAZOLE Ceyline TABLETS Softcare OINTMENT USP 0.05% w/w USP OINTMENT 0.05% w/w USP OINTMENT 0.05% w/w USP OINTMENT 0.05% w/w USP OINTMENT MICONAZOLE Nitrate & GENTAMICIN Sulphate CREAM 0.05% 100MG 50MG 50MG 50MG OINTMENT USP 0.05% w/w USP OINTMENT 1784 PROPIONATE CLOBETASOL 1785 PROPIONATE CLOBETASOL 1786 PROPIONATE CLOBETASOL 1787 PROPIONATE CLOBETASOL 1788 PROPIONATE+ CLOBETASOL 1789 CREAM BUTYRATE CLOBETASONE 1790 BP TABLETS CLOMIFENE CITRATE 1791 BP TABLETS CLOMIFENE CITRATE 1792 BP TABLETS CLOMIFENE CITRATE 1793 USP TABLETS CLOMIFENE CITRATE 1794 50MG BP TABLETS CLOMIFENE OVAFIN1795 50MG BP TABLETS CLOMIFENE 1796 FULFYL 50MG BP TABLETS CLOMIFENE TABLETS N/A TABLETS Emerchemie NB Kamazu (Pvt) Ltd TABLETS Micro Labs Ltd INDIA The Esses 16-Jun-18Years Two 1783 PROPIONATE CLOBETASOL I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 167 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 PAKISTAN 14-Jun-16PAKISTAN Full 16-Jul-16INDIA Full ISRAEL 22-Jul-16 Full INDIA 10-Jul-15 Full 27-Nov-18 Years Two SWITZERLAND 22-Apr-15INDIA Full INDIA 26-Dec-17SWITZERLAND Full 19-Nov-17 07-Sep-17 Full Full INDIA 27-Oct-17 Years Two OBS Pakistan (Pvt) Ltd (Pvt ) Ltd Cadila Healthcare Ltd Teva Pharmaceuticals Industries Ltd Corona Remedics (Pvt) Ltd Renata Limited BANGLADESHRemedica limited 27-Apr-14 CYPRUS Full Medochemie Ltd CYPRUS 13-Oct-15Novartis Pharma Full 05-Jan-17 Italy SPA Sun Full Pharmaceutical industries (Pvt) Ltd A Roche Farma S Leaganes Spain La for F Hoffmann Roche Ltd Human Verve Care Laboratories (Contd.) (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Ltd Healthcare lanka Ltd (Ceylon) Ltd Drugs (Pvt) Ltd Laboratories (Pvt) Ltd Ltd (Ceylon) Ltd Ltd Agency Pvt Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP FOLISTIM 50 TABLETSSEROPHENE Hemas TABLETSCORPHEN Baur & Co (Pvt) A TABLETSOVULET Sunshine OVA-MIT TABLETS TABLETS Emerchemie NB 25ANAFRANIL Kandana Food & TABLETS Baur & Co (Pvt) A TABLETS TABLETS 50MG BP 50MG BP 50MG BP 25MG 1797 50MG BP TABLETS CLOMIFENE OVAFIN TABLETS Mansel (Ceylon) 1798 50MG BP TABLETS CLOMIFENE VOI1799 50MG BP TABLETS CLOMIFENE 1800 FULFYL 50MG IP CLOMIPHENE CITRATE TABLETS1801 50MG CLOMIPHENE CITRATE TABLETS Ceyoka (Pvt) Ltd1802 Kamazu (Pvt) Ltd TABLETS CLOMIPHENE CITRATE Genix Pharma Micro Labs Ltd INDIA1803 TABLETS CLOMIPHENE CITRATE 1804 TABLETS CLOMIPHENE CITRATE 16-Jun-18Years 1805 Two 50MG BP TABLETS CLOMIPHENE DUINUM1806 CLOMIPRAMINE HYDROCHLORIDE TABLETS1807 25MGTABLETS CLOMIPRAMINE CLOFRANIL Associated 1808 25MG BP TABLETS CLOMIPRAMINE CLOMIRIGHT TABLETS1809 0.5MGTABELTS CLONAZEPAM TABLETS Emerchemie NB 0.5MG RIVOTRIL Chamee Chemist TABLETS1810 2MGTABLETS Alvita Pharma CLONAZEPAM Baur & Co (Pvt) A CLOPAM TABLETS Leader Pharma 168 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 SWITZERLAND 19-Nov-17 Full INDIAINDIA 27-Oct-17INDIA Years Two 18-Aug-17INDIA Years Two 05-Apr-14INDIA Full 18-Aug-17INDIA Years Two 16-Nov-17INDIA Years Two 13-Sep-17INDIA Full 16-Nov-17 Years Two ARGENTINA 20-Sep-17 Years Two 29-Jan-15SRI LANKA Full 01-Jan-15FRANCE Full 31-Jan-18PAKISTAN Full 11-Mar-14INDIA Full 04-Apr-14 Full Winthrop fi Roche Farma S A A Roche Farma S Leaganes Spain La for F Hoffmann Roche Ltd Verve Human Verve Care Laboratories Pvt Ltd Pharmafabrikon Unit Pvt Ltd Pvt Ltd Pharmaceuticals Pvt Ltd Sunrise International LabS Ltd Laboratoires Bago S. A (Ceylon) (Pvt) Ltd Industrie LaboratoriesIPCA INDIA CCL Pharmaceuticals (Pvt) Ltd 08-Jun-18Years Two Medibios Laboratories (Pvt) Ltd (Contd.) Lanka Ltd Sano fi Ltd Agency Pvt Ltd (Pvt) Ltd Pharmaceutical (Pvt) Ltd (Ceylon) Ltd Ltd Pharmaceuticals Lanka (Pvt) Ltd (Ceylon) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP PLAVIX TABLETS Sano SULPHATE TABLETS 75MG TABLETS SULPHATE 1811 2MGTABLETS CLONAZEPAM RIVOTRIL TABLETS Baur & Co (Pvt) A 1812 2MGTABLETS CLONAZEPAM 1813 0.5MG USP TABLETS CLONAZEPAM CLOPAM CLONAX 0.5MG TABLETS1814 0.5MG USP TABLETS CLONAZEPAM 0.5 NAZA TABLETS PharmAce (Pvt) Ltd1815 0.5MG USP TABLETS CLONAZEPAM Consern Pharma CLONAX 0.5MG TABLETS Leader Pharma TABLETS1816 2MG USP TABLETS CLONAZEPAM CLONAX 2 Novachem Lanka PharmAce (Pvt) Ltd1817 2MG USP TABLETS CLONAZEPAM Consern Pharma ZEE-02 TABLETS1818 2MG USP TABLETS CLONAZEPAM CLONAX-2 PharmAce (Pvt) Ltd1819 2MG USP Consern Pharma TABLETS CLONAZEPAM TABLETS CLOCALM TABLETSAssociates Pharma 1820 2MG USP TABLETS CLONAZEPAM The Madras TABLETS PharmAce (Pvt) Ltd 2 NEURYL Consern Pharma 1821 2MG USP CLONAZEPAM Kent TABLETS1822 HYDROGEN CLOPIDOGREL Emerchemie NB N/A1823 75MGTABLETS CLOPIDOGREL 75 CLOPACT 1824 75MG TABLETS CLOPIDOGREL TABLETS CLOPITAB TABLETS1825 75MGTABLETS CLOPIDOGREL Emar Pharma (Pvt) N/A TABLETS CLOPIMED CCL TABLETS M S J Industries Emerchemie NB I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 169 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIA 08-Jul-17 Full INDIAARGENTINA 04-Dec-15 19-Oct-17BANGLADESH Full Years Two 12-Jul-18INDIA Full INDIA 06-Jul-18 Full 22-May-18 Provisional INDIAINDIA 30-Jan-17 Years Two INDIA 15-Jul-18 Full BANGLADESH 25-May-15 14-Nov-14ARGENTINA Full Full 19-Oct-17INDIA Years Two INDIA 16-Jul-14 Full 13-Aug-15 Full Pharmaceuticals Simpex Pharma (Pvt) Ltd Quimica Montpellier SA Navana Pharmaceuticals Ltd G D Laboratories (India) Pvt Ltd Aurochem Pharmaceuticals (India) Ltd Cipla LtdAtoz Pharmaceuticals INDIA(Pvt) Ltd Cadila Healthcare Ltd 25-Aug-18Windlas Biotech Full (Pvt) Ltd Baximco Pharmaceuticals Quimica Montpellier SA Pharmaceuticals Ltd Akums Drugs & Pharmaceuticals Ltd (Contd.) eld fi Somer Pharmaceuticals (Pvt) Ltd (Ceylon) Ltd Co Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd Healthcare lanka Ltd Pharmaceuticals (Pvt) Ltd (Ceylon) Ltd (Ceylon) Ltd (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP TABLETS 1826 75MGTABLETS CLOPIDOGREL CLOPID TABLETSAssociates Pharma The Madras 1827 75MG IP TABLETS CLOPIDOGREL CLOPISIM FILM COA 1828 75MG USP TABLETS CLOPIDOGREL TROKEN1829 75MG USP TABLETS CLOPIDOGREL CLOPET TABLETS1830 75MG USP TABLETS CLOPIDOGREL 75 CIDOGRIL TABLETS Emerchemie NB TABLETS1831 75MG USP TABLETS CLOPIDOGREL Darley Butler & CLOPIKIND 75 Lifeline TABLETS1832 75MG USP TABLETS CLOPIDOGREL CLOPIVAS Hemas 1833 75MG USP TABLETS CLOPIDOGREL 75 FRELET TABLETS1834 75MG TABLETS USP TABLETS CLOPIDOGREL Breathe Free Lanka NOKLOTAsian Pharma Euro 1835 75MG USP TABLETS CLOPIDOGREL 75 COREL TABLETS1836 75MG USP TABLETS CLOPIDOGREL Sunshine TABLETS ODREL1837 75MG USP TABLETS CLOPIDOGREL Lifeline TROKEN TABLETS1838 75MG USP TABLETS CLOPIDOGREL 75 FLAMOGREL TABLETS TABLETS Emerchemie NB 1839 75MG USP TABLETS CLOPIDOGREL VEXAGRIL Emerchemie NB PharmAce (Pvt) Ltd Flamingo TABLETS Global Impex AV 170 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 AUSTRALIA 28-Feb-15PAKISTAN Full 21-Nov-16INDIA Full 28-May-14 Full INDIAINDIA 13-Jun-17 Full INDIA 13-May-14INDIA Full 27-Mar-14INDIA Full 27-Jun-15INDIA Full 07-Aug-14INDIA Full 24-Mar-14PAKISTAN Full 05-Feb-15 25-Jun-14 Full INDIA Full 25-Jan-18INDIA Provisional INDIA 26-Sep-14 Full 16-Sep-14 Full MSN Laboratories Ltd Nabiqasim Industries (Pvt) Ltd Ltd Zim Laboratories Ltd Agio Pharmaceuticals Ltd Ajantha Pharma Ltd Belco Pharma (Pvt) Ltd Pharmaceuticals (Pvt) ltd Triveni Formulations Ltd Ltd Zafa Pharmaceuticals Laboratories (Pvt) Ltd Heathcare TILL Pvt Ltd J Duncan Healthcare (Pvt) Ltd S Kant Healthcare Ltd (Contd.) Ltd Health (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Ltd Agency Pvt Ltd Services (Pvt) Ltd (Pvt) Ltd Pharmaceuticals Manufacturer Corporation Pharmaceuticals (Pvt) Ltd Co Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP 1851 75MG USP TABLETS CLOPIDOGREL RIDLOR1852 75MG USP TABLETS CLOPIDOGREL 75 CLOPLATE TABLETS TABLETS1853 75MG USP TABLETS CLOPIDOGREL PLASEP Baur & Co (Pvt) A George Steuart TABLETS Axia (Pvt) Ltd MSN Laboratories 1841 75MG USP TABLETS CLOPIDOGREL AGIREL1842 75MG USP TABLETS CLOPIDOGREL INSTACLOP TABLETS1843 75MG USP TABLETS CLOPIDOGREL CLOPIDOGREL TABLETS Citihealth Imports TABLETS1844 75MG USP TABLETS CLOPIDOGREL 75 CLOP Baur & Co (Pvt) A Leader Pharma 1845 75MG USP TABLETS CLOPIDOGREL WINKLOT TABLETS1846 75MG USP TABLETS CLOPIDOGREL CLOPIDEC Algarash (Pvt) Ltd TABLETS Surien 1847 75MG USP TABLETS CLOPIDOGREL PLAEAGG-I TABLETS Trivopharma TABLETS Harcourts (Pvt) Ltd1848 75MG USP TABLETS CLOPIDOGREL Coral Laboratories N/A International Yaden 1849 75MG USP TABLETS CLOPIDOGREL N/A TABLETS1850 75MG USP TABLETS CLOPIDOGREL CLOPIDEL State TABLETS TABLETS Slim Delmege Forsyth & 1840 75MG USP TABLETS CLOPIDOGREL CLOPIZIM 75 TABLETS Tabrane I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 171 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 05-Apr-14INDIA Full 19-Feb-16 Full INDIA 17-Nov-14 Full BANGLADESH 11-Nov-14 01-Jan-15INDIA Full Full 08-Jul-14 Full INDIAINDIA 05-Sep-16 Full 23-Nov-15 Full INDIABANGLADESH 07-Jul-16 22-Sep-14 Full Full XL Laboratories XL (Pvt) Ltd Centurion Laboratories Pvt Ltd Sai Mirra Innopharm (Pvt) Ltd Theon Pharmaceuticals Ltd Healthcare Pharmaceuticals Sun Pharmaceutical industries U S V Ltd INDIA Torrent Pharmaceuticals Ltd 08-Jul-18Pharmaceuticals Ltd Years Two Micro Labs Ltd INDIAOrchid Healthcare INDIAMacleods 08-Feb-18Pharmaceuticals Ltd 03-Sep-14 Full Pharmaceuticals Full Ltd (Contd.) (Pvt) Ltd (Pvt) Ltd Healthcare lanka Ltd Pharmaceuticals (Pvt) Ltd Citihealth Imports (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Ltd (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP TABLETS 1854 75MG USP TABLETS CLOPIDOGREL CLOPIDA TABLETS SM Pharmaceutical 1855 75MG USP TABLETS CLOPIDOGREL N/A1856 75MG USP TABLETS CLOPIDOGREL 75 CLOGREL TABLETS TABLETS1857 75MG USP TABLETS CLOPIDOGREL 75 THEOCLOT International Yaden Sunshine TABLETS1858 75MG USP TABLETS CLOPIDOGREL REPLET Slim 1859 75MG USP TABLETS CLOPIDOGREL CLOPILET FILM COA 1860 75MG USP TABLETS CLOPIDOGREL TABLETS PURIL Hemas 1861 75MG USP TABLETS CLOPIDOGREL DEPLATT TABLETS1862 75MG USP TABLETS CLOPIDOGREL PLATFREE TABLETS Hemas 1863 Edna Medicals (Pvt) 75MG USP TABLETS TABLETS CLOPIDOGREL PLAGERINE1864 75MG USP TABLETS CLOPIDOGREL PharmAce (Pvt) Ltd 75 TABLETS PIDLET Medley 1865 75MG USP TABLETS CLOPIDOGREL CLOPI 75 Micro Mega Lanka TABLETS1866 75MG USP TABLETS CLOPIDOGREL Asian Pharma Euro ANCLOG 75 TABLETS TABLETS Pettah Pharmacy PharmAce (Pvt) Ltd Square 172 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 21-Nov-16 Full INDIA 21-Nov-16 Full INDIA 20-Sep-14 Full INDIA 05-Jul-14 Full INDIA 08-Apr-15 Full INDIA 22-May-18 Full MALAYSIA 19-Aug-15 10-Aug-18 Full INDIA Full INDIA 07-Jun-18 Full INDIA 07-Jun-16 Full INDIA 17-Feb-16 Full 10-Nov-17 Full Ind-Swift Ltd INDIACentaur Pharmaceutical (Pvt) Ltd Centaur 25-Jun-14Pharmaceutical (Pvt) Ltd Full Jenburkt Pharmaceuticals Ltd Dupen Laboratories (Pvt) Ltd Fourrts (India) Laboratories Ltd Sava Healtheare Ltd Glenmark Pharmaceuticals Ltd Pharmaceuticals SDN BHD Glenmark Pharmaceuticals Ltd Glenmark Pharmaceuticals Ltd Unijules Life Sciences Ltd Centaur Pharmaceutical (Pvt) Ltd (Contd.) Ltd Health (Pvt) Ltd Health (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Healthcare lanka Ltd (Pvt) Ltd Healthcare lanka Ltd Healthcare lanka Ltd Healthcare lanka Ltd Pharmaceuticals (Pvt) Ltd Health (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP CREAM Lifeline TRANSLIPO -CB CREAMTRANSLIPO -CB George Steuart CREAMTRIBEN-B George Steuart CREAMD' FUNGI-B CREAM Hemas FUNGID B Pharma Tech Bio CREAMBECLOGEN CREAM Sunshine CANDID-B Radiant Health Care LOTIONCANDACORT CREAM Sunshine CANDID PLUS EAR DROPS Indoscan (Pvt) Ltd Hoe Sunshine CREM BECLOMETHASONE DIPROPIONATE BECLOMETHASONE DIPROPIONATE 0.025% CREAM BP BECLOMETHASONE DIPROPIONATE 0.025% CREAM BP BECLOMETHASONE DIPROPIONATE 0.025% CREAM BP BECLOMETHASONE DIPROPIONATE 0.025% CREAM BP BECLOMETHASONE DIPROPIONATE 0.025% CREAM BP 0.025% & BETAMETHASONE 0.1% CREAM GENTAMICIN BECLOMETHASONE DIPROPIONATE 0.025% LOTION 1% HYDROCORTISONE 2% Ear Drops HCL 1867 75MG USP TABLETS CLOPIDOGREL CAPLOR1868 CLOTRIMAZOLE 1%, TABLETS1869 CLOTRIMAZOLE 1%, Emar Pharma (Pvt) 1870 CLOTRIMAZOLE 1%, 1871 CLOTRIMAZOLE 1%, 1872 CLOTRIMAZOLE 1%, 1873 CLOTRIMAZOLE 1%, 1874ANHYDROUS CLOTRIMAZOLE 1%,+ 1875 CLOTRIMAZOLE 1% & 1876 CLOTRIMAZOLE 1% +LIGNOCAINE 1877 CLOTRIMAZOLE 1% CREAM1878 CANDID CLOTRIMAZOLE 1% CREAM BP CLOTRIZOLE 1879 CLOTRIMAZOLE 1% CREAM BP CREAM TRANSLIPO -C Sunshine CREAM George Steuart I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 173 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 06-May-14 Full 18-Apr-18MALAYSIA Full 07-Jun-16MALAYSIA Full 10-Jan-14INDIA Full INDIA 16-Nov-17BANGLADESH Full 09-Jul-15 02-May-15INDIA Full Full INDIA 31-Aug-15 Full 09-Mar-17INDIA Full INDIA 10-Mar-17 Full INDIA 26-Aug-14 Full 10-May-17 Years Two & Co Ltd S Kant Healthcare Ltd Remedica limited CYPRUSPharmaceuticals 13-Dec-15SDN BHD Kotra pharma (M) Full Ltd (india) (Pvt) Ltd Agio Pharmaceuticals Ltd Healthcare Pharmaceuticals Indoco Remedies India Geno Pharmaceuticals Pvt Ltd Agio Pharmaceuticals Ltd Pharmaceuticals (India) Ltd Glenmark Pharmaceuticals Ltd Sterling Lab INDIA 25-Feb-18Years Two (Contd.) Co Ltd Drugs (Pvt) Ltd Co Ltd (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd Healthcare lanka Ltd Co Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP LAMONTE-BG CREAMCANISON 1% Mansel (Ceylon) CREAMKANDICHEM-B LOTION Citihealth Imports CANDID-B PharmAce (Pvt) Ltd Aurochem SKIN CREAM Sunshine BETAMETHASONE DIPROPIONATE DIPROPIONATE BETAMETHASONE & GENTAMICIN 0.025% USP 0.1% CREAM BP SULPHATE 1%,BECLOMETHASONE 0.025% DIPROPINATE 1%,BECLOMETHASONE 0.025% DIPROPINATE 1%,BECLOMETHASONE 0.025% DIPROPINATE 1880 CLOTRIMAZOLE 1% CREAM BP1881 N/A CLOTRIMAZOLE 1% CREAM BP1882 FUNGIDEL CLOTRIMAZOLE 1% CREAM BP1883 1% MYCORIL CLOTRIMAZOLE 1% CREAM BP CREAM CREAM CREAM CANDAZOLE1884 Chamee Chemist Delmege Forsyth & CLOTRIMAZOLE 1% CREAM USP CREAM Gopaldas Visram Kandana Food & CREOBIC1885 CLOTRIMAZOLE 1% CREAM USP CANDIGEN Indoscan (Pvt) Ltd1886 CREAM CLOTRIMAZOLE 1% CREAM USP Hoe CANISON CREAM1887 Delmege Forsyth & CLOTRIMAZOLE 1% CREAM USP CREAM TRIDERM Ceyoka (Pvt) Ltd1888 CLOTRIMAZOLE 1% CREAM USP Galentic Pharma CLOB CREAM Citihealth Imports CREAM1889 CLOTRIMAZOLE 1%, CREAM Citihealth Imports Hemas 1890 CLOTRIMAZOLE 1891 CLOTRIMAZOLE 1892 CLOTRIMAZOLE 1893 CLOTRIMAZOLE TRIODERM CREAM Darley Butler & 174 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAPAKISTAN 30-Jan-14 31-Mar-18 Full BANGLADESH 27-Sep-17 Full Years Two INDIAINDIA 16-Jan-14INDIA Full 23-Jul-14 Full BANGLADESH 02-Dec-17 24-Apr-15 Full Full INDIAINDIA 22-Apr-15PAKISTAN Full 20-Oct-17 26-Jul-16 Years Two Full MALAYSIA 02-Aug-16INDIA Full 07-Jun-16 Full Agio Pharmaceuticals Ltd Shaigan Pharmaceuticals (Pvt) Ltd Pharmaceuticals Industry Ltd Ltd Dupen Laboratories (Pvt) Ltd Jenburkt Pharmaceuticals Ltd Pharmaceuticals Ltd Pharmaceutical (Pvt) Ltd Nabiqasim Industries (Pvt) Ltd Sterling Lab INDIAPharmaceuticals SDN BHD Glenmark 22-Mar-18Pharmaceuticals Ltd Years Two (Contd.) (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Health (Pvt) Ltd Co Ltd Healthcare lanka Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP LOTION Indoscan (Pvt) Ltd Hoe CLOZOXH CREAMFUNGIN-B Akbar CREAMN/AD-FUNGI Ceyoka (Pvt) Ltd The IBN SINA CREAM CREAM Harcourts (Pvt) Ltd Pharma Bio Tech Coral Laboratories CANEZOLEDERMOSPORIN CREAM CREAMCLOSTAT Pharmatec (Pvt) Ltd Belco Pharma George Steuart POWDERW/V Darley Butler & HYDROCORTISONE 10MG/G HYDROCORTISONE CREAM BP BETAMETHASONEVALERATE 0.1% CREAM W/W W/W W/W WW 1 % 1894 CLOTRIMAZOLE CANISON-BN CREAM Citihealth Imports 1894 CLOTRIMAZOLE CANISON-BN CREAM1895 CLOTRIMAZOLE 10MG & Citihealth 1896 1%, CLOTRIMAZOLE BP 1897 CLOTRIMAZOLE CREAM 1% B.P 1898 CLOTRIMAZOLE CREAM 1% B.P 1899 1% W/W CLOTRIMAZOLE CREAM BP TRIBEN1900 1% W/W CLOTRIMAZOLE CREAM BP AFUN 1% CREAM1901 1% W/W CLOTRIMAZOLE CREAM I.P CREAM EMDID Hemas 1902 1% CLOTRIMAZOLE CREAM USP PharmAce (Pvt) Ltd Square 1903 CREAM 1% CLOTRIMAZOLE CREAM USP Associates1904 Pharma CLOTRIMAZOLE DUSTING POWDER Central drugs and 1905 1% W/V CLOTRIMAZOLE LOTION BP CANDAZOLE 1% 1906 CLOTRIMAZOLE mouth paint 1% CANDID MOUTH PAINT Sunshine I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 175 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 28-Jan-16 Full INDIA 26-Oct-17 Years Two INDIA 18-Mar-15 Full INDIA 07-Jun-17 Years Two INDIA 16-Sep-15 Full INDIA 07-Jun-17 Years Two PAKISTAN 07-Jun-18 16-May-18 Full Provisional INDIAINDIA 09-Apr-18 Full PAKISTAN 22-Jun-18 Years Two 27-Jan-17INDIA Full INDIA 07-Jun-15 Full 30-Jun-15 Full Umedica Laboratories (Pvt) Ltd Bliss GVS Pharma Ltd Bliss GVS Pharma Ltd Glenmark Pharmaceuticals Ltd Agio Pharmaceuticals Ltd Glenmark Pharmaceuticals Ltd Glenmark Pharmaceuticals Ltd Nabiqasim Industries (Pvt) Ltd Glenmark Pharmaceuticals Ltd Agio Pharmaceuticals Ltd Hemis NOA Pharmaceuticals Glenmark Pharmaceuticals Ltd Glenmark Pharmaceuticals Ltd (Contd.) Pharmaceuticals Pvt Ltd Sunshine Healthcare lanka Ltd Healthcare lanka Ltd Sunshine Healthcare lanka Ltd Citihealth Imports (Pvt) Ltd Sunshine Healthcare lanka Ltd Healthcare lanka Ltd George Steuart Health (Pvt) Ltd Healthcare lanka Ltd Citihealth Imports (Pvt) Ltd Negolec Lifescience (Pvt) Ltd Sunshine Healthcare lanka Ltd Sunshine Healthcare lanka Ltd PESSARIES SOLUTION SOLUTION SOLUTION CREAM VAGINAL INSERTS TABLETS TABLETS TABLETS SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP CLORIFORT PESSARIES 200VAGID Gamma VAGINAL VAGID-5CANDID PESSARIES Sunshine CANISON 1% TOPICAL TOPICAL CANDIDCANDID TOPICAL GYNOSPORIN POWDER VAGINAL Sunshine CANISON 100 VAGINAL GYNOTEC 6 VAGINAL CANDID-V6 VAGINAL CANDID V3 VAGINAL SOLUTION SUP 1% SOLUTION SUP 100MG 200MG 500MG 1% SOLUTION SUP 1% SOLUTION SUP POWDER 2% IP 100MG USP 100MG USP 100MG USP 200MG 1911 CLOTRIMAZOLE TOPICAL 1907 CLOTRIMAZOLE PESSARIES BP 1908 CLOTRIMAZOLE PESSARIES BP 1909 CLOTRIMAZOLE PESSARIES BP 1910 CLOTRIMAZOLE TOPICAL 1912 CLOTRIMAZOLE TOPICAL 1913 1%DUSTING CLOTRIMAZOLE USP 1914 CREAM CLOTRIMAZOLE VAGINAL 1915 2 % GEL CLOTRIMAZOLE VAGINAL CANDID V1916 INSERTS CLOTRIMAZOLE VAGINAL GEL1917 INSETS CLOTRIMAZOLE VAGINAL Sunshine 1918 INSETS CLOTRIMAZOLE VAGINAL 1919 TABLETS CLOTRIMAZOLE VAGINAL 176 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 PAKISTAN 22-Jan-16 Full PAKISTAN 22-Jan-16INDIA Full INDIA 28-Jan-16 Full 08-Dec-14PAKISTAN Full 15-Jul-17PAKISTAN Years Two 15-Jul-17INDIA Years Two INDIA 07-Jun-16 Full SRI LANKA 02-Oct-17 Years Two 05-Oct-14INDIA Full INDIA 02-Oct-15 Full INDIA 15-Mar-18 Full 17-Jan-15 Full NOA Hemis NOA Pharmaceuticals Remedica limited CYPRUS Hemis NOA Pharmaceuticals 09-Nov-18Years Two Umedica Laboratories (Pvt) Ltd Ltd Remedica limited CYPRUSNabiqasim Industries (Pvt) 24-Nov-17Ltd Nabiqasim Full Industries (Pvt) Ltd Glenmark Pharmaceuticals Ltd Brassica Pharma Pvt Ltd Pharmaceuticals Manufacturer Corporation Laboratories (Pvt) Ltd Laboratories (Pvt) Ltd Ltd (Contd.) Hayleys Consume Produsts Ltd Drugs (Pvt) Ltd Negolec Lifescience (Pvt) Ltd Pharmaceuticals Pvt Ltd Drugs (Pvt) Ltd George Steuart Health (Pvt) Ltd George Steuart Health (Pvt) Ltd Sunshine Healthcare lanka Ltd International (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP TABLETS TABLETS TABLETS TABLETS TABLETS GYNOTEC 1 VEGINAL 500MYCORIL TABLETSGYNOTEC 1 Kandana Food & VEGINAL CLORIFORT PESSARIESCLOTICOR Gamma 100MYCORIL PESSARIES TABLETS Harcourts (Pvt) LtdGYNSOPORIN Coral Laboratories VAGINAL Kandana Food & GYNSOPORIN VAGINAL CANDID V-1 VAGINAL NEPIBETA CREAMSPMC Softcare ALCLOX CAPSULES N/A CAPSULES Ceyoka (Pvt) Ltd Leben State 500MG 500MG 500MG 100MG BP 100MG BP 100MG BP 500MG USP 500MG USP 500MG USP & NEOMYCIN DIPROPIONATE CREAM SULFATE 500MG 500MG 1920 TABLETS CLOTRIMAZOLE VAGINAL 1921 TABLETS CLOTRIMAZOLE VAGINAL 1922 TABLETS CLOTRIMAZOLE VAGINAL 1923 TABLETS CLOTRIMAZOLE VAGINAL 1924 TABLETS CLOTRIMAZOLE VAGINAL 1925 TABLETS CLOTRIMAZOLE VAGINAL 1926 TABLETS CLOTRIMAZOLE VAGINAL 1927 TABLETS CLOTRIMAZOLE VAGINAL 1928 TABLETS CLOTRIMAZOLE VAGINAL 1929 CLOTRIMAZOLE, BECLOMETASONE 1930 CLOXACILLIN CAPSULES BP 1931 CLOXACILLIN CAPSULES BP 1932 250MG CLOXACILLIN CAPSULES BP ALCLOX1933 250MG CLOXACILLIN CAPSULES BP CLOXAFIL CAPSULES Ceyoka (Pvt) Ltd CAPSULES Leben Kamazu (Pvt) Ltd Arvind Remedies I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 177 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 22-Mar-18 Full INDIA 31-Dec-14 Full INDIA 27-Oct-17 Years Two INDIA 26-Apr-18 Years Two INDIA 27-Oct-17 Years Two INDIA 07-Apr-18 Years Two INDIA 27-Dec-17 Years Two INDIA 02-Dec-17 Years Two INDIA 20-May-17 Years Two 12-Sep-15 Full Uni Medicolabs INDIA 17-Oct-17CinnaGen Co. IRAN Full Laboratories (Pvt) Ltd 09-Mar-18 Provisional Pharmaceuticals (Pvt) Ltd Pharmaceuticals Pvt Ltd Medico Remedies (Pvt) Ltd Pharmaceuticals Pvt Ltd Medico Remedies (Pvt) Ltd Pharmaceuticals Pvt Ltd Ltd Injectcare Parenterals (Pvt) Ltd Healthcare Formulation (Pvt) Ltd (Contd.) Pharmaceuticals (Pvt) Ltd Slim Pharmaceuticals (Pvt) Ltd Ceyoka (Pvt) Ltd Leben Pharma Associates Baroque Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd INJECTION SOLUTION SUSPENSION SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP UCLOX 250 CAPSULES 500CLOXIL Slim UCLOX 500 CAPSULES N/A POWDER / ALCLOXSYCLOX ORAL Astron (Pvt) Ltd SRI LANKAN/A ORAL 12-May-18N/A Full CAPSULESN/A PharmAce (Pvt) Ltd Pil CAPSULESN/A Akbar CAPSULESN/A PharmAce (Pvt) Ltd Pil CAPSULESDECALOX Akbar CAPSULESN/A CAPSULES PharmAce (Pvt) Ltd Pil CIC Holdings PLCARCILLIN 250 S Kant Healthcare INJECTION INJECTION Slim International Yaden 500MG 250MG 500MG 125MG/5ML 125MG/5ML SYRUP 250MG USP 250MG USP 250MG USP 500MG USP 500MG USP 500MG USP 500MG INJECTION B.P 250MG INJECTION IP 1936 CLOXACILLIN INJECTION B.P 1934 CLOXACILLIN CAPSULES USP 1935 CLOXACILLIN CAPSULES USP 1937 SOLUTION CLOXACILLIN ORAL 1938 SOLUTION B.P CLOXACILLIN ORAL 1939 CLOXACILLIN SODIUM CAPSULES 1940 CLOXACILLIN SODIUM CAPSULES 1941 CLOXACILLIN SODIUM CAPSULES 1942 CLOXACILLIN SODIUM CAPSULES 1943 CLOXACILLIN SODIUM CAPSULES 1944 CLOXACILLIN SODIUM CAPSULES 1945 CLOXACILLIN SODIUM FOR 1946 CLOXACILLIN SODIUM FOR 178 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 29-May-15 Full INDIAINDIA 12-Sep-16 Full INDIA 07-Apr-18INDIA Full 27-Mar-18PAKISTAN Full 30-Mar-17 18-Aug-14INDIA Full Full 03-Jun-17UNITED Full STATES INDIAINDIA 17-Aug-17 Years Two SRI LANKA 10-Aug-15 11-Aug-18 Full Provisional INDIAINDIA 19-Sep-18 Years Two SRI LANKA 22-Aug-18 14-Aug-18 Provisional Provisional Encube Ethicals (Pvt) Ltd Healthcare Formulation (Pvt) Ltd Sun Pharmaceutical industries Novachem Lanka (Pvt) Ltd Pharmaceuticals Medizan Laboratories (Pvt) Ltd Centurion Laboratories Pvt Ltd Orchid Healthcare INDIAGrifols Biological Inc 26-Feb-15 Full Torrent Pharmaceuticals Ltd Pharmaceuticals (Pvt) Ltd Maan Pharmaceutical Ltd Mercury Laboratories Ltd Pharmaceuticals (Pvt) Ltd (Contd.) Sunshine Healthcare lanka Ltd Pharmaceuticals (Pvt) Ltd (Ceylon) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd Ltd C Medical (Pvt) T P Ltd (Pvt) Ltd N/A Navesta SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP SOLUTION INJECTION INJECTION IONAX TIONAX SCALP ARCILLIN 500 INJECTION Slim ALPHANINE SD INJECTION Mansel (Ceylon) CTS-SCALP SOLUTION 1.2UNICLAV Mega Pharma (Pvt) INJECTION 1200MANOXELAY POWDER FOR N/AN/A 600UNICLAV Navesta POWDER FOR TABLETS International Yaden 2% SCALP SOLUTION 2% SCALP INJECTIUON IP 500MG INJECTIUON IP (Human) 500IU/10ML 4.25%+SALICYLIC ACID 2.0% SOLUTION 1.2G BP 1.2G BP 1.2G BP 600MG 1955ACID 4.25% & SALICYLIC TAR COAL 1947 CLOXACILLIN SODIUM FOR 1948 100MGTABLETS CLOZAPINE SIZOPIN-1001949 100MG IP TABLETS CLOZAPINE TABLETS 100 CLONIA 1950 100MG USP TABLETS CLOZAPINE N/A Emerchemie NB TABLETS1951 100MG USP TABLETS CLOZAPINE CLIPIN 100 Novachem Lanka 1952 100MG USP TABLETS CLOZAPINE TABLETS TABLETS N/A1953 100MG USP Ceyline AssociatesTABLETS CLOZAPINE Pharma The Madras 100MG CHROZAP TABLETS1954 IX FACTOR COAGULATION TABLETSAsian Pharma Euro International Yaden 1956 SOLUTION TROPICAL TAR COAL 1957 FOR INJECTION CO-AMOXICLAV 1958 FOR INJECTION CO-AMOXICLAV 1959 FOR INJECTION CO-AMOXICLAV 1960 INJECTION BP CO-AMOXICLAV I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 179 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 CHINA 08-Aug-17CHINA Years Two 08-Aug-17INDIA Full 14-Aug-17INDIA Years Two 01-Nov-16 Full INDIA 27-Dec-17 Years Two INDIA 09-Oct-15 Full INDIA 04-Aug-17INDIA Years Two 27-Jun-18 Years Two Zhuhai United Laboratories (Zhongshan) Co. Ltd Zhuhai United Laboratories (Zhongshan) Co. Ltd Fist Twenty Century Pharmaceutical Pvt Ltd Protech Biosystems (Pvt) Ltd Medochemie Ltd CYPRUS 27-Nov-14Pharmaceuticals Pvt Ltd Full Medochemie Ltd CYPRUS 21-Oct-15Nitin Lifesciences Ltd Full Medochemie Ltd CYPRUS Fist Twenty Century 30-Jul-18Pharmaceutical Pvt Ltd Full Aurobindo Pharam Ltd (Contd.) Hemas Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Alaris Lanka (Pvt) Ltd (Pvt) Ltd Laboratories (Pvt) Ltd PharmAce (Pvt) Ltd Pil Laboratories (Pvt) Ltd Slim Pharmaceuticals (Pvt) Ltd Laboratories (Pvt) Ltd Ltd Ltd INJECTION SUSPENSION SUSPENSION INJECTION SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP CLAVAMOX POWDER FOR CLAVAMOX INJECTIONXOMOX CV DS Hemas ORAL 1200FIBELL INJECTIONMOXICLAV NGN Enterprises INJECTION CV 125MOXIPIL ORAL Associated MOXICLAV SUSPENSION Associated 1.2gN-CLAV POWDER FOR (500MG+100MG) 1.2G (1000mg +200mg) 228.5MG SUSPENSION BP 1200MG 1.2G 156.56/5ML BP SUSPENSION (AMOXICILLIN ORAL ACID 125MG & CLAVULANIC 31.25MG/5ML 1.2G SOLUTION FOR INJECTION BP 1961 FOR INJECTION BP CO-AMOXICLAV 1962 FOR INJECTION BP CO-AMOXICLAV 1963 FOR ORAL CO-AMOXICLAV 1964 INJECTION CO-AMOXICLAV 1965 INJECTION BP CO-AMOXICLAV 1966 SUSPENSION ORAL CO-AMOXICLAV 1967 POWDER FOR CO-AMOXICLAV 1968 POWDER FOR CO-AMOXICLAV 1969 375MG BP TABLETS CO-AMOXICLAV 375 MOXICLAV TABLETS1970 375MG BP TABLETS CO-AMOXICLAV XOMOX CV 375 Associated TABLETS1971 625MG BP TABLETS Alaris Lanka (Pvt) CO-AMOXICLAV 625 KOACT TABLETS Alaris Lanka (Pvt) 180 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIA 04-Aug-18INDIA Full 22-Jun-15INDIA Full BANGLADESH 22-Feb-18 06-Dec-17 Years Two Full INDIAINDIA 25-Aug-18 Provisional INDIA 16-Jul-16 Full INDIA 18-Jun-16 Full INDIA 19-Sep-17 Years Two INDIA 11-Mar-16 Full 26-Sep-14 Full Twenty Fist Twenty Century Pharmaceutical Pvt Ltd Marksons Pharma Ltd Pharmaceuticals Pvt Ltd Globe Pharmaceuticals Ltd Medochemie Ltd CYPRUSRemedica limited 16-Oct-15 CYPRUS Full Mercury 10-Apr-15Laboratories Ltd Centurion Full Laboratories Pvt Ltd Centurion Laboratories Pvt Ltd Renown Pharmaceuticals Pvt Ltd (Pvt) Ltd Shefa Healthcare (Pvt) ltd (Contd.) Ltd Plc (Pvt) Ltd Laboratories (Pvt) Ltd Drugs (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd Softcare International (Pvt) Ltd Health (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP TABLETS Kandana Food & CAPSULES CLAVOMID CLAVOMID 675MG N/AN/A TABLETSLEVODOPA TABLETS International Yaden TABLETS International Yaden International Yaden MAXDEINE TABLETS George Steuart (AMOXICILLIN 500MG +CLAVULANIC (AMOXICILLIN 500MG +CLAVULANIC ACID 125MG ) 50MG/200MG RELEASE TABLETS 250MG BP 250/25MG (LEVODOPA BP25MG) &CARBIDOPA BP100MG & 250/25MG (LEVODOPA 25MG) BP CARBIDOPA 500MG 8MG+PARACETAMOL BP TABLETS 1972 625MG BP TABLETS CO-AMOXICLAV XOMOX CV 625 TABLETS1973 625MG BP TABLETS Alaris Lanka (Pvt) CO-AMOXICLAV 625 CLAVMARK TABLETS1974 625MG BP TABLETS CO-AMOXICLAV 625 CLAVAMYCIN TABLETS Browns & Company 1975 625MG BP TABLETS CO-AMOXICLAV N/A PharmAce (Pvt) Ltd Kopran Ltd1976 625MG BP TABLETS CO-AMOXICLAV 625 ULTRACLAV TABLETS INDIA TABLETS1977 625MG BP TABLETS CO-AMOXICLAV 625MG MOXICLAV Healthcare Tabrane TABLETS PharmAce (Pvt) Ltd Pil 01-Jan-141978 Associated 625MG BP TABLETS CO-AMOXICLAV Full 1979 MODIFIED CO-CARELDOPA 1980 BP TABLETS CO-CARELDOPA 1981 BP TABLETS CO-CARELDOPA 1982 CAPSULES 300MG COD LIVER OIL N/A1983 CAPSULES 300MG COD LIVER OIL CODRIL1984 CODEINE PHOSPHATE GELATIN SOFT CAPSULES PharmAce (Pvt) Ltd Softech Pharma I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 181 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 25-Jul-18INDIA Years Two 24-Jan-14INDIA Full 30-Mar-18 Full INDIA 29-Jan-18 Provisional INDIA 04-Aug-17 Years Two INDIA 19-Apr-18 Years Two INDIA 25-Jan-18 Provisional GERMANY 09-Oct-17 08-Sep-17 Years Two INDIA Full INDIA 26-Nov-18 Years Two INDIA 30-Jun-14CHINA Full 09-Feb-14 Full 25-Feb-14 Full c Biosciences c Biosciences fi fi Mercury Laboratories Ltd Inga Laboraories (Pvt) Ltd Axon Drugs (Pvt) Ltd Gu Pvt Ltd SRS Pharmaceuticals (Pvt) Ltd VHB Medi Sciences Ltd Gu Pvt Ltd (Pvt) Ltd Arzneimittel GmbH, Germany Agio Pharmaceuticals Ltd Ambala Sarabhal Enterprises Claris Otsuka Private Limited Pharmaceutical Co. Ltd (Contd.) (Pvt) Ltd Co Ltd Sunshine Healthcare lanka Ltd Slim Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd International Yaden (Pvt) Ltd Slim Pharmaceuticals (Pvt) Ltd Klintas (Pvt) Ltd United Biotech (Pvt) Ltd Swedish Trading Co Ltd Pharmaceuticals (Pvt) Ltd TABLETS INJECTION INJECTION POW INJECTION INJECTION TABLETS SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP COLBACT 1 MIUCOLBACT POWDER / COLIBAN 1 INJECTIONCOLISIN-RD Innovate POWDER / 2 MIUCOLBACT LYOPHILIZED COLICRAFT MONOIRUXOL POWDER / OINTMENTBENZODERM CIC Holdings PLC Nordmark OINTMENTN/A Citihealth Imports N/A CHEWABLE N/A INJECTION RLWIDA Akbar INFUSION INJECTION Pharma Associates Sichuan Kelun Aristons (Pvt) Ltd Widatra BhaktiT P INDONESIA 26-Dec-14 Full INJECTION BP 1 MIU (MILLION I.U) INJECTION BP 1 MIU (MILLION I.U) INJECTION BP 1,000,000 IU INJECTION BP 2,000,000 IU INJECTION BP (MILLION I.U) 1 MIU (MILLION I.U) INJECTION IP (CLOSTRIDIOPETIDASE A) 1.2U/1g OINTMENT 15G BP OINTMENT 250MG TRISILICATE 500ML INTRAVENOUS INFUSION BP INTRAVENOUS INFUSION BP INTRAVENOUS 1985 0.5MG BP TABLETS COLCHICINE N/A1986 0.5MG BP TABLETS COLCHICINE GOUTNIL1987 1MG BP TABLETS COLCHICINE TABLETS COLOCIN TABLETS1988 SODIUM FOR COLISTIMETHATE International Yaden Trading Swedish UNCOATED 1989 SODIUM FOR COLISTIMETHATE 1990 SODIUM FOR COLISTIMETHATE 1991 SODIUM FOR COLISTIMETHATE 1992 SODIUM FOR COLISTIMETHATE 1993 COLLAGENASE N 1994ACID COMPOUND BENZOIC 1995 COMPOUND MAGNESIUM 1996 COMPOUND SODIUM LACTATE 1997 COMPOUND SODIUM LACTATE 1998 COMPOUND SODIUM LACTATE 182 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAMALAYSIA 15-Apr-16 16-Nov-17INDIA Full Full INDIA 22-Mar-18 Full 05-Mar-16INDIA Full SRI LANKA 01-Jul-17 22-Feb-16INDIA Full Full INDIA 28-Jan-15INDIA Full 31-Dec-15INDIA Full 20-Oct-16 Full 08-Jan-16INDIA Full 17-Nov-15INDIA Full 10-Jul-17 Years Two Ltd B Braun Medical Industries Aculife Healthcare (Pvt) Ltd Unicure Ramadies (Pvt) Ltd Laboratories (Pvt) Ltd (Ceylon) (Pvt) Ltd Laboratories (Pvt) Ltd MMC Healthcare Ltd Medopharm (PVT Ltd Fourrts (India) Laboratories Ltd Cipla LtdAmbala Sarabhal Enterprises INDIASunwaya Rohto 03-Jul-14Pharmaceutical Pvt Ltd Full (Contd.) Ltd Healthcare lanka Ltd Ltd E I & M (Pvt) Ltd Fizer CanadaCeyoka (Pvt) Ltd CANADA Leben 28-Sep-14 Full Ltd Pharmaceuticals (Pvt) Ltd Healthcare lanka Ltd (Pvt) Ltd Co Ltd International Yaden (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP CREAM SUSPENSION SOLUTION N/AN/AN/A I.V INFUSION Chamee Chemist INJECTION Axa Parenterals CONJURIN B Braun Lanka (Pvt) INFUSION TABLETS Sunshine L-TRIM Emar Pharma (Pvt) N/A ORAL L-TRIM TABLETSN/A TABLETS N/AEMPRIM Ceyoka (Pvt) Ltd Leben TABLETSMEGATRIM TABLETS M S J Industries Markss HLC (Pvt) TABLETS Akbar CROMAL Sunshine EYE DROPS 1000COBA Breathe Free Lanka PENTOLATE INJECTION CIC Holdings PLC OPHTHALMIC (India) Ltd Tablets INDIA 28-Jul-17Years Two HYDROCHLORIDE OPTHALMIC SOLUTION 1% INTRAVENOUS INFUSION BP INTRAVENOUS INFUSION BP INTRAVENOUS INFUSION BP INTRAVENOUS 0.320/100ML 0.625MG 240MG/5ML SUSPENSION IP 480MG 480MG 480MG 480MG 480MG 2% W/V SOLUTION U.S.P 1000MCG/ML 2011 10% CREAM BP CROTAMITON CROMITON-HC CREAM Trading Swedish 2013 CYCLOPENTOLATE 1999 COMPOUND SODIUM LACTATE 2000 COMPOUND SODIUM LACTATE 2001 COMPOUND SODIUM LACTATE 2002 ESTROGEN USP CONJUGATED 2003 ESTROGEN 0.625MG CONJUGATED PREMARIN2004 CO-TRIMOXAZOLE ORAL VAGINAL 2005 BP CO-TRIMOXAZOLE TABLET 2006 IP CO-TRIMOXAZOLE TABLET 2007 BP CO-TRIMOXAZOLE TABLETS 2008 BP CO-TRIMOXAZOLE TABLETS 2009 BP CO-TRIMOXAZOLE TABLETS 2010 SODIUM OPTHALMIC CROMOLYN 2012 INJECTION CYANOCOBALAMIN I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 183 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 11-Sep-16 Full 14-Dec-15 Full 20-May-14 Full INDIAINDIA 07-Sep-17INDIA Years Two 07-Sep-16INDIA Full 17-Sep-17INDIA Years Two 03-Mar-16INDIA Full 03-Mar-15INDIA Full 21-Oct-17 Full INDIA 12-Sep-14 Full SWITZERLAND/ 21-Oct-17GERMANY Full INDIAGERMANY 26-Apr-14 12-Dec-15UNITED Full STATES Full CZECH REPUBLIC Micro Labs Ltd INDIALaboratories Ltd 09-Jan-14Laboratories Ltd Full United Biotech (Pvt) Ltd Getwell Pharmaceuticals Getwell Pharmaceuticals Macleods Pharmaceuticals Ltd J Duncan Healthcare (Pvt) Ltd Macleods Pharmaceuticals Ltd Catalent German Eberbach Gmbh Panacea Biotec (Pvt) Ltd Catalent German Eberbach Gmbh Allergan Sales LLC Teva Teva Pharmaceuticals Industries Ltd (Contd.) Ltd Ceyoka (Pvt) Ltd Khandelwal Ceyoka (Pvt) Ltd Khandelwal Health (Pvt) Ltd Pharmacy (Pvt) Ltd Pharmacy (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Ltd Pharmaceuticals (Pvt) Ltd Ltd Hemas Pharmaceuticals (Pvt) Ltd Access International (Pvt) Ltd INJECTION INJECTION CAPSULES Baur & Co (Pvt) A CAPSULES Baur & Co (Pvt) A EMULSION POWDER FOR INHELER SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP DILATEONCOMIDE EYE DROPS SMM Halcyon (Pvt) ONCOMIDE POWDER FOR UNIPHPS 500 POWDER FOR INJECTIONCYPHOS George Steuart CYPHOS INJECTIONCOXERIN The Esses INJECTION The Esses CAPSULESCAPCIKO Pettah Pharmacy COXERIN CAPSULES Slim CAPSULESNEORAL Pettah Pharmacy SANDIMMUN NEORAL RESTASIS OPHTHALMIC PANIMUN BIORALPANIMUN CAPSULES Hemas HYDROCHLORIDE OPTHALMIC 1% SOLUTION USP 1000MG INJECTION BP 500MG INJECTION BP 500MG IP 100MG USP 200MG USP 250MG 250MG 250MG CAPSULES 50MG EMULSION 0.05% USP 2014 CYCLOPENTOLATE 2015 CYCLOPHOSPHAMIDE FOR 2016 CYCLOPHOSPHAMIDE FOR 2017 CYCLOPHOSPHAMIDE INJECTION 2018 CYCLOPHOSPHAMIDE INJECTION 2019 CYCLOPHOSPHAMIDE INJECTION 2020 CYCLOSERINE CAPSULES USP 2021 CYCLOSERINE CAPSULES USP 2022 CYCLOSERINE CAPSULES USP 2023 CYCLOSPORIN 25MG CAPSULES SANDIMMUN 2026 GELATINE CYCLOSPORIN SOFT 2027 CYCLOSPORINE OPTHALMIC 2024 CYCLOSPORIN CAPSULES 100MG 100 EQUORAL CAPSULES 2025 CYCLOSPORIN CAPSULES 100MG 184 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 12-Feb-15 Full 20-May-16 Full NEW ZEALAND 27-Aug-15 Full INDIAINDIA 02-Mar-14 Full 09-Nov-17INDIA Years Two GERMANY 26-Jul-18 07-Apr-15 Years Two Full Aristopharma Ltd BANGLADESH 08-Jan-15Themis Mediare Full INDIA 04-Oct-18 Provisional Pharmaceuticals Laboratories (Pvt) Ltd Themis Mediare INDIARenata Limited BANGLADESH 06-Feb-15Douglas 07-Jan-15Manufacturing Full Ltd Auckland Full New Zealand for Douglas Pharmaceuticals Ltd. Naprod Life Scienc (Pvt) Ltd United Biotech (Pvt) Ltd Cipla LtdGetwell Pharmaceuticals INDIA Pharma Vetter -fertingung GMBH 25-May-16 Full (Contd.) Pharmaceuticals (Pvt) Ltd Healthcare lanka Ltd Healthcare lanka Ltd (Ceylon) Ltd Ltd (Pvt) Ltd Health (Pvt) Ltd (Pvt) Ltd The Esses Pharmacy (Pvt) Ltd Pharmaceuticals (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP INJECTION CYPORIN DROPSPERITOL Hemas APETAMIN-P SYRUP SYRUPHEPTIN Sunshine CYPRO CIC Holdings PLC SYRUP (India) Ltd Tablets INDIAPERITOL TABLETS Pharma Associates The Madras 23-Mar-14 Ceyoka (Pvt) LtdGIANE 35 TABLETS Leben Full ESTELLE 35 ED Sunshine TABLETS TABLETS Emerchemie NB Farnell Ceylon (Pvt) CYTROSTAR INJECTION 100ONCOTAR INJECTION Ravilux Company DECARB 200 George Steuart INJECTION 0.5MGTINOWEL POWDER FOR Breathe Free Lanka FRAGMIN INJECTION Hemas

HYDROCHLORIDE USP 2MG/5ML HYDROCHLORIDE USP OPTHALMIC EMULSION 0.05% W/V IP HYDROCHLORIDE SYRUP 2MG/5ML 2MG/ 5ML HYDROCHLORIDE USP 4MG 4MG 0.035MG ETHYNYLESTRADIOL 0.035MG ETHYNYLESTRADIOL 100MG/5ML ML 500MCG (0.5MG) USP ANTI- XA 200MG 2031 CYPROHEPTADINE 2028 CYCLOSPORINE STERILE 2029 CYPROHEPTADINE 2030 CYPROHEPTADINE 2032 B.P TABLETS CYPROHEPTADINE 2033 I.P TABLETS CYPROHEPTADINE 2034 2MG & ACETATE CYPROTERONE 2035 2MG & ACETATE CYPROTERONE 2036 INJECTION BP CYTARABINE 2037 100MG/ INJECTION BP CYTARABINE 2038 DACARBAZINE FOR INJECTION USP 2039 DACTINOMYCIN FOR INJECTION 2040 SODIUM 2500IU/ 0.2ML DALTEPARIN I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 185 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 07-Apr-15 Full INDIAINDIA 26-Jul-18 Provisional INDIA 03-Jun-18 Years Two INDIA 21-Mar-18 Full INDIA 07-Mar-18 Full INDIA 16-Jun-18 Years Two INDIA 08-Jun-18 Years Two INDIA 27-Nov-18INDIA Full 21-May-18 Years Two 12-Jun-18 Years Two GERMANY/ BELGIUM Emcure Pharmaceuticals Ltd Pharmaceuticals (India) Ltd Zim Laboratories Ltd Zim Laboratories Ltd Inventia Healthcare (Pvt) Ltd Pharmaceuticals (India) Ltd Pharmaceuticals Centurion Laboratories Pvt Ltd Centurion Laboratories Pvt Ltd Cipla LtdCipla Ltd INDIAMedochemie Ltd CYPRUS INDIA 06-Feb-17 21-Oct-17 Full 06-Feb-18 Full Full Vetter Pharma Vetter -fertingung GMBH (Contd.) (Ceylon) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Emerchemie NB (Ceylon) Ltd (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd Laboratories (Pvt) Ltd Pharmaceuticals (Pvt) Ltd DISSOLVING DISSOLVING TABLETS SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP DAX-30DPX 30 TABLETS PharmAce (Pvt) LtdDPX 60 Aurochem TABLETS EJELAG 60 Tabrane TABLETS MOUTH Tabrane N/A INJECTION Emerchemie NB FRAGMIN SOLUTION Hemas TABLET 30MG TABLET 30MG TABLET 60MG TABLET 60MG TABLETS TABLET 30MG TABLET ANTI- XA 2046 DAPOXETINE HYDROCHLORIDE 2047 DAPOXETINE HYDROCHLORIDE 2048 DAPOXETINE HYDROCHLORIDE 2049 DAPOXETINE MOUTH DISSOLVING 2050 60MGTABLET DAPOXETINE 2051 DAX-60 60MGTABLET DAPOXETINE 2052 25MG BP TABLETS DAPSONE D MAX 60 TABLETS N/A2053 50MG BP TABLETS DAPSONE TABLETS PharmAce (Pvt) Ltd Aurochem N/AAssociates Pharma The Madras TABLETS International Yaden TABLETS International Yaden 2042 100MG CAPSULES USP DANAZOL DANOGEN2043 200MG CAPSULES USP DANAZOL DANOGEN CAPSULES2044 200MG CAPSULES USP DANAZOL Breathe Free Lanka ANARGIL CAPSULES2045 DAPOXETINE HYDROCHLORIDE Breathe Free Lanka CAPSULES Associated 2041 SODIUM 5000IU/ 0.2ML DALTEPARIN 186 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 09-Apr-15INDIA Full 30-Apr-14INDIA Full 20-Dec-18INDIA Years Two 20-Dec-18INDIA Years Two 10-Oct-18INDIA Provisional 20-Dec-18INDIA Years Two 11-Oct-18 Provisional INDIA 21-Dec-18 Years Two INDIA 21-Dec-18 Years Two INDIA 28-Jun-18INDIA Full 24-Jun-18ITALY Full 08-Mar-15INDIA Full 04-Nov-14 Full INDIA 12-Sep-17 Years Two 22-Feb-18 Years Two zer Italy fi SG Pharma (Pvt) Ltd SG Pharma (Pvt) Ltd Dr Reddy's Laboratories Ltd Dr Reddy's Laboratories Ltd Limited Dr Reddy's Laboratories Ltd Limited Jodas Expoim Pvt Ltd Jodas Expoim Pvt Ltd Therdose Pharma (Pvt) Ltd Therdose Pharma (Pvt) Ltd VHB Medi Sciences Ltd Actavis Italy S.P.A For p Sun Pharmaceutical industries Dr Reddy's Laboratories Ltd (Contd.) Pharmacy (Pvt) Ltd Pharmacy (Pvt) Ltd (Ceylon) Ltd (Ceylon) Ltd Pharma LtdDIVASA Hetero Biopharma (Ceylon) Ltd Pharma LtdDIVASA Hetero Biopharma International (Pvt) Ltd International (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Hemas Pharmaceuticals (Pvt) Ltd Emerchemie NB (Ceylon) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP INJECTION INJECTION POWDER INJECTION CRESPCRESP INJECTIONDERISE Emerchemie NB INJECTIONCRESP Emerchemie NB SOLUTION FOR DERISE INJECTION Emerchemie NB SOLUTION FOR DAUNOPLUS INJECTIONDAUNOBLASTINA INJECTION Medmart Pharma Hemas 100MCG 25MCG 25MCG/0.42ML 40MCG 40MCG/0.4ML 20MG FOR INJECTION USP POWDER FOR INJECTION 20MG 2054 100MG USP TABLETS DAPSONE N/A2055 50MG USP TABLETS DAPSONE 2056 N/A INJECTION DARBEPOETIN ALFA 2057 TABLETS INJECTION DARBEPOETIN ALFA 2058 The Esses INJECTION DARBEPOETIN ALFA TABLETS2059 INJECTION DARBEPOETIN ALFA The Esses 2060 INJECTION DARBEPOETIN ALFA 2061 20MG TABLETS DASATINIB 2062 50MGTABLETS DASATINIB JODASA2063 50MGTABLETS DASATINIB 50 JODASA TABLETS2064 70MGTABLETS DASATINIB TABLETS Softcare N/A2065 DAUNORUBICIN HYDROCHLORIDE Softcare N/A2066 DAUNORUBICIN HYDROCHLORIDE TABLETS2067 FOR INJECTION 50MG DECITABINE TABLETS DECITEX Pharma R N Vision 2068 Pharma R N Vision FOR INJECTION 50MG DECITABINE REDTIBIN LYOPHILIZED POWDER FOR I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 187 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 03-Jul-18 Years Two 15-May-18 Years SWITZERLAND Two 02-Apr-15SRI LANKA Full 05-Jul-18INDIA Provisional SWITZERLAND 03-Mar-16 02-Apr-15SRI LANKA Full Full 05-Jul-18INDIA Provisional INDIA 13-Oct-16 Full SWITZERLAND 12-Dec-17 22-Mar-18 Years Two INDIA Full SWITZERLAND 09-Mar-18 26-Dec-15 Years Two INDIA Full INDIA 19-May-15 Full 19-Oct-18 Years Two Therdose Pharma (Pvt) Ltd Getwell Pharmaceuticals Pharmachemie BV NETHERLANDS 20-Feb-18Novartis Pharma Full A G Priivate Limited Centurion Laboratories Pvt Ltd Novartis Pharma A G Priivate Limited Centurion Laboratories Pvt Ltd Centurion Laboratories Pvt Ltd Novartis Pharma Stein .AG SG Pharma (Pvt) Ltd Novartis Pharma A G SG Pharma (Pvt) Ltd Coast West Pharmaceurical works Ltd (Contd.) R N Vision Pharma R N Vision (Pvt) Ltd The Esses Pharmacy (Pvt) Ltd (Pvt) Ltd Baur & Co (Pvt) A Ltd (Pvt) Ltd Baur & Co (Pvt) A Ltd (Pvt) Ltd (Pvt) Ltd Ltd Pharmacy (Pvt) Ltd Ltd Pharmacy (Pvt) Ltd (Pvt) Ltd INJECTION INJECTION TABLETS TABLETS SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP DECIMA 50DECIMA DACOGEN POWDER / ASUNRA INJECTION Pettah Pharmacy CIOSYN 100 DISPERSIBLE TABLETSN/A N/AASUNRA TABLETSCIOSYN 400 DISPERSIBLE International Yaden TABLETS Celogen Lanka N/A N/AN/A TABLETSJADENU 90 International Yaden Celogen Lanka TABLETS TABLETS International Yaden Baur & Co (Pvt) A FOR INJECTION 50MG INJECTION 50MG 100MG TABLETS 100MG TABLETS 100MG TABLETS 400MG TABLETS 400MG TABLETS 400MG TABLETS 500MG TABLETS 90MG TABLETS 2069 FOR INJECTION 50MG DECITABINE N/A2070 POWDER LYOPHILIZED DECITABINE 2071 POWDER FOR DECITABINE POWDER FOR 2072 DEFERASIROX DIPERSIBLE 2073 DEFERASIROX DIPERSIBLE 2074 DEFERASIROX DIPERSIBLE 2075 DEFERASIROX DIPERSIBLE 2076 DEFERASIROX DIPERSIBLE 2077 DEFERASIROX DIPERSIBLE 2078 DEFERASIROX DIPERSIBLE 2079 DEFERASIROX FILMCOATED 2080 100MGTABLETS DEFERASIROX N/A2081 360MGTABLETS DEFERASIROX JADENU 360MG2082 DEFERIPRONE CAPSULES 250MG TABLETS N/A2083 TABLETS 30GTABLETS DEFLAZACORT Baur & Co (Pvt) A The Esses 30 CORTIVEX CAPSULES TABLETS The Esses Global Impex AV 188 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 29-May-18 Provisional INDIA 19-Oct-18 Years Two INDIA 30-May-18 Years Two 26-Jul-18INDIA Full 25-Jul-18INDIA Full 23-Jun-18SWITZERLAND 09-Jan-14 Full GREECE Full 23-Sep-17PAKISTAN Full 27-Sep-18BANGLADESH 04-Sep-18 Full Full BANGLADESH 17-Dec-14 Full BANGLADESH 03-Jun-15 Full Yash Yash Pharmaceuticals Coast West Pharmaceurical works Ltd Pharma Yash Laboratories (Pvt) Ltd Concept Pharmaceuticals Ltd Concept Pharmaceuticals Ltd Concept Pharmaceuticals Ltd Novartis Pharma A G A Demo S Pharmaseutical Industry S J & G Fazul Ellahie (Pvt) Ltd Pharmaceuticals Ltd Navana Pharmaceuticals Ltd Opsonin Pharma Ltd (Contd.) (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd Softcare International (Pvt) Ltd Softcare International (Pvt) Ltd Softcare International (Pvt) Ltd Ltd Access International (Pvt) Ltd (Pvt) Ltd Co Ltd Pharmaceuticals (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP SUSPENSION TABLETS ORAL SUSPENSION INJECTION SYRUP Darley Butler & DISOCAIN ORAL DISOGEL CHEWABLE DISOGEL SUSPENSION DESFERALDEMOFERIDONE INJECTION POWDER Baur & Co (Pvt) A SYRUP 400MG+ALUMINUM HYDROXIDE 250MG+ MAGNESIUM HYDROXIDE 250MG+SIMETHICONE 40MG ORAL SUSPENSION 400MG+ALUMINUM HYDROXIDE 250MG+ MAGNESIUM HYDROXIDE 250MG+SIMETHICONE 40MG TABLETS 400MG+ALUMINUM HYDRPXIDE 250MG+ MAGNESIUM HYDROXIDE 250MG+SIMETHICONE 40MG ORAL SUSPENSION 500MG 500MG INJECTION USP 2084 6MGTABLETS DEFLAZACORT 2085 6MGTABLETS YESCORT DEFLAZACORT 6 CORTIVEX 2086 TABLETS 6MGTABLETS DEFLAZACORT TABLETS Pharma Avenier YESCORT2087 LIQUORICE DEGLYCYRRHIZINATED Global Impex AV TABLETS2088 Pharma Avenier LIQUORICE DEGLYCYRRHIZINATED 2089 LIQUORICE DEGLYCYRRHIZINATED 2090 DESFERRIOXAMINE MESILATE 2091 FOR DESFERRIOXAMINE MESILATE 2092 0.5MG SYRUP DESLORATADINE DESORA20932.5MG/5ML SYRUP DESLORATADINE SEDNO SYRUP SOLUTION SYRUP2094 2.5MG/5ML SYRUP DESLORATADINE DESATROL PharmAce (Pvt) Ltd Square V H Distributors A 2095 2.5MG/5ML SYRUP DESLORATADINE DES SYRUP Biolife I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 189 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIABANGLADESH 03-Jan-15 12-Mar-17 Years Two Full PAKISTAN 08-Mar-18BANGLADESH 03-Aug-16 Full Full PAKISTAN 02-Apr-14BANGLADESH 17-Dec-14 Full Full BANGLADESH 03-Jun-15 Full INDIAARGENTINA 08-Nov-14 08-Apr-17INDIA Full Full PAKISTAN 12-Feb-14 01-Apr-14 Full INDIA Full 16-May-15 Full Gracure Pharmaceuticals Ltd Beximco Pharmaceuticals Ltd Zee Laboratories INDIAS J & G Fazul Ellahie (Pvt) Ltd 30-Oct-18Chemical Years Two Industries Getz Pharma Pakistan (Pvt) Ltd Navana Pharmaceuticals Ltd Opsonin Pharma Ltd Akums Drugs & Pharmaceuticals Ltd Quimica Montpellier SA Zim Laboratories Ltd Semos Pharmaceuticals (Pvt) Ltd Laboratories XL (Pvt) Ltd (Contd.) (Pvt) Ltd (Ceylon) Ltd Services Pvt. Ltd Celyon (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Co Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd (Ceylon) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Ltd TABLETS Darley Butler & SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP TABLETS 2096 2.5MG/5ML SYRUP DESLORATADINE DESTACURE SYRUP2097 2.5MG/5ML SYRUP DESLORATADINE MEMNTO VN Pharmaceuticals 2098 5MGTABLETS DESLORATADINE SYRUP VEROMON2099 5MGTABLETS DESLORATADINE Emerchemie NB DESORA TABLETS2100 5MGTABLETS DESLORATADINE DESLORIN ABC Pharma TABLETS2101 5MG TABLETS DESLORATADINE TABLETS LARINEX Associated Pharma 2102 5MG TABLETS DESLORATADINE CIC Holdings PLC Advanced DESATROL TABLETS2103 5MG TABLETS DESLORATADINE Hemas DES2104 5MGTABLETS DESLORATADINE VEXLOR 52105 5MGTABLETS DESLORATADINE TABLETS TABLETS DESLORAT2106 5MGTABLETS DESLORATADINE Biolife Global Impex AV DESLORID 5 TABLETS2107 5MGTABLETS DESLORATADINE TABLETS Emerchemie NB DELOR2108 5MGTABLETS Tabrane DESLORATADINE DELOPA TABLETS Pharma Tech Bio TABLETS SMM Halcyon (Pvt) 190 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 BANGLADESH 15-Nov-17INDIA Full HUNGARY 21-Dec-14 16-Dec-14 Full INDIA Full INDIA 28-Jun-17INDIA Full 01-Mar-18CYPRUS Full 10-Mar-18 Full 19-Feb-15BANGLADESH Full 11-Mar-17 Full INDIABANGLADESH 17-Sep-15 14-Sep-16 Full Full SWITZERLAND 06-Sep-18 Full SWITZERLAND 06-Sep-16 Full Delta Pharma Ltd BANGLADESH 17-Oct-15The ACME Full Laboratories Ltd Healthcare (Pvt) Ltd Teva Pharmaceuticals Industries Ltd Akums Drugs & Pharmaceuticals Ltd Zota Healthcare Ltd Cadila pharmaceuticals Ltd Delobris Pharmaceuticals 01.06.18 Ltd-AT Yaden-LO42/17 Beximco Pharmaceuticals Ltd Sun Pharmaceutical industries Pharmaceuticals Ltd Ferring International center SA Ferring International center SA (Contd.) Pharmaceuticals (Pvt) Ltd Ltd (Ceylon) Ltd Pharmaceuticals (Pvt) Ltd Ltd Healthcare lanka Ltd (Pvt) Ltd (Ceylon) Ltd (Ceylon) Ltd Healthcare lanka Ltd Healthcare lanka Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP MINIRINMINIRIN TABLETS Sunshine TABLETS Sunshine 0.1MG 0.2MG TABLETS 2111 5MGTABLETS DESLORATADINE D-LOR TABLETS Ceyoka (Pvt) Ltd Global Pharma 2110 5MGTABLETS DESLORATADINE ORINEX2112 TABLETS 5MGTABLETS DESLORATADINE DESLO Mega Pharma (Pvt) 2113 5MG TABLETS DESLORATADINE LORFACT-D TABLETS2114 5MGTABLETS DESLORATADINE TABLETS DESLOZED 5 Emerchemie NB 2115 5MG TABLETS DESLORATADINE Lotus TABLETS DES-OD2116 5MGTABLETS DESLORATADINE Alaris Lanka (Pvt) DAREQ TABLETS2117 5MGTABLETS DESLORATADINE Sunshine TABLETS MOMENTO2118 5MGTABLETS DESLORATADINE Access International TABLETS DAZIT2119 5MG BP TABLETS DESLORATADINE SEDNO Emerchemie NB TABLETS TABLETS Emerchemie NB PharmAce (Pvt) Ltd Square 2109 5MG TABLETS DESLORATADINE SEDNOX TABLETS Hyena 2120 TABLETS DESMOPRESSIN ACETATE 2121 DESMOPRESSIN ACETSTE I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 191 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIA 20-Oct-16 Full INDIAINDIA 04-Jan-18 Years Two 07-Oct-17 Full INDIAIRELAND 29-Jan-15 01-Dec-17BANGLADESH Full Years Two 04-Mar-15 Full BANGLADESH 08-Apr-18 Years Two BANGLADESH 14-Mar-15 Full INDIA 21-May-16 Full India Ltd INDIA 04-Aug-15 Full fi Sava Healtheare Ltd Ferring GMBH GERMANYN.V.Organon 26-Aug-18 NETHERLANDS Full 20-Oct-14Encube Ethicals (Pvt) Ltd Full Encube Ethicals (Pvt) Ltd (Pvt) Ltd Allergan Pharmaceuticals Popular Pharmaceuticals Ltd Medochemie Ltd CYPRUSBeximco 05-Nov-14Pharmaceuticals Ltd Full Popular Pharmaceuticals Ltd Pharmafabrikon Unit (Contd.) Lanka Ltd Sano fi Emerchemie NB (Ceylon) Ltd Healthcare lanka Ltd Ltd Healthcare lanka Ltd Sunshine Healthcare lanka Ltd Pharmaceuticals (Pvt) Ltd ABC Pharma Services Pvt. Ltd Associated Laboratories (Pvt) Ltd Emerchemie NB (Ceylon) Ltd Services Pvt. Ltd (Pvt) Ltd SOLUTION SOLUTION SOLUTION SOLUTION DROPS SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP DES-PRESS INTRANASAL MINIRINFEMILON SPRAY NASAL Sunshine TABLETS Baur & Co (Pvt) A SOFRADEX CREAM Sano DEXACORTOZURDEX INJECTION Pharmatec (Pvt) Ltd Belco Pharma IMPLANTSORBIDEX Hemas DEXAMED ELIXIR OPHTHALMIC ORAL INFLAVISORBIDEX-T EYE & EAR EYE DROPSN/A ABC Pharma INJECTION Novachem Lanka SOLUTION BP 10MCG SOLUTION BP 10MCG/Dose 0.02mg 0.15mg+ETHINYLESTRADIOL TABLETS 0.1%W/W FRAMYCETIN SULPHATE 1.0% W/W I.P 8MG/2ML 0.7MG IMPLANT 1mg/ml (0.1%) SOLUTION BP 0.5MG/5ML EYE/EAR DROPS 0.1% TOBRAMYCIN 0.1% PHOSPHATE 0.3% INJECTION BP PHOSPHATE 4MG/2ML 2122 DESMOPRESSIN INTRANASAL 2123 SPRAY DESMOPRESSIN NASAL 2124 DESOGESTREL 2125 DESONIDE CREAM 0.05%2126 DESONIDE LOTION 0.05% DESOWEN2127 BP DEXAMETHASONE ACETATE CREAM DESOWEN Sunshine TOPICAL 2128 DEXAMETHASONE INJECTION USP 2129 DEXAMETHASONE INTRAVITREAL 2130 DEXAMETHASONE OPTHALMIC 2131 SOLUTION DEXAMETHASONE ORAL 2132 DEXAMETHASONE PHOSPHATE 2133 DEXAMETHASONE SODIUM 2134 DEXAMETHASONE SODIUM 192 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 26-Apr-14BANGLADESH Full 07-Sep-17 04-Aug-16 Full Full INDIAINDIA 22-Jan-16INDIA Full 24-Oct-14 Full 30-Jul-18INDIA Full PAKISTAN 26-Aug-14 01-Apr-14INDIA Full Full INDIA 30-May-17INDIA Full 04-Jul-14INDIA Full 10-Oct-15INDIA Full 25-Sep-14INDIA Full 06-Sep-17 Full 10-Jun-14 Full Vital Healthcare Vital (Pvt) Ltd (Pvt) Ltd Chemical Industries Parmax Labo. Ltd (Pvt) Ltd Magbro Healthcare Scottish Pharma INDIALtd Semos 25-Sep-18Pharmaceuticals Years Two (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd Pharmaceuticals Ltd Ltd Comed Chemical Ltd Co. LLC (Contd.) (Pvt) Ltd CIC Holdings PLC Advanced Ltd Services Pvt. Ltd Ltd (Pvt) Ltd Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP DROPS DEXOVITDEXARIGHT INJECTION INJECTION International Yaden ACILOT Chamee Chemist Alvita Pharma NAXIDEX EYE & EAR DEXAMIN SYRUPDEXASONE 0.5 TABLETS Markss HLC (Pvt) TABLETSSCODEX Pharmatec (Pvt) Ltd Belco Pharma ABC Pharma DEXAMETA TABLETSN/A TABLETS Alaris Lanka (Pvt) Kamazu (Pvt) LtdN/A B D H Industries TABLETSDEXARIGHT Pharma Bio Tech TABLETSNEBADEX TABLETS Chamee Chemist PharmAce (Pvt) Ltd TABLETSN/A Swiss Pharma Alvita Pharma PharmAce (Pvt) LtdCODEXO Nestor METHODEX TABLETS TABLETS TABLETS Chamee Chemist C Medical (Pvt) T P Bajaj Healthcare Ceyoka (Pvt) Ltd Global Pharma PHOSPHATE INJECTION BP 4MG/ML INJECTION BP PHOSPHATE INJECTION USP PHOSPHATE 8MG/2ML OPTHALMIC PHOSPHATE 0.1% SOLUTION USP SOLUTION BP ORAL PHOSPHATE 0.5ML/5ML 0.5MG 0.5MG 0.5MG 0.5MG 0.5MG 0.5MG 0.5MG 0.5MG 0.5MG 0.5MG 0.5MG 2135 DEXAMETHASONE SODIUM 2136 DEXAMETHASONE SODIUM 2137 DEXAMETHASONE SODIUM 2138 DEXAMETHASONE SODIUM 2139 BP DEXAMETHASONE TABLETS 2140 BP DEXAMETHASONE TABLETS 2141 BP DEXAMETHASONE TABLETS 2142 BP DEXAMETHASONE TABLETS 2143 BP DEXAMETHASONE TABLETS 2144 BP DEXAMETHASONE TABLETS 2145 BP DEXAMETHASONE TABLETS 2146 BP DEXAMETHASONE TABLETS 2147 BP DEXAMETHASONE TABLETS 2148 BP DEXAMETHASONE TABLETS 2149 BP DEXAMETHASONE TABLETS I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 193 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 24-Oct-14INDIA Full 16-Feb-14 Full INDIA 29-Sep-18 Years Two INDIA 30-May-18 Years SRI LANKA Two 01-Aug-17 10-Oct-15INDIA Years Two Full 24-May-18 Years Two PAKISTAN 14-Jun-14INDIA Full INDIA 16-Mar-16 Full INDIA 25-Apr-17 Years Two BELGIUM 25-Apr-17 Years Two 25-Oct-15 Full Belco Pharma (Pvt) Ltd Medopharm (PVT Ltd Pharmaceuticals Ltd Treffer Pharmaceuticals (Pvt) Ltd (Ceylon) (Pvt) Ltd Treffer Pharmaceuticals Themis Mediare INDIAThemis Mediare INDIA 26-Feb-18Years Two Elko Organization (Pvt) Ltd 26-Feb-18Aculife Healthcare Years Two (Pvt) Ltd Otsuka Pharmaceuticals (Pvt) Ltd Otsuka Pharmaceuticals (Pvt) Ltd Alocon Couvreur N V (Contd.) Agency Pvt Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd Healthcare lanka Ltd Healthcare lanka Ltd Emerchemie NB (Ceylon) Ltd Healthcare lanka Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Ltd SUSPENSION EYE DROPS Baur & Co (Pvt) A SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP DEXAMINN/A TABLETSN/A Leader Pharma TABLETSN/A Akbar TABLETSDEXACEE 4 Pharma AssociatesN/A TABLETS Bafna TABLETSN/A PharmAce (Pvt) Ltd International Yaden Globela Pharma DEXEM TABLETS TABLETS N/ADEXEM INJECTION International Yaden Sunshine TEARSFORTE INJECTION OPHTHALMIC M S J Industries 40 NSNIRTRAN Sunshine INJECTION Sunshine 40MICROSPAN INJECTION Akbar 40MICROSPAN INJECTION Akbar 11 NATURALE 0.5MG 0.5MG 4MG 4MG 4MG 500MCG 8MG HYDROCHLORIDE INJECTION 100MCG HYDRPCHLORIDE INJECTION 100MCG OPTHALMIC SOLUTION 10.0%, 0.9% 500ML INJECTION IP SODIUM CHLORIDE (0.9)% IV INFUSION SODIUM CHLORIDE (0.9)% IV INFUSION 2150 BP DEXAMETHASONE TABLETS 2151 BP DEXAMETHASONE TABLETS 2152 BP DEXAMETHASONE TABLETS 2153 BP DEXAMETHASONE TABLETS 2154 BP DEXAMETHASONE TABLETS 2155 BP DEXAMETHASONE TABLETS 2156 BP DEXAMETHASONE TABLETS 2157 DEXMEDETOMIDINE 2158 DEXMEDETOMIDINE 2159 DEXTRAN 0.1% +HPMC 0.3% 2160 DEXTRAN 40 IN SODIUM CHLORIDE 2161 10% DEXTRAN 40 INJECTION BP 2162 10% DEXTRAN 40 INJECTION BP 2163 DEXTRAN 70 0.1% TEARS 194 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIA 18-Nov-17INDIA Full 18-Nov-17INDIA Full 28-Dec-15MALAYSIA Full 03-Jan-15THAILAND Full INDONESIA 12-Jul-17 Years Two 19-Feb-14PHILIPPINES Full 08-Jul-14THAILAND Full PHILIPPINES 09-Jul-15 23-Jul-14 Full PHILIPPINES Full 15-Feb-17INDIA Full MALAYSIA 20-Mar-15 29-Aug-17 Years Two Full Laboratories (Pvt) Ltd Laboratories (Pvt) Ltd Centaur Pharmaceutical (Pvt) Ltd Ain Medicare Sdn Bhd Patana Co Ltd Indonesia Laboratories Philippines Ltd Patana Co Ltd Laboratories Philippines Ltd Laboratories Philippines Ltd Healthcare Vital (Pvt) Ltd Ain Medicare Sdn Bhd (Contd.) Health (Pvt) Ltd Syndicate Medical Ltd (Pvt) Ltd Syndicate Medical Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP LIBITUS SYRUP SYRUP Ceyoka (Pvt) LtdLIBITUS SYRUP Leben SYRUP Ceyoka (Pvt) LtdSINAREST Leben LINCTUS D10INFUSOL George Steuart INJECTION Commercial N/AD5S INFUSION IVN/A Indoscan (Pvt) Ltd Euromed INJECTIONN/A Sonali & Sudesh INJECTION Thai Nakorn Indoscan (Pvt) Ltd Euromed INJECTION Indoscan (Pvt) Ltd Euromed HYDROBROMIDE 10MG+CHLORPHENAMINE 2MG PHENYLEPHRINE MALEATE SYRUP 5MG/5ML HYDROBROMIDE 10MG+CHLORPHENAMINE 2MG PHENYLEPHRINE MALEATE SYRUP 5MG/5ML HYDROBROMIDE 10MG+CHLORPHENAMINE 4MG+Menthol 3mg in 10ml MALEATE INFUSION BP CHLORIDE 0.45% SOLUTION FOR INFUSION INTRAVENUOS CHLORIDE 0.9% INJECTION USP CHLORIDE INJECTION USP 2164 DEXTROMETHORPHAN 2165 DEXTROMETHORPHAN 2166 DEXTROMETHORPHAN 2167 DEXTROSE 10% INTRAVENOUS 2168 DEXTROSE 10% INJECTION USP DIOW2169 DEXTROSE 25% INJECTION BP2170 N/A DEXTROSE 5% + SODIUM INJECTION2171 Sonali & Sudesh DEXTROSE 5% + SODIUM Thai Nakorn INJECTION2172 DEXTROSE 5% IN 0.9% SODIUM Aristons (Pvt) Ltd Otsuka T P 2173 DEXTROSE 50% SOLUTION FOR IV 2174 50% DEXTROSE INJECTION USP DEXTROVIT-G2175 5% DEXTROSE INTRAVENOUS INJECTION D5 INFUSOL International Yaden INJECTION Commercial I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 195 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 PHILIPPINES 09-May-15PHILIPPINES Full 08-May-16INDIA Full SRI LANKA 15-Feb-14 21-Feb-14INDIA Full Full INDIA 10-Nov-17 Years Two INDIA 10-Nov-17 Years Two INDIA 05-Jun-18 Provisional INDONESIA 25-Oct-18 25-Jul-14INDIA Full Full INDIA 02-Aug-18 Full SRI LANKA 25-Jul-18 Years Two 23-Feb-14INDIA Full INDIA 15-Jun-18 Full 08-May-15 Full Laboratories Philippines Ltd Laboratories Aristo Pharmaceuticals Ltd (Ceylon) (Pvt) Ltd Centaur Pharmaceutical (Pvt) Ltd Centaur Pharmaceutical (Pvt) Ltd Human Verve Care Laboratories PharmaceuticalS (Pvt) Ltd Actavis T P Indonesia Bliss GVS Pharma Ltd Bliss GVS Pharma Ltd (Ceylon) (Pvt) Ltd Cadila Healthcare Ltd Unique Pharmaceutical Labs (Contd.) Co Ltd Health (Pvt) Ltd Health (Pvt) Ltd Agency Pvt Ltd Emerchemie NB (Ceylon) Ltd Healthcare lanka Ltd Healthcare lanka Ltd Hemas Pharmaceuticals (Pvt) Ltd Health (Pvt) Ltd SOLUTION TABLETS SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP N/AN/A INFUSIONARISTOZYME LIQUID ORAL Indoscan (Pvt) Ltd INJECTION Euromed Darley Butler & Indoscan (Pvt) Ltd Euro-Med STESOLID RECTAL KALZANASteuart LOZENGES CHEWABLE SUPERIL George INFUSION BP 5% W/V INFUSION BP INJECTION 25% W/V LIQUID ORAL 10MG/5ML 5MG/2.5ML 200 430MG+CHOLECALCIFEROL IU+ASCORBIC ACID 40 0.6m+ (2,4)+AMYLMETACRESOL LOZENGES 2176 DEXTROSE INTRAVENOUS 2177 DEXTROSE SOLUTION FOR IV 2178AND PEPSIN 50MG DIASTASE 2179 2MG B.P DIAZEPAM 2180 B.PTABLETS 5MG DIAZEPAM SOLINA2181 B.PTABLETS 5MG DIAZEPAM N/A SOLINA2182 5MG/ML INJECTION B.P TABLETS DIAZEPAM VERZEPAM2183 TABLETS 5MG/ML INJECTION B.P DIAZEPAM George Steuart TABLETS N/A INJECTION N/A2184 Leader Pharma SOLUTION RECTAL DIAZEPAM George Steuart 2185 2.5MG SUPPOSITORIES DIAZEPAM INJECTION SLIPIZEM 5 M S J Industries Ceyoka (Pvt) Ltd2186 5MG SUPPOSITORIES DIAZEPAM Ciron Drugs & SLIPIZEM 52187 10MG BP TABLETS DIAZEPAM 2188 DIBASIC CALCIUM PHOSPHATE N/A Sunshine 2189 ALCOHOL 1.2mg DICHLOROBENZYL Sunshine TABLETS N/A M S J Industries 196 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAPAKISTAN 03-Sep-14 27-May-15 Full INDIA Full INDIA 08-Apr-14 Full INDIA 03-Sep-14 Full 11-Mar-14INDIA Full INDIA 23-Nov-17 Years Two INDIA 30-Aug-18INDIA Full 11-Oct-16 Full 28-May-16 Full SWITZERLAND 01-Feb-18 Provisional INDIA 27-Jun-18 Years Two Novartis Consumer Health SA Cipla LtdPvt Ltd INDIA 10-Jan-17 Full Cadila Healthcare Ltd Platinum Pharmaceuticals (Pvt) Ltd Sun Pharmaceutical industries Cadila Healthcare Ltd Healthcare Vital (Pvt) Ltd Unique Pharmaceutical Labs Pharmaceutical Troikaa Pharmaceuticals Ltd Laboratories (Pvt) Ltd Medochemie Ltd CYPRUS 25-Jan-17 Full

(Contd.) (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Health (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Health (Pvt) Ltd Slim Pharmaceuticals (Pvt) Ltd Laboratories (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP GEL Smithkline Beecham OINTMEN VOLTAREN VOLTAREN EMULGEL COFENAC GEL GELZOBID D 50 TABLETS Breathe Free Lanka CIC Holdings PLC Abbott Healthcare JONAC GEL GEL GELFASTAID GEL Hemas VOLINI George Steuart JONAC GEL GEL GEL Hemas DIVON CR Hemas DICLORAN CAPSULES Kamazu (Pvt) Ltd GELTOPLINE Micro Labs Ltd INDIA QPSDYNAPAR GEL TOPICAL George Steuart ADIFLAM 17-Sep-15Associates Pharma Full Central drugs and GELALMIRAL GEL GEL Ceyoka (Pvt) Ltd Leben Associated GEL 1.16% W/W BP 1.16% W/W BP 1.16% W/W BP 1.16% W/W BP PROLONGED RELEASE BP1.16% w/w 4% TOPICAL 1% GEL 1% GEL 1% GEL GEL 1% (1% W/W) GEL 50 MG TABLETS 2201 DICLOFENAC DIETHYLAMMONIUM 2202 DICLOFENAC DIETHYLAMMONIUM 2203 DICLOFENAC DISPERSIBLE 2196 DICLOFENAC DIETHYLAMINE 1% 2190 DICLOFENAC DIETHYLAMINE GEL 2191 DICLOFENAC DIETHYLAMINE GEL 2192 DICLOFENAC DIETHYLAMINE GEL 2193 DICLOFENAC DIETHYLAMINE GEL 2194 DICLOFENAC 1% GEL2195 DICLOFENAC CAPSULES 100MG N/A2197 DICLOFENAC DIETHYLAMINE GEL 2198 DICLOFENAC DIETHYLAMINE GEL GEL2199 DICLOFENAC DIETHYLAMMONIUM International Yaden 2200 DICLOFENAC DIETHYLAMMONIUM I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 197 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 31-Jan-15 Full INDIA 25-May-16 Full INDIA 11-Apr-18 Years Two 18-Jan-17 Full THAILANDINDIA 30-Jan-16 Full PAKISTAN 27-Jun-16 18-Mar-16INDIA Full Full INDIA 16-May-17INDIA Full 09-Dec-14PAKISTAN Full 12-Oct-17 Years Two 24-Dec-14 Full Themis Mediare INDIAAgio Pharmaceuticals Ltd 09-Jan-18Years Two Unijules Life Sciences Ltd Ankur Drugs & Pharma (Pvt) Ltd Themis Mediare INDIABal Pharma Ltd INDIA 09-Jan-18Years Two Laboratories Lekar Pharma 16-May-15(Pvt) Ltd Swiss Full Pharmaceuticals (Pvt) Ltd Jenburkt Pharmaceuticals Ltd Raptakos Brett & Company Ltd Medizest Pharmaceuticals (Pvt) Ltd Brookes Pharma (Pvt) Ltd Lincolin Pharmaceuticals (Contd.) Healthcare lanka Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd International (Pvt) Ltd Healthcare lanka Ltd (Pvt) Ltd Health (Pvt) Ltd Ltd Pharmaceuticals (Pvt) Ltd Co Ltd Pharmaceuticals Ltd Pharmaceuticals (Pvt) Ltd T & J Pharma T Imports (Pvt) Ltd GEL Sunshine GEL Sunshine GEL Hemas CREAM SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP GEL GEL GEL 2211 1% W/W B.P DICLOFENAC GEL GEL FLEXY GEL TOPICAL Medinex (Pvt) Ltd Drugs P T 2204 1% W/W B.P DICLOFENAC GEL TPM INSTANAC 2205 1% W/W B.P DICLOFENAC GEL DICLOGEN2206 1% W/W B.P DICLOFENAC GEL GEL RELINAC2207 1% W/W B.P DICLOFENAC GEL RONAC GEL GEL TOPICAL Citihealth Imports 2208 1% W/W B.P DICLOFENAC GEL Lifeline GEL2209 VIVIAN 1% W/W B.P DICLOFENAC GEL TPM INSTANAC 2210 Softcare 1% W/W B.P DICLOFENAC GEL TOPICAL LOFEN2212 1.15% W/W B.P DICLOFENAC GEL N/A GEL2213 2% W/W B.P DICLOFENAC GEL SWISO GEL2214 1% BP DICLOFENAC GEL International Yaden GEL GEL2215 1% BP DICLOFENAC GEL POWERGESIC George Steuart 2216 Pharma (Pvt) 1% BP DICLOFENAC GEL Talex SUBSYDE GEL2217 GEL 1% BP DICLOFENAC GEL DICLOKARE GEL GEL TOPICAL Mediccon ARNIL Trading Swedish GEL Hemas 198 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 TURKEY 11-Mar-16PAKISTAN Full 17-Jun-14PAKISTAN Full 23-Jan-14 Full INDIATHAILAND 19-Mar-18 Years Two 19-Oct-14PAKISTAN Full 30-Mar-16PAKISTAN Full 10-Jan-16BANGLADESH 05-Nov-14 Full Full PAKISTAN 05-Apr-17INDIA Full INDIA 11-May-17 Full 16-Aug-18 Provisional Cipla LtdHilton Pharma (Pvt) Ltd INDIA CCL Pharmaceuticals (Pvt) Ltd 08-Sep-17Years Two Micro Labs Ltd INDIAPharmaceuticals (India) Ltd 10-Dec-17Years Two & Well Well Pharma (Pvt) Ltd Nabiqasim Industries (Pvt) Ltd Incepta Pharmaceuticals Ltd Fozen Pharmaceutical Industries Pvt Ltd Zim Laboratories Ltd Centurion Laboratories Pvt Ltd Novartis Urunleri A.S Unison Laboratories Co Ltd (Contd.) (Pvt) Ltd Healthcare lanka Ltd Pharmaceuticals Lanka (Pvt) Ltd Ltd Laboratories (Pvt) Ltd Health (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Ltd Sunshine Healthcare lanka Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP TABLETS DEFLAM KNEODOL TABLETSAUROFLAM 50 TABLETS CCL TABLETS SMM Halcyon (Pvt) LESFLAM 50 PharmAce (Pvt) Ltd Aurochem FILM COA RELPAINKLODIC TABLETS Associated KINTAFENAC TABLETS TABLETS George Steuart POFEN 50 Citihealth Imports TABLETSDICLOFLAN Pharma Tropical TABLETSN/A Tabrane CAPSULES International Yaden 50MG 50MG 50MG USP 50MG USP 50MG USP 50MG BP 50MG USP 50MG USP 50MG USP 0.4MG BP TABLETS RELEASE 2219 50MG DICLOFENAC POTASSIUM K-FENAC2220 50MG DICLOFENAC POTASSIUM MAXIT TABLETS2221 TABLETS DICLOFENAC POTASSIUM Breathe Free Lanka TABLETS2222 TABLETS DICLOFENAC POTASSIUM Sunshine 2223 TABLETS DICLOFENAC POTASSIUM 2224 TABLETS DICLOFENAC POTASSIUM 2225 TABLETS DICLOFENAC POTASSIUM 2226 TABLETS DICLOFENAC POTASSIUM 2227 TABLETS DICLOFENAC POTASSIUM 2228 TABLETS DICLOFENAC POTASSIUM 2229 TABLETS DICLOFENAC POTASSIUM 2230 DICLOFENAC PROLONGED 2218 50MG DICLOFENAC POTASSIUM 50 CATAFLAM TABLETS Baur & Co (Pvt) A I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 199 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 BANGLADESH 01-Apr-16 Full INDIABANGLADESH 14-Oct-17 20-Jun-15 Full Full BANGLADESH 30-Nov-16 Full INDIAINDIA 28-Sep-17 Years Two INDIA 21-Apr-17 Years Two 03-May-18 Provisional INDIA 01-Jan-18 Full THAILANDINDIA 06-Jun-18 Years Two INDIA 28-Sep-17 Full 22-Oct-14 Full Pharmaceuticals Ltd Synmedic Laboratories (Pvt) Ltd Pharmaceuticals Industry Ltd Unique Pharmaceutical Labs Magbro Healthcare Theon Pharmaceuticals Ltd Kalbe FarmaT P INDONESIA 01-Jan-18Unique Pharmaceutical Labs Full State Pharmaceuticals Manufacturer Corporation Win Medicare ltd INDIA 17-Feb-14 Full Ltd. Pharmaceuticals Astamed Healthcare (Pvt) Ltd (Contd.) PharmAce (Pvt) Ltd Square Pharmaceuticals (Pvt) Ltd Health (Pvt) Ltd Services Pvt. Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Health (Pvt) Ltd State Pharmaceuticals Manufacturer Corporation Robert Hall & Co Ltd Celyon (Pvt) Ltd TABLETS (EN. TABLETS COA.) RELEASE TABLETS TABLETS SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP CLOFENAC SR 100MG SYFEN SR100 TABLETSANODYNE Lifeline TABLETSDICLORAN Medinex (Pvt) Ltd TABLETSN/A The IBN SINA George Steuart THEORAN 50 TABLETS TABLETSN/A Slim ABC Pharma DIVOLTAR DELAYED TABLETSDICLORAN Hemas TABLETSSOLUDOL George Steuart DISPERSIBLE VOLTA 1% GELVOLTA GEL PharmAce (Pvt) Ltd Man Pharma T DICLOLABRHUMANC GEL GEL GEL Pharma Associates Associated Pharma Laborate RELEASE TABLETS BP 100MG BP TABLETS RELEASE RELEASE TABLETS BP 100MG BP TABLETS RELEASE TABLETS 25MG RELEASE TABLETS 50MG USP TABLETS RELEASE 50MG USP TABLETS RELEASE 50MG USP TABLETS RELEASE 50MG USP TABLETS RELEASE 50MG USP TABLETS RELEASE 50MG DISPERSIBLE TABLETS W/W BP W/W BP W/W BP 2231 DICLOFENAC PROLONGED 2232 DICLOFENAC PROLONGED 2233 DICLOFENAC SODIUM 50MG BP 2234 DICLOFENAC SODIUM DELAYED 2235 DICLOFENAC SODIUM DELAYED 2236 DICLOFENAC SODIUM DELAYED 2237 DICLOFENAC SODIUM DELAYED 2238 DICLOFENAC SODIUM DELAYED 2239 DICLOFENAC SODIUM DELAYED 2240 DICLOFENAC SODIUM 2241 1.0% DICLOFENAC SODIUM GEL 2242 1.0% DICLOFENAC SODIUM GEL 2243 1.0% DICLOFENAC SODIUM GEL 200 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 MALAYSIA 23-Apr-15INDIA Full SWITZERLAND 06-Feb-18 19-Nov-17 Years Two Years Two SWITZERLAND 28-Nov-16THAILAND Full 03-Mar-15INDIA Full INDIA 18-Mar-15 Full GERMANY 06-Dec-17 21-Mar-18 Full Provisional INDIABANGLADESH 05-Dec-14 22-Sep-14 Full Full MALAYSIA 19-Apr-18SWITZERLAND 25-Oct-17 Years Two Years Two SDN BHD Laboratories (Pvt) Ltd Novartis Pharma A G Novartis Pharma Italy SPA Unison Laboratories Co Ltd Bliss GVS Pharma Ltd Galen Pharmaceuticals (Pvt) Ltd Denk Pharma GmbH & Co. Medochemie Ltd CYPRUSCadila Healthcare 30-Jul-17Ltd Full Pharmaceuticals Ltd SDN BHD Delpharm S A Huningue S (Contd.) Ltd Ltd Healthcare lanka Ltd Healthcare lanka Ltd (Pvt) Ltd Akbar Pharmaceuticals (Pvt) Ltd Laboratories (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP VOREN GEL Indoscan (Pvt) Ltd Industries / S P Y VOLTAREN SR100VOLTAREN TABLETS 75VOLTAREN-SR Baur & Co (Pvt) A TABLETS Baur & Co (Pvt) A DICLOVINGALINAC 100DICLO-DENK 100 RECTAL Sunshine 100ALMIRAL Pharma Tropical JONACCLOFENAC SUPPOSITORY Associated Hemas SUPPOSITORY PharmAce (Pvt) LtdVOREN Square 12.5VOLTAREN SUPPOSITORY SUPPOSITORY Baur & Co (Pvt) A Indoscan (Pvt) Ltd Industries / S P Y W/W BP RELEASE TABLETS 100MG RELEASE TABLETS 75MG RELEASE TABLETS 100MG SUPPOSITORIES 100MG SUPPOSITORIES 100MG SUPPOSITORIES 100MG SUPPOSITORIES 100MG SUPPOSITORIES 12.5MG SUPPOSITORIES 12.5MG SUPPOSITORIES 12.5MG SUPPOSITORIES 2244 1.0% DICLOFENAC SODIUM GEL 2245 50MG DICLOFENAC SODIUM IP ADIFLAM2246 DICLOFENAC SODIUM MODIFIED 2247 TABLETS DICLOFENAC SODIUM MODIFIED 2248 1% Ceyoka (Pvt) Ltd DICLOFENAC SODIUM SPRAY UNIREN SPRAY Leben SPRAY2249 DICLOFENAC SODIUM Sunshine 2250 DICLOFENAC SODIUM 2251 DICLOFENAC SODIUM 2252 DICLOFENAC SODIUM 2253 DICLOFENAC SODIUM 2254 DICLOFENAC SODIUM 2255 DICLOFENAC SODIUM 2256 DICLOFENAC SODIUM I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 201 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 FRANCE 25-Oct-17 Years Two BANGLADESH 07-Jan-15 Full INDIAFRANCE 18-Mar-16 Full 25-Oct-17 Years Two INDIA 26-Jul-18 Full SWITZERLAND 10-Jan-14 Full INDIA 21-Nov-17 Years Two INDIAGERMANY 31-Jan-18 04-Jul-18 Full INDIA Years Two 17-Dec-14 Full Delpharm S A Huningue S France Novartis France Pharmaceuticals Ltd Bliss GVS Pharma Ltd Delpharm S A Huningue S France Novartis France Bliss GVS Pharma Ltd Medochemie Ltd CYPRUSNovartis Urunleri FOR 30-Jul-17Turkey Novartis Pharma Stein Full Blue Cross Laboratories Ltd Medochemie Ltd CYPRUSAgio 09-Aug-18Pharmaceuticals Ltd Full Laboratories (Pvt) Ltd Denk Pharma GmbH & Co. (Contd.) Ltd Healthcare lanka Ltd Ltd Healthcare lanka Ltd Laboratories (Pvt) Ltd Ltd Produsts Ltd Laboratories (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd TABLETS Akbar SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP VOLTAREN 25VOLTAREN Baur & Co (Pvt) A CLOFENAC SUPPOSITORY PharmAce (Pvt) LtdDICLOVIN Square 25VOLTAREN DICLOVIN 50 Sunshine Baur & Co (Pvt) A 50ALMIRAL VOLTAREN Sunshine TABLETS D.T.DICLOTAL Associated Baur & Co (Pvt) A TABLETS 50ALMIRAL Hayleys Consume TABLETSDICLOGEN Associated TABLETSDICLO-DENK 100 RETARD Citihealth Imports ADIFLAM TABLETS Ceyoka (Pvt) Ltd Leben SUPPOSITORIES 25MG SUPPOSITORIES SUPPOSITORIES 25MG SUPPOSITORIES 25MG SUPPOSITORIES 25MG SUPPOSITORIES 50MG SUPPOSITORIES 50MG SUPPOSITORIES 50MG 50MG 50MG 100MG SR 100 100MG SR 100 25MG 2257 DICLOFENAC SODIUM 2258 DICLOFENAC SODIUM 2259 DICLOFENAC SODIUM 2260 DICLOFENAC SODIUM 2261 DICLOFENAC SODIUM 2262 DICLOFENAC SODIUM 2263 TABLETS DICLOFENAC SODIUM 2264 TABLETS DICLOFENAC SODIUM 2265 B.P TABLETS DICLOFENAC SODIUM 2266 BP TABLETS DICLOFENAC SODIUM 2267 BP TABLETS DICLOFENAC SODIUM 2268 BP TABLETS DICLOFENAC SODIUM 202 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAGERMANY 15-May-18 04-Jul-18INDIA Full Years Two INDIA 15-May-17PAKISTAN Full 23-Mar-14 21-Jan-18INDIA Full Full INDIA 05-Feb-16 Full INDIA 31-Jan-18 Full INDIA 03-Feb-15 Full INDIA 30-Dec-17 Full 21-May-16 Full INDIA 26-Nov-14 Full Wings Biotech INDIAUnicure Ramadies (Pvt) Ltd Denk Pharma 10-May-18GmbH & Co. Years Two Unicure Ramadies (Pvt) Ltd Laboratories XL (Pvt) Ltd CCL Pharmaceuticals (Pvt) Ltd Akriti pharmaceuticals Pvt Ltd Agio Pharmaceuticals Ltd Pharmaceuticals (Pvt) ltd Unique Pharmaceutical Labs Medochemie Ltd CYPRUSPharm Products 13-Dec-15(Pvt) Ltd Full Unique Pharmaceutical Labs (Contd.) (Pvt) Ltd Ltd Pharmaceuticals (Pvt) Ltd Ltd Ltd Pharmaceuticals Lanka (Pvt) Ltd Ltd (Pvt) Ltd Health (Pvt) Ltd Laboratories (Pvt) Ltd Healthcare lanka Ltd Health (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP TABLETS George Steuart DICLOWIN 25 TABLETS International Yaden FLAGONDICLO-DENK 50 TABLETS TABLETSFLAGON Akbar Emar Pharma (Pvt) CLOFENEX TABLETS TABLETS Emar Pharma (Pvt) SMM Halcyon (Pvt) DICLOGEN TABLETSDICLORAN SR 100 Citihealth Imports DICLORAN SR 75 TABLETS George Steuart 25ALMIRAL TABLETSDS 50 Associated TABLETS Sunshine 25MG Gastro resistant 50MG 50MG 50MG 50MG PROLONGED RELEASE PROLONGED RELEASE PROLONGED RELEASE 25MG BP TABLETS 50MG BP TABLETS 2269 BP TABLETS DICLOFENAC SODIUM 2270 BP TABLETS DICLOFENAC SODIUM 2271 BP TABLETS DICLOFENAC SODIUM 2272 BP TABLETS DICLOFENAC SODIUM 2273 BP TABLETS DICLOFENAC SODIUM 2274 50MG BP TABLETS DICLOFENAC DINAC2275 50MG BP TABLETS DICLOFENAC ZIC TABLETS2276 100MG BP TABLETS DICLOFENAC CCL 2277 100MG BP TABLETS DICLOFENAC TABLETS Alaris Lanka (Pvt) 2278 50MG BP TABLETS DICLOFENAC DILOFEN2279 75MG BP TABLETS DICLOFENAC TABLETS2280 DICLOFENAC GASTRO RESISTANT Algarash (Pvt) Ltd Surien 2281 DICLOFENAC GASTRO RESISTANT I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 203 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 30-Jun-17 Full INDIA 04-Apr-15PHILIPPINES Full 07-Nov-14 26-Nov-14PAKISTAN Full Full 18-Mar-16PAKISTAN Full 13-Oct-16 Full INDIAINDIA 21-Jul-14INDIA Full 17-Dec-14INDIA Full 27-Jul-16 Full BANGLADESH 17-Mar-17 09-Sep-14 Full Full INDIA 04-Jun-17 Years Two Mepro Pharmaceuticals (Pvt) Ltd Agio Pharmaceuticals Ltd (Pvt) Ltd Swiss Pharmaceuticals (Pvt) Ltd Brookes Pharma (Pvt) Ltd S Kant Healthcare Ltd SG Pharma (Pvt) Ltd Fourrts (India) Laboratories Ltd Glaxo Smithkiline Pharmaceuticlas Pharmaceuticals Ltd Cipla Ltd Healthcare Vital (Pvt) Ltd INDIA 16-Feb-17 Full Amherst Laboratories (Contd.) Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Ltd Pharmaceuticals (Pvt) Ltd Co Ltd Pharmacy (Pvt) Ltd Healthcare lanka Ltd Pharmaceuticlas (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd George Steuart Health (Pvt) Ltd COA.) SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP VEWODINA 50VEWODINA TABLETS Akbar DICLOGEN TABLETSDS 50 Citihealth Imports NEO PYRAZON (EN. TABLETS TABLETSSWISO 50 Harcourts (Pvt) Ltd Pharm Products TABLETSARNIL Pharma (Pvt) Talex DIVON 50 TABLETSDICLODEC TABLETS Hemas N/A TABLETS Kamazu (Pvt) Ltd Micro Labs Ltd Delmege Forsyth & INDIA INJECTIONBANOCIDE The Esses 21-Nov-17 TABLETSYears Two 0.05%ECZENA CREAM GlaxoSmithkiline PharmAce (Pvt) Ltd Square TABLETS BP 50MG BP TABLETS TABLETS BP 50MG BP TABLETS 50MG BP TABLETS 50MG BP TABLETS 50MG BP TABLETS 50MG BP TABLETS 50MG BP TABLETS (300MG/20ML) 15MG/ML 50MG IP TABLETS 0.05% USP TABLETS BP 50MG BP TABLETS 2282 DICLOFENAC GASTRO RESISTANT 2283 DICLOFENAC GASTRO RESISTANT 2284 DICLOFENAC GASTRO RESISTANT 2285 DICLOFENAC GASTRO RESISTANT 2286 DICLOFENAC GASTRO RESISTANT 2287 DICLOFENAC GASTRO RESISTANT 2288 DICLOFENAC GASTRO RESISTANT 2290 INJECTION EDETATE DICOBALT 2291 20MG BP TABLETS DICYCLOMINE COLIGON2292 DIETHYLCARBAMAZINE CITRATE TABLETS2293 CREAM DIFLOROSONE DIACETATE Sunshine 2294 500MG BP TABLETS DIFLUNISAL DIFLAM2295 0.25M/ML DIGOXIN INJECTION BP N/A TABLETS Breathe Free Lanka INJECTION International Yaden 2289 DICLOFENAC GASTRO RESISTANT 204 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 22-Jul-17INDIA Full 07-Apr-15INDIA Full 27-Feb-18 Years Two INDIA 16-Jun-18 Provisional INDIA 15-May-18INDIA Full 30-Apr-14INDIA Full 06-Jun-18 Years Two INDONESIA 07-Oct-14 30-Aug-15 Full Full SRI LANKA 29-Dec-17INDIA Full INDIA 05-Sep-17 Years Two INDIA 20-May-15 Full 01-Jan-18 Full Sciences (Pvt) Ltd SG Pharma (Pvt) Ltd Human Verve Care Laboratories Kwality Pharmaceuticals Pvt Ltd Unicure Ramadies (Pvt) Ltd SG Pharma (Pvt) Ltd Inventia Healthcare (Pvt) Ltd Inventia Healthcare (Pvt) Ltd Tanabe T P Indonesia for Mitsubishi Pharma Tanabe Corporation, Japan Pharmaceuticals Manufacturer Corporation J.B.Chemicals & Pharmaceuticals Laboratories (Pvt) Ltd Torrent Pharmaceuticals Ltd (Contd.) Pharmacy (Pvt) Ltd Agency Pvt Ltd (Pvt) Ltd Ltd Pharmacy (Pvt) Ltd (Ceylon) Ltd (Ceylon) Ltd Pharmaceuticals (Pvt) Ltd Health (Pvt) Ltd Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP DIXIN INJECTION Pharma Associates Samarth Life N/A INJECTION International Yaden ZEM XL90 CAPSULES 120ZEM XL Emerchemie NB CAPSULES Emerchemie NB N/ADILCARDLIA TABLETS TABLETSDILTRIT N/A George Steuart DILZEM-60 TABLETS TABLETS Ceyoka (Pvt) Ltd State Leben Edna Medicals (Pvt) 2 ML IN 2 ML CAPSULES EXTENDED RELEASE 120MG (EXTENDED RELEASE) CAPSULES USP USP TABLETS USP TABLETS USP TABLETS USP TABLETS 2296 0.5MG IN DIGOXIN INJECTION BP 2297 250MCG/ML DIGOXIN INJECTION BP DIXCOOL2298 250MCG/ML DIGOXIN INJECTION BP DIGIVER INJECTION2299 0.25MG DIGOXIN INJECTION USP The Esses INJECTION2300 0.25MG BP TABLETS DIGOXIN Leader Pharma 2301 0.25MG USP TABLETS DIGOXIN CARDIGO N/A2302 HYDROCHLORIDE 90MG DILTIAZEM TABLETS2303 HYDROCHLORIDE DILTIAZEM Emar Pharma (Pvt) TABLETS2304 HYDROCHLORIDE 30MG DILTIAZEM HERBESSER The Esses TABLETS Hemas 2305 HYDROCHLORIDE 60MG DILTIAZEM 2306 HYDROCHLORIDE 60MG DILTIAZEM 2307 HYDROCHLORIDE 60MG DILTIAZEM 2308 HYDROCHLORIDE 60MG DILTIAZEM I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 205 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 JAPANJAPAN 15-Sep-15 Full 12-Sep-15 Full INDIAINDIA 10-Feb-15INDIA Full 13-Jan-16INDIA Full 19-Feb-15 Full INDIA 04-Jun-17INDIA Full 13-Jan-16INDIA Full 01-Jan-17INDIA Full 08-Sep-17INDIA Years Two 13-Jan-16SRI LANKA Full 23-Oct-14 28-Jan-18 Full Years Two Mitsubishi Tanabe Mitsubishi Tanabe Pharma Factory Ltd Mitsubishi Tanabe Mitsubishi Tanabe Pharma Factory Ltd J.B.Chemicals & Pharmaceuticals Ltd Pharmaceuticals Ltd Centurion Laboratories Pvt Ltd Ltd Torrent Pharmaceuticals Ltd J.B.Chemicals & Pharmaceuticals Ltd Sun Pharmaceutical industries Pharmaceuticals Manufacturer Corporation GA Bayer Pharma GERMANY 26-Oct-15 Full (Contd.) Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Health (Pvt) Ltd (Pvt) Ltd Ltd Health (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd CAPSULES Hemas CAPSULES Hemas SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP HERBESSER -R 200 HERBESSER R-100 DILC.RDIA SR 90DILC.RDIA TABLETS George Steuart ANDICO 120 TABLETSTRIAZEM-30 TABLETS Harcourts (Pvt) LtdN/A Coral Laboratories Pharmacare LtdANDICO 30 Troikaa TABLETSDILZEM TABLETS International Yaden Harcourts (Pvt) LtdDILCARDIA Coral Laboratories TABLETSANDICO 90 TABLETS Edna Medicals (Pvt) ANGIZEM-60 TABLETS George Steuart TABLETS Harcourts (Pvt) Ltd Coral Laboratories Hemas MAGNEVIST INJECTION Hemas SUSTAINED RELEASE CAPSULES SUSTAINED 200MG SUSTAINED RELEASE CAPSULES SUSTAINED 100MG SUSTAINED RELEASE TABLETS TABLETS RELEASE SUSTAINED 90MG TABLETS USP 120MG USP TABLETS 30MG USP TABLETS 30MG USP TABLETS 30MG USP TABLETS 30MG USP TABLETS 30MG USP TABLETS 90MG USP TABLETS 60MG TABLETS 469 MG/ML 2311 HYDROCHLORIDE DILTIAZEM 2309 HYDROCHLORIDE DILTIAZEM 2310 HYDROCHLORIDE DILTIAZEM 2312 HYDROCHLORIDE DILTIAZEM 2313 HYDROCHLORIDE DILTIAZEM 2314 HYDROCHLORIDE DILTIAZEM 2315 HYDROCHLORIDE DILTIAZEM 2316 HYDROCHLORIDE DILTIAZEM 2317 HYDROCHLORIDE DILTIAZEM 2318 HYDROCHLORIDE DILTIAZEM 2319 MODIFIED RELEASE DILTIAZEM 2320 30 MG USP TABLETS DILTIAZEM N/A2321 DIMEGLUMINE GADOPENTETATE TABLETS N/A State 206 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 PAKISTAN 20-Aug-18PAKISTAN Full 06-Mar-14PAKISTAN Full 12-Feb-18 Full SRI LANKA 12-Aug-17Years Two BELGIUM 21-Nov-15KOREA Full 28-Dec-17 Years Two INDIA 18-Oct-18 Provisional INDIA 13-Aug-16 Full Nabiqasim Industries (Pvt) Ltd Nabiqasim Industries (Pvt) Ltd Nabiqasim Industries (Pvt) Ltd Remedica limited CYPRUS 11-Apr-15 Full Ltd Glaxo Smithkiline A Biologicals S G Life Sciences L Ltd Biotechnics (Pvt) Ltd Biological E Ltd INDIASerum Institute of India (Pvt) Ltd 21-Aug-17Years Two (Contd.) Lanka Ltd Shantha fi Health (Pvt) Ltd Health (Pvt) Ltd Health (Pvt) Ltd Kandana Food & Drugs (Pvt) Ltd Pharmaceuticlas (Pvt) Ltd Services Pvt. Ltd Healthcare lanka Ltd (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP EXPECTORANT EXPECTORANT SYRUP GRAVINATE TABLETSGLANDIN E2 GEL VAGINAL Morison PLC George Steuart Searle-Pakistan PAKISTAN 21-Aug-14 Full GLANDIN E2 GEL VAGINAL George Steuart GLANDIN E2 TABLETSBELARMIN EXPEC George Steuart PHENYCOF CAPSULES N/A Inter Pharm (Pvt) BOOSTRIX INJECTIONEUPENTA GlaxoSmithkiline VACCINESHAN 6 ABC Pharma INJECTIONN/A Sano N/A INJECTION Sunshine INJECTION Citihealth Imports 50MG 2MG/3G 1MG/3MG 3MG 14MG,AMMONIUM CHLORIDE 1.1MG 135MG+MENTHOL HYDROCHLORIDE CAPSULES USP HYDROCHLORIDE CAPSULES USP 25MG ,ACELLULAR PERTUSSIS VACCINE VACCINE ,ACELLULAR PERTUSSIS RECOMBINED B (Rdna) (WHOLE CELL) ,HEPATITIS & HAEMOPHILUS INFLUENZE VACCINE TYPE B CONJUGATED SINGLE DOSE ADSORBED IP B & (WHOLE CELL) ,HEPATITIS TYPE B HAEMOPHILUS INFLUENZA MULTIDOSE (WHOLE CELL) VACCINE ADSORBED 10 DOSES AND HAEMOPHILUS B ,HEPATITIS TYPE B CONJUGATED INFLUENZE (10DOSE VI) VACCINE 2322 BP TABLETS DIMENHYDRINATE 2323 GEL VAGINAL DINOPROSTONE 2324 GEL VIGINAL DINOPROSTONE 2325 TABLETS VIGINAL DINOPROSTONE 2326 DIPHENHYDRAMINE HCL 2327 DIPHENHYDRAMINE 2328 & ,TETANUS DIPHTHERIA 2329 PERTUSSIS ,TETANUS, DIPHTHERIA 2330 PERTUSSIS ,TETANUS, DIPHTHERIA 2331 PERTUSSIS ,TETANUS, DIPHTHERIA 2332 PERTUSSIS ,TETANUS, DIPHTHERIA I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 207 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 FRANCE 01-Sep-17INDIA Full 13-Feb-16 Full BELGIUM 04-Jul-16 Full INDIA 18-Oct-14INDIA Full INDIA 20-Oct-14 Full INDIA 21-Oct-14 Full INDIA 08-Jul-15 Full INDIA 04-Oct-17 Full 28-Jun-14 Full Pasteur fi Serum Institute of India (Pvt) Ltd Biological E Ltd INDIAGlaxo Smithkiline 12-Mar-18A Biologicals S Full Serum Institute of India (Pvt) Ltd Serum Institute of India (Pvt) Ltd Serum Institute of India (Pvt) Ltd Centurion Laboratories Pvt Ltd Cadila Healthcare Ltd (Pvt) Ltd S A (Contd.) Lanka Ltd Sano fi (Pvt) Ltd Healthcare lanka Ltd GlaxoSmithkiline Pharmaceuticlas (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd INJECTION SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP INFANRIX HEXAINFANRIX VACCINE N/AN/A INJECTION Citihealth Imports INJECTION Sunshine N/AN/A INJECTION Citihealth Imports N/A INJECTION Citihealth Imports INJECTION Citihealth Imports N/A TABLETS Chamee Chemist Alvita Pharma HEXAXIM INJECTION Sano TAVALENT TAVALENT uenza 10 fl ,HEPATITIS B AND HAEMOPHILUS B ,HEPATITIS TYPE B CONJUGATED INFLUENZE ADSORBAD,SINGLE DOSE VACCINE HAEMOPHILUS B rDNA ,HEPATITIS TYPE B CONJUGATED INFLUENZE ADSORBAD,PEN VACCINE 40IU,ACELLULAR PERTUSSIS B RECOM 10MG, 25MCG, HEPATITIS TYPE 40 POLIOMYELLITIS INACT D-ANTIGEN VCCINconju Haemoph in 5Lf NLT TOXOID TETANUS & ADSORBED (ADULTS VACCINE ADOLESENT) 10 DOSES 5LF TOXOID 25LF+TETANUS ADSORBED VACCINE TOXOID25LF,TETANUSTOXOID 04IU0.5ML PERTUSIS 5LF,B 100MG VACCINE ,HEPATITIS B AND HAEMOPHILUS B ,HEPATITIS TYPE B CONJUGATED INFLUENZE (10DOSE VI) VACCINE 2334 PERTUSSIS ,TETANUS, DIPHTHERIA 2335 PERTUSSIS ,TETANUS, DIPHTHERIA 2336 30IU,TETANUS DIPHTHERIA 2337 5Lf & NMT DIPHTHERIA 2338 TOXOID DIPHTHERIA 2339 DIPHTHERIA 2340TABLETS DIPYRIDAMOLE 100MG BP N/A2341 25MG BP TABLETS DIPYRIDAMOLE ZANTIN 25 TABLETS2342 USP DIPYRIDAMOLE TABLETS TABLETS International Yaden Hemas 2333 PERTUSSIS ,TETANUS, DIPHTHERIA 208 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 24-Oct-15 Full INDIA 06-Apr-14 Full INDIA 09-Oct-16INDIA Full 21-Jan-15INDIA Full 03-Nov-17 Years Two 18-Aug-15ARGENTINA Full 27-Nov-14INDIA Full INDIA 17-Jul-15INDIA Full 03-Sep-15 Full 08-Jun-16 Full Indoco Remedies India Unijules Life Sciences Ltd Torrent Pharmaceuticals Ltd SG Pharma (Pvt) Ltd PharmaceuticalS (Pvt) Ltd Naprod Life Scienc (Pvt) Ltd Sanbe FarmaT P INDONESIA 19-Aug-15 Bioprofarma SA Terrada Full Zydus Hospira Oncology (Pvt) Ltd Fresenius Kabi Oncology Ltd Zydus Hospira Oncology (Pvt) Ltd Cipla LtdAdley Formulation INDIA INDIAAdley Formulation INDIA 22-Apr-14 15-May-15 Full Full 30-Apr-14 Full (Contd.) Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Ltd Pharmacy (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Ceylon) Ltd Pharmaceuticals (Pvt) Ltd Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Healthcare lanka Ltd Healthcare lanka Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP CIRTAL SYRUP Hemas JUCITRON SYRUP Lifeline DOBUGEN-PFV INJECTIONN/A The Esses CARDOMIN INJECTIONDOXETASAN INJECTION Ceyoka (Pvt) Ltd INJECTION Ravilux Company Ciron Drugs & Lifeline 160ZYTAX INJECTIONDAXOTEL Hemas INJECTION Markss HLC (Pvt) 120DOCETAX INJECTIONADOXI Citihealth Imports ADOXI INJECTION Sunshine INJECTION Sunshine SYRUP 1.37G/5ML SYRUP SYRUP 1.4g/5ML SYRUP 12.5MG/ML 12.5MG/ML 250MG FOR INFUSION USP CONCENTRATE 40MG/ML 160MG/16ML 20 & 80 & 80MG IN 2ML 0.5ML 120MG/3ML CONCENTRATE 120MG/3ML CONCENTRATE 20MG/0.5ML CONCENTRATE 2343 DISODIUM HYDROGEN CITRATE 2344 DISODIUM HYDROGEN CITRATE 2345 250MG USP TABLETS DISULFIRAM ESPERAL2346 INJECTION USP DOBUTAMINE TABLETS2347 INJECTION USP DOBUTAMINE Edna Medicals (Pvt) 2348 INJECTION USP DOBUTAMINE 2349 ANHYDROUS DOCETAXEL 2350 INJECTION 40MG/1ML DOCETAXEL DONATAXEL2351 INJECTION DOCETAXEL INJECTION Emerchemie NB 2352 INJECTION 20MG IN DOCETAXEL 2353 INJECTION 20MG/2ML DOCETAXEL 20 ZYTAX 2354 INJECTION DOCETAXEL INJECTION2355 INJECTION DOCETAXEL Hemas 2356 INJECTION DOCETAXEL I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 209 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIA 25-Apr-18 Full INDIAINDIA 04-Sep-14INDIA Full 06-Jan-18INDIA Full 17-Jul-16INDIA Full 27-Feb-18AUSTRALIA Full 27-Feb-18 17-Oct-14 Full Full SUADI ARABIA 10-Nov-15 Full Cipla LtdUnited Biotech INDIA(Pvt) Ltd Cipla Ltd 25-Jun-18Cipla Ltd Provisional INDIAAdley Formulation INDIA INDIA 25-Jun-19ADMAC Lifesciences 30-Apr-14 Full 25-Jun-17Years Two Celon Full Laboratories Ltd Zydus Hospira Oncology (Pvt) Ltd Therdose Pharma (Pvt) Ltd Therdose Pharma (Pvt) Ltd Riyadh Pharma Medical &Cosmetic Products Dexa MedicaT P INDONESIA 25-Oct-18 Full Contract Manufacuring & Packging Services pty Ltd (Contd.) (Pvt) Ltd Health (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd Healthcare lanka Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Ltd Alaris Lanka (Pvt) Ltd CAPSULES SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP DOCETAX INJECTION Breathe Free Lanka DOCETEC 80 INJECTIONDOCETAX George Steuart DOCETAX INJECTIONADOXI Breathe Free Lanka INJECTION Breathe Free Lanka 120ADMOXEL INJECTION INJECTION Sunshine 80CELTERE Slim INJECTIONN/A Medmart Pharma 20NOVOTAXEL INJECTION INJECTION 80NOVOTAXEL Novachem Lanka INJECTION Hemas NATOCARE Pharma R N Vision GELETIN SOFT WAXSOL EAR DROPS Hemas CONCENTRATE 20MG/0.5ML+1.5ML 20MG/0.5ML+1.5ML CONCENTRATE SOLVENT CONCENTRATE 80MG/2ML CONCENTRATE 80MG/2ML CONCENTRATE 80MG/2ML CONCENTRATE 80MG/2ML USP CONCENTRATE 120MG/3ML 80MG/2ML 80MG/8ML INFUSION 20MG/2ML INFUSION 80MG/2ML 200MG & ELCOSAPENTAENOIC 40MG FROM 800MG (EPA) ACID +FOLIC OF FISH OIL IODIDE 500MCG+POTASIUM 150mg iodine To 199.6MG EQV. 0.5% 2357 INJECTION DOCETAXEL 2358 INJECTION DOCETAXEL 2359 INJECTION DOCETAXEL 2360 INJECTION DOCETAXEL 2361 INJECTION DOCETAXEL 2362 INJECTION USP DOCETAXEL 2363 INJECTION USP DOCETAXEL 2364 INJECTION USP DOCETAXEL 2365 SOLUTION FOR DOCETAXEL 2366 SOLUTION FOR DOCETAXEL 2367 DOCOSAHEXAENOIC ACID (DNA) 2368 SODIUM EAR DROPS DOCUSATE 2369 10MGTABLETS DOMPERIDONE VOMETA TABLETS Baur & Co (Pvt) A 210 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIA 08-Feb-18 Years Two INDIABANGLADESH 04-Aug-16 29-Aug-14 Full Full BELGIUM 26-Jun-18PAKISTAN Provisional 23-Oct-17INDIA Full INDIA 18-Oct-15 Full PAKISTAN 29-Jan-15 13-Dec-17 Full BANGLADESH Years Two 08-Jan-16 Full PAKISTAN 10-Jun-15 Full SRI LANKA 31-Mar-17Years Two Micro Labs Ltd INDIA 25-Oct-17Pharmaceuticals Ltd Full Cadila pharmaceuticals Ltd Marksons Pharma Ltd Janssen Pharmaceuticals NV Torrent Pharmaceuticals Ltd Laboratories (Pvt) Ltd Platinum Pharmaceuticals (Pvt) Ltd Cadila pharmaceuticals Ltd Pharmaceuticals Ltd Industries (Pvt) Ltd/DIS. By Mackwood &Phillips Co. Pakistan Ltd (Contd.) (Pvt) Ltd Healthcare lanka Ltd Browns & Company Plc Kamazu (Pvt) Ltd Micro Labs Ltd INDIA 22-Aug-15 Full Pettah Pharmacy (Pvt) Ltd Ltd George Steuart Health (Pvt) Ltd Sunshine Healthcare lanka Ltd PharmAce (Pvt) Ltd Square Ceyoka (Pvt) Ltd Karach Chemical N/A Inter Pharm (Pvt) SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP TABLETS TABLETS SUSPENSION SUSPENSION SUSPENSION SUSPENSION SUSPENSION SUSPENSION MARKDOME 10 DISPERSIBLE 10MOTIFAST TABLETSGASTRIUM-DT PharmAce (Pvt) Ltd DISPERSIBLE Square MOTILIUM ORAL DOMISET ORAL DOMSTAL SUSPENSIONDOMPERON Edna Medicals (Pvt) ORAL VOMILUXMOTIGUT SUSPENSION Morison PLC ORAL TYPERDON ATCO ORAL DPERON ORAL TABLETS 10MG TABLETS 10MG TABLETS 10MG TABLETS 1MG/ML 1MG/ML 1MG/ML 1MG/ML 5MG/5ML 5MG/5ML 5MG/5ML 5MG/5ML 2371 10MGTABLETS DOMPERIDONE EMELIUM2372 DOMPERIDONE DISPERSIBLE 2373 DOMPERIDONE DISPERSIBLE TABLETS Micro Mega Lanka 2374 DOMPERIDONE DISPERSIBLE 2375 SUSPENSION DOMPERIDONE ORAL 2370 10MG DOMPERIDONE TABLETS DOMPERON TABLETS Sunshine 2376 SUSPENSION DOMPERIDONE ORAL 2377 SUSPENSION DOMPERIDONE ORAL 2378 SUSPENSION DOMPERIDONE ORAL 2379 SUSPENSION DOMPERIDONE ORAL 2380 SUSPENSION DOMPERIDONE ORAL 2381 SUSPENSION DOMPERIDONE ORAL 2382 SUSPENSION DOMPERIDONE ORAL I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 211 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 PAKISTAN 24-Mar-17 Full INDIAINDIA 07-Jan-16 Full INDIA 04-Nov-16 Full INDIA 04-Nov-17INDIA Full 30-Jun-14PAKISTAN Full 17-Feb-18 Years Two 02-Oct-14BANGLADESH 05-Feb-16 Full Full BANGLADESH 13-May-18 Full INDONESIA 10-Jan-14INDIA Full 15-Jul-17 Full Fozen Pharmaceutical Industries Pvt Ltd Polipharm Co Ltd THAILAND 23-May-17 Full Bliss GVS Pharma Ltd Bliss GVS Pharma Ltd Bliss GVS Pharma Ltd Navana Pharmaceuticals Ltd MMC Healthcare Ltd Unijules Life Sciences Ltd Pharmaceuticals (Pvt) Ltd Intermed INDIA 11-Oct-15 Full Incepta Pharmaceuticals Ltd Pharmaceuticals Ltd P T T Ferron P Pharmaceutical, Indunesia /Dexa Medica Indonesia (Contd.) Tropical Pharma Tropical (Pvt) Ltd Bio Tech Pharma Bio Tech (Pvt) Ltd Healthcare lanka Ltd Healthcare lanka Ltd Healthcare lanka Ltd Co Ltd Ltd Lifeline Pharmaceuticals (Pvt) Ltd PharmAce (Pvt) Ltd Alina Combine Salveo Pharma (Pvt) Ltd (Pvt) Ltd A Baur & Co (Pvt) A Ltd SUSPENSION SUSPENSION SUSPENSION Markss HLC (Pvt) SUSPENSION SUSPENSION SUSPENSION SUSPENSION SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP RAZIM ORAL DOMPERDONE ORAL VOMVIN 10 SUPPOSITORY Sunshine VOMVIN 30VOMVIN 60DOMPI SUSPENION Sunshine PERIDONE Sunshine ORAL ALMEDON ORAL DOMLINPERIDOM SUSPENSION Darley Butler & ORAL OMIDON SUSPENSION Citihealth Imports VOMETA ORAL 5MG/5ML 5MG/5ML 10MG 30MG 60MG 1MG/1ML 1MG/1ML 1MG/1ML 5MG/5ML 5MG/5ML 5MG/5ML 5MG/5ML 2383 SUSPENSION DOMPERIDONE ORAL 2384 SUSPENSION DOMPERIDONE ORAL 2385 DOMPERIDONE SUPPOSITORIES 2386 DOMPERIDONE SUPPOSITORIES 2387 DOMPERIDONE SUPPOSITORIES 2388 DOMPERIDONE SUSPENSION 2389 DOMPERIDONE SUSPENSION 2390 DOMPERIDONE SUSPENSION 2391 DOMPERIDONE SUSPENSION 2392 DOMPERIDONE SUSPENSION 2393 DOMPERIDONE SUSPENSION 2394 DOMPERIDONE SUSPENSION 2395 5MG/5ML DOMPERIDONE SYRUP MOTINORM SYRUP PharmAce (Pvt) Ltd Medley 212 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 01-Jan-15 Full BANGLADESH 06-Dec-16 09-Oct-17 Years Two Full PAKISTAN 10-May-18 Years SRI LANKA Two 13-Jun-18 Provisional PAKISTAN 23-Oct-17BANGLADESH Years Two 09-Oct-19 Full BANGLADESH 11-Dec-14 Full BANGLADESH 25-Mar-17 Full INDIABANGLADESH 24-Jul-14 29-Dec-14 Full Full INDIA 28-Apr-15 Full Pharmaceuticals Ltd Navana Pharmaceuticals Ltd Laboratories (Pvt) Ltd Pharmaceuticals Manufacturer Corporation Platinum Pharmaceuticals (Pvt) Ltd Navana Pharmaceuticals Ltd Pharmaceuticals Ltd Medicon Pharmaceuticals Ltd Fourrts (India) Laboratories Ltd Chemical Industries Pondchy Pharmaceuticals Torrent Torrent Pharmaceuticals Ltd (Contd.) Co Ltd Health (Pvt) Ltd Co Ltd (Pvt) Ltd Healthcare lanka Ltd Pharmaceuticals (Pvt) Ltd Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP 2397 10MGTABLETS DOMPERIDONE MOTINORM2398 10MG BP TABLETS DOMPERIDONE DOMILIN TABLETS2399 10MG BP TABLETS DOMPERIDONE PharmAce (Pvt) Ltd VOMILUX TABLETS Medley 2400 10MG BP TABLETS DOMPERIDONE Darley Butler & N/A TABLETS Morison PLC2401 10MG BP TABLETS DOMPERIDONE DOMISET ATCO TABLETS2402 10MG BP TABLETS DOMPERIDONE TABLETS DOMILIN N/A2403 10MG BP George Steuart TABLETS DOMPERIDONE MOTIGUT TABLETS2404 10MG BP TABLETS DOMPERIDONE Darley Butler & State TABLETS DORIDON2405 10MG BP PharmAce (Pvt) LtdTABLETS DOMPERIDONE Square TABLETS DOMPERIT2406 Act Enterpriese 10MG BP TABLETS DOMPERIDONE TABLETS VAVE Sunshine 2407 10MG BP TABLETS DOMPERIDONE DOMDONE TABLETS TABLETS CIC Holdings PLC Advanced Neon 2396 10MGTABLETS DOMPERIDONE DOMSTAL TABLETS Edna Medicals (Pvt) I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 213 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAPAKISTAN 07-Apr-14 10-Jun-15 Full Full INDIAINDIA 20-Nov-15BANGLADESH Full 21-Jan-17 16-Feb-17 Full Full SRI LANKA 15-Sep-15INDIA Full 19-Mar-14INDONESIA Full 26-Feb-14SRI LANKA Full 25-May-16BANGLADESH 03-Jun-17 Full Years Two SRI LANKA 22-Dec-15 Full Delta Pharma Ltd BANGLADESH 09-Sep-15MMC Healthcare Full Ltd Industries (Pvt) Ltd/DIS. By Mackwood &Phillips Co. Pakistan Zim Laboratories Ltd Incepta Pharmaceuticals Ltd Ltd Pharmaceuticals Medochemie Ltd CYPRUS T Dankos P 11-Nov-15Farma Full (Ceylon) (Pvt) Ltd Beximco Pharmaceuticals Ltd Ltd Healthcare Ltd (Contd.) Pharmaceuticals (Pvt) Ltd Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Laboratories (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Ceylon) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP 2411 10MG BP TABLETS DOMPERIDONE 10 DOLONIT TABLETS Kamazu (Pvt) Ltd Syncom 2408 10MG BP TABLETS DOMPERIDONE DEGUT TABLETS Hyena 2409 10MG BP TABLETS DOMPERIDONE DOMPITAB2410 10MG BP TABLETS DOMPERIDONE TYPERDON TABLETS TABLETS Markss HLC (Pvt) Ceyoka (Pvt) Ltd Karach Chemical 2412 10MG BP TABLETS DOMPERIDONE DOM 102413 10MG BP TABLETS DOMPERIDONE OMIDON TABLETS2414 10MG BP TABLETS DOMPERIDONE Tabrane N/A TABLETS2415 10MG BP TABLETS DOMPERIDONE EMITOP Citihealth Imports 2416 10MG BP TABLETS DOMPERIDONE COSTI 10MG TABLETS TABLETS2417 TABLETS 10MG BP TABLETS DOMPERIDONE N/A DOMETICAssociates Pharma The Madras Associated 2418 10MG BP TABLETS DOMPERIDONE TABLETS N/A2419 10MG BP TABLETS DOMPERIDONE Inter Pharm (Pvt) DEFLUX Hemas 2420 10MG BP TABLETS DOMPERIDONE TABLETS DPERON TABLETS N/A Emerchemie NB TABLETS N/A M S J Industries Inter Pharm (Pvt) 214 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIA 19-Jul-15INDIA Full INDIA 22-May-18 Years Two 22-May-18 Years Two BANGLADESH 07-May-14 Full INDONESIA 28-Dec-17INDIA Years Two INDIA 12-Jan-18 Provisional INDIA 11-Jan-18 Provisional INDIA 12-May-17 Full 11-Mar-15 Full INDIAINDIA 24-Jul-15 16-May-14 Full Full Brussels Laboratories (Pvt) Ltd Micro Labs Ltd INDIASun Pharmaceutical industries 11-Mar-15Sun Pharmaceutical industries Full Micro Labs Ltd INDIAPharmaceuticals Ltd 11-Mar-18Farma Full Eisai Pharmaceticals India Pvt Ltd Eisai Pharmaceticals India Pvt Ltd Pharmafabrikon Unit Pharma Torrent Germany Rel Abbott Healthcare SAS,France for Abbott Health Care Products BV Nethalnad SG Pharma (Pvt) Ltd Healthcare Vital (Pvt) Ltd (Contd.) Supplies (Pvt) Ltd (Pvt) Ltd (Ceylon) Ltd (Ceylon) Ltd (Pvt) Ltd Ltd Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmacy (Pvt) Ltd (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP MOTIVIN 10 TABLETS Innovative Medical DONEZEL 10MGDOPEZIL TABLETS TABLETS Micro Mega Lanka 5MGDOPEZOL Emerchemie NB TABLETSDONEZEL Emerchemie NB ELZER 5 TABLETS Micro Mega Lanka GERSIA TABLETS 10ARICEP PharmAce (Pvt) Ltd Square TABLETS TABLETS 5ARICEP Hemas Health Care Dankos T P Baur & Co (Pvt) A TABLETSNEPEZ 5 5MGTORPEZIL Baur & Co (Pvt) A TABLETS TABLETS Novachem Lanka Hemas DOPASOLN/A INJECTION The Esses INJECTION International Yaden 10MG TABLETS 10MG TABLETS 10MG TABLETS 5MG TABLETS 5MG TABLETS 5MG TABLETS 5MG TABLETS 10MG IP TABLETS 5MG IP TABLETS 5MG IP TABLETS 5MG USP TABLETS USP 40MG/ML 40MG/5ML INJECTION USP 2421 USP DOMPERIDONE TABLETS 2422 HYDROCHIORIDE DONEPEZIL 2423 HYDROCHIORIDE DONEPEZIL 2424 HYDROCHIORIDE DONEPEZIL 2425 HYDROCHIORIDE DONEPEZIL 2426 HYDROCHIORIDE DONEPEZIL 2427 HYDROCHIORIDE DONEPEZIL 2428 HYDROCHIORIDE DONEPEZIL 2429 HYDROCHIORIDE DONEPEZIL 2430 HYDROCHIORIDE DONEPEZIL 2431 HYDROCHIORIDE DONEPEZIL 2432 HYDROCHLORIDE DOPAMINE 2433 HYDROCHLORIDE FOR DOPAMINE I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 215 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 24-Aug-15 Full 08-Apr-15 Full FRANCE 01-Jul-15TURKEY Full 23-Mar-18INDIA Full INDIA 19-Jul-18 Full TURKEY 13-Oct-16 Full 29-Mar-18INDIA Years Two INDIA 23-Apr-15 Full 23-Nov-18 Full PharmaceuticalS (Pvt) Ltd Micro Labs Ltd INDIALaboratoire Merck Sharp & Dohme France for Merck Sharp & Dohme 08-Feb-14Ltd UK Full Sunway Rohto Pharmaceutical Pvt Ltd Indoco Remedies India Medicine World Ilac san ve Amanta Healthcare Ltd Medicine World Ilac san ve Amanta Healthcare Ltd PharmaceuticalS (Pvt) Ltd Cipla Ltd INDIA 11-Jul-16 Full Micro Labs Ltd INDIAMicro Labs Ltd INDIA 20-May-17Years Two 17-Apr-17Years Two (Contd.) Ltd Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Citihealth Imports (Pvt) Ltd Slim Pharmaceuticals (Pvt) Ltd Citihealth Imports (Pvt) Ltd Ceyoka (Pvt) Ltd Ciron Drugs & Breathe Free Lanka (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd OPHTHALMIC SOLUTION SOLUTION OPHTHALMIC SOLUTION SOLUTION SOLUTION SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP N/A INJECTION Ceyoka (Pvt) Ltd Ciron Drugs & ALEMBIC AUGDOR MISOPTCOSOPT EYE DROPS SMM Halcyon (Pvt) EYE DROPS Baur & Co (Pvt) A ZOLICHEK-T EYE DROPSDORZASPOT Hemas EYE DROPSALEMBIC Slim DOREMDIC N/ADORZOX OPHTHALMIC OPHTHALMIC DOTHIP-25 TABLETS Micro Mega Lanka DOTHIP-75 TABLETS Micro Mega Lanka BP 40MG/ML BP HYDROCHLORIDE2%+TIMOLOL HYDROCHLORIDE2%+TIMOLOL 0.5% W/V OPHTHALMIC MALEATE SOLUTION USP OPHTHALMIC OPHTHALMIC 0.5% EYE MALEATE 2% &TIMOLOL DROPS 5MG MALEATE 20MG &TIMOLOL EYE DROPS OPTHALMIC SOLUTION 2% W/V OPTHALMIC SOLUTION 20MG/ML OPHTHALMIC SOLUTION 2% W/W TABLES BP 25MG BP TABLES TABLES BP 75MG BP TABLES 2434 STERILE CONCENTRATE DOPAMINE 2435 DORZO 2436 0.5% DORZOLAMIDE 2% +TIMOLOL 2437 0.5% DORZOLAMIDE 2% +TIMOLOL 2438 DORZOLAMIDE EYE DROPS 2% DORZAMED2439 2% DORZOLAMIDE EYE DROPS BP DORZOWAY OPHTHALMIC 2440 EYE DROPS DORZOLAMIDE HYDROCHLORIDE International Yaden 2441 DORZOLAMIDE HYDROCHLORIDE 2442 DORZOLAMIDE HYDROCHLORIDE 2443 DORZOLAMIDE HYDROCHLORIDE 2444 DOSULEPIN HYDROCHLORIDE 2445 DOSULEPIN HYDROCHLORIDE 2446 DOSULEPIN HYDROCHLORIDE 216 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 29-May-18 Provisional 20-Jun-17 Years Two INDIAITALY 30-Jan-14INDIA Full 11-Sep-17INDIA Full 23-May-15INDIA Full 23-May-15INDIA Full 15-Jun-15INDIA Full 15-Jun-15 Full 10-Nov-15BANGLADESH Full 08-May-14 Full INDIABANGLADESH 30-Oct-14 06-Feb-17 Full Full zer Italy fi Centurion Laboratories Pvt Ltd Adley Formulation INDIALaboratories Ltd 19-Apr-14 Actavis Italy S.P.A For p Full Parenteral Drugs Ltd INDIA Cipla LtdBeacon Pharmaceuticals INDIALtd 03-Apr-14Beacon Pharmaceuticals Full Ltd Acme Formulation (Pvt) Ltd (Pvt) Ltd Belco Pharma (Pvt) Ltd (Pvt) Ltd Belco Pharma (Pvt) Ltd Therdose Pharma (Pvt) Ltd (Contd.) (Pvt) Ltd Healthcare lanka Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd (Ceylon) Ltd (Ceylon) Ltd Healthcare lanka Ltd Pharmatec (Pvt) Ltd Belco Pharma Leader Pharma Agency Pvt Ltd Pharmatec (Pvt) Ltd Belco Pharma Leader Pharma Agency Pvt Ltd Novachem Lanka (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP INJECTION INJECTION INJECTION INJECTION INJECTION DOXORUBIN INJECTIONADRIBLASTINA INJECTION Ceyoka (Pvt) Ltd Khandelwal ADROWIN 10 Hemas POWDER ADROWIN 10 POWDER ADROWIN 50 POWDER FOR ADROWIN 50 POWDER FOR 50DOXOPAR INJECTIONONCODOX 10 Omacx Healthcare INJECTIONXORUBIN 10 Citihealth Imports INJECTIONDOXOTHER 10 Emerchemie NB POWDER / XORUBIN 50 INJECTION Emerchemie NB 50MG USP 50MG USP 10MG FOR INJECTION BP 10MG FOR INJECTION BP 50MG FOR INJECTION BP 50MG FOR INJECTION BP FOR INJECTION USP INJECTION 50MG(LYOPHLIZED 10MG INJECTION USP 10MG INJECTION USP 10MG INJECTION USP 50MG INJECTION USP 2448 50MG DOXEPIN CAPSULES BP N/A2449 10MG/5ML DOXORUBICIN HCL ADRIB2450 DOXORUBICIN HYDROCHLORIDE CAPSULES2451 DOXORUBICIN HYDROCHLORIDE International Yaden INJECTION2452 Sunshine DOXORUBICIN HYDROCHLORIDE 2453 DOXORUBICIN HYDROCHLORIDE 2454 DOXORUBICIN HYDROCHLORIDE 2455 DOXORUBICIN HYDROCHLORIDE 2456 DOXORUBICIN HYDROCHLORIDE 2457 DOXORUBICIN HYDROCHLORIDE 2458 DOXORUBICIN HYDROCHLORIDE 2459 DOXORUBICIN HYDROCHLORIDE 2460 DOXORUBICIN HYDROCHLORIDE 2447 25MG B.P TABLES DOTHIEPIN PROTHIADEN TABLETS Sunshine I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 217 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 22-Jul-18INDIA Full 05-Apr-16 Full 30-Jan-15INDIA Full INDIA 07-Aug-15 Full INDIA 21-Jul-14 Full 19-Apr-16 Full INDIAINDIA 21-Sep-14 Full INDIA 31-Aug-18 Full 01-Mar-16 Full Getwell Pharmaceuticals Sun Pharmaceutical industries Laboratories Ltd Adley Formulation INDIAG D Laboratories (India) Pvt Ltd 22-Apr-14Agio Full Pharmaceuticals Ltd Lincolin Pharmaceuticals Micro Labs Ltd INDIAMedochemie Ltd CYPRUS 20-Jan-18 05-Jan-14Laboratories (Pvt) Ltd Full Full Pharmaceuticals (India) Ltd Macleods Pharmaceuticals Ltd Micro Labs Ltd INDIARemedica limited CYPRUS 12-Feb-17 22-Feb-17 Full Full (Contd.) Pharmacy (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Healthcare lanka Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Imports (Pvt) Ltd (Pvt) Ltd Laboratories (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd Drugs (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP XORUNWEL-L INJECTION The Esses CHEMODOX INJECTIONDOXORUBIN Hemas INJECTIONADRIB Ceyoka (Pvt) Ltd Khandelwal GDDOX INJECTION Sunshine AGIDOX 100 CAPSULES CAPSULES Lifeline ALLDOX Citihealth Imports MICRODOX CAPSULESMEDOMYCIN CAPSULES & J Pharma T Micro Mega Lanka CAPSULESDOXYLEB Associated CAPSULESDOXY-DT Ceyoka (Pvt) LtdREVIDOX TABLETS Leben PharmAce (Pvt) Ltd Aurochem MICRODOX-DT TABLETS TABLETSREMYCIN Pettah Pharmacy Micro Mega Lanka TABLETS Kandana Food & LIPOSOME INJECTION 20MG/10ML LIPOSOME INJECTION 2MG/ML 10MG INJE USP 50MG/25ML 100MG 100MG 100MG 100MG 100MG 100MG 100MG BP TABLETS 100MG USP 100MG TABLETS 100MG 2461 DOXORUBICIN HYDROCHLORIDE 2462 DOXORUBICIN HYDROCHLORIDE 2463 DOXORUBICIN HYDROCHLORIDE 2464 DOXORUBICIN INJECTION USP 2465 DOXYCYCLINE CAPSULES B.P 2466 DOXYCYCLINE CAPSULES B.P 2467 DOXYCYCLINE CAPSULES B.P 2468 DOXYCYCLINE CAPSULES B.P 2469 DOXYCYCLINE CAPSULES B.P 2470 DOXYCYCLINE CAPSULES B.P 2471 DOXYCYCLINE DISPERSIBLE 2472 TABLETS DOXYCYCLINE HYCLATE 2473 DOXYCYCLINE MONOHYDRATE 2474 USP DOXYCYCLINE TABLETS 218 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIA 19-Nov-14INDIA Full 22-Mar-18GERMANY Full 13-Jan-16 Full INDIAINDIA 14-Dec-17 Years Two PAKISTAN 04-Aug-17 Years Two PAKISTAN 27-Apr-18 Provisional 19-Apr-14PAKISTAN Full PAKISTAN 27-Apr-18 Provisional 12-Aug-17PAKISTAN Full 28-Apr-18PAKISTAN Years Two 23-Aug-17BANGLADESH Years Two 04-Aug-14 Full Sai Mirra Innopharm (Pvt) Ltd Wallace Labotatories (Pvt) Ltd for Wallace Pharmaceuticals (Pvt) Ltd Bayer Weiner GmbH & Co. KC Germany for AG Bayer Pharma Germany OBS Pakistan (Pvt) Ltd Getz Pharma Pakistan (Pvt) Ltd OBS Pakistan (Pvt) Ltd Company Ltd Laboratories (Pvt) Ltd Company Ltd Pharmaceuticals Ltd Sun Pharmaceutical industries Sun Pharmaceutical industries (Contd.) Healthcare lanka Ltd Ltd Pharmaceuticals (Pvt) Ltd (Ceylon) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Hemas Pharmaceuticals (Pvt) Ltd Hemas Pharmaceuticals (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP TABLETS TABLETS ACIFREE-O SUSPENSION Sunshine DIOVOL TABLETSYAZ Emar Pharma (Pvt) DRONIB TABLETS Hemas DELSLA FILM COA FILM COA 250MG,MAGNE HYDRACHLORIDE 250MG + SIMETHICONE 50MG SUSPENSION 240MG,MAGNESIUM HYDROXIDE 100MG+MAGNISIUM CARBONATE DIMETHI 25MG ACTIVA, 60MG TABLETS 0.02MG 3MG+EHYNYLESTRADIOL TABLETS 0.02MG 3MG+EHYNYLESTRADIOL TABLETS 0.03MG 3MG+EHYNYLESTRADIOL TABLETS 2475 DRIED ALUM.HYDROX.GEL 2476 ALUMINIUM HYDROXIDE GEL DRIED 2477 DROSPIRENONE 2478 DROSPIRENONE 2479 DROSPIRENONE 2480 DULOXETINE CAPSULES 20MG2481 C-YALTA DULOXETINE CAPSULES 20MG LYTA2482 CAPSULES DULOXETINE CAPSULES 20MG Emerchemie NB 2483 C-YALTA DULOXETINE CAPSULES 20MG CAPSULES2484 ZENBAR DULOXETINE CAPSULES 30MG Hemas CAPSULES ILARIO 30 Mansel (Ceylon) 2485 TABLETS DULOXETINE CAPSULES 30MG CAPSULES2486 ZENBAR DULOXETINE CAPSULES 60MG Morison PLC PharmAce (Pvt) Ltd DILINER DR Wilshire The Searle CAPSULES CAPSULES Morison PLC PharmAce (Pvt) Ltd Square The Searle I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 219 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 PAKISTAN 23-Aug-17INDIA Full INDIA 02-Nov-17 Years Two BANGLADESH 09-Nov-17 19-Mar-16 Years Two Full PAKISTAN 25-Oct-15INDIA Full INDIA 24-Jun-18 Full INDIA 24-Jun-18 Full INDIA 24-Jun-18 Provisional INDIA 24-Jun-18 Provisional INDIA 18-Dec-17INDIA Years Two 26-Nov-17INDIA Full 28-May-14INDIA Full 14-Dec-17 Years Two 27-Jun-18 Full Company Ltd Zim Laboratories Ltd Zim Laboratories Ltd Pharmaceuticals Ltd Hilton Pharma (Pvt) Ltd Sun Pharmaceutical industries Sun Pharmaceutical industries Sun Pharmaceutical industries Sun Pharmaceutical industries India Ltd Care (Pvt) Ltd Crescent Therapeutics Ltd India Ltd India Ltd (Contd.) Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Healthcare lanka Ltd (Ceylon) Ltd (Ceylon) Ltd (Ceylon) Ltd (Ceylon) Ltd (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP DULOX 30 CAPSULESDULOX 60 Tabrane CAPSULESDILINER DR Tabrane CAPSULESDULAN 30 PharmAce (Pvt) Ltd Square CAPSULES 20DUZELA Sunshine CAPSULES 20DUZELA Emerchemie NB CAPSULESDUZELA Emerchemie NB 60DUZELA CAPSULES Emerchemie NB CAPSULES 20LOXEPIL Emerchemie NB DULOTOR TABLETSAMBIDEXT PharmAce (Pvt) Ltd CAPSULES Psychotropics 30LOXEPIL Harcourts (Pvt) Ltd TABLETS Health Tech Pell 60LOXEPIL TABLETS Euro Asian Pharma TABLETS PharmAce (Pvt) Ltd Psychotropics PharmAce (Pvt) Ltd Psychotropics CAPSULES USP 30MG CAPSULES USP 60MG CAPSULES USP CAPSULES 30MG CAPSULES 30MG CAPSULES DR 20MG CAPSULES DR 20MG CAPSULES DR 30MG CAPSULES DR 60MG 20MG TABLETS 30MG TABLETS 30MG TABLETS 30MG TABLETS 60MG TABLETS 2487 DULOXETINE CAPSULES 60MG ZENBAR TABLETS Morison PLC The Searle 2488 RELEASE DULOXETINE DELAYED 2489 RELEASE DULOXETINE DELAYED 2490 DULOXETINE HYDROCHLORIDE 2491 DULOXETINE HYDROCHLORIDE 2492 DULOXETINE HYDROCHLORIDE 2493 DULOXETINE HYDROCHLORIDE 2494 DULOXETINE HYDROCHLORIDE 2495 DULOXETINE HYDROCHLORIDE 2496 DULOXETINE HYDROCHLORIDE 2497 DULOXETINE HYDROCHLORIDE 2498 DULOXETINE HYDROCHLORIDE 2499 DULOXETINE HYDROCHLORIDE 2500 DULOXETINE HYDROCHLORIDE 220 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 POLAND 11-Feb-18 Full NETHERLANDS 16-Oct-15PAKISTAN Full 26-Jun-14MALAYSIA Full 01-Dec-14 Full BELGIUM 28-Oct-17BELGIUM Years Two 28-Oct-17BANGLADESH Years Two 06-Oct-16MALAYSIA Full 27-Jan-14MALAYSIA Full 18-Aug-17BANGLADESH 06-Apr-18 Full Years Two BANGLADESH 06-Apr-18 Years Two INDIA 13-Feb-15 Full Pharma Fabrikon INDIA 12-Mar-18Years Two GlaxoSmithkiline Pharmaceuticlas (Pvt) Ltd Pharmix Laborateries (Pvt) Ltd SDN BHD Cipla LtdBV INDIA 26-Feb-14 Full Janssen Pharmaceuticals NV Pharmaceuticals Ltd Pharmaceuticals SDN BHD SDN BHD General Pharmaceuticals Ltd General Pharmaceuticals Ltd SG Pharma (Pvt) Ltd Janasen Pharmaceuticals N V (Contd.) (Pvt) Ltd Health (Pvt) Ltd Health (Pvt) Ltd Pharmacy (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd Pharmaceuticlas Ltd Breathe Free Lanka (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP CREAM George Steuart CREAM George Steuart CAPSULES PEVISONE CREAMPEVITIN CREAM CREAM Pettah Pharmacy ECOCORT PharmAce (Pvt) Ltd Square CREAMECONAZINE CREAM Indoscan (Pvt) Ltd TRICODERMA Hoe CREAM Indoscan (Pvt) Ltd Industries / S P Y TRICODERMA 10G N/A INJECTION The Esses AVODART CAPSULES Glaxo Smithkiline DUPROST GELETIN SOFT HIRONEN/A TABLETS Lanka (Pvt) Tabrane PESSARIES Indoscan (Pvt) Ltd Industries / S P Y TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE 1MG CREAM USP TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE CREAM TRIAMCINOLONE ACETONIDE 0.1% CREAM TRIAMCINOLONE ACETONIDE 0.1% CREAM TRIAMCINOLONE ACETONIDE BP 0.1%W/W CREAM +TRIAMCINOLONE ACETONIDE BP 0.1% W/W CREAM 200MG/ML INJECTION USP 0.5MG 0.5MG 10MG 150MG 2511 10MG & ECONAZOLE NITRATE 2507 1% CREAM ECONAZOLE NITRATE PEVARYL CREAM Pettah Pharmacy 2508 1% ECONAZOLE NITRATE 2509 1% ECONAZOLE NITRATE 2510 1% ECONAZOLE NITRATE 2512 1% BP ECONAZOLE NITRATE 2513 1%W/W BP ECONAZOLE NITRATE 2514 CALCIUM DISODIUM EDETATE 2502 CAPSULES SOFT DUTASTERIDE 2501 20MGTABLETS DULOXETINE DULOCINE 20 TABLETS Novachem Lanka 2503 CAPSULES SOFT DUTASTERIDE 2505 USP DYDROGESTERONE TABLETS 2506 PESSARIES BP ECONAZOLE NITATE 2504 DYDROGESTERONE 10MG DUPHASTON TABLETS CIC Holdings PLC Abbott Biological I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 221 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 25-Oct-18 Years Two INDIABANGLADESH 12-Oct-17 18-Sep-18 Years Two Provisional UNITED KINGDOM INDIA 24-Oct-17 Years Two BANGLADESH 11-Oct-18 Years Two BANGLADESH 06-Apr-18 Years Two GERMANY 23-Jan-18BANGLADESH Provisional 26-Nov-18 Years Two GERMANY 25-Jan-18 Provisional INDIAPAKISTAN 07-Jul-16 18-Jun-18 Full Provisional Hetero Labs Ltd INDIAMeyer Organics (Pvt) Ltd 24-Sep-16Beacon Pharmaceuticals Full Ltd Glaxo Operations UK Ltd Delta Pharma Ltd BANGLADESH 30-Nov-18Years Two The Acme Laboratories Ltd Nipro JMI Pharma Ltd Boehringer Ingelheim Pharma gmBH & Co.Kg The ACME Laboratories Ltd Boehringer Ingelheim Pharma gmBH & Co.Kg Hetero Labs Ltd INDIAMacleods Pharmaceuticals Ltd 07-Jun-17OBS Pakistan (Pvt) Ltd Full Oaknet Healthcare Pvt Ltd (Contd.) (Pvt) Ltd Ltd (Ceylon) Ltd Ltd Pharmaceuticals (Pvt) Ltd Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd (Ceylon) Ltd Health (Pvt) Ltd CREAM George Steuart SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP FEROGLOBIN CAPSULES SMM Halcyon (Pvt) TENOF EM TABLETS Mansel (Ceylon) RENITEC TABLETS Emerchemie NB EFATOP PE EFATOP CREAM ACID 500MCG+VIT. B6 5MG,+ZINC ACID 500MCG+VIT. 12MG COPPER 2MG CAPSULES TABLETS FUMARATE DISOPROXIL 200MG & 300MG 10MG SODIUM LACTATE VITAMIN E+OLIVE VITAMIN SODIUM LACTATE OIL 2516 IRON 24MG+FOLIC ELEMENTAL 2517 50MGTABLETS ELTROMBOPAG ELBONIX 502518 50MGTABLETS ELTROMBOPAG TABLETS REVOLADE 50 Emerchemie NB TABLETS2520 10MG TABLETS Baur & Co (Pvt) EMPAGLIFLOZIN A EMPAZIN2521 10MGTABLETS EMPAGLIFLOZIN EMZIN 10 TABLETS2522 10MGTABLETS EMPAGLIFLOZIN 10 EMPA Hyena 2523 10MG TABLETS EMPAGLIFLOZIN TABLETS JARDIANCE 10MG TABLETS Mega Pharma (Pvt) TABLETS2524 25MGTABLETS EMPAGLIFLOZIN Hemas EMZIM 25 Imedra Healthcare 2525 25MG TABLETS EMPAGLIFLOZIN JARDIANCE 25MG TABLETS TABLETS2526 TENOFOVIR EMTRICITABINE Hemas Mega Pharma (Pvt) 2527 5MG USP MALEATE ENALAPRIL 5 MACPRIL 2528 TABLETS MALEATE ENALAPRIL TABLETS Pettah Pharmacy 2515 600MGTABLETS EFAVIRENZ ESTIVA TABLETS Mansel (Ceylon) 2519 CREAM CONTAINING EMOLIENT 222 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 GERMANY 29-Jan-15PAKISTAN Full INDIA 18-Jun-18 Full INDIA 21-Jul-15 Full INDIA 07-Jul-16 Full 24-Nov-14INDIA Full INDIA 17-Oct-17INDIA Years Two 07-Nov-17 Years Two INDIA 06-Feb-17 Full INDIA 21-Jul-15 Full 21-Jul-15INDIA Full 26-Apr-18 Provisional Denk Pharma GmbH & Co. Agio Pharmaceuticals Ltd Macleods Pharmaceuticals Ltd Stallion Laboratories Pvt Ltd Kopran LtdS Kant Healthcare INDIALtd Dr Reddy's Laboratories Ltd 28-Jan-14Cadila pharmaceuticals Ltd Full Unique Pharmaceutical Labs Agio Pharmaceuticals Ltd Kopran LtdSPMC/State INDIAPharmaceuticals Manufacturing COP 28-Jan-14 Full OBS Pakistan (Pvt) Ltd (Contd.) Pharmaceuticals (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd Ltd Co Ltd (Ceylon) Ltd Healthcare lanka Ltd Health (Pvt) Ltd (Pvt) Ltd Ltd Pharmaceuticals Manufacturing COP (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP ENA-DENK TABLETS Akbar 10AMPRIL TABLETS 10MACPRIL Citihealth Imports TABLETS 10ENSTAL Pettah Pharmacy TABLETS 10VASONORM TABLETS Siba Healthcare 10DELAPRIL Alaris Lanka (Pvt) TABLETSENAM Delmege Forsyth & ENVAS TABLETSMYOPRIL TABLETS Emerchemie NB 5AMPRIL Sunshine TABLETS George Steuart 5 TABLETSVASONORM TABLETSN/A Citihealth Imports Alaris Lanka (Pvt) TABLETS SPMC/State 10MG 5MG 10MG 10MG 10MG 10MG 10MG 10MG 10MG 10MG 5MG 5MG 2535 USP TABLETS MALEATE ENALAPRIL 2541 USP TABLETS MALEATE ENALAPRIL 2529 TABLETS MALEATE ENALAPRIL 2530 5MGTABLETS MALEATE ENALAPRIL RENITEC2531 USP TABLETS MALEATE ENALAPRIL TABLETS2532 USP TABLETS MALEATE ENALAPRIL Mansel (Ceylon) 2533 USP TABLETS MALEATE ENALAPRIL 2534 USP TABLETS MALEATE ENALAPRIL 2536 USP TABLETS MALEATE ENALAPRIL 2537 USP TABLETS MALEATE ENALAPRIL 2538 USP TABLETS MALEATE ENALAPRIL 2539 USP TABLETS MALEATE ENALAPRIL 2540 USP TABLETS MALEATE ENALAPRIL I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 223 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 20-Jan-15 Full INDIA 28-Feb-17INDIA Full 07-Nov-17 Years Two INDIA 05-Feb-17 Full INDIA 18-Nov-17 Full INDIA 27-Nov-17 Full 15-Aug-17 Full FRANCEINDIA 16-Oct-15CHINA Full 16-Aug-16 Full 04-Aug-15CHINA Full 04-Aug-15INDIA Full INDIA 27-Oct-17 Full 27-Oct-17 Full Winthrop fi Stallion Laboratories Pvt Ltd Pharmaceuticals Ltd Dr Reddy's Laboratories Ltd Cadila Laboratories Ltd Intas Pharmaceuticals Ltd Medopharm (PVT Ltd Gland Pharma (Pvt) Ltd Gland Pharma (Pvt) Ltd Shenzhen Techdow Pharmaceuticals Co Ltd Shenzhen Techdow Pharmaceuticals Co Ltd Sun Pharmaceutical industries Sun Pharmaceutical industries Industrie (Contd.) Lanka Ltd Sano fi (Pvt) Ltd (Ceylon) Ltd Healthcare lanka Ltd Co Ltd Pharmaceuticals (Pvt) Ltd Services Pvt. Ltd Services Pvt. Ltd Slim Pharmaceuticals (Pvt) Ltd Slim Pharmaceuticals (Pvt) Ltd (Ceylon) Ltd (Ceylon) Ltd INJECTION INJECTION SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP ENSTAL 5ENSTAL TABLETS 5ENCARDIL TABLETS Siba Healthcare ENAM PharmAce (Pvt) Ltd Medley 5ENVAS TABLETSENAPRIL TABLETS Emerchemie NB Sunshine N/A TABLETS Darley Butler & TABLETSCLEXANE Akbar INJECTION Sano CUTENOXN/A INJECTION ABC Pharma PROLONGIN SOLUTION FOR SOLUTION FOR 5MG 5MG 5MG 5MG 5MG 5MG 1000IU/0.1ml 40MG/0.4ML 40MG/0.4ML BP 60MG/0.6ML BP 2543 USP TABLETS MALEATE ENALAPRIL 2544 USP TABLETS MALEATE ENALAPRIL 2545 USP TABLETS MALEATE ENALAPRIL 2546 USP TABLETS MALEATE ENALAPRIL 2547 USP TABLETS MALEATE ENALAPRIL 2548 SODIUM 60MG/0.6ML ENOXAPARIN CUTENOX2549 SODIUM INJECTION ENOXAPARIN INJECTION ABC Pharma 2542 USP TABLETS MALEATE ENALAPRIL 2550 SODIUM INJECTION ENOXAPARIN 2551 SODIUM INJECTION ENOXAPARIN 2552 SODIUM INJECTION ENOXAPARIN 2553 200MGTABLETS ENTACAPONE ADCAPONE2554 200MGTABLETS ENTACAPONE TABLETS ADCAPONE Emerchemie NB TABLETS Emerchemie NB 224 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 06-Oct-16 Full 01-Jan-16 Full 17-Dec-18 Provisional INDIAIRELAND 31-Dec-17 16-May-14 Full INDIA Full 31-Dec-17 Full INDIAINDIA 30-Mar-15INDIA Full 14-Sep-17INDIA Full 10-Jun-16INDIA Full 26-May-15 Full 14-Sep-17 Full UNITED STATES INDIAUNITED KINGDOM 27-Nov-14GERMANY/ AUSTRALIA Full INDIA 05-Apr-14 Full Sun Pharmaceutical industries Allergan Pharmaceuticals Sun Pharmaceutical industries Adley Formulation INDIANaprod Life Scienc (Pvt) Ltd 10-Apr-14United Biotech (Pvt) Ltd Full Getwell Pharmaceuticals VHB Medi Sciences Ltd United Biotech (Pvt) Ltd Vital Healthcare Vital (Pvt) Ltd Martindale Pharmaceuticals Hameln Pharmaceuticals GmbH Germany Mayne Pharma (Pvt) Ltd Parenteral Drugs Ltd INDIA Catalent Pharma Solutios LLC (Contd.) Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Healthcare lanka Ltd (Pvt) Ltd George Steuart Health (Pvt) Ltd The Esses Pharmacy (Pvt) Ltd Medmart Pharma (Pvt) Ltd Health (Pvt) Ltd (Pvt) Ltd Niix Holdings (Pvt) Ltd (Pvt) Ltd Omacx Healthcare (Pvt) Ltd Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP INJECTION INJECTION INJECTION INJECTION INJECTION EPINASTRELESTAT EYE DROPS Hemas DROPSEPINAST Hemas ADRICIN EYE DROPS Hemas 4-EPEEDO-10 INJECTION INJECTION Sunshine EPIRUBITEC Ravilux Company POWDER FOR 50EPIRUBA POWDER FOR EPICIN RDEPIRUBITEC POWDER FOR INJECTION George Steuart VITADRINEN/A INJECTION International Yaden N/A SOLUTION FOR INJECTION S J Enterprises 10EPRIPAR POWDER / INJECTON 10MG INJECTON OPTHALMIC SOLUTION 0.5MG/ML OPTHALMIC SOLUTION 0.5MG/ML OPTHALMIC SOLUTION 0.5MG/ML INJECTION 50MG/25ML 50MG INJECTON 50MG INJECTON 50MG INJECTON INJECTION 10MG INJECTION BP 30MG/ML INJECTION BP 30MG/ML INJECTION BP 30MG/ML INJECTION 10MG 2563 EPIRUBICIN HYDROCHLORIDE FOR 2559 EPINASTINE HYDROCHLORIDE 2560 EPINASTINE HYDROCHLORIDE 2561 EPINASTINE HYDROCHLORIDE 2562 EPIRUBICIN HYDROCHLORIDE 2564 EPIRUBICIN HYDROCHLORIDE FOR 2565 EPIRUBICIN HYDROCHLORIDE FOR 2566 EPIRUBICIN HYDROCHLORIDE FOR 2567 EPIRUBICIN HYDROCHLORIDE 2555 CAPSULES 40MG ENZALUTAMIDE 40 XTANDI 2556 EPHEDRINE HYDROCHLORIDE CAPSULES2557 EPHEDRINE HYDROCHLORIDE Baur & Co (Pvt) A 2558 INJECTION EPHEDRINE SULPHATE 2568 EPIRUBICIN HYDROCHLORIDE I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 225 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIA 03-Jun-16ITALY Full SWITZERLAND 11-Nov-17 28-Feb-17 Full Full FRANCE 25-Apr-16 Full INDIAINDIA 17-Dec-14INDIA Full 29-Mar-18 Provisional INDIA 20-Mar-15 Full 11-Jul-17 Full zer Italy fi Getwell Pharmaceuticals Sanbe FarmaT P INDONESIA 23-Apr-15 Actavis Italy S.P.A For p Full Cilag AG International SAS,France for Abbott Health Care Products BV Nethalnad Novo Nordisk DENMARKNovo Nordisk 12-Oct-16 DENMARK Full 12-Oct-15AryoGen Pharmed IRAN Full SG Pharma (Pvt) Ltd 02-May-18 Provisional Kwality Pharmaceuticals Pvt Ltd PharmaceuticalS (Pvt) Ltd Healthcare Vital (Pvt) Ltd (Contd.) The Esses Pharmacy (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Healthcare lanka Ltd Healthcare lanka Ltd Pharmaceuticals (Pvt) Ltd Pharmacy (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd INJECTION SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP EPIRUBA 10EPIRUBA POWDER FOR RUBISANDIN INJECTIONFARMORUBICIN Lifeline INJECTION Hemas EPREXTEVETEN INJECTION Pettah Pharmacy TABLETSNOVOSEVEN CIC Holdings PLC Abbott Healthcare INJECTION Sunshine NOVOSEVEN INJECTION Sunshine SEVENARYO INJECTIONN/A Slim N/A TABLETSN/A INJECTION The Esses ERGOVITA International Yaden INJECTION INJECTION Ceyoka (Pvt) Ltd International Yaden Ciron Drugs & INJECTION 10MG INJECTION 2MG/ML INJECTION 50MG ERYTHROPOIETIN RECOMBINANT INJ. 4000IU/0.4ML 600MG HUMAN RECOMBINANT - 1MG A VII FACTOR COAGULATION (50KIU) HUMAN RECOMBINANT ( r A VII FACTOR COAGULATION FVIIA) 2 MG (100KIU) POWDER & FOR SOLUTION SOLVENT INJECTION SOLUTION FOR INJECTION 1.2MG 10,000IU 0.25MG IN 1ML 0.5MG IN 1ML 0.5MG IN 1ML 2570 EPIRUBICIN HYDROCHLORIDE 2571 EPIRUBICIN HYDROCHLORIDE 2572 HUMAN ALFA EPOETINUM 2573 TABLETS MESYLATE EPROSARTAN 2574 (ACTIVATED) ALFA EPTACOG 2575 (ACTIVATED) ALFA EPTACOG 2576 POWDER FOR ALFA EPTACOG 2577 B.P TABLETS ERGOCALCIFOROL 2578 ERGOMETRINE INJECTION BP 2579 ERGOMETRINE INJECTION BP 2580 ERGOMETRINE INJECTION BP 2569 EPIRUBICIN HYDROCHLORIDE 226 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIABANGLADESH 24-Oct-16 17-Mar-15ITALY Full Full INDIA 20-Mar-15 Full INDIA 16-Jul-16 Full ITALY 11-Jan-19 Years Two 30-Jun-14INDIA Full INDIA 16-Jul-17INDIA 31-Aug-17 Full INDIA Years Two 18-Nov-17 Years Two FRANCE 26-Dec-18 Years Two 08-Feb-14INDIA Full 28-Jan-18 Years Two Neon Laboratories Ltd Beacon Pharmaceuticals Ltd Laboratoire Merck Sharp & Dohme France for Merck Sharp & Dohme Ltd UK United Biotech (Pvt) Ltd Roche SPA VIA VIA Roche SPA Morelli 2 Pharmaceuticals International (Pvt) Ltd Jodas Expoim Pvt Ltd F Hoffman- La Roche Ltd Switzerland by Roche SPA MILAN Production site segrate-italy Pharmaceuticals Therdose Pharma (Pvt) Ltd Laboratories Ltd Jodas Expoim Pvt Ltd (Contd.) (Pvt) Ltd (Ceylon) Ltd Ltd Health (Pvt) Ltd Ltd International (Pvt) Ltd Ltd (Pvt) Ltd International (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP N/AERLONIX 150 TABLETS INJECTION Emerchemie NB Ravilux Company INVANZ INJECTIONLYORTAM Baur & Co (Pvt) A INJECTION George Steuart 0.5MG IN 1ML 150MG TABLETS VIAL INJECTION 1G 2581 ERGOMETRINE INJECTION BP 2582 ERLOTINIB HYDROCHLORIDE 2583 100MGTABLETS ERLOTINIB 2584 100MGTABLETS ERLOTINIB TARCEVA BIRLOTIB 1002585 TABLETS 150MGTABLETS ERLOTINIB TABLETS Baur & Co (Pvt) A 2586 150 JOCEVA 150MGTABLETS ERLOTINIB Associates Pharma BDR TABLETS TARCEVA Softcare 2587 150MGTABLETS ERLOTINIB TABLETS2588 150MGTABLETS ERLOTINIB Baur & Co (Pvt) A BIRLOTIB 1502589 150MGTABLETS ERLOTINIB TABLETS N/A2590 25MGTABLETS ERLOTINIB Associates Pharma ERLOTAZ BDR 2591 FOR INJECTION 1 G/ ERTAPENEM 25 JOCEVA TABLETS TABLETS Pharma R N Vision TABLETS Ceyoka (Pvt) Ltd2592 Khandelwal SODIUM FOR ERTAPENEM Softcare I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 227 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAPAKISTAN 13-Nov-16 17-Dec-17 Full PAKISTAN Years Two 11-Feb-16BANGLADESH 29-Jan-14 Full INDIA Full SRI LANKA 16-Feb-14 04-May-18 Full PAKISTAN Full 26-Nov-18INDIA Provisional CHINA 06-Jul-16 Full 03-Nov-16INDIA Full INDIA 31-Jan-18 Years Two GERMANY 16-Aug-16 14-Mar-16 Full Full Centurion Laboratories Pvt Ltd Indus Pharma (Pvt) Ltd Indus Pharma (Pvt) Ltd Incepta Pharmaceuticals Ltd Medispray Laboatories (Pvt) Ltd Pharmaceuticals Manufacturer Corporation Indus Pharma (Pvt) Ltd Torrent Pharmaceuticals Ltd Sunshine Pharmaceuticals Co Ltd Intas Pharmaceuticals Ltd Reliance Life Sciences (Pvt) Ltd Roche Diagnostics GmbH, Germany, La /F Hoffman Roche Ltd (Contd.) Yaden International Yaden (Pvt) Ltd Sunshine Healthcare lanka Ltd Healthcare lanka Ltd (Pvt) Ltd (Pvt) Ltd Healthcare lanka Ltd Ltd Pharmaceutical Ltd Services Pvt. Ltd Ltd SUSPENSION FOR SYRUP INJECTION ABC Pharma SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP N/AERYTHROCIN GRANULES ORAL ERYTHROCIN TABLETSFIRMAC 250 Sunshine TABLETS 500ERYCIP Citihealth Imports TABLETSN/A Breathe Free Lanka ERYTHROCIN TABLETS TABLETSERAZIT N/A Sunshine EPIAO GEL TOPICAL Mega Pharma (Pvt) State ERYKINE INJECTION Ceyoka (Pvt) LtdRELIPOIETIN INJECTION Shenyang 2000IU Novex RECORMON INJECTION Baur & Co (Pvt) A ORAL SUSPENSION BP 125MG/5ML SUSPENSION BP ORAL SUSPENSION ORAL SUCCINATE 125MG/5ML USP USP 250MG 500MG IP TABLETS 250MG BP TABLETS 250MG 4% W/W HUMAN INJECTION 4000IU HUMAN) INJECTION PFS 4000IU/ML HUMAN IN 2000 IU/0.5ML PRE- 5000IU/0.3ML RECOMBINANT FILLED 2594 ETHYL ERYTHROMYCIN 2595 500MG STEARATE ERYTHROMYCIN 2596 BP STEARATE ERYTHROMYCIN 2597 STEARATE ERYTHROMYCIN 2598 STEARATE ERYTHROMYCIN 2599 USP STEARATE ERYTHROMYCIN 2600 USP GEL TOPICAL ERYTHROMYCIN 2601 (ALPHA) RECO. ERYTHROPOIETIN 2602 (RECO. ALFA ERYTHROPOIETIN 2603 RECO. ALFA ERYTHROPOIETIN 2604 , HUMAN BETA ERYTHROPOIETIN 2593 SUCCINATE ETHYL ERYTHROMYCIN 228 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 03-May-18INDIA Provisional 07-Jun-18 Full 16-Aug-18SWITZERLAND Full 14-Mar-16 Full CHINA 16-Aug-16PAKISTAN Full INDIA 27-Sep-17 Full PAKISTAN 08-Jan-15 24-Feb-15 Full BANGLADESH 21-Jan-15 Full PAKISTAN Full PAKISTAN 27-Sep-17 Full 27-Feb-18INDIA Years Two 04-Apr-14 Full Serum Institute of India (Pvt) Ltd Serum Institute of India (Pvt) Ltd Reliance Life Sciences (Pvt) Ltd Intas INDIAYears Roche Diagnostics GmbH, Germany, 16-Aug-18 La /F Hoffman Roche Ltd Two Sunshine Pharmaceuticals Co Ltd OBS Pakistan (Pvt) Ltd Sun Pharmaceutical industries Hilton Pharma (Pvt) Ltd Pharmaceuticals Ltd OBS Pakistan (Pvt) Ltd Nabiqasim Industries (Pvt) Ltd Ranbaxy laboratories Ltd (Contd.) (Pvt) Ltd Citihealth Imports (Pvt) Ltd Services Pvt. Ltd Pharmaceutical Ltd Ltd (Ceylon) Ltd (Ceylon) Ltd Healthcare lanka Ltd (Pvt) Ltd Health (Pvt) Ltd Pharmaceuticals (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP INJECTION Citihealth Imports PRE-FILLED SYRINGES INJECTION ABC Pharma REPOITIN FREFILLED REPOITIN FREFILLED RELIPOIETIN 10000IU ERYKINERECORMON INJECTION INJECTION Novex Baur & Co (Pvt) EPIAO A NODEP INJECTION Ceyoka (Pvt) Ltd 10NEXITO Shenyang TABLETS TABLETS 10CITANEW Emerchemie NB Emerchemie NB TABLETSOXAPRO 5 Sunshine TABLETSNODEP PharmAce (Pvt) LtdES-PRAMCIT Square TABLETS TABLETSCILENTRA Mansel (Ceylon) George Steuart TABLETS Hemas HUMAN ERYTHROPOIETIN HUMAN ERYTHROPOIETIN 5000IU/0.3MLPRE-FILLED STRINGES 10MG 2000IU/0.5ML 4000IU/0.4ML RECO.HUMAN ERYTHROPOIETIN 10,000 IU/ML ALFA ) Injection 2000IU (ALPHA ALPHA HUMAN ERYTHROPOIETIN INJECTION 2000iU 10MG 10MG 10MG 10MG 10MG 10MG 2611 TABLETS OXALATE ESCITALOPRAM 2609 RECO. ERYTHROPOIETIN 2605 INJECTION BP ERYTHROPOIETIN 2606 INJECTION BP ERYTHROPOIETIN 2607 INJECTION BP ERYTHROPOIETIN 2608 RECO. HUMAN ERYTHROPOIETIN 2610 RECO. ERYTHROPOIETIN 2612 TABLETS OXALATE ESCITALOPRAM 2613 TABLETS OXALATE ESCITALOPRAM 2614 TABLETS OXALATE ESCITALOPRAM 2615 TABLETS OXALATE ESCITALOPRAM 2616 TABLETS OXALATE ESCITALOPRAM 2617 TABLETS OXALATE ESCITALOPRAM I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 229 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 ARGENTINA 22-Dec-17BANGLADESH Years Two 06-Oct-17 Years Two INDIAINDIA 23-Sep-14PAKISTAN Full 26-Sep-15PAKISTAN 28-Sep-18 Full Years Two 17-Feb-15INDIA Full PAKISTAN 01-Feb-17INDIA 27-Sep-17 Years Two Full PAKISTAN 08-Jan-15 11-Feb-15 Full CHINA Full 01-Apr-15PAKISTAN Full 25-Jun-15 Full Pharmaceuticals Ltd Laboratoires Bago S. A India Ltd Cassel Research Laborarories (Pvt) Ltd OBS Pakistan (Pvt) Ltd Hilton Pharma (Pvt) Ltd India Ltd OBS Pakistan (Pvt) Ltd Sun Pharmaceutical industries Hilton Pharma (Pvt) Ltd Shangdone Jewim pharmaceutical Co. Ltd Medochemie Ltd CYPRUSMedizan Laboratories (Pvt) 24-Nov-14Ltd Medochemie Ltd Full CYPRUS 28-Nov-14 Full (Contd.) Emerchemie NB (Ceylon) Ltd Healthcare lanka Ltd (Ceylon) Ltd Healthcare lanka Ltd (Ceylon) Ltd (Ceylon) Ltd Healthcare lanka Ltd (Ceylon) Ltd Celyon (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Celyon (Pvt) Ltd TABLETS SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP ECINIL 10ECINIL 10ESCIPRA TABLETS TABLETS PharmAce (Pvt) LtdNODEP Psychotropics Sunshine 20CITANEW TABLETS TABLETS 20ECINIL Emerchemie NB Sunshine NODEP TABLETS 5NEXITO PharmAce (Pvt) Ltd Psychotropine TABLETS 5 TABLETSCITANEW Emerchemie NB Emerchemie NB TABLETS 10MGEZIT Sunshine TABLETS Emerchemie NB 10MG 10MG 20MG 20MG 20MG 5MG 5MG 5MG 10MG BP 2631 5MGTABLETS ESCITALOPRAM OXAPRO 5 TABLETS PharmAce (Pvt) Ltd Square 2619 TABLETS OXALATE ESCITALOPRAM 2620 TABLETS OXALATE ESCITALOPRAM 2621 TABLETS OXALATE ESCITALOPRAM 2622 TABLETS OXALATE ESCITALOPRAM 2623 TABLETS OXALATE ESCITALOPRAM 2624 TABLETS OXALATE ESCITALOPRAM 2625 TABLETS OXALATE ESCITALOPRAM 2626 TABLETS OXALATE ESCITALOPRAM 2627 10MGTABLETS ESCITALOPRAM 10 MERSINOL 2628 20MGTABLETS ESCITALOPRAM TABLETS CIRONEX 202629 20MGTABLETS ESCITALOPRAM Associated Pharma TABLETS 20MG MERSINOL 2630 20MGTABLETS TABLETS ESCITALOPRAM Ceyline 20 BAGOCIT-S Associated Pharma FILM COA 2618 TABLETS OXALATE ESCITALOPRAM 230 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 PAKISTANPAKISTAN 09-Jul-18 Full 21-Jan-15INDIA Full PAKISTAN 21-Aug-15 08-Dec-16 Full INDIA Full PAKISTAN 16-Mar-17INDIA 09-Jul-18 Full Full INDIA 05-Sep-15 Full INDIA 20-Feb-18INDIA Full 10-Mar-18PAKISTAN Full 20-Jun-17INDIA 27-Sep-17 Full Years Two INDIA 21-Aug-15 Full INDIA 27-Jun-17 Full 10-Mar-18 Full (Pvt ) Ltd Getz Pharma Pakistan (Pvt) Ltd Akums Drugs & Pharmaceuticals Ltd Genome Pharmceuticals (Pvt) Ltd Pharmaceuticals Ltd (Pvt ) Ltd Akums Drugs & Pharmaceuticals Ltd Sun Pharmaceutical industries Pvt Ltd Akums Drugs & Pharmaceuticals Ltd OBS Pakistan (Pvt) Ltd Akums Drugs & Pharmaceuticals Ltd Akums Drugs & Pharmaceuticals Ltd Pvt Ltd (Contd.) Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Ltd (Pvt) Ltd (Ceylon) Ltd Plc (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP DEPSITAVESTALO TABLETS TABLETSESCIVEX 10 Ceyoka (Pvt) Ltd Hemas Genix Pharma TABLETSPRAMIS 10 Global Impex AV TABLETS 10DEXANIL Lanka (Pvt) Tabrane TABLETSDEPSIT PharmAce (Pvt) Ltd Concept ESCIVEX 20 TABLETS TABLETS 20NEXITO Ceyoka (Pvt) Ltd Global Impex AV Genix Pharma TABLETS Emerchemie NB 10MG 10MG 10MG 10MG 10MG 20MG 20MG 20MG 2632 USP TABLETS ESCITALOPRAM 2633 USP TABLETS ESCITALOPRAM 2634 USP TABLETS ESCITALOPRAM 2635 USP TABLETS ESCITALOPRAM 2636 USP TABLETS ESCITALOPRAM 2637 USP TABLETS ESCITALOPRAM 2638 USP TABLETS ESCITALOPRAM 2639 USP TABLETS ESCITALOPRAM 2640 5MG USP TABLETS ESCITALOPRAM 5 DEXANIL 2641 5MG USP TABLETS ESCITALOPRAM 5 ESITOPAM TABLETS TABLETS2642 5MG USP TABLETS ESCITALOPRAM PharmAce (Pvt) Ltd NODEP Consern Pharma Browns & Company 2643 5MG USP TABLETS ESCITALOPRAM ESCIVEX 5 TABLETS2644 5MG USP TABLETS ESCITALOPRAM TABLETS 5 ESITOPAM Mansel (Ceylon) Global Impex AV TABLETS2645 5MG USP TABLETS ESCITALOPRAM 5 DEXANIL Lotus TABLETS PharmAce (Pvt) Ltd Consern Pharma I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 231 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 PAKISTAN 30-May-18PAKISTAN Full BANGLADESH 14-Sep-17 30-Apr-14 Full BANGLADESH Full 22-Feb-16 Full SRI LANKA 22-Mar-18INDIAYears Two PAKISTAN 08-Apr-15 03-Aug-17PAKISTAN Full Full 24-Mar-16INDIA Full SRI LANKA 01-Apr-15 25-Jan-18PAKISTANYears Two Full 23-Mar-16PAKISTAN Full 23-Aug-17INDIA Full INDIA 17-Sep-16 Full 08-Apr-16 Full Company Ltd OBS Pakistan (Pvt) Ltd The ACME Laboratories Ltd Navana Pharmaceuticals Ltd Sciences (Pvt) Ltd Baader Schulz Laboratories Pharmaceuticals Pvt Ltd & Well Well Pharma (Pvt) Ltd Scences Sciences (Pvt) Ltd & Well Well Pharma (Pvt) Ltd Pharmaceuticals Pvt Ltd Baader Schulz Laboratories Health Pell Tech Care (Pvt) Ltd (Contd.) (Pvt) Ltd Ltd Co Ltd (Pvt) Ltd Laboratories (Pvt) Ltd Laboratories (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP ESPELL 20ESPELL CAPSULES Slim 20MG 2647 ESOMEPRAZOLE CAPSULES 20MG NEXPRAZOLE2648 CAPSULES ESOMEPRAZOLE CAPSULES 20MG 20 MAXIMA Mansel (Ceylon) 2649 ESOMEPRAZOLE CAPSULES 20MG 20 ESOTAC CAPSULES Mega Pharma (Pvt) 2650 TABLETS ESOMEPRAZOLE CAPSULES 20MG EMPREZ 202651 Darley Butler & ESOMEPRAZOLE CAPSULES 20MG ESMOSULZ 20 CAPSULES2652 CAPSULES ESOMEPRAZOLE CAPSULES 20MG N/A CASTRAZOL Radiant Health Care CAPSULES2653 ESOMEPRAZOLE CAPSULES 20MG EMPEL Klintas (Pvt) Ltd Emergen Life 2654 Hansel ESOMEPRAZOLE CAPSULES 20MG 20 ESOSWIFT CAPSULES2655 TABLETS ESOMEPRAZOLE CAPSULES 40MG EMPREZ 40 Associated 2656 ESOMEPRAZOLE CAPSULES 40MG PharmAce (Pvt) Ltd EMPEL Swiss Garnier Life CAPSULES N/A2657 ESOMEPRAZOLE CAPSULES 40MG 40 GASTRAZOL CAPSULES CAPSULES2658 Associated ESOMEPRAZOLE CAPSULES 40MG Klintas (Pvt) Ltd ESMOSULZ Emergen Life 2659 Hansel ESOMEPRAZOLE CAPSULES USP CAPSULES Radiant Health Care 2646 ESOMEPRAZOLE CAPSULES 20MG EZIUM CAPSULES Morison PLC The Searle 232 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 PAKISTAN 01-Jun-16INDIA Full BANGLADESH 12-Jan-18 10-Mar-16 Full Full PAKISTANBANGLADESH 13-Mar-14 19-Feb-16 Full BANGLADESH Full 07-Sep-14 Full INDIAINDIA 24-Jan-14PAKISTAN Full 24-Mar-17 15-Jun-16 Full INDIA Full 01-Apr-15PAKISTAN Full 31-Jan-18SWEDEN Years Two 14-Jun-17 Full Getz Pharma Pakistan (Pvt) Ltd Windlas Biotech (Pvt) Ltd Navana Pharmaceuticals Ltd Zee Laboratories INDIALtd The ACME 07-Jul-17Laboratories Ltd Years Two Pharmaceuticals Ltd Ltd Sunrise International LabS Ltd Medisure Laboratories Pakistan (Pvt) Ltd Ltd Renata Limited BANGLADESHGetz Pharma 28-Nov-17Pakistan (Pvt) Ltd Full AB Astra Zeneca ,Sweden (Contd.) Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Co Ltd Services Pvt. Ltd Ltd Pharmaceutical (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Ceylon) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP ESOME CAPSULES Hemas 20MG 2660 ESOMEPRAZOLE CAPSULES USP 2661 40MGTABLETS ESOMEPRAZOLE 40 NEXZOL 2662 40MGTABLETS ESOMEPRAZOLE TABLETS ESOTAC2663 Lifeline 40MGTABLETS ESOMEPRAZOLE ESOMIVIN TABLETS2664 40MGTABLETS ESOMEPRAZOLE FASTESO Darley Butler & TABLETS2665 40MGTABLETS ESOMEPRAZOLE 40 MAXIMA ABC Pharma TABLETS2666 40MGTABLETS ESOMEPRAZOLE PROXUM 40 CAPSULES CIC Holdings PLC2667 PharmEvo (Pvt) 40MGTABLETS ESOMEPRAZOLE Mega Pharma (Pvt) TABLETS ESOFLUX2668 40MGTABLETS ESOMEPRAZOLE PharmAce (Pvt) Ltd Square ESOZOLE 40 TABLETS2669 40MGTABLETS ESOMEPRAZOLE TABLETS Burhani Enterprises EXZIUM Saga laboratories Kent 2670 40MGTABLETS ESOMEPRAZOLE 40 ESOSWIFT TABLETS2671 40MGTABLETS ESOMEPRAZOLE TABLETS MAXPRO Slim 2672 40MGTABLETS ESOMEPRAZOLE PharmAce (Pvt) Ltd ESOME Swiss Biogenics TABLETS2673 40MGTABLETS ESOMEPRAZOLE NEXIUM Emerchemie NB CAPSULES Hemas TABLETS Hemas I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 233 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 19-Jan-15 Full PAKISTAN 20-Sep-14 01-Aug-17 Full PAKISTAN Years Two 01-Aug-17INDIA Years Two INDIA 18-Mar-16 Full INDIA 13-Feb-17INDIA Full 20-Jul-17 Years Two 16-Oct-16INDIA Full INDIA 25-Mar-14INDIA Full 29-Jan-15PAKISTAN Full 15-Dec-17 14-Sep-17 Full Full Glenmark Pharmaceuticals Ltd Medispray Laboatories (Pvt) Ltd (Pvt ) Ltd (Pvt ) Ltd Laboratories Titan (Pvt) Ltd Fredun Pharmaceuticals Ltd Celogen Pharma Pvt Torrent Pharmaceuticals Ltd Export LtdTorrent INDIACelogen Pharma Pvt 05-May-14Cadila Healthcare Ltd Full Laboratories XL (Pvt) Ltd OBS Pakistan (Pvt) Ltd (Contd.) Healthcare lanka Ltd (Pvt) Ltd (Pvt) Ltd Health (Pvt) Ltd (Pvt) Ltd Ltd Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Ltd (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP ESOMAC 40 TABLETSZOLERIC Breathe Free Lanka ZOLERIC CAPSULES Ceyoka (Pvt) LtdE- ZOLE 20 CAPSULES Genix Pharma Ceyoka (Pvt) Ltd CAPSULESESOFRED 20 Genix Pharma Negolec Lifescience CAPSULESESOGEN 20 George Steuart NEXPRO TABLETS Pharma Villorgen 40ESSTOR TABLETSESOGEN 40 TABLETS Edna Medicals (Pvt) 40ZYPRA TABLETS Edna Medicals (Pvt) Pharma Villorgen CAPSULES Hemas DELAYED RELEASE TABLETS 40MG TABLETS RELEASE DELAYED TABLETS USP TABLETS RELEASE DELAYED 40MG TABLETS RELEASE USP DELAYED 20MG TABLETS RELEASE USP DELAYED 20MG TABLETS RELEASE USP DELAYED 20MG 20MG TABLETS 20MG TABLETS 40MG I P TABLETS 40MG TABLETS TRIHYDRATE 40MG DELAYED TRIHYDRATE RELEASE CAPSULES 2675 ESOMEPRAZOLE + MAGNESIUM 2676 ESOMEPRAZOLE + MAGNESIUM 2677 ESOMEPRAZOLE + MAGNESIUM 2678 ESOMEPRAZOLE + MAGNESIUM 2679 ESOMEPRAZOLE + MAGNESIUM 2680 ESOMEPRAZOLE + MAGNESIUM 2681 ESOMEPRAZOLE + MAGNESIUM 2682 ESOMEPRAZOLE + MAGNESIUM 2683 ESOMEPRAZOLE + MAGNESIUM 2684 ESOMEPRAZOLE + MAGNESIUM 2685 ESOMEPRAZOLE CAPSULES 40MG FRAZONE2686 ESOMEPRAZOLE CAPSULES 40MG NEXPRAZOLE TABLETS2687 CAPSULES ESOMEPRAZOLE CAPSULES 40MG EZIUM SMM Halcyon (Pvt) Mansel (Ceylon) CAPSULES Morison PLC Searle-Pakistan PAKISTAN 20-Jun-14 Full 2674 40MGTABLETS ESOMEPRAZOLE ESOZ TABLETS Sunshine 234 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 PAKISTAN 14-Mar-14PAKISTAN Full 02-Apr-16PAKISTAN Full 09-Feb-14BANGLADESH 11-Oct-16 Full INDIA Full INDIA 17-Dec-14 Full INDIA 01-Nov-17 Full PAKISTAN 06-Jul-15 09-Feb-14 Full PAKISTAN Full 25-Jun-15PAKISTAN Full 05-Apr-14PAKISTAN Full 26-Feb-18INDIA Provisional PAKISTAN 01-Nov-17 26-Sep-17 Full Full CCL CCL Pharmaceuticals (Pvt) Ltd Shaigan Pharmaceuticals (Pvt) Ltd Shrooq Pharmaceutical Pvt Ltd Healthcare Pharmaceuticals Fredun Pharmaceuticals Ltd Zim Laboratories Ltd Medopharm (PVT Ltd Shrooq Pharmaceutical Pvt Ltd Medizan Laboratories (Pvt) Ltd Shaigan Pharmaceuticals (Pvt) Ltd Brookes Pharma (Pvt) Ltd Zim Laboratories Ltd Pharmix Laborateries (Pvt) Ltd (Contd.) Pharmaceuticals Lanka (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd Health (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP 2688 ESOMEPRAZOLE CAPSULES 40MG N/A2689 ESOMEPRAZOLE CAPSULES 40MG ESSO 40 CAPSULES2690 ESOMEPRAZOLE CAPSULES 40MG ESOMALT CAPSULES CCL Akbar 2691 ESOMEPRAZOLE CAPSULES 40MG CAPSULES 40 SERGEL 2692 Salveo Pharma ESOMEPRAZOLE CAPSULES 40MG ESOFRED 40 CAPSULES Citihealth Imports CAPSULES2693 ESOMEPRAZOLE CAPSULES 20MG ESOPRO 20 George Steuart 2694 CAPSULES ESOMEPRAZOLE CAPSULES 20MG ESOPEL Tabrane 2695 ESOMEPRAZOLE CAPSULES 20MG ESOMALT CAPSULES2696 Akbar ESOMEPRAZOLE CAPSULES 20MG CAPSULES ESSOM 20 Salveo Pharma 2697 ESOMEPRAZOLE CAPSULES 20MG CAPSULES ESSO 20 Ceyline 2698 ESOMEPRAZOLE CAPSULES 20MG EPRAZOLE 20MG CAPSULES CAPSULES Akbar 2699 Hemas ESOMEPRAZOLE CAPSULES 20MG ESOPRO 202700 CAPSULES ESOMEPRAZOLE CAPSULES 20MG 20 TRUTIL Tabrane CAPSULES Lanka (Pvt) Tabrane I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 235 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 BANGLADESH 31-Jan-14PAKISTAN Full 11-Mar-14INDIA Full PAKISTAN 15-Dec-15PAKISTAN 19-Jun-17 Full Full 26-Sep-17INDIA Full INDIA 05-Jan-17 Years Two INDIA 20-Jan-15 Full PAKISTAN 05-Jan-18 Provisional PAKISTAN 03-Jan-18 Years Two 30-Dec-17INDIA Full INDIA 05-Jan-17 Full PAKISTAN 08-Apr-16 23-Apr-17 Full Years Two Healthcare Pharmaceuticals CCL Pharmaceuticals (Pvt) Ltd Sharon Bio- Medicine Ltd S J & G Fazul Ellahie (Pvt) Ltd Pharmix Laborateries (Pvt) Ltd Inventia Healthcare (Pvt) Ltd Cadila Healthcare Ltd Inventia Healthcare (Pvt) Ltd Ferozsons Laboratories Ltd Nabiqasim Industries (Pvt) Ltd Inventia Healthcare (Pvt) Ltd Health Pell Tech Care (Pvt) Ltd Laboratories (Pvt) Ltd (Contd.) (Pvt) Ltd Pharmaceuticals Lanka (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd Ltd (Ceylon) Ltd Pharmaceuticals (Pvt) Ltd (Ceylon) Ltd (Ceylon) Ltd Health (Pvt) Ltd (Ceylon) Ltd Pharmaceuticals (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP ESOMEZOL CAPSULES 20ZYPRA Emerchemie NB CAPSULESESOMEZOL Hemas CAPSULESESOMEGA Emerchemie NB ES-LOPROT CAPSULES Emerchemie NB CAPSULESESOMEZOL George Steuart CAPSULES 40ESPELL Emerchemie NB CAPSULESECOROX Slim CAPSULES Morison PLC ATCO RELEASE CAPSULES 20MG RELEASE CAPSULES 20MG RELEASE CAPSULES 40MG RELEASE CAPSULES 40MG RELEASE CAPSULES 40MG RELEASE CAPSULES 40MG RELEASE CAPSULES 40MG 20MG RELEASE CAPSULES USP 2711 ESOMEPRAZOLE DELAYED 2702 ESOMEPRAZOLE CAPSULES 20MG ESPRA2703 ESOMEPRAZOLE CAPSULES 20MG N/A CAPSULES2704 ESOMEPRAZOLE CAPSULES 40MG CONTOUR CCL 2705 ESOMEPRAZOLE CAPSULES 40MG 40 TRUTIL CAPSULES CAPSULES2706 Pharma V H Distributors Avenier A ESOMEPRAZOLE DELAYED CAPSULES Lanka (Pvt) Tabrane 2707 ESOMEPRAZOLE DELAYED 2708 ESOMEPRAZOLE DELAYED 2709 ESOMEPRAZOLE DELAYED 2710 ESOMEPRAZOLE DELAYED 2712 ESOMEPRAZOLE DELAYED 2713 ESOMEPRAZOLE DELAYED 2701 ESOMEPRAZOLE CAPSULES 20MG SERGEL CAPSULES Citihealth Imports 236 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 PAKISTAN 30-Dec-17PAKISTAN Full PAKISTAN 14-Sep-17 Years Two INDIA 14-Sep-17 Years Two BANGLADESH 13-Jul-18 06-Feb-18 Provisional Full BANGLADESH 07-Feb-17 Years Two INDIAPAKISTAN 24-Mar-17 31-Mar-18 Full BANGLADESH 23-Jan-17 Full PAKISTAN Full 23-May-18INDIA Full 24-Mar-17 Full c Stridden c Stridden fi fi Nabiqasim Industries (Pvt) Ltd Ferozsons Laboratories Ltd Ferozsons Laboratories Ltd Medibios Laboratories (Pvt) Ltd Eskayef Bangaladesh Ltd Eskayef Bangaladesh Ltd Hetero Labs Ltd INDIAHetero Labs Ltd INDIAGu 30-Jan-18Biopharma Pvt ltd Full 30-Jan-18Getz Pharma Years Two Pakistan (Pvt) Ltd Pharmaceuticals Ltd Shaigan Pharmaceuticals (Pvt) Ltd GU Biopharma Pvt ltd (Contd.) Health (Pvt) Ltd (Ceylon) Ltd (Ceylon) Ltd (Ceylon) Ltd Healthcare lanka Ltd Healthcare lanka Ltd (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Hemas Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP SOLUTION ES-LOPROT CAPSULESESOMEGA George Steuart ESOMEGA CAPSULES Emerchemie NB MEDIPRAZOLE 20 TABLETS CAPSULES Emerchemie NB Emerchemie NB ESORAL 40ESORAL TABLETS TABLETS Sunshine YESOM 40 Sunshine YESOM 20 TABLETSSTULCER TABLETS Mansel (Ceylon) Mansel (Ceylon) INJECTIONESOME IV Slim INJECTABLE PROXUM 40 INJECTIONESSO 40 IV PharmAce (Pvt) Ltd Square INJECTIONSTULCER Akbar INJECTION Slim RESISTANT TABLETS 20MG TABLETS RESISTANT VIAL RELEASE CAPSULES USP 20MG RELEASE CAPSULES USP 20MG RELEASE TABLETS 20MG RELEASE TABLETS 20MG TABLETS 20MG TABLETS 40MG TABLETS 40MG RESISTANT VIAL VIAL VIAL VIAL 2721 ESOMEPRAZOLE GASTRO 2722 ESOMEPRAZOLE INJECTION 40MG/ 2714 ESOMEPRAZOLE DELAYED 2715 ESOMEPRAZOLE DELAYED 2716 ESOMEPRAZOLE DELAYED 2717 ESOMEPRAZOLE ENTERIC COATED 2718 ESOMEPRAZOLE ENTERIC COATED 2719 ESOMEPRAZOLE ENTERIC COATED 2720 TABLETS ESOMEPRAZOLE GASTRO 2723 ESOMEPRAZOLE INJECTION 40MG/ 2724 ESOMEPRAZOLE INJECTION 40MG/ 2725 ESOMEPRAZOLE INJECTION 40MG/ 2726 ESOMEPRAZOLE INJECTION 40MG/ I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 237 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 20-Sep-14 Full INDIA 02-Mar-15 Full PAKISTAN 06-May-15 26-Feb-18 Full INDIA Provisional INDIA 01-Nov-17 Full INDIA 18-Mar-16 Full INDIA 18-Mar-16 Full INDIA 11-Oct-16 Full INDIA 29-Nov-15 Full INDIA 16-Sep-16 Full 05-Nov-17 Full Renata Limited BANGLADESH 02-Jul-18Medispray Years Two Laboatories (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd Brookes Pharma (Pvt) Ltd Zim Laboratories Ltd Laboratories Titan (Pvt) Ltd Laboratories Titan (Pvt) Ltd Stallion Laboratories Pvt Ltd Sun Pharmaceutical industries Sun Pharmaceutical industries Torrent Pharmaceuticals Ltd (Contd.) (Ceylon) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP MAXPROESOMAC 20 INJECTION Emerchemie NB TABLETSANESO Breathe Free Lanka ANESO TABLETSAssociates Pharma EPRAZOLE 40MG CAPSULES AMN Life Science TABLETS Hemas Associates Pharma ESOPRO 40 AMN Life Science CAPSULESE- ZOLE 40 Tabrane CAPSULESE- ZOLE 20 Negolec Lifescience CAPSULES 20ZEMEP Negolec Lifescience TABLETSSOMPRAZ 20 TABLETS Siba Healthcare SOMPRAZ 40 Hemas TABLETSNEXPRO Hemas TABLETS Edna Medicals (Pvt) 40MG & STERILE 0.9% SODIUM CHLORIDE SOLUTION BP 20MG TABLETS RELEASE DELAYED TABLETS 20MG TABLETS RELEASE DELAYED TABLETS USP TABLETS RELEASE DELAYED 40MG USP TABLETS RELEASE DELAYED 40MG USP TABLETS RELEASE DELAYED 40MG USP TABLETS RELEASE DELAYED 40MG USP TABLETS RELEASE DELAYED 20MG 20MG TABLETS 20MG TABLETS 40MG TABLETS 40MG TABLETS 2728 ESOMEPRAZOLE MAGNESIUM 2729 ESOMEPRAZOLE MAGNESIUM 2730 ESOMEPRAZOLE MAGNESIUM 2731 ESOMEPRAZOLE MAGNESIUM 2732 ESOMEPRAZOLE MAGNESIUM 2733 ESOMEPRAZOLE MAGNESIUM 2734 ESOMEPRAZOLE MAGNESIUM 2735 ESOMEPRAZOLE MAGNESIUM 2736 ESOMEPRAZOLE MAGNESIUM 2737 ESOMEPRAZOLE MAGNESIUM 2738 ESOMEPRAZOLE MAGNESIUM 2727 ESOMEPRAZOLE IV INJECTION 238 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 SWEDEN 10-Jan-16PAKISTAN Full INDIA 27-Sep-18 Full BANGLADESH 06-Nov-15 25-Nov-15 Full Full INDIAPAKISTAN 27-Sep-18BANGLADESH 13-Aug-14 Full 30-Aug-17 Years Full Two INDIAINDIA 12-Jan-18PAKISTAN Full 25-Feb-15INDIA 22-Jan-15 Full Full 24-Mar-17 Full Aristopharma Ltd BANGLADESH 27-Nov-17Years Two AB Astra Zeneca ,Sweden S J & G Fazul Ellahie (Pvt) Ltd SRS Pharmaceuticals (Pvt) Ltd Globe Pharmaceuticals Ltd Glenmark Pharmaceuticals Ltd Unichem Laboratories Ltd Incepta Pharmaceuticals Ltd Windlas Biotech (Pvt) Ltd Hemis NOA Pharmaceuticals Sunrise International LabS Ltd (Contd.) Hemas Pharmaceuticals (Pvt) Ltd Hemas Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Healthcare Tabrane (Pvt) Ltd Sunshine Healthcare lanka Ltd Baur & Co (Pvt) A Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Produsts Ltd Pharmaceutical (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP INJECTION INJECTION INJECTION COA.) COA.) EMEPNEXIUM POWDER / CONTOUR POWDER ESOSAN POWDER V H Distributors A 40EMA INJECTION Lifeline POWDER FOR FOR SOLUTION INJECTION INFUSION 40MG INJECTION 40MG INJECTION 40MG INJECTION 40MG 40MG WITH 5ML SUCCINATE 0.9% AMPOULE CONTAINING SODIUM CHLORIDE SOLUTION 2740 ESOMEPRAZOLE POWDER 2739 ESOMEPRAZOLE POWDER FOR 2741 ESOMEPRAZOLE SODIUM FOR 2742 ESOMEPRAZOLE SODIUM FOR 2743 ESOMEPRAZOLE SODIUM 2744 20MGTABLETS ESOMEPRAZOLE 20 ESOFAG 2745 20MGTABLETS ESOMEPRAZOLE ESOZ 20 TABLETS2746 20MGTABLETS ESOMEPRAZOLE Kamazu (Pvt) Ltd FASTESO (EN. TABLETS 2747 20MGTABLETS ESOMEPRAZOLE Micro Labs Ltd ESONIX 20 INDIA TABLETS2748 20MGTABLETS ESOMEPRAZOLE TABLETS CIC Holdings PLC 20 NEXZOL 28-Sep-18 PharmEvo (Pvt) 2749 20MGTABLETS ESOMEPRAZOLE Provisional Citihealth Imports TABLETS IZRA-202750 20MGTABLETS ESOMEPRAZOLE Lifeline ARTEK2751 20MGTABLETS ESOMEPRAZOLE (EN. TABLETS ESOZOLE 20 TABLETS TABLETS Hayleys Consume Kent I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 239 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 BANGLADESH 29-May-14 Full BANGLADESH 14-Feb-16 Full PAKISTAN 22-Jan-17BANGLADESH Full 20-Sep-17 Full INDIAINDIA 26-Jun-14INDIA Full 12-Sep-17 Years Two PAKISTAN 05-Sep-16NETHERLANDS 22-Jan-17 Full 07-Sep-17 Years Two Full GERMANY 09-Jul-15NETHERLANDS 28-Aug-17 Full Years Two Globe Pharmaceuticals Ltd Pharmaceuticals Ltd Renata Limited BANGLADESHABAstra Zeneca 30-Nov-17 SWEDENYears Two Hemis NOA 13-Aug-14Pharmaceuticals Full Beximco Pharmaceuticals Ltd Unichem Laboratories Medibios Laboratories (Pvt) Ltd Akums Drugs & Pharmaceuticals Ltd Hemis NOA Pharmaceuticals BV Bayer Schering G Ltd A Pharma BV (Contd.) (Pvt) Ltd (Ceylon) Ltd Pharmaceuticals (Pvt) Ltd Produsts Ltd (Ceylon) Ltd Ltd (Ceylon) Ltd (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd TABLETS CIC Holdings PLC Abbott Biological SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP FEMOSTON FEMOSTON CONTI 1/5 ANGELIQ 2/10FEMOSTON TABLETS TABLETS Hemas CIC Holdings PLC Abbott Biological 1MG+DIDROGESTERONE 5MG TABLETS 2MG TABLETS 2MG+DYDROGESTERONE 10MG 2753 20MGTABLETS ESOMEPRAZOLE PROXUM 202754 20MGTABLETS ESOMEPRAZOLE TABLETS MAXPRO2755 20MG ESOMEPRAZOLE TABLETS PharmAce (Pvt) Ltd Square NEXIUM TABLETS2756 40MGTABLETS ESOMEPRAZOLE ARTEK Emerchemie NB TABLETS2757 40MGTABLETS ESOMEPRAZOLE 40 ESOFAG 2758 Hemas 40MGTABLETS ESOMEPRAZOLE TABLETS OPTON TABLETS2759 40MGTABLETS ESOMEPRAZOLE Hayleys Consume Kamazu (Pvt) Ltd IZRA-402760 TABLETS 40MGTABLETS ESOMEPRAZOLE Micro Labs Ltd MEDIPRAZOLE 40 INDIA TABLETS Emerchemie NB TABLETS2761 40MGTABLETS ESOMEPRAZOLE Emerchemie NB VEXSO 40 Baur & Co (Pvt) A 16-Jun-182762 40MGTABLETS ESOMEPRAZOLE TABLETS Full ARTEK2763 ESTRADIOL Global Impex AV 2764 TABLETS 1MG+DROSPIRENONE ESTRADIOL Negolec Lifescience 2765 & ESTRADIOL TAB 2MG ESTRADIOL 2752 20MGTABLETS ESOMEPRAZOLE EMA-20 TABLETS Healthcare Tabrane 240 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 22-Apr-15 Full NETHERLANDS 07-Nov-17 Years Two FRANCE 22-Apr-17GERMANY/ FRANCE Full INDIAINDIA 17-Mar-14GERMANY Full 28-Apr-15 27-Jul-14 Full Full INDIAINDIA 17-Mar-17 Full INDIA 03-Jul-15 Full INDIA 16-May-15 Full INDIA 04-Jan-18 Full GERMANY 06-Nov-15 02-Apr-17 Full Full BV Delpharm Lille S S France for A AG Bayer pharma Germany Delpharm Lille S S France for A AG Bayer pharma Germany Ltd Bayer Weiner GmbH & Co. KC Germany for AG Bayer Pharma Germany Zim Laboratories Ltd Cadila Healthcare Ltd Cadila Healthcare Ltd Cadila Healthcare Ltd B Braun Melsungen A G Macleods Pharmaceuticals Ltd Macleods Pharmaceuticals Ltd (Contd.) Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Sunshine Healthcare lanka Ltd Healthcare lanka Ltd Healthcare lanka Ltd Ltd (Pvt) Ltd (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP S.R TABLETS Tabrane SUSPENSION TABLETS REL TABLETS Sunshine INJECTION B Braun Lanka (Pvt) FEMOSTON 1/10FEMOSTON TABLETS CIC Holdings PLC Abbott Biological PROGYNOVA TABLETS Hemas N/ADIANE 35 TABLETS TABLETS Chamee Chemist Hemas Bajaj Healthcare ETHOLLINE SR 150mg DERIPHYLLIN 300 RETARD DERIPHYLLIN 150 RETARD DERIPHYLLINE SYRUPETOMIDATE- LIPURO Sunshine 1MG+DYDROGESTERONE TABLETS 1MG+DYDROGESTERONE TABLETS 10MG 2MG TABLETS B P 400MG B P TABLETS 0.035MG+CYPROTERONE 2MG TABLETS THEOPHYLLINE 35MG SUSTAINED TABLETS RELEASE 150MG THEOPHYLLINE 69MG 35MG THEOPHYLLINE IP RELEASE 150MG SUSTAINED 14.0MG 46.5MG+THEOPHYLLINE IP SYRUP 5ML EMULSION 2766 TAB ESTRADIOL 2767 1MGTABLET VALERATE ESTRADIOL PROGYNOVA TABLETS2768 TABLETS VALERATE ESTRADIOL Hemas 2769TABLETS 400MG B.P ETHAMBUTOL ECOX2770 HYDROCHLORIDE ETHAMBUTOL TABLETS2771 ETHINYLOESTRADIOL Pettah Pharmacy 2772 250MG USP TABLETS ETHIONAMIDE ETHOMID2773 + 115MG ETOFYLLINE TABLETS Pettah Pharmacy 2774 231MG & ETOFYLLINE 2775 + 115MG IP ETOFYLLINE 2776 IP ETOFYLLINE 2777 20MG/10ML ETOMIDATE-LIPURO I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 241 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 NETHERLANDS 25-Jul-18JAPAN Full INDIA 29-Jun-15INDIA Full 24-Oct-17INDIA Full 22-Nov-18INDIA Full 10-Oct-17 Years Two 11-Sep-17 Years Two INDIABANGLADESH 21-Nov-18 16-Aug-18 Years Two Full INDIAINDIA 12-May-17 Full BANGLADESH 31-Oct-18 05-Dec-17 Years Two Years Two BANGLADESH 05-Dec-17 Years Two N V Organon Klopseteraat Ltd (Pvt) Ltd Getwell Pharmaceuticals Sun Pharma Laboratories Ltd Sun Pharmaceutical industries Micro Labs Ltd INDIAZim Laboratories Ltd 31-Dec-17General Pharmaceuticals Ltd Full Akums Drugs & Pharmaceuticals Ltd Mankind Pharma Ltd Incepta Pharmaceuticals Ltd Incepta Pharmaceuticals Ltd Micro Labs Ltd INDIA 31-Dec-17 Full (Contd.) Ltd Pharmacy (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Health (Pvt) Ltd Plc Pharmaceuticals (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP ETOPA 100ETOPA 120ETOSHINE INJECTION TABLETS The Esses 60ETOSHINE Hemas TABLETS Hemas 100MG/5ML 120MG TABLETS DISINTEGRATING 60MG TABLETS DISINTEGRATING 2779 CAPSULES 100MG ETOPOSIDE 2780 LASTET 100MG CAPSULES BP ETOPOSIDE ETOGLOB2781 INJECTION SUP ETOPOSIDE CAPSULES CAPSULES2782 FAST ETORICOXIB Morison PLC PharmAce (Pvt) Ltd Globela Pharma 2783 Euji Capsule Co. FAST ETORICOXIB 2784 120MGTABLETS ETORICOXIB 2785 120MG TABLETS ETORICOXIB 120 ETORICA TABLETS ETRICIB2786 120MGTABLETS ETORICOXIB Micro Mega Lanka 120 ZENTOCOX 2787 TABLETS 120MGTABLETS ETORICOXIB TABLETS Tabrane VEROXIB 120 George Steuart 2788 120MGTABLETS ETORICOXIB TABLETS 120 BRUTAFLAM 2789 120MGTABLETS ETORICOXIB TABLETS Browns & Company ORICOX 120 Hemas 2790 120MGTABLETS ETORICOXIB TABLETS ORICOX 1202791 120MGTABLETS ETORICOXIB Citihealth Imports TABLETS 120 ETORICA Citihealth Imports TABLETS Micro Mega Lanka 2778 68MG IMPLANT ETONOGESTREL NXT IMPLANT IMPLANTS Baur & Co (Pvt) A 242 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 21-Aug-14INDIA Full 27-Feb-14 Full 24-Jan-15 Full INDIA 15-Jan-14 Full INDIABANGLADESH 11-Nov-14 03-Oct-17 Years Two Full INDIAINDIA 23-Jun-17 Full INDIA 12-May-17INDIA Full 25-Sep-18BANGLADESH Full 31-Aug-18 12-Nov-18 Years Two Full Torrent Pharma Torrent Germany Rel Abbott Healthcare SAS,France for Abbott Health Care Products BV Nethalnad Akums Drugs & Pharmaceuticals Ltd Pharmaceuticals Cadila Healthcare Ltd Aristopharma Ltd BANGLADESH 10-Oct-15 Full Theon Pharmaceuticals Ltd Pharmaceuticals Ltd Fredun Pharmaceuticals Ltd Akums Drugs & Pharmaceuticals Ltd Zim Laboratories Ltd Sai Mirra Innopharm (Pvt) Ltd Incepta Pharmaceuticals Ltd (Contd.) Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Healthcare lanka Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Health (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Ltd Healthcare lanka Ltd (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP TABLETS Hemas 120 2792 120MGTABLETS ETORICOXIB 120 ETOVEX 2793 120MGTABLETS ETORICOXIB TABLETS2794 120MG TABLETS ETORICOXIB 120 ETOCOX Global Impex AV TABLETS NUCOXIA2795 120MGTABLETS ETORICOXIB Associates Pharma The Madras 120 XIBRA TABLETS2796 120MGTABLETS ETORICOXIB Sunshine TABLETS BCD TORCOXIA Hemas 2797 120MGTABLETS ETORICOXIB 120 ETROVA 2798 120MGTABLETS ETORICOXIB TABLETS 120 TORY 2799 120MGTABLETS ETORICOXIB Slim TABLETS 120 ETOROCZIA 2800 120MGTABLETS ETORICOXIB TABLETS PharmAce (Pvt) Ltd Square VEROXIB 120 George Steuart 2801 60MGTABLETS ETORICOXIB TABLETS2802 60MGTABLETS ETORICOXIB ETRICIB Lotus 2803 ENCOXIB 60 60MGTABLETS ETORICOXIB TABLETS TABLETS ORICOX 60 Lanka (Pvt) Tabrane Sunshine TABLETS Citihealth Imports I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 243 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIA 15-Jan-15 Full BANGLADESH 23-Mar-17 Full BANGLADESH 03-Oct-17 Years Two INDIAINDIA 21-Jun-17 Years Two 11-Nov-14 Full BANGLADESH 16-Aug-18 Years Two INDIAPAKISTAN 31-Oct-18 Years Two 08-May-15 Full INDIAINDIA 13-Aug-14 Full 24-Jan-14 Full Torrent Torrent Pharmaceuticals Ltd Delta Pharma Ltd BANGLADESH 21-Dec-17Years Two Globe Pharmaceuticals Ltd Pharmaceuticals Ltd Sava Healtheare Ltd Theon Pharmaceuticals Ltd General Pharmaceuticals Ltd Mankind Pharma Ltd Genome Pharmceuticals (Pvt) Ltd Aristopharma Ltd BANGLADESH 10-Oct-15Micro Labs Ltd Full INDIAAkums Drugs & Pharmaceuticals Ltd 31-Dec-14Cadila Healthcare Ltd Full (Contd.) Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd (Ceylon) Ltd Pharmaceuticals (Pvt) Ltd Health (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd Healthcare lanka Ltd TABLETS Hemas SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP 60 2811 60MGTABLETS ETORICOXIB BCD TORCOXIA 2812 60MGTABLETS ETORICOXIB 602813 ETO 60MGTABLETS ETORICOXIB 602814 ETOXIB 60MGTABLETS ETORICOXIB TABLETS TABLETS 60 Hyena 2815 TORY 60MGTABLETS ETORICOXIB Healthcare Tabrane 2816 60MGTABLETS ETORICOXIB TORIXIB TABLETS 60 ETROVA PharmAce (Pvt) Ltd Square TABLETS TABLETS Emerchemie NB Slim 2805 60MGTABLETS ETORICOXIB 602806 BRUTAFLAM 60MGTABLETS ETORICOXIB TABLETS2807 ARCOX 60MGTABLETS ETORICOXIB Hemas 602808 XIBRA 60MGTABLETS ETORICOXIB TABLETS2809 60MGTABLETS ETORICOXIB Lanka (Pvt) Tabrane 60 ETORICA TABLETS TABLETS 602810 ETOVEX Hemas 60MG TABLETS ETORICOXIB Micro Mega Lanka TABLETS NUCOXIA Global Impex AV TABLETS Sunshine 2804 60MGTABLETS ETORICOXIB 60 ZENTOCOX TABLETS George Steuart 244 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 14-Jun-17 Full 23-Jun-17 Years Two INDIAINDIA 21-Nov-18 Full INDIA 31-Oct-18 Years Two INDIA 31-Aug-18 Full 24-Jan-18 Years Two INDIAINDIA 17-Sep-14 Full INDIA 03-Jan-17 Full INDIA 13-Aug-14 Full 15-Jan-15 Full Sai Mirra Innopharm (Pvt) Ltd Torrent Pharmaceuticals Ltd Akums Drugs & Pharmaceuticals Ltd Fredun Pharmaceuticals Ltd Aristopharma Ltd BANGLADESH 10-Oct-18Zim Laboratories Ltd Full Mankind Pharma Ltd Cadila Healthcare Ltd Micro Labs Ltd INDIASun Pharmaceutical industries 31-Dec-14Gracure Pharmaceuticals Ltd Full Akums Drugs & Pharmaceuticals Ltd Delta Pharma Ltd BANGLADESH 26-Sep-15 Full (Contd.) Sunshine Healthcare lanka Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Health (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Healthcare lanka Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP TABLETS TABLETS Hemas 90 2817 60MGTABLETS ETORICOXIB 2818 VEROXIB 60 60MGTABLETS ETORICOXIB TABLETS 602819 ETOROCIA 90MGTABLETS ETORICOXIB Lotus TABLETS 902820 XIBRA 90MG TABLETS ETORICOXIB George Steuart 2821 ETRICIB TABLETS 90MGTABLETS ETORICOXIB Hemas 902822 BRUTAFLAM 90MGTABLETS ETORICOXIB TABLETS TABLETS Tabrane 2823 ENCOXIB 90 90MGTABLETS ETORICOXIB Hemas FILM COA 902824 NUCOXIA 90MGTABLETS ETORICOXIB TABLETS2825 90MGTABLETS ETORICOXIB 90 ETORICA Sunshine TABLETS 902826 ETOSHINE 90MGTABLETS ETORICOXIB TABLETS Micro Mega Lanka 2827 E-COX 90MGTABLETS ETORICOXIB Hemas 902828 ETOVEX 90MGTABLETS ETORICOXIB TABLETS TABLETS BCD 2829 TORCOXIA VN Pharmaceuticals 90MGTABLETS ETORICOXIB Global Impex AV 90 ETO TABLETS Hyena I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 245 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIABANGLADESH 28-Jun-17 03-Oct-17 Years Two Full BANGLADESH 24-Mar-17 Full BANGLADESH 23-Nov-14 Full INDIA 11-Nov-14 Full SWITZERLAND 26-Sep-16 Full SWITZERLAND 26-Sep-16 Full SWITZERLAND 05-Apr-18 Full Fredun Pharmaceuticals Ltd Pharmaceuticals Ltd Globe Pharmaceuticals Ltd Pharmaceuticals Industry Ltd Theon Pharmaceuticals Ltd Hetero Labs Ltd INDIAHetero Labs Ltd INDIA 08-Jun-18Years Two Hetero Labs Ltd INDIA 08-Jun-18Years Two Novartis Pharma Stein .AG Switzerland for 08-Jun-18novatis Pharma Years Two Shcweiz AG Switzerland Novartis Pharma Stein .AG Switzerland for novatis Pharma Shcweiz AG Switzerland Novartis Pharma A G (Contd.) Health (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Healthcare lanka Ltd Healthcare lanka Ltd Healthcare lanka Ltd Baur & Co (Pvt) A Ltd Ltd Ltd TABLETS SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP AFINITOR DISPERSIBLE AFINITOR TABLETS Baur & Co (Pvt) A TABLETS 10MG TABLETS 5MG TABLETS 2831 90MGTABLETS ETORICOXIB 902832 TORY 90MGTABLETS ETORICOXIB 902833 ETOXIB TABLETS 90MGTABLETS ETORICOXIB PharmAce (Pvt) Ltd TABLETS2834 ALGIREX 90 Square 90MGTABLETS ETORICOXIB Healthcare Tabrane TABLETS 902835 ETROVA 120MG IP TABLETS ETORICOXIB Medinex (Pvt) Ltd EROXIB TABLETS The IBN SINA 2836 60MG IP TABLETS ETORICOXIB Slim EROXIB TABLETS2837 90MG IP TABLETS ETORICOXIB Sunshine EROXIB 90 TABLETS2838 EVEROLIMUS DISPERASIBLE TABLETS Sunshine Sunshine 2839 EVEROLIMUS DISPERASIBLE 2840 0.25mgTABLETS EVEROLIMUS CERTICAN TABLETS Baur & Co (Pvt) A 2830 90MGTABLETS ETORICOXIB 90 ETOROCIA TABLETS George Steuart 246 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 05-Jun-15 Full INDIAINDIA 09-May-18INDIA Full 08-Jun-18 Years Two INDIA 29-Nov-15 Full 03-Feb-16 Full INDIAINDIA 26-Sep-18 Years Two INDIA 10-Jan-19 Years Two 20-Aug-16PAKISTAN Full 01-Sep-17INDIA Years Two PAKISTAN 20-Apr-18 Provisional 15-Mar-14UNITED STATES Full zer Italia SRL ITALY 29-Nov-17Years Two fi Bayer A G LtdA Bayer AUSTRIABaxter AG 01-Mar-18 AUSTRIAYears (Pvt) Ltd Two 03-Jan-18 Full Ltd Akriti pharmaceuticals Pvt Ltd Akriti pharmaceuticals Pvt Ltd Laboratories Ltd Grifols Biological Inc Mercury Laboratories Ltd Jodas Expoim Pvt Ltd P Getz Pharma Pakistan (Pvt) Ltd Atoz Pharmaceuticals (Pvt) Ltd CCL Pharmaceuticals (Pvt) Ltd (Contd.) international Ltd international Ltd Ltd Ltd Pharma Associates Celon (Pvt) Ltd (Pvt) Ltd International (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Pharmaceuticals Lanka (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP TABLETS INJECTION Mansel (Ceylon) IMMUNINE 600IU INJECTIONFEIBA J Medichem A INJECTION J Medichem A 500IU INJECTION 500U/vial INJECTION 600iu 2850 PASSING BY VIII INHIBITOR FACTOR 2851 40MGTABLETS FAMOTIDINE 40 FAMO-D TABLETS Pharmatec (Pvt) Ltd Belco Pharma 2849 IX CONCETRATE FACTOR 2852 20MG BP TABLETS FAMOTIDINE FOTIDIN2853 20MG BP TABLETS FAMOTIDINE ZIDIN 202854 TABLETS 40MG BP TABLETS FAMOTIDINE ZIDIN 40 TABLETS Chamee Chemist Bajaj Healthcare Alaris Lanka (Pvt) TABLETS Alaris Lanka (Pvt) 2841 10MGTABLETS EVEROLIMUS 2842 25MGTABLETS EXEMESTANE N/A JOMESTANE2843 25MGTABLETS EXEMESTANE TABLETS2844 25 TABLETS XCEL 25MGTABLETS EXEMESTANE Softcare International AROMASIN Yaden 2845TABLETS EZETIMIBE 10MG FILM COA TABLETS2846 10MGTABLETS EZETIMIBE EZITA Hemas 2847 10MG EZETIMIBE TABLETS MIBE 10 TABLETS2848 IX COMPLEX 500 IU/5ml FACTOR EZEMIBE Hemas TABLETS PROFILNINE SD Asian Pharma Euro TABLETS CCL I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 247 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 15-Jun-16SRI LANKA Full 24-Jul-17 Years Two 26-Nov-15INDIA Full BANGLADESH 19-Mar-17 18-Dec-15 Full INDIA Full INDIA 04-May-17SRI LANKA Full 21-May-17 09-Jan-16INDIA Full Full INDIA 24-Apr-18CHINA Full 23-Jul-18 Years Two GERMANY 28-Jan-15 02-Aug-16GERMANY Full Full 02-Aug-16CHINA Full 12-Jan-17 Years Two XL Laboratories XL (Pvt) Ltd Medopharm (PVT Ltd Pharmaceuticals Manufacturer Corporation Pharmaceuticals Pharmaceuticals Ltd Belco Pharma (Pvt) Ltd Sun Pharmaceutical industries (Ceylon) (Pvt) Ltd Belco Pharma (Pvt) Ltd Sun Pharmaceutical industries Fresenius Kabi A.B B Braun Melsungen A G B Braun Melsungen A G Sino Swed Pharmaceutical Co (Contd.) Ltd Pharmaceuticals (Pvt) Ltd Agency Pvt Ltd (Ceylon) Ltd Agency Pvt Ltd (Ceylon) Ltd Pharmaceuticals (Pvt) Ltd Ltd Ltd Pharmaceuticals (Pvt) Ltd INJECTION B Braun Lanka (Pvt) INJECTION B Braun Lanka (Pvt) SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP LCT 10% LCT 20% MCT/LCT INTRALIPID 20% INJECTION Hemas INJECTION 20%w/v 2856 20MG USP TABLETS FAMOTIDINE N/A2857 20MG USP TABLETS FAMOTIDINE N/A TABLETS2858 20MG USP TABLETS FAMOTIDINE LABOTINE 20 Akbar 2859 20MG USP TABLETS FAMOTIDINE TABLETS TABLETS 20 FAMOTACK N/A TABLETS2860 20MG USP TABLETS Associates FAMOTIDINE Pharma Laborate 20 FAMO-D PharmAce (Pvt) Ltd2861 20MG USP TABLETS FAMOTIDINE Square FAMOCID TABLETS State 2862 20MG USP TABLETS FAMOTIDINE Leader Pharma TABLETS N/A2863 40MG USP TABLETS FAMOTIDINE 40 Emerchemie NB FAMO-D 2864 40MG USP TABLETS FAMOTIDINE 40MG FAMOCID TABLETS TABLETS TABLETS2865 EMULSION INJECTION 10% FAT Leader Pharma N/A Emerchemie NB INTRALIPID 10% INJECTION2866 EMULSION INJECTION 10% FAT Hemas MCT. LIPOFUNDIN 2867 EMULSION INJECTION 20% FAT M S J Industries LIPOFUNDIN 2868 EMULSION INTRAVENOUS FAT 2855 40MG BP TABLETS FAMOTIDINE KEAMOTIN 40 TABLETS SMM Halcyon (Pvt) 248 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 25-Jul-18 Years Two 25-Jul-18 Years Two PAKISTANINDIA 26-Jun-18 Years Two INDIA 27-Apr-18INDIA Provisional 08-Dec-18 Years Two PAKISTAN 25-Jul-18 Years Two 26-Jun-18 Years Two SWEDEN 21-Jan-18 Full INDIAINDIA 02-Jan-16 Full INDIA 09-Jan-14 Full 27-May-17 Years Two Pharmaceuticals Astra Zeneca SWEDENAB Astra Zeneca ,Sweden 12-Apr-18Astra Zeneca Full SWEDENCadila Healthcare Ltd 12-Apr-18Cadila Healthcare Full Ltd Cadila Healthcare Ltd Mercury Laboratories Ltd Delta Pharma Ltd BANGLADESH 20-Sep-18 Provisional Ltd Alice Pharma Private Ltd. Cadila Healthcare Ltd Ltd Cassel Research Laborarories (Pvt) Ltd (Contd.) Pharma Associates The Madras Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Healthcare lanka Ltd Healthcare lanka Ltd Healthcare lanka Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Services Pvt. Ltd Healthcare lanka Ltd Healthcare lanka Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP TABLETS PLENDIL 2.5PLENDIL TABLETS TABLETS Hemas PLENDIL Hemas FELOGARD-ER TABLETS TABLETS Hemas FELOCARD ER Sunshine TABLETS Sunshine RELEASE TABLETS 10MG USP TABLETS RELEASE 5MG 5MG USP TABLETS 2878 FELODIPINE 2.5MG EXTENDED 2880 FELODIPINE EXTENDED RELEASE 2869 40MGTABLETS FEBUXOSTAT ZURIG 402870 40MGTABLETS FEBUXOSTAT 2871 40MGTABLETS FEBUXOSTAT 40 FEBURY TABLETS FEBULAS 40 Sunshine TABLETS2872 40MGTABLETS FEBUXOSTAT TABLETS International Yaden 2873 40MGTABLETS FEBUXOSTAT GOURIC 40 Hyena 2874 80MGTABLETS FEBUXOSTAT URIC 40 TABLETS2875 80MGTABLETS FEBUXOSTAT PEBSTAT CIC Holdings PLC TABLETS PharmEvo (Pvt) ZURIG 802876 80MGTABLETS FEBUXOSTAT FILM COA ABC Pharma 2877 FELODIPINE 10MG EXTENDED GOURIC TABLETS Sunshine TABLETS2879 CIC Holdings PLC FELODIPINE EXTENDED RELEASE PharmEvo (Pvt) 2881 FELODIPINE EXTENDED RELEASE 2882 CAPSULES 200MG FENOFIBRATE 200 FIBA CAPSULES Sunshine I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 249 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 PAKISTAN 20-May-14BANGLADESH 16-Jan-16 Full Full INDIA 18-Oct-14 Full INDIACHINA 04-Apr-14 24-Feb-18 Full INDIA Years Two INDIA 14-Oct-14INDIA Full 02-May-15PAKISTAN Full 23-Jun-17 04-Jun-17 Full Years Two PAKISTAN 09-Feb-18GERMANY Years Two 05-Dec-14 Full Getz Pharma (Pvt) Ltd The white horse Pharmaceutical Micro Labs Ltd INDIACadila Healthcare Ltd 10-Sep-15U S V Ltd Full INDIARanbaxy laboratories Ltd Yichang Humanvell 10-Jun-18Pharmaceuticals Years Two Co Ltd Neon Laboratories Ltd Human Verve Care Laboratories Sparsha Pharma International Pvt Ltd Pharmaceuticals & Chemical Works Shrooq Pharmaceutical Pvt Ltd GmbH Takeda Robert Bosch Str (Contd.) Pharmaceuticals (Pvt) Ltd Ltd Ltd Healthcare lanka Ltd Pharmaceuticals (Pvt) Ltd (Ceylon) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Agency Pvt Ltd Pharmaceutical (Pvt) Ltd (Pvt) Ltd Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP LIPICARD CAPSULES Hemas N/AFENT INJECTIONVERFEN Slim INJECTIONFEN-TOUCH INJECTION Ravilux Company Leader Pharma HEALTHION-S SYRUP Kent Ceyoka (Pvt) LtdNOVARISE ISIS TABLETSVENOFER Salveo Pharma INJECTION Baur & Co (Pvt) A 200MG 0.1MG/2ML 100MCG/2ML 50MCG/ML 25MCG/H (10CM CONTAIN PATCHES 2.5MG OF FENTANYL) ACID BP 45MG+ FOLIC USP B6 BP B1 1MG VIT. 0.5MG,VITAMIN 10MG/5ML 2MG+ NIACINAMIDE BP (IRON WITH MULTIVITAMIN) SYRUP ACD 0.75MG 100MG & FOLIC INJECTION COMPLEX 100MG/5ML 2884 CAPSULES 200MG FENOFIBRATE FIBRE 2002885 CAPSULES 200MG FENOFIBRATE FIBRAL CAPSULES2886 CAPSULES 67MG FENOFIBRATE Alaris Lanka (Pvt) 67 FENOCHOL CAPSULES2887 CAPSULES USP CAPSULES FENOFIBRATE Mega Pharma (Pvt) Sunshine 2888 160MGTABLETS FENOFIBRATE STANLIP2889 INJECTION CITRATE FENTANYL TABLETS2890 INJECTION USP CITRATE FENTANYL Emerchemie NB 2891 INJECTION USP CITRATE FENTANYL 2892 TRANSDERMAL FENTANYL 2893 FERRIC AMMONIUM CITRATE 2894 FERRIC HYDROXIDE POLYMALTOSE 2895 FERRIC HYDROXIDE+SUCROSE 2883 CAPSULES 200MG FENOFIBRATE FENOGET CAPSULES Hemas 250 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 25-Mar-16 Full THAILAND 06-Sep-17 01-Jan-17 Full SRI LANKA Full 08-Feb-18 Provisional INDIA 16-Feb-18INDIA Full 10-Nov-17INDIA Full 01-Jan-18 Provisional THAILAND 28-Feb-14INDIA Full 28-Aug-15 Full Laboratories (Pvt) Ltd Cadila Healthcare Ltd Mega Lifesciences (Pvt) Ltd Priivate Limited Apex Laboratories Ltd E Merck (India) Ltd Remedica limited CYPRUS 27-Nov-14Ltd Thailand for Ranbaxy Unichem Full Pharmaceuticals Ltd Simpex Pharma (Pvt) Ltd (Contd.) eld fi Ceyoka (Pvt) Ltd Leben Hemas Pharmaceuticals (Pvt) Ltd Ltd Ltd (Ceylon) Ltd Drugs (Pvt) Ltd Pharmaceuticals (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP SUSPENSION CAPSULES CHELFERRY ORAL SGFERUP GELETIN SOFT FERROVIT CAPSULESFERROGEN Baur & Co (Pvt) A FZZn TABLETS N/A CAPSULES Somer Celogen Lanka ZINCOFER CAPSULES Baur & Co (Pvt) A ANEMIDOX CAPSULES Emerchemie NB FOLIRONThailand F.B.C.FILMTAB TABLETS TABLETS Kandana Food & R.B.TONE Henry's OLIC SYRUP PharmAce (Pvt) Ltd Medley 30MG OF ELEMENTAL IRON +FOLIC 30MG OF ELEMENTAL ACID 550MCG) ACID 1.5MG BP +FOLIC TO IRON EQUIVALENT 53.25MG+FOLIC ACID 0.75MG+ B12 7.5MCG CAPSULES VITAMIN BP TABLETS ACID 0.4MG FOLIC ACID 0.5MG & ZINE FOLIC 41.2MG MONOHYDRATE SULPHATE CAPSULES ACID,CALCIUM VIT. C& VIT.B C& VIT.B ACID,CALCIUM VIT. COMPLEX 350+CYANOCOBALAMINE 350+CYANOCOBALAMINE 5MCG+FOLIC ACID 1MG+ASCORBIC ACID 75MG+PYRIDOXINE HCL 55MG Capsules 1.5MG+ZINC SUL 360MG+FOLIC ACID 400MG,CYANCCOBALAMINE 200MG 15MCG+CARBONATE 400 +CHOLECALCIFEROL IU+ASCORBIC ACID 75MG CAPSULES 0.35MG ACID BP 310MG+FOLIIC TABLETS B COMPLEX 38MG,VIT 200MG,VIT.C & CALCIUM 2896 (Eq. FERROUS ASCORBATE TE 2897 152MG FERROUS FUMARATE 2898 162MG FERROUS FUMARATE 2899 182.4MG+ FERROUS FUMARATE 2900 185MG+ FERROUS FUMARATE 2904 FERROUS FUMARATE+FOLIC 2901 FERROUS FUMARATE 2902 FERROUS FUMARATE 2903 BP FERROUS FUMARATE 2905 FERROUS GLUCONATE I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 251 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 BANGLADESH 19-Nov-14 Full INDIAINDIA 27-Oct-18 Full JORDAN 27-Oct-17 Years Two 07-Aug-15BANGLADESH 31-Jan-18 Full Years Two INDIAINDIA 13-Nov-16INDIA Full 16-Sep-14 Full 19-Sep-17 Years Two PAKISTAN 05-Apr-14PAKISTAN Full 03-Jan-14 Full India Ltd INDIA 30-Apr-14 Full fi Navana Pharmaceuticals Ltd Zim Laboratories Ltd Zim Laboratories Ltd The United Pharmaceutica Manufacturer Healthcare Pharmaceuticals Centurion Laboratories Pvt Ltd Ltd Treffer Pharmaceuticals Micro Labs Ltd INDIA 28-Sep-17 Full CCL CCL Pharmaceuticals (Pvt) Ltd Zee Laboratories INDIA 19-Jul-18 Provisional Shaigan Pharmaceuticals (Pvt) Ltd (Contd.) Lanka Ltd Sano fi Co Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Ltd (Pvt) Ltd International Yaden (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd Pharmaceuticals Lanka (Pvt) Ltd Services Pvt. Ltd Pharmaceuticals (Pvt) Ltd COATED COATED TABLETS SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP ZIFEF-TRFOLRON CAPSULES Darley Butler & FOLRON CAPSULES Tabrane FEFOL CAPSULES Tabrane PLUSPRENAT CAPSULES CAPSULES Baur & Co (Pvt) A Citihealth Imports N/AN/A SUGAR FEROSFEXICO 180 TABLETS TABLETSALLEGRA TABLETS Chamee Chemist International Yaden Bajaj Healthcare Micro Mega Lanka TABLETS Sano ALRINZEX 120 TABLETS CCL TABLETS ABC Pharma FIFEX TABLETS Akbar ACID 0.5MG CAP+ZINC SULPHATE ACID 0.5MG CAP+ZINC SULPHATE 61.8MG ACID 0.5MG CAPSULES ACID 0.5MG CAPSULES ACID 500MCG ACID 500MCG ,THAIMINE 2MG,RIBOFLOVIN MONONITRATE NICOTING 2MG,PYRIDOXINE HCL 10MG,ASCORBIC Acid 50mg TAB TABLETS 200MG 180MG TABLETS 180MG TABLETS 120MG TAB 120MG TABLETS 120MG TAB 2911 200MG BP FERROUS SULPHATE 2907 150MG+FOLIC FERROUS SULPHATE 2908 150MG+FOLIC FERROUS SULPHATE 2909 150MG+FOLIC FERROUS SULPHATE 2910 150MG+FOLIC FERROUS SULPHATE 2912 200MG BP FERROUS SULPHATE 2913 BP TABLETS FERROUS SULPHATE 2914 FEXOFENADINE HYDROCHLORIDE 2915 FEXOFENADINE HYDROCHLORIDE 2906 150MG+FOLIC FERROUS SULPHATE 2917 FEXOFENADINE HYDROHLORIDE 2918 FEXOFENADINE HYDROHLORIDE 2916 FEXOFENADINE HYDROHLORIDE 252 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 BANGLADESH 21-Jul-17 Years Two PAKISTAN 14-Dec-14BANGLADESH 26-Jun-14 Full PAKISTAN Full 15-Mar-14PAKISTAN Full 05-Apr-15PAKISTAN Full 22-Oct-17 Years Two PAKISTANBANGLADESH 27-Jan-17 03-Oct-17 Full PAKISTAN Full 31-Jan-14INDIA Full PAKISTAN 17-Jan-14 24-Jan-16 Full Full Beximco Pharmaceuticals Ltd Micro Labs Ltd INDIAHilton Pharma (Pvt) Ltd 16-Sep-17Globe Pharmaceuticals Years Two Ltd CCL Pharmaceuticals (Pvt) Ltd Shaigan Pharmaceuticals (Pvt) Ltd Getz Pharma (Pvt) Ltd Renata Limited BANGLADESH Hemis NOA 30-Nov-17Pharmaceuticals Years Two Pharmaceuticals Ltd Getz Pharma Pakistan (Pvt) Ltd Aristo Pharmaceuticals Ltd Hemis NOA Pharmaceuticals (Contd.) (Ceylon) Ltd Ltd Healthcare lanka Ltd Healthcare Tabrane (Pvt) Ltd Pharmaceuticals Lanka (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Ceylon) Ltd Negolec Lifescience (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Co Ltd (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP ORAL ORAL SUSPENSION ORAL SUSPENSION AXODIN 120 TABLETSFEXICO 120 Emerchemie NB FEXO TABLETS Mega Pharma (Pvt) FEXONA SUSPENSION TABLETSALRIN Sunshine FIFEX TABLETSFEXET CCL TABLETSFENADIN Akbar TABLETSFENADRIN SUSPENTION TABLETS Hemas FEXO Emerchemie NB FEXET SUSPENSION PharmAce (Pvt) Ltd Square FEXOFEN 180 TABLETS TABLETSFENADRIN Hemas Darley Butler & TABLETS Negolec Lifescience 120MG TABLETS SUSPENSION 30MG/5ML 120MG TABLETS 120MG TABLETS 30MG/5ML 60MG TABLETS 60MG TABLETS 60MG TABLETS 60MG TABLETS SUSPENSION 30MG/5ML BP30MG TABLET 180MG TABLETS 180MG TABLETS 2921 FEXOFENADINE HYDROHLORIDE 2927 FEXOFENADINE HYDROHLORIDE 2919 FEXOFENADINE HYDROHLORIDE 2920 FEXOFENADINE HYDROHLORIDE 2922 FEXOFENADINE HYDROHLORIDE 2923 FEXOFENADINE HYDROHLORIDE 2924 FEXOFENADINE HYDROHLORIDE 2925 FEXOFENADINE HYDROHLORIDE 2926 FEXOFENADINE HYDROHLORIDE 2928 FEXOFENADINE HYDROHLORIDE 2929 FEXOFENADINE HYDROHLORIDE 2930 FEXOFENADINE HYDROHLORIDE 2931 FEXOFENADINE HYDROHLORIDE I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 253 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 PAKISTAN 23-Dec-17PAKISTAN Years Two 11-Mar-14PAKISTAN Full 14-Dec-14INDIA Full 23-Apr-14 Full INDIAINDIA 29-Nov-18 Full INDIA 01-Feb-18 Full PAKISTAN 29-Nov-17 Years Two 05-Mar-15PAKISTAN Full INDIA 27-Jan-17 Full INDIA 18-Jan-16 Full BANGLADESH 11-Nov-16 11-Jan-15 Full Full India Ltd INDIA 18-Apr-14 Full fi Shaigan Pharmaceuticals (Pvt) Ltd CCL Pharmaceuticals (Pvt) Ltd Hilton Pharma (Pvt) Ltd Pharmaceuticals Ltd G D Laboratories (India) Pvt Ltd Umedica Laboratories (Pvt) Ltd Platinum Pharmaceuticals (Pvt) Ltd Hemis NOA Pharmaceuticals Agio Pharmaceuticals Ltd Akums Drugs & Pharmaceuticals Ltd Healthcare Pharmaceuticals Zim Laboratories Ltd (Contd.) Lanka Ltd Sano fi Pharmaceuticals (Pvt) Ltd Pharmaceuticals Lanka (Pvt) Ltd Healthcare lanka Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals Pvt Ltd Health (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP FIFEX FORTE TABLETSALRIN Akbar FEXO TABLETS 180ULTIGRA CCL TABLETS TABLETSALLEGRA Sunshine PharmAce (Pvt) Ltd Medley TABLETS Sano EXOFIN 120 TABLETS 120FIXDEP Lifeline TABLETSALGITAB Gamma FENADRIN TABLETSGDIFEX 120 George Steuart TABLETS TABLETS Negolec Lifescience FEXOVEX 120 Citihealth Imports TABLETSVIFAS Global Impex AV TABLETS Citihealth Imports FEXORIL TABLETS Tabrane TABLETS 180MG TABLETS 180MG TABLETS 180MG TABLETS 180MG TABLETS 120MG IP TABLETS TABLETS USP 120MG USP TABLETS 120MG USP TABLETS 120MG USP TABLETS 120MG USP TABLETS 120MG USP TABLETS 120MG USP TABLETS 120MG USP TABLETS TABLETS USP 120MG USP TABLETS 2933 FEXOFENADINE HYDROHLORIDE 2934 FEXOFENADINE HYDROHLORIDE 2935 FEXOFENADINE HYDROHLORIDE 2936 FEXOFENADINE HYDROHLORIDE 2932 FEXOFENADINE HYDROHLORIDE 2938 FEXOFENADINE HYDROHLORIDE 2939 FEXOFENADINE HYDROHLORIDE 2940 FEXOFENADINE HYDROHLORIDE 2941 FEXOFENADINE HYDROHLORIDE 2942 FEXOFENADINE HYDROHLORIDE 2943 FEXOFENADINE HYDROHLORIDE 2944 FEXOFENADINE HYDROHLORIDE 2937 FEXOFENADINE HYDROHLORIDE 254 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIA 14-Sep-17 Full PAKISTAN 25-Jul-14 Full INDIAINDIA 12-Aug-17BANGLADESH Years Two 29-Mar-18 26-Nov-17 Years Two INDIA Full 28-Apr-18 Full PAKISTAN 22-Oct-15 Full INDIAPAKISTAN 10-Jun-16 09-Nov-16 Full INDIA Full 10-Jun-16 Full c fi Fredun Pharmaceuticals Ltd Paci Pharmaceutical Ltd Comed Chemical Ltd Care (Pvt) Ltd Pharmaceuticals Ltd Cadila pharmaceuticals Ltd Sterling LabRenata Limited INDIA BANGLADESHGetz Pharma (Pvt) 10-Nov-17Ltd 16-Feb-15 Full Renata Limited Full BANGLADESHZim Laboratories 18-Aug-18Ltd Years Two Platinum Pharmaceuticals (Pvt) Ltd Zim Laboratories Ltd (Contd.) Health (Pvt) Ltd Ltd Ltd Healthcare lanka Ltd Co Ltd (Ceylon) Ltd Pharmaceuticals (Pvt) Ltd (Ceylon) Ltd Pharmaceuticals (Pvt) Ltd Health (Pvt) Ltd Pharmaceuticals (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP FEXOFRED 120 TABLETSNOVAHIST George Steuart TABLETS Markss HLC (Pvt) XADINEFEGRA TABLETS 120FEATON Morison PLC TABLETS TABLETSFEXO 120 C Medical (Pvt) T P Searle-Pakistan Harcourts (Pvt) Ltd PAKISTAN Health Tech Pell 120 TABLETSALLERSTAT TABLETS 21-Mar-14 PharmAce (Pvt) Ltd Square ALLEFAST Sunshine Full FENADIN TABLETSFEXET Darley Butler & TABLETSFENADIN Emerchemie NB TABLETS 180FEXORIL TABLETS Hemas TABLETSALGITAB Emerchemie NB Tabrane 180FEXORIL TABLETS TABLETS George Steuart Tabrane TABLETS USP 120MG USP TABLETS 120MG USP TABLETS TABLETS USP 120MG USP TABLETS 120MG USP TABLETS 180MG USP TABLETS TABLETS USP 120MG USP TABLETS TABLETS USP 120MG USP TABLETS 120MG USP TABLETS 120MG USP TABLETS 120MG USP TABLETS 120MG USP TABLETS 180MG USP TABLETS 180MG USP TABLETS 180MG USP TABLETS 2945 FEXOFENADINE HYDROHLORIDE 2946 FEXOFENADINE HYDROHLORIDE 2953 FEXOFENADINE HYDROHLORIDE 2954 FEXOFENADINE HYDROHLORIDE 2956 FEXOFENADINE HYDROHLORIDE 2948 FEXOFENADINE HYDROHLORIDE 2947 FEXOFENADINE HYDROHLORIDE 2949 FEXOFENADINE HYDROHLORIDE 2950 FEXOFENADINE HYDROHLORIDE 2951 FEXOFENADINE HYDROHLORIDE 2952 FEXOFENADINE HYDROHLORIDE 2955 FEXOFENADINE HYDROHLORIDE 2957 FEXOFENADINE HYDROHLORIDE 2958 FEXOFENADINE HYDROHLORIDE I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 255 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIA 09-Jul-16INDIA Full INDIA 14-Sep-17 Full BANGLADESH 11-Nov-14 17-Apr-18 Full BANGLADESH Full 17-Dec-14INDIA Full BANGLADESH 29-Mar-18 11-Nov-16 Years Two PAKISTAN Full 22-Oct-14PAKISTAN Full 08-Nov-17 Years Two INDIAINDIA 23-Nov-15 Full 26-Dec-14 Full India Ltd INDIA 28-Oct-17Years Two fi Akums Drugs & Pharmaceuticals Ltd Sterling LabFredun INDIAPharmaceuticals Ltd Akums Drugs & Pharmaceuticals 10-Apr-14Ltd Full Beximco Pharmaceuticals Ltd Healthcare Pharmaceuticals Comed Chemical Ltd Pharmaceuticals Ltd Getz Pharma (Pvt) Ltd Company Ltd Cipla Ltd INDIA 05-Sep-18Years Two XL Laboratories XL (Pvt) Ltd Sai Mirra Innopharm (Pvt) Ltd (Contd.) Lanka Ltd Sano fi Pharmaceuticals (Pvt) Ltd Darley Butler & Co Ltd Health (Pvt) Ltd (Pvt) Ltd (Ceylon) Ltd (Pvt) Ltd Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Ltd Healthcare lanka Ltd TABLETS SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP HISTAFREE 180HISTAFREE TABLETSALLEFAST Hemas FEXOFRED 180 FILM COA TABLETSFEXOVEX 180 George Steuart TABLETSAXOCDIN 180 Global Impex AV TABLETSVIFAS Emerchemie NB 180FEGRA TABLETSFEXO 180 TABLETS Citihealth Imports C Medical (Pvt) T P TABLETSFEXET PharmAce (Pvt) Ltd Square XADINE TABLETS Hemas TABLETS Morison PLC The Searle TILFUR 120 TABLETS SMM Halcyon (Pvt) FEXIL 120FEXIL TABLETS Sunshine TABLETS USP 180MG USP TABLETS 180MG USP TABLETS 180MG USP TABLETS 180MG USP TABLETS 180MG USP TABLETS 180MG USP TABLETS 180MG USP TABLETS 180MG USP TABLETS 180MG USP TABLETS 60MG USP TABLETS 120MG 120MG 2960 FEXOFENADINE HYDROHLORIDE 2961 FEXOFENADINE HYDROHLORIDE 2962 FEXOFENADINE HYDROHLORIDE 2963 FEXOFENADINE HYDROHLORIDE 2964 FEXOFENADINE HYDROHLORIDE 2965 FEXOFENADINE HYDROHLORIDE 2966 FEXOFENADINE HYDROHLORIDE 2967 FEXOFENADINE HYDROHLORIDE 2968 FEXOFENADINE HYDROHLORIDE 2969 120MGTABLETS FEXOFENADINE 120 FEXIGRA 2970 30MG IP TABLETS FEXOFENADINE TABLETS ALLEGRA Breathe Free Lanka TABLETS Sano 2959 FEXOFENADINE HYDROHLORIDE 2972 USP FEXOFENADINE TABLETS 2971 USP FEXOFENADINE TABLETS 256 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 PAKISTANINDIA 08-Nov-17 Years Two INDIA 17-Jan-14 Full 23-Nov-17ARGENTINA Full 13-Aug-17 Years Two INDIAARGENTINA 16-Aug-15 16-Aug-16INDIA Full Full ARGENTINA 11-Mar-18 23-Aug-17 Provisional Years Two INDIA 14-Nov-17 Years Two INDIA 14-Nov-17 Years Two INDIA 13-Aug-14 Full Company Ltd Laboratories XL (Pvt) Ltd Sai Mirra Innopharm (Pvt) Ltd Intas INDIAYears Biosidus S.A.Av de Los 21-May-18 Two Dr Reddy's Laboratories Ltd Bioprofarma SA Terrada Reliance Life Sciences (Pvt) Ltd Biosidus S.A.Av de Los Dr Reddy's Laboratories Ltd Dr Reddy's Laboratories Ltd Akums Drugs & Pharmaceuticals Ltd (Contd.) SMM Halcyon (Pvt) Ltd Healthcare lanka Ltd Novex Pharmaceutical Ltd Pharmaceuticals (Pvt) Ltd (Ceylon) Ltd (Ceylon) Ltd Services Pvt. Ltd Pharmaceuticals (Pvt) Ltd (Ceylon) Ltd (Ceylon) Ltd (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP TABLETS INTRAVENOUS XADINETILFUE 180 TABLETS 180FEXIL FILM COA Morison PLC TABLETSNEUKINE The Searle Sunshine NEUTROMAX SOLUTION FOR INJECTIONGRASTIM Slim FILGEN INJECTIONRELIGRAST Emerchemie NB INJECTIONNEUTROMAX INJECTION Emerchemie NB ABC Pharma INJECTIONGRASTIM Slim INJECTION Emerchemie NB GRASTIM INJECTION Emerchemie NB IN 1ML 180MG 180MG 180MG IN 1ML IN 1ML IN 1ML 30MU/0.5ML(300MCG) 480MCG.0.5ML FILLED SYRINGE INJECTION 300MCG/1M HUMAN RECOMBINANT GRANULOCYTE COLONY (G-GSF) FACTOR STIMULATING INJECTION FILLED SYRINGE INJECTION 300MCG/1M HUMAN RECOMBINANT GRANULOCYTE COLONY (G-GSF) FACTOR STIMULATING INJECTION 2977 FILGRASTIM INJECTION 300MCG 2973 USP FEXOFENADINE TABLETS 2974 USP FEXOFENADINE TABLETS 2975 USP FEXOFENADINE TABLETS 2976 FILGRASTIM INJECTION 300MCG 2978 FILGRASTIM INJECTION 300MCG 2979 FILGRASTIM INJECTION 300MCG 2980 FILGRASTIM INJECTION 2981 FILGRASTIM INJECTION 2982 FILGRASTIM INJECTION PRE 2983 FILGRASTIM INJECTION PRE 2984TABLETS FINASTERIDE 1MG USP VEXFIN 1 TABLETS Global Impex AV I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 257 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 19-Aug-15 Full UNITED STATES/ UNITED KINGDOM INDIAINDIA 28-Jun-17 Full INDIA 28-Jun-17 Full 13-Jun-17BANGLADESH Full 02-Mar-14 Full INDIAINDIA 05-Sep-14 Full INDIA 25-Mar-16 Full INDIA 13-Jun-17INDIA Full 15-Feb-18INDIA Full 25-Jan-14 Full 24-Aug-18 Years Two MSD International GmbH (Purerto Rico Branch LLC) Merck Sharp & Dohme-UK Akums Drugs & Pharmaceuticals Ltd Akums Drugs & Pharmaceuticals Ltd Cipla LtdPharmaceuticals INDIALtd Akums Drugs & Pharmaceuticals Ltd 27-Feb-18Stallion Full Laboratories Pvt Ltd Akums Drugs & Pharmaceuticals Ltd Dr Reddy's Laboratories Ltd Elder Pharmaceutical Ltd Concept Pharmaceuticals Ltd Akums Drugs & Pharmaceuticals Ltd (Contd.) Ltd Pharmaceuticals (Pvt) Ltd Plc (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Ceylon) Ltd Healthcare lanka Ltd International (Pvt) Ltd Plc SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP FLUCREME NM OINTMENT Softcare 0.25MG,NEOMYCIN SULPHATE 0.25MG,NEOMYCIN SULPHATE BP 5.0MG,MICONAZOLE NITRATE 20MG OINTMENT 2987 1MG USP TABLETS FINASTERIDE 1 BENPROPHY TABLETS2988 5MG USP TABLETS FINASTERIDE 5 BENPROPHY Lotus TABLETS2989 5MG USP TABLETS FINASTERIDE FINCAR Browns & Company 2990 5MG USP TABLETS FINASTERIDE PRONOR-5 TABLETS2991 5MG USP TABLETS FINASTERIDE TABLETS VEXFIN 5 Breathe Free Lanka 2992 5MG USP TABLETS FINASTERIDE PharmAce (Pvt) Ltd Square 5 FINSTAL TABLETS2993 5MG USP TABLETS FINASTERIDE Global Impex AV TABLETS 5 BENPROPHY TABLETS2994 5MG USP TABLETS FINASTERIDE Siba Healthcare FINAST Lotus 2995 200MG BP TABLETS FLAVOXATE N/A TABLETS2996 FLUOCINOLONE ACETONIDE BP Emerchemie NB TABLETS Sunshine 2985 5MGTABLETS FINASTERIDE PROSCAR TABLETS Baur & Co (Pvt) A 2986 1MG USP TABLETS FINASTERIDE 1 BENPROPHY TABLETS Browns & Company 258 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIABANGLADESH 19-Aug-14 25-Oct-18 Years Two Full BANGLADESH 13-Jul-14BANGLADESH Full 06-Feb-18 Full BANGLADESH 30-Jan-18INDIA Full 31-Oct-15 Full BANGLADESH 25-Oct-18 Years Two BANGLADESH 14-Feb-15 Full INDIABANGLADESH 06-Feb-18 01-Jul-17 Full Full Zee Laboratories INDIAUnijules Life Sciences Ltd 07-Apr-14 Full Chemical Industries Pharmaceuticals Ltd Globe Pharmaceuticals Ltd Navana Pharmaceuticals Ltd Ltd Kopran LtdOrion pharma Ltd INDIA BANGLADESH 23-Jun-16Chemical Full Industries 26-Oct-17Years Two Pharmaceuticals Ltd Ltd Globe Pharmaceuticals Ltd (Contd.) Services Pvt. Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Co Ltd Ltd Co Ltd (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP FLUZEC-NM CREAMUNILONE CREAM CREAM ABC Pharma FLUCLOX Lifeline CAPSULESPHYLOPEN CIC Holdings PLC CAPSULES Advanced ISOCLOX PharmAce (Pvt) Ltd Square FLUBIOTIC 250 CAPSULES CAPSULES Healthcare Tabrane Darley Butler & F CLODAXFLUPEN 250 CAPSULES CAPSULES Harcourts (Pvt) Ltd 250FLUSTAPH Coral Laboratories CAPSULES Alaris Lanka (Pvt) FLUCLOX Darley Butler & CAPSULESPHYLOPEN DS CAPSULES CIC Holdings PLC Advanced FCLODAX PharmAce (Pvt) Ltd Square ISOCLOX 500 CAPSULES CAPSULES Harcourts (Pvt) Ltd Coral Laboratories Healthcare Tabrane USP 0.025% w/w USP 250MG 500MG 0.25MG,NEOMYCIN SULPHATE 0.25MG,NEOMYCIN SULPHATE 20MG 5.0MG,MICONAZOLE BP CREAM 250MG 250MG 250MG 250MG 250MG 250MG 500MG 500MG 500MG 2998 FLUCINOLONE ACETONIDE CREAM 3005 FLUCLOXACILLIN CAPSULES BP 3006 FLUCLOXACILLIN CAPSULES BP 2997 FLUOCINOLONE ACETONIDE BP 2999 FLUCLOXACILLIN CAPSULES BP 3000 FLUCLOXACILLIN CAPSULES BP 3001 FLUCLOXACILLIN CAPSULES BP 3002 FLUCLOXACILLIN CAPSULES BP 3003 FLUCLOXACILLIN CAPSULES BP 3004 FLUCLOXACILLIN CAPSULES BP 3007 FLUCLOXACILLIN CAPSULES BP 3008 FLUCLOXACILLIN CAPSULES BP 3009 FLUCLOXACILLIN CAPSULES BP I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 259 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 BANGLADESH 03-Feb-18 Full BANGLADESH 14-Feb-16 Full SRI LANKA 10-Jul-18BANGLADESHYears Two 21-Jun-15BANGLADESH Full 21-May-18 Years Two BANGLADESH 25-Oct-18 Years Two BANGLADESH 07-Feb-18 Full CYPRUS 11-Mar-14INDIA Full BANGLADESH 11-May-17 04-Aug-18 Full Full INDIA 26-Jul-18 Full Navana Pharmaceuticals Ltd Orion pharma Ltd BANGLADESH 23-Jun-16Pharmaceuticals Full Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals Ltd Globe Pharmaceuticals Ltd Chemical Industries Navana Pharmaceuticals Ltd Delobris Pharmaceuticals 01.06.18 Ltd-AT Yaden-LO42/17 Unimax Laboratories Pharmaceuticals Ltd Agio Pharmaceuticals Ltd (Contd.) Co Ltd Co Ltd PharmAce (Pvt) Ltd Square N/A Navesta Healthcare Tabrane (Pvt) Ltd CIC Holdings PLC Advanced Darley Butler & Co Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd FOR ORAL FOR ORAL SOLUTION INJECTION SOLUTION SUSPENSION SUSPENSION SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP FLUBIOTIC 500 CAPSULES 500 Darley Butler & FLUSTAPH CAPSULESPHYLOPEN Darley Butler & POWDER UNIFLOXPHYLOPEN POWDER FOR INJECTIONISOCLOX PharmAce (Pvt) Ltd Square FLAGENTYL ORAL ORAL FLUBIOTIC 125 POWDER 500MG 500MG SOLUTION BP FOR ORAL 125MG/5ML 500MG 500MG 125MG/5ML BP 125MG/5ML SUSPENSION BP 125MG/5ML SUSPENSION BP 3011 FLUCLOXACILLIN CAPSULES BP 3012 POWDER FLUCLOXACILLIN DRY 3013 FLUCLOXACILLIN INJECTION BP 3014 FLUCLOXACILLIN INJECTION BP 3015 SOLUTION FLUCLOXACILLIN ORAL 3016 FLUCLOXACILLIN ORAL 3017 FLUCLOXACILLIN ORAL 3018 FLUCONAZOLE CAPSULES 100MG FLUCOZAL3019 CAPSULES 150MGTABLETS FLUCONAZOLE Access International NUFORCE 1503020 TABLETS FLUCONAZOLE CAPSULES 150MG 150 FLUGAL Hemas 3021 FLUCONAZOLE CAPSULES 150MG CAPSULES PLUCAZ 150 PharmAce (Pvt) Ltd Square CAPSULES Citihealth Imports 3010 FLUCLOXACILLIN CAPSULES BP 260 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 GERMANY 19-Dec-17INDIA Full BANGLADESH 24-Mar-18 19-Jul-15MALAYSIA Full Full 11-Sep-17GERMANY Years Two 19-Dec-17INDIA Full BANGLADESH 09-Mar-18 30-Aug-14 Provisional GERMANY Full 19-Dec-15 Full BANGLADESH 24-Aug-17 Years Two INDIAINDIA 18-Sep-14BANGLADESH Full 18-Jun-18 04-Aug-14 Years Two Full BANGLADESH 03-Oct-16 Full Denk Pharma GmbH & Co. Denk Pharma GmbH & Co. Denk Pharma GmbH & Co. Beximco Pharmaceuticals Ltd Ltd Umedica Laboratories (Pvt) Ltd Healthcare Pharmaceuticals Pharmaniaga Manufacturing berhand Laboratories XL (Pvt) Ltd General Pharmaceuticals Ltd Win Medicare ltd INDIA 06-Jan-16 Full Centurion Laboratories Pvt Ltd Pharmaceuticals Ltd Healthcare Pharmaceuticals (Contd.) Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Ceylon) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd (Ceylon) Ltd Ltd Health (Pvt) Ltd Ltd (Pvt) Ltd (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP CAPSULES Akbar CAPSULES Akbar CAPSULES Akbar 100 150 100 OMASTIN CAPSULESN/A Emerchemie NB CAPSULES Chamee Chemist Bajaj Healthcare 150MG 150MG 3022 FLUCONAZOLE CAPSULES 150MG FLUCONA-DENK 3023 FLUCONAZOLE CAPSULES 150MG UMEFLUC3024 FLUCONAZOLE CAPSULES 150MG CAPSULES CANDINIL3025 FLUCONAZOLE CAPSULES 150MG Gamma N/A CAPSULES3026 FLUCONAZOLE CAPSULES 150MG Citihealth Imports FLUCONA-DENK 3027 CAPSULES FLUCONAZOLE CAPSULES 150MG FUNGBY Emerchemie NB 3028 FLUCONAZOLE CAPSULES 150MG GALFON 150 CAPSULES3029 CAPSULES FLUCONAZOLE CAPSULES 150MG SMM Halcyon (Pvt) FLUCONA-DENK George Steuart 3030 FLUCONAZOLE CAPSULES 150MG LOGICAN3031 FLUCONAZOLE CAPSULES USP CAPSULES3032 FLUCONAZOLE CAPSULES USP Robert Hall & Co 3033 FLUCONAZOLE CAPSULES 200MG N/A3034 FLUCONAZOLE CAPSULES 50MG 50 FLUGAL 3035 CAPSULES FLUCONAZOLE CAPSULES 50MG CAPSULES 50 CANDINIL International Yaden PharmAce (Pvt) Ltd Square CAPSULES Citihealth Imports I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 261 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 BANGLADESH 24-Aug-17 Years Two BANGLADESH 24-Aug-17 Years Two BANGLADESH 05-Dec-17 Years Two BANGLADESH 05-Dec-17 Years Two INDIAINDIA 16-Mar-16BANGLADESH Full 15-Jul-15 23-Apr-14BANGLADESH Full Full 11-May-18 Years Two INDIABANGLADESH 18-Jul-17 23-Dec-17 Years Two Full INDIAINDIA 18-Apr-18INDIA Years Two 17-Dec-14INDIA Full 13-Jun-18 Years Two 10-Apr-16 Full Beximco Pharmaceuticals Ltd Beximco Pharmaceuticals Ltd Incepta Pharmaceuticals Ltd Incepta Pharmaceuticals Ltd Ltd Fresenius Kabi India Pvt Ltd Healthcare Pharmaceuticals Pharmaceuticals Ltd Cadila pharmaceuticals Ltd Globe Pharmaceuticals Ltd United Biotech (Pvt) Ltd SG Pharma (Pvt) Ltd Mercury Laboratories Ltd SG Pharma (Pvt) Ltd (Contd.) (Ceylon) Ltd (Ceylon) Ltd (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd PharmAce (Pvt) Ltd Square Healthcare lanka Ltd (Pvt) Ltd Health (Pvt) Ltd Pharmacy (Pvt) Ltd (Pvt) Ltd Pharmacy (Pvt) Ltd SUSPENSION SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP OMASTIN CAPSULESOMASTIN Emerchemie NB CAPSULESNISPORE 150 Emerchemie NB CAPSULESNISPORE 150 Citihealth Imports CAPSULESAxa-Zole F Citihealth Imports INFUSION Chamee ChemistCANDINIL Axa Parenterals FLUGAL SUSPENSION Citihealth Imports POWDER FOR FLUZOLE 150 TABLETSFLUDABINE 50 Healthcare Tabrane INJECTIONN/A George Steuart FLUDRICORT TABLETSN/A TABLETS International Yaden The Esses INJECTION The Esses 50MG 50MG 50MG 50MG 200mg/100ml SUSPENSION 50MG 50MG/5ML SUSPENSION USP 150MG 50MG INJECTION USP 0.1MG USP TABLETS 100MCG USP TABLETS 0.5MG/5ML 3037 FLUCONAZOLE CAPSULES USP 3038 FLUCONAZOLE CAPSULES BP 3039 FLUCONAZOLE CAPSULES BP 3040 FLUCONAZOLE INFUSION 3041 FLUCONAZOLE INFUSION 2MG/ML FRESOCAN3042 FLUCONAZOLE POWDER FOR INFUSION3043 FLUCONAZOLE POWDER FOR Hemas 3044 150MG FLUCONAZOLE TABLETS FLUZON3045 USP FLUCONAZOLE TABLETS TABLETS3046 FLUDARABINE PHOSPHATE Sunshine 3047 ACETATE FLUDROCORTISONE 3048 ACETATE FLUDROCORTISONE 3049 INJECTION USP FLUMAZENIL 3036 FLUCONAZOLE CAPSULES USP 262 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 BANGLADESH 02-Feb-17 Full INDIA 07-Jan-15 Full BANGLADESH 13-Feb-16 Full INDIAINDIA 15-Feb-14INDIA Full 22-Jul-14 Full BANGLADESH 27-Nov-16 24-Nov-16 Full Full INDIAINDIA 18-Dec-17 Years Two INDIA 30-Jul-15 Full BANGLADESH 07-Jun-17 14-Mar-14 Years Two Full Geno Pharmaceuticals Pvt Ltd F D C Limited INDIAPharmaceuticals Ltd 04-Mar-15 Full Glenmark Pharmaceuticals Ltd Pharmaceuticals Ltd Glenmark Pharmaceuticals Ltd Chemical Industries Navana Pharmaceuticals Ltd Naprod Life Scienc (Pvt) Ltd Geno Pharmaceuticals Pvt Ltd Cassel Research Laborarories (Pvt) Ltd Pharmaceuticals Ltd F D C Limited INDIA 04-Mar-14 Full (Contd.) (Pvt) Ltd Healthcare lanka Ltd Healthcare lanka Ltd Healthcare lanka Ltd Co Ltd (Pvt) Ltd (Pvt) Ltd Healthcare lanka Ltd Healthcare lanka Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP CREAM Sunshine DONARIZINE 10 TABLETSFLUNARIN Mansel (Ceylon) TABLETS Sunshine SUPRICORT CREAM MZFLUCORT OINTMENTSUPRICORT Swiss Biogenics Ltd Glenmark CREAMSKINALAR Sunshine OINTMENT CIC Holdings PLC Advanced TABLETS 10MG TABLETS 10MG TABLETS 0.025% + NEOMYCIN SULPHATE 0.5% CREAM BP 0.01% +MICONAZOLE NITRATE 2% SKIN OINTMENT 0.025% 0.025% 3053 10MGTABLETS FLUNARIZINE 10 FLUMIGRA TABLETS PharmAce (Pvt) Ltd Square 3050 CAPSULES 5MG FLUNARIZINE HCL 5 IMIGRA 3051 FLUNARIZINE HYDROCHLORIDE CAPSULES Darley Butler & 3052 FLUNARIZINE HYDROCHLORIDE 3054 10MGTABLETS FLUNARIZINE 3055 5MGTABLETS FLUNARIZINE NAPRONIN3056 TABLETS DONARIZINE 5 5MGTABLETS FLUNARIZINE TABLETS Ravilux Company 3057 FLUNAR 5 5MGTABLETS FLUNARIZINE Mansel (Ceylon) TABLETS3058 5 FLUMIGRA 5MG FLUNARIZINE TABLETS TABLETS Sunshine 3059 FLUNARIN FLUOCINOLONE ACETONIDE PharmAce (Pvt) Ltd Square TABLETS3060 FLUOCINOLONE ACETONIDE BP Sunshine 3061 FLUOCINOLONE ACETONIDE BP 3062 FLUOCINOLONE ACETONIDE BP I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 263 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 BANGLADESH 14-Mar-15 Full INDIAPAKISTAN 23-Jul-14 06-Jun-16 Full Full PAKISTAN 04-Nov-14PAKISTAN Full 19-Aug-17BANGLADESH Full 10-Jul-14INDIA Full BANGLADESH 20-May-14 09-May-18 Years Two Full INDIAINDIA 16-Feb-18FRNACE Full 05-Mar-14 25-Apr-15 Full Full Advanced Chemical Industries SG Pharma (Pvt) Ltd Elko Organization (Pvt) Ltd Alcon Couvreur BELGIUMAristopharma Ltd BANGLADESH 13-Nov-17 01-Jan-15 Full Remington pharmaceutical Full Industries (Pvt) Ltd The Schazoo Pharmaceutucal Laboratories (Pvt) Ltd Popular Pharmaceuticals Ltd Getwell Pharmaceuticals Beacon Pharmaceuticals Ltd United Biotech (Pvt) Ltd Getwell Pharmaceuticals Laboratories Ltd (Contd.) Colombo Ltd Pharmacy (Pvt) Ltd Emerchemie NB (Ceylon) Ltd Ltd Hemas Pharmaceuticals (Pvt) Ltd Delmege Forsyth & Co Ltd Ltd Services Pvt. Ltd Pharmacy (Pvt) Ltd (Ceylon) Ltd Health (Pvt) Ltd Pharmacy (Pvt) Ltd SOLUTION SUSPENSION SUSPENSION EYE DROPS Edna Medicals (Pvt) INJECTION The Esses SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP SKINALAR CREAMN/AFLOROZIL Chemical Industries FLAREX INJECTION OPHTHALMIC The Esses AFM EYE DROPS Baur & Co (Pvt) A EYFEM OPHTHALMIC OPHTHALMIC FLOROM EYE DROP FLUSOL RACIWEL EYE DROPS1G/20ML ABC Pharma FLUROXAN 500 INJECTION Emerchemie NB ONCOFLUOR INJECTION 500RACIWEL George Steuart INJECTIONLUVOX 100 The Esses TABLETS CIC Holdings PLC Mylan CREAM 0.025% W/W 500MG/5ML 4.0% SODIUM CROMOGLYCATE STERILE OPTHALMIC SUSPENSION 0.1%/WV STERILE OPTHALMIC SUSPENSION 0.1%/WV SUSPENSION 0.1% 0.1% SUSPENSION USP 0.1% SUSPENSION USP 1G/20ML 500MG 250MG/5ML 500MG/10ml 100MG 3064 FLUORESCEIN INJECTION USP 3065 FLUOROMETHOLONE 0.1% + 3066 FLUOROMETHOLONE ACETATE 3067 FLUOROMETHOLONE ACETATE 3068 FLUOROMETHOLONE OPTHALMIC 3069 FLUOROMETHOLONE OPTHALMIC 3070 FLUOROMETHOLONE OPTHALMIC 3071 INJECTION BP FLUOROURACIL 3072 INJECTION BP FLUOROURACIL 3073 INJECTION IP FLUOROURACIL 3074 INJECTION BP FLUOROURACIL 3075 TABLETS FLUOXAMINE MALEATE 3063 FLUOCINOLONE ACETONIDE 264 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIABANGLADESH 03-Jun-17 30-Jul-18 Years Two Full INDIAINDIA 27-Apr-18 Years Two 06-Jan-18INDIA Full INDIA 03-Feb-17 Full FRANCE 19-Jul-17FRANCE 25-Apr-16 Full Full 25-Apr-16 Full INDIAINDIA 25-May-16 Full 27-Mar-14 Full Sun Pharmaceutical industries Laboratories Ltd Laboratories Ltd SA H Lundbeck DENMARK SA H Lundbeck 01-Jul-14 DENMARK Full 01-Jan-18Pharmafabrikon Full Unit Pharmafabrikon Unit Centurion Laboratories Pvt Ltd Formulation Ltd Medochemie Ltd CYPRUS 02-Feb-16Pvt Ltd Laboratories XL Full (Pvt) Ltd Micro Labs Ltd INDIACadila Laboratories Ltd 09-Dec-15 Full (Contd.) (Ceylon) Ltd Healthcare lanka Ltd Healthcare lanka Ltd (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd Laboratories (Pvt) Ltd Ltd (Pvt) Ltd Healthcare lanka Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP INJECTION Sunshine PRODEPLUVOX 50 CAPSULES Emerchemie NB LUVOX 50 TABLETS FLUANXOL TABLETS CIC Holdings PLCDEPOT Mylan CIC Holdings PLC Mylan N/AN/A INJECTION Novachem Lanka INJECTION Novachem Lanka ML USP 20 MG USP 50MG 50MG INJECTION 40mg/2ml 25MG/ML INJECTION BP 3087 0.5MG TABLETS FLUPENTIXOL FLUANXOL3088 1MGTABLETS FLUPENTIXOL 3089 TABLETS 20MG/ INJECTION BP FLUPENTIXOL FLUANXOL Sunshine TABLETS Swiss Biogenics Ltd SA H Lundbeck DENMARK 01-Jan-14 Full 3076 20MG FLUOXETINE CAPSULES BP N/A3077 20MG FLUOXETINE CAPSULES BP 20 PROLERT 3078 20MG FLUOXETINE CAPSULES BP CAPSULES CAPSULES MAGRILAN International Yaden PharmAce (Pvt) Ltd3079 Square 20MG FLUOXETINE CAPSULES USP COZAC 20 CAPSULES3080 Associated 20MG FLUOXETINE CAPSULES USP ADEF- XL CAPSULES3081 20MG FLUOXETINE CAPSULES USP DAWNEX PharmAce (Pvt) Ltd Consern Pharma CAPSULES3082 20MG FLUOXETINE CAPSULES USP FLUDAC SMM Halcyon (Pvt) CAPSULES3083 FLUOXETINE HYDROCHLORIDE Micro Mega Lanka CAPSULES Sunshine 3084 TABLETS FLUOXETINE MALEATE 3085 TABLETS FLUOXETINE MALEATE 3086 DECANOATE FLUPENTIXOL 3090 FLUPHENAZINE DECANOATE I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 265 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 31-Mar-17 Full INDIA 21-Apr-17 Full INDIABANGLADESH 21-Sep-17 21-Mar-16 Years Two Full INDIAINDIA 16-Jan-18 Full INDIA 16-Jan-18INDIA Full 26-Dec-15INDIA Full 10-Sep-15UNITED Full KINGDOM 21-Jun-18 Full INDIABANGLADESH 12-Aug-17 15-Jan-14 Years Two INDIA Full 31-Dec-15 Full Cadila Healthcare Ltd Pharmaceuticals Ltd Concept Pharmaceuticals Ltd Biodeal Gujarat INDIA 16-Jan-15 Full PharmaceuticalS (Pvt) Ltd PharmaceuticalS (Pvt) Ltd SG Pharma (Pvt) Ltd Glaxo Smithkiline Pharmaceuticlas Sava Healtheare Ltd Glaxo Operations UK Ltd Pharmaceuticals (Pvt) Ltd Beximco Pharmaceuticals Ltd Glenmark Pharmaceuticals Ltd (Contd.) Healthcare lanka Ltd International (Pvt) Ltd (Pvt) Ltd Pharmacy (Pvt) Ltd Pharmaceuticlas (Pvt) Ltd (Ceylon) Ltd Pharmaceuticlas (Pvt) Ltd (Ceylon) Ltd Pharmaceuticals (Pvt) Ltd NASAL SPRAYNASAL Softcare SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP FLUTIAIRFLIXIVATE SPRAY NASAL Radiant Health Care SPRAY NASAL Healthcey (Pvt) Ltd Biodeal N/AN/A INJECTIONN/A Ceyoka (Pvt) Ltd INJECTION Ciron Drugs & Ceyoka (Pvt) Ltd TABLETS Ciron Drugs & FLUTIAIR FT The Esses SPRAY NASAL AVAMYS Emerchemie NB SPRAY NASAL GlaxoSmithkiline PERINASE SPRAY NASAL FLUSORT Emerchemie NB SPRAY NASAL Hemas FLONASPRAY SPRAY NASAL PharmAce (Pvt) Ltd Square FLUTICONE SPRAY NASAL Sunshine FLUTILET NASAL NASAL FLUTILET SPRAY 50MCG 50MCG INJECTION BP 25MG/ML INJECTION BP 25MG/ML INJECTION BP 2.5MG USP TABLETS 0.05% SPRAY 27.5MCG BP SPRAY 50MCG 50MCG 50MCG 50MCG 50MCG 3097 BP SPRAY FLUTICASONE NASAL 3098 BP SPRAY FLUTICASONE NASAL 3092 FLUPHENAZINE DECANOATE 3093 FLUPHENAZINE HYDROCHLORIDE 3094 0.05% FLUTICASONE CREAM IP FLUTIVATE3095 NASAL FLUTICASONE FUROATE CREAM3096 NASAL FLUTICASONE FUROATE GlaxoSmithkiline 3099 BP SPRAY FLUTICASONE NASAL 3100 BP SPRAY FLUTICASONE NASAL 3091 FLUPHENAZINE DECANOATE 3102 BP SPRAY FLUTICASONE NASAL 3103 IP SPRAY FLUTICASONE NASAL 3101 BP SPRAY FLUTICASONE NASAL 266 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 26-Jan-15 Full INDIA 15-Apr-16 Full UNITED KINGDOM BANGLADESH 19-Feb-18 Provisional CHINA 11-Sep-14 Full SPAIN 28-Mar-16SRI LANKA Full 28-Apr-18Years Two BANGLADESH 09-Mar-18 Years Two FRANCE 27-Jun-16FRANCE Full 11-Aug-16 Full INDIA 10-Sep-14 Full BANGLADESH 03-Apr-18 Full Ltd Glaxo Operations UK Ltd General Pharmaceuticals Ltd Shandong Jewim Pharmaceutical Co. Ltd Glaxo Wellcome Glaxo Wellcome S A Sciences (Pvt) Ltd Cipla Ltd INDIACipla Ltd 01-Jul-15 Full INDIA 27-May-14 Full General Pharmaceuticals Ltd Glaxo Wellcom Glaxo Wellcom Production Zone Industrille Glaxo Wellcom Glaxo Wellcom Production Zone Industrille Glaxo Smithkiline Pharmaceuticlas Pharmaceuticals Ltd (Contd.) Chamee Chemist Axa Parenterals Pharmaceuticlas (Pvt) Ltd Health (Pvt) Ltd (Ceylon) Ltd Pharmaceuticlas (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd Health (Pvt) Ltd GlaxoSmithkiline Pharmaceuticlas (Pvt) Ltd GlaxoSmithkiline Pharmaceuticlas (Pvt) Ltd Pharmaceuticlas (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP SUSPENTION NASAL SPRAYNASAL Emerchemie NB NASAL SPRAYNASAL GlaxoSmithkiline METERED DOSE AE METERED DOSE AE AXAFLU RS RESPIRATOR CUTIVATE OINTMENTCUTISONE GlaxoSmithkiline OINTMENT George Steuart FLUTIMATE-E FLUTIMATE-E NS 50 FLIXONASE AQUEOUS FLOMISTFLUTIHALE NS 50 SPRAY NASAL SPRAY NASAL N/A Breathe Free Lanka Emergen Life FLOHALE 50 INHALER Breathe Free Lanka CUTISONE CREAM George Steuart FLIXOTIDE EVOHALER TICASFLUTIVATE OINTMENT OINTMENT PharmAce (Pvt) Ltd Square GlaxoSmithkiline RESPIRATORY SUSPENSION RESPIRATORY 0.5MG/2ML Ointment 0.005% 0.005% BP OINTMENT SPRAY BP 50MCG BP SPRAY SPRAY 50MCG SPRAY SPRAY 0.05% SPRAY 50MCG BP SPRAY METERED DOSE INHALER 50MCG/ DOSE 250MCG 0.05% CREAM BP 125MCG/DOSE 0.005% W/W W/W 3111 NASAL FLUTICASONE PROPIONATE 3116 FLUTICASONE PROPIONATE 3114 FLUTICASONE PROPIONATE 3115 FLUTICASONE PROPIONATE 3113 NASAL FLUTICASONE PROPIONATE 3110 NASAL FLUTICASONE PROPIONATE 3112 NASAL FLUTICASONE PROPIONATE 3109 FLUTICASONE PROPIONATE 3107 FLUTICASONE PROPIONATE 3108 FLUTICASONE PROPIONATE 3106 FLUTICASONE PROPIONATE 3104 BP FLUTICASONE OINTMENT 3105 0.005% IP FLUTICASONE OINTMENT I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 267 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 FRANCE 06-Oct-15 Full ITALY 01-Apr-14 Full ITALY 31-Jul-14 Full SWITZERLAND 10-Apr-16 Full SWITZERLAND 10-Apr-18 Full INDIAINDIA 15-Aug-14INDIA Full 22-Aug-17INDIA Years Two 16-Nov-17INDIA Years Two 16-Nov-17 Years Two SRI LANKA 21-Jun-18 07-Jan-16SRI LANKA Full Full 28-Oct-14INDIA Full 31-Jan-16 Full

Glaxo Wellcome Glaxo Wellcome Production Merck Serono Delle Vis A S P Magnolie Merck Serono S P A Merck Serono S P A Merck Serono S P A Pvt Ltd Pvt Ltd Pvt Ltd Pharmaceuticals (India) Ltd (Ceylon) (Pvt) Ltd Pharmaceuticals Manufacturer Corporation Pharmaceuticals Ltd Ltd (Contd.) Pharmaceuticlas (Pvt) Ltd Ltd Ltd Ltd Ltd INHALER GlaxoSmithkiline SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP SERETIDE EVOHALER GONAL -FGONAL INJECTION Baur & Co (Pvt) A GONAL -FGONAL INJECTION Baur & Co (Pvt) A GONAL -F-75GONAL INJECTION Baur & Co (Pvt) A PERGLIM 1 INJECTION Baur & Co (Pvt) A PROPIONATE+SALMETEROL PROPIONATE+SALMETEROL 250/25MCG (XINOFOATE) FOR SOLVENT FOR SOLUTION FOR SOLVENT FOR INJECTION 1050IU/1.75ML (77MCG/1.75ML) FOR INJECTION 900IU/1.5ML FOR INJECTION 900IU/1.5ML (66MCG/1.5ML 5.5mcg 150IU+LUTROPIN ALFA r-HLH 150IU+LUTROPIN ALFA FOR AND SOLVENT POWDER SOLUTION INJECTION 3118 50MG BP TABLETS FLUVOXAMINE FREEVOX 50 TABLETS Galanica (Pvt) Ltd Prism Life Science 3117 FLUTICASONE 3119 50MG BP TABLETS FLUVOXAMINE OCIVOX 50 TABLETS PharmAce (Pvt) Ltd Consern Pharma 3129 POWDER FOLLITROPIN ALFA 3128 (SOLUTION FOLLITROPIN ALFA 3127 (R-HFSH)75 IU ALFA FOLLITROPIN 3120 100MG BP TABLETS FLUVOXAMINE OCIVOX 1003121 100MG BP TABLETS FLUVOXAMINE TABLETS OCIVOX 1003122 1MG BP TABLETS ACID FOLIC TABLETS PharmAce (Pvt) Ltd Consern Pharma FOLI-13123 PharmAce (Pvt) Ltd 1MG BP TABLETS ACID FOLIC Consern Pharma 3124 N/A 1MG BP TABLETS ACID FOLIC TABLETS N/A PharmAce (Pvt) Ltd3125 1MG BP TABLETS Aurochem ACID FOLIC TABLETS 1 TESHA 3126 (R-HFSH) FOLLITROPIN ALFA TABLETS N/A TABLETS N/AAssociates Pharma Bafna M S J Industries State 268 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIA 11-Oct-17 Years Two INDIASRI LANKA 10-May-18 Years Two 09-Jul-16 Full INDIA 10-Mar-18 Years Two INDIA 11-Oct-17 Years Two INDIA 10-May-18 Years Two INDIA 10-Mar-17 Full ITALY 12-Oct-16 Full SRI LANKA 28-Jan-18 Provisional Concept Pharmaceuticals Ltd Sciences (Pvt) Ltd Glenmark Pharmaceuticals Ltd Cipla LtdCadila Healthcare Ltd INDIA 17-Sep-14 Full Concept Pharmaceuticals Ltd Glenmark Pharmaceuticals Ltd N.V.Organon NETHERLANDSN.V.Organon 03-Mar-17 NETHERLANDS Full 03-Mar-17 Full Cipla LtdCipla Ltd INDIACadila Healthcare Ltd INDIA 01-Dec-15 Full 17-Sep-15 Full Sciences (Pvt) Ltd Merck Serono S P A (Contd.) International (Pvt) Ltd Hemas Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Sunshine Healthcare lanka Ltd International (Pvt) Ltd Hemas Pharmaceuticals (Pvt) Ltd Ltd Ltd (Pvt) Ltd (Pvt) Ltd Sunshine Healthcare lanka Ltd Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP CAPSULES Softcare INHALATION DOSE INHALER CAPSULES Softcare INHALATION CAPSULES N/ACAPSULES Breathe Free Lanka Emergen Life DOSE INHALER FORMOHALE 200 POWDER DRY N/A DPI FOROLET 6/200 MCG Emergen Life AIRTEC FB 200AIRTEC AEROSOL FORACORTFORMONIDE INHALER METERED Breathe Free Lanka FOROLET DPI FOROLET 6/200 MCG AIRTEC FB 100AIRTEC AEROSOL RECAGONRECAGON INJECTION FORMOFORTE Baur & Co (Pvt) A INJECTION400 Baur & Co (Pvt) A DP FORACORT CAPS 100 100FORACORT INHALERFORMONIDE Breathe Free Lanka METERED GONAL -FGONAL INJECTION Baur & Co (Pvt) A 6MCG+BUDESONIDE 200MCG DP 6MCG+BUDESONIDE 200MCG DP 6MCG+BUDESONIDE 200MCG DP 6MCG+BUDESONIDE 200MCG DP 6MCG+BUDESONIDE 200MCG DP 6MCG+BUDESONIDE 200MCG DP 6MCG+BUDESONIDE 100MCG DP 50IU/0.5ML 12MCG+BUDESONIDE 400MCG DRY CAPSULE POWDER INHELATION 6MCG+BUDESONIDE 100MCG DP 6MCG+BUDESONIDE 100MCG DP 100IU/0.5ML 6MCG+BUDESONIDE 100MCG DP INJECTION 300IU/0.5ML 3142 FUMARATE FORMOTEROL 3143 FUMARATE FORMOTEROL 3141 FUMARATE FORMOTEROL 3140 FUMARATE FORMOTEROL 3139 FUMARATE FORMOTEROL 3138 FUMARATE FORMOTEROL 3137 FUMARATE FORMOTEROL 3132 INJECTION FOLLITROPIN BETA 3133 FUMARATE FORMOTEROL 3135 FUMARATE FORMOTEROL 3136 FUMARATE FORMOTEROL 3131 INJECTION FOLLITROPIN BETA 3134 FUMARATE FORMOTEROL 3130 SOLUTION FOR ALFA FOLLITROPIN I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 269 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIASRI LANKA 10-Mar-18 Years Two 29-May-15 Full SRI LANKA 09-Jul-16 Full INDIA 08-Jun-18 Years Two INDIASRI LANKA 08-Sep-14 01-Jan-18 Full Full INDIA 30-Sep-14 Full INDIA 16-May-14 Full INDIA 16-May-14 Full India Ltd INDIA 03-Sep-14 Full India Ltd INDIA 01-Jan-14 Full fi fi Cipla LtdCipla Ltd INDIA INDIA 01-Dec-15 Full 29-Sep-14 Full Manufacturing (Pvt) Ltd Cadila Healthcare Ltd Sciences (Pvt) Ltd Cipla LtdConcept Pharmaceuticals INDIALtd 01-Dec-16 Full (Ceylon) (Pvt) Ltd Gland Pharma (Pvt) Ltd Harson Laborstories Vital Healthcare Vital (Pvt) Ltd Vital Healthcare Vital (Pvt) Ltd (Contd.) Lanka Ltd Sano Lanka Ltd Sano fi fi (Pvt) Ltd (Pvt) Ltd Sunshine Healthcare lanka Ltd N/A Emergen Life (Pvt) Ltd Softcare International (Pvt) Ltd Services Pvt. Ltd (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd CAPSULES Breathe Free Lanka CREAM Sano DOSE INHALER FOR INHALATION POWDER INHALATION SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP FORMOVENT 400FORMOVENT INHALATION N/A DP FORACORT CAPS 400 FORACORT Lina INHALERSKIN CREAM Breathe Free Lanka FORMONIDE METERED FORMOHALE 400 POWDER DRY FORACORT DPI FOROLET POWDER DRY 6/400 Breathe Free Lanka LASIX INJECTION Sano N/A INJECTION ABC Pharma N/A INJECTION Citihealth Imports FRUSOVIT INJECTION International Yaden FRUSOVIT INJECTION International Yaden DIHYDRATE 6MCG AND 6MCG DIHYDRATE BUDESONIDE 400MCG Inhaler CFC Free 6MCG+BUDESONIDE 400MCG DP 6MCG+BUDESONIDE 400MCG DP 6MCG+BUDESONIDE 400MCG DP 6MCG+BUDESONIDE 400MCG BP 6MCG+BUDESONIDE 200MCG DP 6MCG+BUDESONIDE 400MCG BP ML IV&IM ML ML ML 10MG/2ML 10MG/2ML 3150 FUMARATE FORMOTEROL 3151 1% FRAMYCETIN SULPHATE SOFRAMYCIN 3148 FUMARATE FORMOTEROL 3149 FUMARATE FORMOTEROL 3147 FUMARATE FORMOTEROL 3146 FUMARATE FORMOTEROL 3144 FUMARATE FORMOTEROL 3145 FUMARATE FORMOTEROL 3152 10MG/ FRUSEMIDE INJECTION IP 3157 40MG B.P TABLETS FRUSEMIDE FUROSEMIDE TABLETS N/A M S J Industries 3156 10MG/ FRUSEMIDE INJECTION BP 3155 10MG/ FRUSEMIDE INJECTION BP 3154 FRUSEMIDE INJECTION BP 3153 FRUSEMIDE INJECTION BP 270 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIA 26-Apr-16 Full PAKISTAN 16-May-14 Full BANGLADESH 15-Oct-18 Years Two IRELAND 20-Jan-14 Full INDIAINDIA 10-May-18 Years Two 25-Mar-15 Full INDIA 26-May-16 Full PAKISTANINDIA 03-Feb-14 Full 15-Jul-14 Full PAKISTANSRI LANKA 01-Jan-14 Full 03-Feb-14 Full India Ltd INDIA 29-Oct-18Years Two fi Pharmaceuticals Ltd Hovid Berhard MALAYSIA 24-Aug-15 Full Caraway Pharmaceuticals Eskayef Bangladesh Ltd Leo Laboratories Ltd, Ireland for Leo Pharmaceutical Products Pharmaceutica (Pvt) Ltd Daffodills Daffodills Pharmaceuticals Ltd Pharmafabrikon Unit PharmaceuticalS (Pvt) Ltd Adamjee Pharmaceuticals (Ceylon) (Pvt) Ltd Adamjee Pharmaceuticals (Contd.) Lanka Ltd Sano fi Pharmaceuticals (Pvt) Ltd Health (Pvt) Ltd Healthcare lanka Ltd Pharmaceuticals (Pvt) Ltd Ltd (Pvt) Ltd P Jayanetti & Sons P Pvt Ltd Pvt Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP SUSPENSION DISUF-H CREAM Thorn FUSIWAY HFUSIWAY CREAM George Steuart FACID HCFACID CREAM Sunshine N/AFUCITHALMIC EYE DROPS INJECTION Hemas Chamee Chemist Samrudh PRUSEX INJECTION Nation Pharma (Pvt) N/AN/A INJECTION Ceyoka (Pvt) Ltd INJECTION Ciron Drugs & Novachem Lanka ENTROZOL ORAL ENTROZOL TABLETS Jayanetti & Sons P HYDROCORTISONE ACETATE 1% ACETATE HYDROCORTISONE HYDROCORTISONE ACETATE 1% ACETATE HYDROCORTISONE HYDROCORTISONE ACETATE 1% ACETATE HYDROCORTISONE 10MG/ML EYE DROPS 20MG/2ML ML ML 25MG/5ML USP 3159 40MG IP TABLETS FRUSEMIDE LASIX TABLETS Sano 3158 40MG B.P TABLETS FRUSEMIDE N/A TABLETSAssociates Pharma Bafna 3170ACID 2% + FUSIDIC 3169ACID 2% + FUSIDIC 3168ACID 2% + FUSIDIC 3166 FUROSEMIDE INJECTION USP 3167ACID 1%W/W VISCOUS FUSIDIC 3165 FUROSEMIDE INJECTION BP 3163 10MG/ FUROSEMIDE INJECTION BP 3164 10MG/ FUROSEMIDE INJECTION BP 3161 FURAZOLIDONE 100MG USP3162 FURAZOLIDONE SUSPENSION N/A TABLETS N/A M S J Industries 3160 TABLETS FURAZOLIDONE 100MG I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 271 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 IRELAND 12-Jun-15INDIA Full INDIA 31-Jan-17 Full INDIA 08-Nov-17MALAYSIA Full 26-Sep-18 10-Jan-14 Full Full INDIA 25-Jun-18 Full PAKISTAN 29-Jan-18 Full PAKISTAN 29-Jan-17PAKISTAN Full 28-Feb-18 Provisional INDIAMALAYSIA 03-Aug-16 23-Jul-17 Full PAKISTAN Full 16-May-14 Full IRELAND 20-Apr-14 Full Centaur Pharmaceutical (Pvt) Ltd Agio Pharmaceuticals Ltd (india) (Pvt) Ltd Kotra pharma (M) Ltd Leo Laboratories Ltd Agio Pharmaceuticals Ltd Tabros Pharma Tabros (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Tabros Pharma Tabros (Pvt) Ltd Pharmaceuticals SDN BHD Pharmaceuticals Oaknet Healthcare Pvt Ltd Leo Laboratories Ltd, Ireland for Leo Pharmaceutical Products (Contd.) Health (Pvt) Ltd (Pvt) Ltd Co Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Laboratories (Pvt) Ltd Laboratories (Pvt) Ltd Health (Pvt) Ltd Pharmaceuticals (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP FUCICORT CREAM Hemas FUSON-B CREAM Citihealth Imports SIRULZ-H HC CREAMPUSIL Ceyoka (Pvt) Ltd CREAM Focus & Rulz Associated FOBANCORT CREAM BFUSIWAY Indoscan (Pvt) Ltd HCPUSIL CREAM Hoe CREAM Lanmed (Pvt) Ltd Caraway Associated FUTOP-B CREAM George Steuart FUCIDIN-H CREAM Hemas BETAMETHASONE 1MG/G BETAMETHASONE BECLOMETHASONE 0.25MG/G DIPROPIONATE HYDROCORTISONE ACETATE 10MG ACETATE HYDROCORTISONE CREAM 10MG ACETATE HYDROCORTISONE CREAM BETAMETHASONE DIPROPIONATE DIPROPIONATE BETAMETHASONE 0.064% W/W CREAM 0.1% W/W BETAMETHASONE 10MG ACETATE HYDROCORTISONE CREAM BETAMETHASONE VALERATE0.1% VALERATE0.1% BETAMETHASONE CREAM HYDROCORTISONE ACETATE 1% ACETATE HYDROCORTISONE 3180 2% W/WACID CREAM BP FUSIDIC FUTOP3181 2% W/WACID CREAM BP FUSIDIC FUSON CREAM CREAM CREAM3182 2% W/WACID CREAM BP FUSIDIC SOFUDAC George Steuart 3183 Citihealth Imports 2% W/WACID CREAM BP FUSIDIC FUSIDIC AXCEL CREAM CREAM Ceyoka (Pvt) Ltd Delmege Forsyth & Galentic Pharma 3179ACID 20MG + FUSIDIC 3178ACID 20MG + FUSIDIC 3176ACID 20MG & FUSIDIC 3177ACID 20MG & FUSIDIC 3173ACID 2% W/W + FUSIDIC 3174ACID 2%W/W + FUSIDIC 3175ACID 20MG & FUSIDIC 3172ACID 2% W/W + FUSIDIC 3171ACID 2% + FUSIDIC 272 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 PAKISTAN 22-Nov-17PAKISTAN Years Two 27-Mar-14 Full INDIAINDIA 08-Nov-17 Full 01-Nov-17MALAYSIA Full 02-Dec-15PAKISTAN Full 16-Oct-15MALAYSIA Full 26-Jul-18PAKISTAN Full 09-Mar-18PAKISTAN Years Two 21-Apr-14IRELAND Full 12-Jun-16PAKISTAN Full 16-Mar-18 Years Two Highnoon Laboratories Ltd Shaigan Pharmaceuticals (Pvt) Ltd Indi Pharma (Pvt) Ltd Micro Labs Ltd INDIAPharmaceuticals SDN BHD Pharma 12-Feb-14Tabros (Pvt) Ltd Full Pharmaniaga Manufacturing berhand Pharmaceuticals (Pvt) Ltd Laboratories (Pvt) Ltd Leo Laboratories Ltd Sante (Private) Limited Cipla Ltd INDIAAgio Pharmaceuticals Ltd 21-Jul-16 Full (Contd.) Healthcare lanka Ltd Pharmaceuticals (Pvt) Ltd Ltd Ltd Laboratories (Pvt) Ltd (Ceylon) Ltd Pharmaceuticals (Pvt) Ltd (Ceylon) Ltd (Pvt) Ltd (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP FUDIC-H CREAM Akbar CREAM 3197 GABAPENTIN CAPSULES 100MG NEUPENTIN CAPSULES Sunshine 3187 2% W/WACID CREAM BP FUSIDIC FUSIWAL3188 2% W/WACID CREAM BP FUSIDIC STAFOBAN CREAM3189 2% W/WACID CREAM BP FUSIDIC FOBAN CREAM Emar Pharma (Pvt) 3190 2% W/WACID CREAM BP FUSIDIC FUSIL SMM Halcyon (Pvt) CREAM3191 2% W/WACID CREAM BP FUSIDIC GREMACID Indoscan (Pvt) Ltd CREAM Hoe 3192 20MG/GACID CREAM BP FUSIDIC CREAM SIRULZ Associated 3193 20MG/GACID CREAM BP FUSIDIC Emerchemie NB MELADERM CREAM3194 20MG/GACID CREAM BP FUSIDIC CREAM FUCIDIN Ceyoka (Pvt) Ltd3195 1.0%ACID EYE DROPS BP FUSIDIC Focus & Rulz Morison PLC FUSIGEL CREAM3196 ACID & HYDROCORTISONE FUSIDIC ATCO EYE DROPS Hemas Emerchemie NB 3185 2% W/WACID CREAM BP FUSIDIC FUSID3186 2% W/WACID CREAM BP FUSIDIC FUSON CREAM CREAM CREAM Citihealth Imports N/A Astron (Pvt) Ltd SRI LANKA 04-Jun-16 Full 3184 2% W/WACID CREAM BP FUSIDIC FUSIBACT CREAM Breathe Free Lanka I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 273 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIA 10-Aug-16 Full INDIA 15-Mar-15 Full BANGLADESH 31-Mar-18 Full PAKISTAN 07-Aug-18 Full PAKISTAN 03-May-18PAKISTAN Years Two PAKISTAN 06-Mar-14 Full 15-Mar-14INDONESIA Full 17-Nov-16BANGLADESH 15-Aug-14 Full Full PAKISTAN 13-Sep-16INDIA Full PAKISTAN 19-Jul-14 14-Mar-14 Full INDIA Full 22-Jun-14 Full Atoz Pharmaceuticals (Pvt) Ltd Sun Pharmaceutical industries Incepta Pharmaceuticals Ltd Getz Pharma Pakistan (Pvt) Ltd (Pvt ) Ltd CCL Pharmaceuticals (Pvt) Ltd Actavis T P Indonesia Incepta Pharmaceuticals Ltd Medizan Laboratories (Pvt) Ltd Coast West Pharmaceurical works Ltd CCL Pharmaceuticals (Pvt) Ltd Cadila Healthcare Ltd Nabiqasim Industries (Pvt) Ltd (Contd.) (Pvt) Ltd (Ceylon) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals Lanka (Pvt) Ltd (Ceylon) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Pharmaceuticals Lanka (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Health (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP GABA100 TABLETS Euro Asian Pharma GABANTIN CAPSULES Emerchemie NB GABAPEN 100 CAPSULES Citihealth Imports GABIX CAPSULES Hemas 100MG 100MG 100MG 100MG 3210 GABAPENTIN CAPSULES USP 3209 GABAPENTIN CAPSULES USP 3208 GABAPENTIN CAPSULES USP 3199 GABAPENTIN CAPSULES 100MG ANATIN3200 GABAPENTIN CAPSULES 100MG PENRAL3201 CAPSULES GABAPENTIN CAPSULES 300MG ALPENTIN Ceyoka (Pvt) Ltd CAPSULES3202 GABAPENTIN CAPSULES 300MG Genix Pharma CCL GABAPEN CAPSULES3203 GABAPENTIN CAPSULES 300MG Emerchemie NB CAPSULES BAPEN3204 GABAPENTIN CAPSULES 300MG Citihealth Imports 300 CABAVEX CAPSULES3205 GABAPENTIN CAPSULES 300MG CAPSULES Ceyline PENTAL Global Impex AV 3206 GABAPENTIN CAPSULES 400MG 400 GABACAP CAPSULES3207 GABAPENTIN CAPSULES USP CAPSULES CCL Hemas 3198 GABAPENTIN CAPSULES 100MG HEUROGAB CAPSULES George Steuart 274 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIA 18-Jun-14 Full INDIA 30-Jan-15 Full INDIA 31-Dec-16 Full INDIA 01-Jan-14 Full INDIA 07-Nov-14 Full PAKISTAN 08-Mar-16 Full PAKISTAN 07-Aug-18INDIA Full 06-Feb-18 Years Two INDIA 01-Jan-14 Full INDIA 07-Nov-17 Full INDIA 21-Oct-15 Full INDIA 27-Apr-16 Full PAKISTAN 30-Jan-18 Years Two INDIA 04-Mar-14 Full XL Laboratories XL (Pvt) Ltd Fredun Pharmaceuticals Ltd Alkem Laboratories Ltd Sun Pharmaceutical industries Windlas Biotech (Pvt) Ltd S J & G Fazul Ellahie (Pvt) Ltd Pharmaceuticals Getz Pharma Pakistan (Pvt) Ltd Sun Pharmaceutical industries Zim Laboratories Ltd XL Laboratories XL (Pvt) Ltd Stallion Laboratories Pvt Ltd Nabiqasim Industries (Pvt) Ltd Pharmaceuticals (Contd.) Ltd Health (Pvt) Ltd (Ceylon) Ltd (Ceylon) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Ceylon) Ltd Pharmaceuticals (Pvt) Ltd Ltd (Pvt) Ltd Health (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP GONNAZ 300 CAPSULES SMM Halcyon (Pvt) GABAFRED 300 CAPSULES George Steuart GABATA 300GABATA CAPSULES Emerchemie NB GABANTIN CAPSULES Emerchemie NB GABATIN CAPSULES Lifeline GABANINGABAFIX CAPSULES Pharma Associates CAPSULES The Madras Pharma Tropical GABIX CAPSULES Hemas GABEX 300 CAPSULES Emerchemie NB GABAZIM 100 CAPSULES Tabrane GONNAZ 100 CAPSULES SMM Halcyon (Pvt) RAVASTOL CAPSULES Siba Healthcare NEUROGAB CAPSULES George Steuart GABANIN CAPSULES Pharma Associates The Madras 300MG 300MG 300MG 300MG 300MG 300MG 300MG 300MG 300MG 100MG 100MG 100MG 100MG 100MG 3211 GABAPENTIN CAPSULES USP 3224 GABAPENTIN CAPSULES USP 3223 GABAPENTIN CAPSULES USP 3222 GABAPENTIN CAPSULES USP 3221 GABAPENTIN CAPSULES USP 3220 GABAPENTIN CAPSULES USP 3218 GABAPENTIN CAPSULES USP 3219 GABAPENTIN CAPSULES USP 3217 GABAPENTIN CAPSULES USP 3216 GABAPENTIN CAPSULES USP 3215 GABAPENTIN CAPSULES USP 3214 GABAPENTIN CAPSULES USP 3213 GABAPENTIN CAPSULES USP 3212 GABAPENTIN CAPSULES USP I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 275 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 10-Feb-18 Full 27-Sep-17 Years Two UNITED STATES UNITED STATES PAKISTAN 28-Mar-14 Full INDIA 24-Oct-15 Full IRELAND 01-Mar-14SWITZERLAND 18-May-16 Full PAKISTAN Full 28-Mar-14 Full GERMANY 24-Apr-14 Full INDIAINDIA 19-May-18PAKISTAN Full 06-Feb-18 09-Oct-16 Years Two INDIA Full INDIA 04-Aug-18 Provisional 05-Oct-17 Full Allergan Sales LLC Allergan Sales LLC Ramington Pharmaceutical Industries (Pvt) Ltd Kemwell Biopharma (Pvt) Ltd F Hoffman-La F Hoffman-La Roche Ltd Remington pharmaceutical Industries (Pvt) Ltd G E Health Care Ireland Limited Bayer Schering G Ltd A Pharma Pharmaceuticals Medizan Laboratories (Pvt) Ltd Treffer Pharmaceuticals Atoz Pharmaceuticals (Pvt) Ltd Zim Laboratories Ltd (Contd.) Hemas Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Co Ltd Pharmaceuticals (Pvt) Ltd Ltd Co Ltd Healthcare lanka Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd SOLUTION SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP ZYMAXID OPHTHALMIC ZYMAR EYE DROPS Hemas LOXIGET OINTMENT Delmege Forsyth & ZYMAR EYE OINTMENT Hemas OMNISCAN INJECTION Sunshine GABANIN CAPSULES Pharma Associates The Madras GADOVIST INJECTION Hemas GABAZIM 300 CAPSULES Tabrane SOLUTION 0.5% (5mg/ml) SOLUTION 0.3% 0.3% 0.3% 0.5MMOL/ML 300MG MMOL) SOLUTION FOR INJECTION 300MG 3237 OPHTALMIC GATIFLOXACIN 3236 OPHTALMIC GATIFLOXACIN 3235 EYE OINTMENT GATIFLOXACIN 3232 GANCICLOVIR INJECTION 500MG CYMEVENE3233 EYE DROPS 0.3% GATIFLOXACIN LOXIGET INJECTION Baur & Co (Pvt) A 3234 EYE OINTMENT GATIFLOXACIN EYE DROPS Delmege Forsyth & 3231 GADODIAMIDE INJECTION 3226 GABAPENTIN CAPSULES USP 3227 100MG GABAPENTIN TABLETS BAPEN3228 0.5MG USP TABLETS GABAPENTIN N/A3229 300MG USP TABLETS GABAPENTIN 300 GABA TABLETS3230 (1 604.72MG/ML Ceyline GADOBUTROL TABLETS TABLETS International Yaden Asian Pharma Euro 3225 GABAPENTIN CAPSULES USP 276 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIA 09-May-14 Full INDIA 04-Apr-14 Full INDIA 08-Feb-16 Full INDIA 17-Sep-18 Full ARGENTINA 02-Mar-15 Full INDIA 29-Nov-15 Full INDIA 08-Feb-16 Full ARGENTINA 29-Jan-15 Full INDIAINDIA 13-Feb-17INDIA Full 02-Jan-19 Years Two 10-Jan-19 Years Two INDIA 23-Feb-15 Full Parenteral Drugs Ltd INDIA Zydus Hospira Oncology (Pvt) Ltd United Biotech (Pvt) Ltd P T Sanbe FarmaT P INDONESIA 29-Apr-15Sun Pharmaceutical Full industries Bioprofarma SA Bioprofarma SA Terrada Zydus Hospira Oncology (Pvt) Ltd United Biotech (Pvt) Ltd Bioprofarma SA Bioprofarma SA Terrada Getwell Pharmaceuticals Jodas Expoim Pvt Ltd Natco Pharma Ltd INDIAFresenius Kabi A.B 19-Aug-18Years Two Cipla LtdUnited Biotech (Pvt) Ltd INDIA 25-May-15 Full (Contd.) (Pvt) Ltd Pharmaceuticals (Pvt) Ltd George Steuart Health (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Ceylon) Ltd Pharmaceuticals (Pvt) Ltd Health (Pvt) Ltd (Ceylon) Ltd Pharmacy (Pvt) Ltd International (Pvt) Ltd Healthcare lanka Ltd Ltd (Pvt) Ltd Health (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP INJECTION GEMCITAPAR 200GEMCITAPAR INJECTION Omacx Healthcare ZYGEM 200 INJECTION Hemas BIOGEM 200 POWDER FOR GETANOSAN 200GETANOSAN INJECTION Lifeline 200GEMTAZ INJECTION Hemas GEMBIO 200 INJECTION Emerchemie NB ZYGEM 1000 INJECTION Hemas BIOGEM 1000 INJECTION George Steuart GEMBIO 1G INJECTION Emerchemie NB 200MG 200MG 200MG 200MG 200G VIAL 200G VIAL 1 G 1 G 1000MG/VIAL 3252 FOR INJECTION USP GEMCITABINE 3251 FOR INJECTION USP GEMCITABINE 3250 FOR INJECTION USP GEMCITABINE 3249 FOR INJECTION USP GEMCITABINE 3248 FOR INJECTION USP GEMCITABINE 3247 FOR INJECTION USP GEMCITABINE 3246 FOR INJECTION USP GEMCITABINE 3245 FOR INJECTION USP GEMCITABINE 3240 250MGTABLET GEFITINIB 3241 250MG GEFITINIB TABLET 250 GEFTIWEL TABLETS3242 250MG IP TABLET GEFITINIB GEFIRESSA The Esses 3243 GEFTINAT TABLETS INJECTION 200MG GEMCITABINE GEMITA3244 Softcare FOR INJECTION GEMCITABINE TABLETS INJECTION Sunshine Markss HLC (Pvt) 3239 250MG IP TABLEST GEFITINIB GEFITEC TABLETS George Steuart 3238 250MGTABLEST GEFITINIB 250 GEFTICIP TABLETS Breathe Free Lanka I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 277 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 GERMANY 28-Feb-18MALAYSIA Years Two 22-Mar-15 Full GERMANY 28-Feb-18 Years Two GERMANY 28-Feb-18 Years Two GERMANY 28-Feb-18 Years Two BANGLADESH 07-Nov-17 Full INDIA 06-Aug-14 Full BANGLADESH 07-Nov-17 Full INDIA 04-Sep-14 Full INDIA 14-Nov-14 Full INDIAINDIA 08-Jan-15 Full 20-Feb-14 Full SDN BHD Oncotec Pharma Produktion Oncotec Pharma Produktion Oncotec Pharma Produktion Oncotec Pharma Produktion Eli Lilly & Co FRANCESun Pharmaceutical industries 03-Mar-15Eli Lilly & Co Full FRANCE 24-Feb-16 Full Beacon Pharmaceuticals Ltd Beacon Pharmaceuticals Ltd ADMAC Lifesciences Zydus Hospira Oncology (Pvt) Ltd Pharmaceutical Pvt Ltd Getwell Pharmaceuticals (Contd.) S J Enterprises (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd S J Enterprises (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Ceylon) Ltd (Ceylon) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmacy (Pvt) Ltd LYOPHILIZED LYOPHILIZED POWDER LYOPHILIZED LYOPHILIZED POWDER SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP BROZIL CAPSULES Indoscan (Pvt) Ltd Industries / S P Y MEDAC GEMCITABINE MADAC INFUSION S J Enterprises MADAC GEMCIT INFUSION S J Enterprises MEDAC GEMCITABINE GEMOXEN INJECTION Emerchemie NB GEMOXEN INJECTION Emerchemie NB GEMELEE 1G INJECTION Slim CITABOLZYGEM 2000 INJECTION Ceyoka (Pvt) Ltd INJECTION Kavbir Hemas GEMCIT 200GEMCIT INJECTION The Esses 300MG INJECTION 38MG/ML 200MG INJECTION 38MG/ML INJECTION 38MG/ML 200MG INJECTION 38MG/ML INJECTION 38MG/ML 100MG INJECTION 38MG/ML INJECTION 38MG/ML 1000MG INJECTION 38MG/ML 200MG/10ML 200MG/10ML 1000MG 200MG & 1000MG VIALS 2G VIAL 200MG 3266 CAPSULES PB GEMFIBROZIL 3265 POWDER FOR GEMCITABINE 3264 POWDER FOR GEMCITABINE 3263 POWDER FOR GEMCITABINE 3259 INJECTION 1MG GEMCITABINE GEMZAR3260 INJECTION 1MG USP GEMCITABINE 1 GEMTAZ INJECTION3261 INJECTION 200MG GEMCITABINE INJECTION Hemas GEMZAR Hemas 3262 POWDER FOR GEMCITABINE INJECTION Hemas 3258 INJECTION HCL GEMCITABINE 3257 INJECTION HCL GEMCITABINE 3256 FOR INJECTION USP GEMCITABINE 3254 FOR INJECTION USP GEMCITABINE 3255 FOR INJECTION USP GEMCITABINE 3253 FOR INJECTION USP GEMCITABINE 278 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 11-Jul-17 Full 28-Mar-14 Full INDIA 02-Feb-15 Full PAKISTAN 12-Sep-17 Years Two PAKISTAN 27-Apr-17 Years Two INDIA 30-Dec-17 Years Two INDIA 29-Nov-17 Years Two INDIA 01-Jun-17 Years Two INDIA 03-Dec-15 Full INDIA 03-Dec-15 Full INDIAINDIA 28-Mar-15 Full 30-May-14 Full INDIA 18-Jul-14 Full (Pvt) Ltd Ltd Akums Drugs & Pharmaceuticals Ltd Pharmafabrikon Unit Laboratories (Pvt) Ltd Nabiqasim Industries (Pvt) Ltd PharmaceuticalS (Pvt) Ltd Centaur Pharmaceutical (Pvt) Ltd F D C Limited INDIAPharmaceuticals 22-Jun-15 Full Belco Pharma (Pvt) Ltd Belco Pharma (Pvt) Ltd B D H Industries Ltd Indoco Remedies India (Contd.) Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Morison PLC ATCO George Steuart Health (Pvt) Ltd Ceyoka (Pvt) Ltd Ciron Drugs & George Steuart Health (Pvt) Ltd Sunshine Healthcare lanka Ltd Pharma Associates Laborate Leader Pharma Agency Pvt Ltd Leader Pharma Agency Pvt Ltd (Pvt) Ltd Hemas Pharmaceuticals (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP DROPS DROPS DROPS DROPS DROPS DROPS DROPS DROPS DROPS N/AGEM INJECTION INJECTION Pharmatec (Pvt) Ltd Belco Pharma PharmAce (Pvt) Ltd Alpa Laboratories GENTAWEL INJECTION Lotus N/A INJECTION Novachem Lanka GENTACIL EYE,EAR GENTABACT EYE & EAR N/A EYE & EAR CENTAMICIN EYE & EAR BACTIGEN EYE,EAR GENTALAB EYE & EAR GARACIN EYE & EAR GARACIN EYE & EAR TAMIGEN-S EYE & EAR IN 2ML IN 2ML ML ML 0.3% 0.3% 0.3% 0.3% 0.3% W/V W/V W/V DEXAMETHASONE SODIUM 0.1% EYE/EAR DROPS PHOSPHATE 3279 80MG INJECTION BP GENTAMICIN 3280 80MG INJECTION BP GENTAMICIN 3278 40MG/ INJECTION BP GENTAMICIN 3277 40MG/ INJECTION BP GENTAMICIN 3276 EYE/EAR DROPS BP GENTAMICIN 3275 EYE/EAR DROPS BP GENTAMICIN 3274 EYE/EAR DROPS BP GENTAMICIN 3273 EYE/EAR DROPS BP GENTAMICIN 3272 EYE/EAR DROPS BP GENTAMICIN 3271 EYE/EAR DROPS 0.3% GENTAMICIN 3270 EYE/EAR DROPS 0.3% GENTAMICIN 3268 0.3% EYE DROPS BP GENTAMICIN GENTASONE3269 EYE/EAR DROPS 0.3% GENTAMICIN EYE DROPS Ravilux Company 3267 0.3% + GENTAMICIN I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 279 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIA 11-Oct-18 Years Two INDIAINDIA 11-Apr-15 Full 12-Jun-15 Full MACAU 15-Jun-14 Full INDIABANGLADESH 15-Feb-18 21-Sep-16 Full Full INDIA 28-Mar-14 Full INDIA 15-Jul-14 Full INDIAICELAND 31-Oct-18 Years Two 19-Feb-18INDIA Provisional INDIA 06-Apr-18 Full INDIA 27-Oct-17 Years Two 09-Aug-16 Full India Ltd INDIA 09-Mar-14 Full fi Sunway Rohto Pharmaceutical Pvt Ltd Pharmaceuticals Indoco Remedies India Ashford Laboratories Ltd Pharmaceuticals Ltd Mackur Laboratories Ltd Belco Pharma (Pvt) Ltd Neon Laboratories Ltd Laboratories (Pvt) Ltd G D Laboratories (India) Pvt Ltd Sunrise International LabS Ltd Pharmaceuticals Ltd India (Contd.) Lanka Ltd Sano fi Yaden International Yaden (Pvt) Ltd Emar Pharma (Pvt) Ltd Ltd Pharmaceticals Agency Pvt Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceutical (Pvt) Ltd DROPS DROPS SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP GENTACORT-MF CREAM Pharma AssociatesGENTAMIDE-HC Laborate EYE & EAR TAMIGEN EYE & EAR GENACYN OINTMENTGENTAPRO PharmAce (Pvt) Ltd Square EYE DROPS Ceylon (Pvt) Teastar MAKGEN INJECTION S P L N/A INJECTION Leader Pharma MYCIN INJECTION Ravilux Company .1%+MICONAZOLE NITRATE 2.0% .1%+MICONAZOLE NITRATE +FLUOCINOLONE ACETONIDE 0.01% CREAM EYE/ ACETATE HYDROCORTISONE EAR DROPS DROPS 0.3% W/W EYE OPHTHALMIC SOLUTION USP 0.3% W/V DROP 80MG/2ML IN 2ML IN 2ML 3289 5MG I.P TABLETS GLIBENCLAMIDE DAONIL TABLETS Sano 3287 SULPHATE GENTAMICIN 3288 WITH GENTAMICIN 3286 EYE/EAR SULPHATE GENTAMICIN 3284 0.1% BP OINTMENT GENTAMICIN 3285 STERILE SULFATE GENTAMICIN 3283 INJETION B.P GENTAMICIN 3282 80MG INJECTION BP GENTAMICIN 3281 80MG INJECTION BP GENTAMICIN 3291 5MG BP TABLETS GLIBENCLAMIDE GICLAMIDE3292 5MG BP TABLETS GLIBENCLAMIDE TABLETS GO-CARE Ceyoka (Pvt) Ltd3293 5MG BP TABLETS GLIBENCLAMIDE TABLETS N/A Leben 3294 5MG BP Lifeline TABLETS GLIBENCLAMIDE GLIBETICS TABLETS TABLETS Kent PharmAce (Pvt) Ltd Flamingo 3290 5MG BP TABLETS GLIBENCLAMIDE GEMID 5 TABLETSAssociates Pharma Maxtar Bio-Genics 280 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIA 26-May-14 Full INDIA 24-Jul-15 Full FRANCE 10-Aug-17 Years Two INDIA 12-May-18 Full INDIA 27-Dec-17 Years Two INDIA 21-Mar-18 Years Two FRANCE 04-Jan-16 Full INDIA 15-Oct-17 Years Two INDIA 25-Jul-17 Years Two INDIAINDIA 25-Jul-17 Years Two 25-Jul-17 Years Two Micro Labs Ltd INDIAAkums Drugs & Pharmaceuticals Ltd 07-Jun-17 Full Indi Pharma (Pvt) Ltd Les Laboratories Servier Akums Drugs & Pharmaceuticals Ltd Dr Reddy's Laboratories Ltd Sun Pharmaceutical industries Les Laboratories Servier Panacea Biotec (Pvt) Ltd Inventia Healthcare (Pvt) Ltd Inventia Healthcare (Pvt) Ltd Micro Labs Ltd INDIABiolab Co Ltd THAILANDInventia 03-Dec-17Healthcare (Pvt) Ltd 05-Jan-17 Full Full (Contd.) (Pvt) Ltd (Pvt) Ltd Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd (Ceylon) Ltd Emerchemie NB (Ceylon) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Ceylon) Ltd (Ceylon) Ltd Ltd Health (Pvt) Ltd (Ceylon) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP RELEASE TABLETS TABLETS Hemas DIANORM OD 30 TABLETSVEXGID MR 30 Micro Mega Lanka TABLETS Global Impex AV GLIX MR 60 TABLETS Emar Pharma (Pvt) DIAMICRON TABLETS Hemas VEXGID MR 60 TABLETS Global Impex AV RECLIDE MR 60 TABLETS Emerchemie NB REMICRON MR MODIFIED DIAMICRON-MR TABLETS Hemas GLICLAZIDE MR 30 GLITROL CR 30GLITROL CAPSULES Emerchemie NB TABLETS 30MG TABLETS TABLETS 30MG TABLETS TABLETS 60MG TABLETS TABLETS 60MG TABLETS TABLETS 60MG TABLETS TABLETS 60MG TABLETS TABLETS 60MG TABLETS TABLETS 30MG TABLETS TABLETS 30MG TABLETS RELEASE CAPSULES 30MG 3308 GLICLAZIDE MODIFIED RELEASE 3307 GLICLAZIDE MODIFIED RELEASE 3306 GLICLAZIDE MODIFIED RELEASE 3305 GLICLAZIDE MODIFIED RELEASE 3304 GLICLAZIDE MODIFIED RELEASE 3303 GLICLAZIDE MODIFIED RELEASE 3302 GLICLAZIDE MODIFIED RELEASE 3301 GLICLAZIDE MODIFIED REALEASE 3300 GLICLAZIDE MODIFIED REALEASE 3298 GLICLAZIDE CAPSULES CR 60MG 60 GLITROL 3299 GLICLAZIDE CONTROLLED CAPSULES Emerchemie NB 3296 5MG BP TABLETS GLIBENCLAMIDE GLIBEN3297 GLICLAZIDE CAPSULES CR 60MG 60 GLITROL TABLETS CAPSULES George Steuart Emerchemie NB 3295 5MG BP TABLETS GLIBENCLAMIDE GLIPIZ TABLETS Mega Pharma (Pvt) I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 281 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 SRI LANKA 09-Aug-15INDIA Full INDIA 02-May-15 Full 11-Nov-17 Years Two SRI LANKA 25-Oct-18FRANCEYears Two 05-Sep-15SRI LANKA Full 20-Aug-15INDIA Full 19-Sep-18 Full INDIA 26-Sep-15 Full INDIA 24-Jul-15 Full INDIA 19-May-18 Full INDIA 27-Dec-17 Years Two Pondchy Pharmaceuticals Akums Drugs & Pharmaceuticals Ltd LaboratoriesIPCA INDIALtd. 11-Oct-14Les Laboratories Servier Full Ltd -Sri Lanka Zim Laboratories Ltd Micro Labs Ltd INDIABal Pharma Ltd INDIA 14-Nov-15Pharmaceuticals Manufacturer Corporation Full 27-Jul-18 Full Ranbaxy laboratories Ltd Indi Pharma (Pvt) Ltd Torrent Torrent Pharmaceuticals Ltd Dr Reddy's Laboratories Ltd (Contd.) Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Ltd Pharmaceuticals (Pvt) Ltd (Ceylon) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP DIANORM OD 60 TABLETS Micro Mega Lanka REMICRON MR TABLETS Hemas CLIX MR 30 TABLETS Emar Pharma (Pvt) AZUKON MR TABLETS Hemas RECLIDE MR TABLETS Emerchemie NB TABLETS 60MG TABLETS TABLETS 30MG TABLETS TABLETS 30MG TABLETS TABLETS 30MG TABLETS TABLETS 30MG TABLETS 3311 GLICLAZIDE MODIFIED RELEASE 3316 80MG BP TABLETS GLICLAZIDE GLIZ3317 80MG BP TABLETS GLICLAZIDE VEXGID 803318 40MGTABLETS GLICLAZIDE TABLETS TABLETS3319 80MGTABLETS GLICLAZIDE Neon GLYCINORM Global Impex AV 3320 80MG GLICLAZIDE TABLETS TABLETS 80 GLYCICON TABLETS3321 Emar Pharma (Pvt) DICMICRON 80MG B.P TABLETS GLICLAZIDE GLYCLAPAN N/A3322 TABLETS 80MG B.P TABLETS GLICLAZIDE TABLETS GLIPEES Hemas N/A CIC Lifesciences TABLETS Tabrane Interpharm (Pvt) 3314 80MG BP TABLETS GLICLAZIDE DIABEND3315 80MG BP TABLETS GLICLAZIDE N/A TABLETS International Yaden TABLETS N/A State 3313 GLICLAZIDE MODIFIED RELEASE 3312 GLICLAZIDE MODIFIED RELEASE 3310 GLICLAZIDE MODIFIED RELEASE 3309 GLICLAZIDE MODIFIED RELEASE 282 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 14-Oct-16 Full INDIA 25-May-15SRI LANKA Full 26-Mar-17 20-Aug-15INDIA Full Full BANGLADESH 26-Apr-18 07-Mar-15 Years Two Full INDIAPAKISTAN 25-May-16INDIA 08-Sep-16 Full Full 02-Jul-15 Full INDIAMALAYSIA 15-Dec-17 Years Two 18-Nov-18 Full Windlas Biotech (Pvt) Ltd Pharmaceuticals Pharmaceuticals Pvt Ltd Akums Drugs & Pharmaceuticals Ltd Pharmaceuticals Ltd Stallion Laboratories Pvt Ltd Martin Daw Marker Ltd Dr Reddy's Laboratories Ltd Micro Labs Ltd INDIAZee Laboratories INDIASai Mirra 03-Dec-17Innopharm (Pvt) Ltd 05-Jan-18 Full Pharmaniaga Years Two Manufacturing berhand Synmedic Laboratories (Pvt) Ltd (Contd.) Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd (Ceylon) Ltd (Ceylon) Ltd (Pvt) Ltd Services Pvt. Ltd Healthcare lanka Ltd (Ceylon) Ltd Pharmaceuticals (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP 3324 80MG B.P TABLETS GLICLAZIDE GLICID 803325 80MG B.P TABLETS GLICLAZIDE TABLETS DIAZIDE 803326 80MG B.P TABLETS GLICLAZIDE GLYCLAPAN Lifeline TABLETS3327 80MG B.P TABLETS GLICLAZIDE TABLETSAssociates Pharma 80 GLYKIND The Madras 3328 80MG B.P TABLETS GLICLAZIDE N/A TABLETS COMPRIDE3329 80MG B.P TABLETS GLICLAZIDE Hemas TABLETS3330 ACLAZIDE 80MG B.P TABLETS GLICLAZIDE Gamma 80 PharmAce (Pvt) Ltd GLISTAL Square TABLETS3331 80MG B.P TABLETS GLICLAZIDE TABLETS NIDONIL N/A3332 80MG B.P TABLETS GLICLAZIDE Siba Healthcare RECLIDE3333 80MG B.P TABLETS GLICLAZIDE TABLETS DIANORM3334 80MG B.P TABLETS GLICLAZIDE TABLETS Astron (Pvt) Ltd Emerchemie NB SRI LANKA GLYZEE3335 80MG BP TABLETS GLICLAZIDE TABLETS Emerchemie NB G-ZIDE 25-Jul-14 Micro Mega Lanka 3336 TABLETS 80MG BP TABLETS GLICLAZIDE Full PHARMAZIDE ABC Pharma TABLETS TABLETS Sunshine Emerchemie NB 3323 80MG B.P TABLETS GLICLAZIDE GLYCOZIDE TABLETS Lifeline I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 283 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 30-Jan-18 Full INDIAINDIA 02-Dec-14 Full INDONESIA 14-Sep-17 04-Jan-14INDIA Full Full SRI LANKA 16-Sep-15 01-Feb-18INDIAYears Two Full INDIA 21-Mar-16 Full INDIA 21-Jan-14 Full BANGLADESH 14-Feb-14 05-Nov-14 Full Full THAILAND 21-Jun-17THAILAND Years Two 25-Apr-14 Full INDIA 05-Oct-18KINGDOM Years Two Fredun Pharmaceuticals Ltd Actavis T P Indonesia S Kant Healthcare Ltd (Ceylon) (Pvt) Ltd G D Laboratories (India) Pvt Ltd Pharmaceuticals Ltd Pharmaceuticals Ltd Incepta Pharmaceuticals Ltd LaboratoriesIPCA INDIAUnison Laboratories Co Ltd 11-Oct-14Laboratories Full Unique Pharmaceutical Labs Actavis UK Ltd UNITED Fredun Pharmaceuticals Ltd for USV Private Ltmited (Contd.) Health (Pvt) Ltd (Ceylon) Ltd Co Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Ltd Healthcare lanka Ltd Health (Pvt) Ltd (Ceylon) Ltd Pharmaceuticals (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP 3340 80MG BP TABLETS GLICLAZIDE GLUCOFRED 80 TABLETS3341 80MG BP TABLETS GLICLAZIDE GLYCAFOR3342 George Steuart 80MG BP TABLETS GLICLAZIDE DELMICRON TABLETS3343 80MG BP TABLETS GLICLAZIDE TABLETS N/A3344 Emerchemie NB 80MG BP TABLETS GLICLAZIDE DIPLOZOD 80 Delmege Forsyth & 3345 80MG BP TABLETS GLICLAZIDE TABLETS TABLETS GLUCOZID3346 Lifeline 80MG BP TABLETS GLICLAZIDE N/A TABLETS CLAZID 803347 80MG BP TABLETS GLICLAZIDE PharmAce (Pvt) Ltd Medley TABLETS CONSUCON 803348 M S J Industries TABLETS 80MG BP TABLETS GLICLAZIDE Associates Pharma Bafna GLYCINORM3349 80MG BP TABLETS GLICLAZIDE Citihealth Imports TABLETS GLUCOZIDE3350 80MG BP TABLETS GLICLAZIDE TABLETS Emar Pharma (Pvt) DICRON Sunshine TABLETS Medinex (Pvt) Ltd Drugs P T 3339 80MG BP TABLETS GLICLAZIDE DIATICA TABLETS George Steuart 3338 80MG BP TABLETS GLICLAZIDE GLYCAFOR TABLETS Emerchemie NB 3337 80MG BP TABLETS GLICLAZIDE GLIZIDE TABLETS Hemas 284 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIA 07-Apr-15INDIA Full INDIA 10-May-15INDIA Full 26-Mar-15INDIA Full 28-Apr-15INDIA Full 11-Nov-17 Full INDIA 22-Dec-16 Full INDIA 26-Apr-16 Full INDIA 07-Apr-15 Full 09-Dec-14PAKISTAN Full 13-Sep-14INDIA Full INDIA 09-Jan-14 Full 05-Jan-17 Full Medochemie Ltd CYPRUSAristo 01-Apr-14Pharmaceuticals Ltd Full Pharmaceuticals Ltd Zim Laboratories Ltd Centurion Laboratories Pvt Ltd Aristo Pharmaceuticals Ltd Indoco Remedies India Indi Pharma (Pvt) Ltd LaboratoriesIPCA INDIAMedizan Laboratories (Pvt) Ltd 28-Dec-17Years Two Medibios Laboratories (Pvt) Ltd Centaur Pharmaceutical (Pvt) Ltd Indoco Remedies India (Contd.) Laboratories (Pvt) Ltd Co Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Co Ltd Pharmaceuticals (Pvt) Ltd Ltd Ltd Pharmaceuticals (Pvt) Ltd (Ceylon) Ltd Health (Pvt) Ltd Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP 3352 80MG BP TABLETS GLICLAZIDE MEDOCLAZIDE3353 TABLETS 80MG BP TABLETS GLICLAZIDE GLICAD 80 Associated 3354 40MG BP TABLETS GLICLAZIDE TABLETS DIAZIDE 403355 40MG BP TABLETS GLICLAZIDE Darley Butler & GLIZ3356 TABLETS 40MG BP TABLETS GLICLAZIDE GLIPEESAssociates Pharma 3357 The Madras 40MG BP TABLETS GLICLAZIDE TABLETS N/A TABLETS3358 40MG BP TABLETS GLICLAZIDE Chamee Chemist Tabrane Bajaj Healthcare GLICAD 403359 40MG BP TABLETS GLICLAZIDE TABLETS TABLETS GLYCHEK3360 40MG IP International TABLETS GLICLAZIDE Yaden Darley Butler & TABLETS3361 GLIX 40 LETS 1MGTAB GLIMEPIRIDE Hemas 3362 LETS 1MGTAB GLIMEPIRIDE GLYREE-1 TABLETS GLIMEX3363 LETS 2MGTAB GLIMEPIRIDE TABLETS Emar Pharma (Pvt) Emar Pharma (Pvt) NUGLIM-23364 LETS 2MGTAB GLIMEPIRIDE TABLETS TABLETS Ceyline 2MG GLIMITAB TABLETS Emerchemie NB George Steuart 3351 80MG BP TABLETS GLICLAZIDE GLYCHEK TABLETS Emar Pharma (Pvt) I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 285 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 PHILIPPINES 09-Apr-14GERMANY Full 14-Mar-18ARGENTINA Full 05-Oct-17INDIA Full 01-Nov-14BANGLADESH Full 27-Mar-17 Years Two INDIA 05-Jan-15INDIA Full 05-Jan-15 Full INDIAINDIA 11-Sep-14 Full 07-Oct-17 Years Two India Ltd INDIA 04-Sep-17Years Two India Ltd INDIA 27-Nov-17 Full fi fi Denk Pharma GmbH & Co. Quimica Montpellier SA Zim Laboratories Ltd LaboratoriesIPCA INDIAEskayef Bangaladesh Ltd 28-Dec-17Pvt Ltd Full Bal Pharma Ltd INDIAPvt Ltd Bal Pharma Ltd 06-Feb-16 INDIA Full 06-Feb-16 Full LLOYD Laboratories Inc Micro Labs Ltd INDIACadila pharmaceuticals Ltd Cadila Healthcare 20-Jan-15Ltd Full (Contd.) Lanka Ltd Sano Lanka Ltd Sano fi fi Pharmaceuticals (Pvt) Ltd (Ceylon) Ltd Pharmaceuticals (Pvt) Ltd Ltd Healthcare lanka Ltd (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Healthcare lanka Ltd Healthcare lanka Ltd TABLETS Akbar SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP DENK 3366 LETS 2MGTAB GLIMEPIRIDE GLIMEPIRIDE 3367 LETS 2MGTAB GLIMEPIRIDE 3368 LETS 2MGTAB GLIMEPIRIDE GLEMAZ 2 GLIMIRYLE 3369 LETS 2MGTAB GLIMEPIRIDE TABLETS TABLETS3370 LETS 2MGTAB GLIMEPIRIDE GLYREE-2 Emerchemie NB Tabrane DIALON3371 1MG LETS IP TAB GLIMEPIRIDE TABLETS GLIMER 13372 1MG LETS IP TAB GLIMEPIRIDE Emar Pharma (Pvt) TABLETS 1 SECRTAG 3373 2MG LETS IP TAB GLIMEPIRIDE TABLETS Sunshine GLIMER 2 TABLETS3374 2MG LETS IP TAB GLIMEPIRIDE CIC Holdings PLC Abbott Healthcare 2 SECRETAC 3375 International Yaden 2MG LETS IP TAB GLIMEPIRIDE TABLETS TABLETS AMARYL CIC Holdings PLC Abbott Healthcare International Yaden TABLETS Sano 3365 LETS 2MGTAB GLIMEPIRIDE 2 SULFAST TABLETS Slim 3376 3MG LETS IP TAB GLIMEPIRIDE AMARYL TABLETS Sano 3377 1MGTABLETS GLIMEPIRIDE 3378 1MG GLIMEPIRIDE TABLETS DIAPRIDE3379 GLUCONORM 2MGTABLETS GLIMEPIRIDE TABLETS TABLETS EUGLIM 2 Micro Mega Lanka Sunshine TABLETS Sunshine 286 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 GERMANY 14-Mar-18 Full PHILIPPINES 09-Apr-14INDIA Full INDIA 15-Sep-15 Full INDIA 31-May-17 Full PAKISTAN 12-Jan-18 15-Mar-14 Full INDIA Full INDIA 06-Jun-14 Full INDIA 26-Jan-18INDIA Full 11-Nov-15 Full 27-Sep-15 Full Micro Labs Ltd INDIA LaboratoriesIPCA INDIALLOYD Laboratories Inc 07-Jun-17Years Two 23-Nov-17Cadila Healthcare Ltd Full Akums Drugs & Pharmaceuticals Ltd Windlas Biotech (Pvt) Ltd CCL Pharmaceuticals (Pvt) Ltd Atra Pharmaceuticals (Pvt) Ltd India for Norvartis India Ltd MMC Healthcare Ltd Akums Drugs & Pharmaceuticals Ltd Aurochem Pharmaceuticals (India) Ltd Micro Labs Ltd INDIADenk Pharma GmbH & Co. 20-Jan-15 Full (Contd.) (Pvt) Ltd Ltd Pharmaceuticals (Pvt) Ltd Healthcare lanka Ltd Plc Pharmaceuticals (Pvt) Ltd Pharmaceuticals Lanka (Pvt) Ltd (Pvt) Ltd Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP TABLETS Akbar DENK 3382 4MGTABLETS GLIMEPIRIDE 3383 4MGTABLETS GLIMEPIRIDE DIAPRIDE 43384 4MGTABLETS GLIMEPIRIDE GLYREE-4 TABLETS3385 4 SULFAST 4MGTABLETS GLIMEPIRIDE Micro Mega Lanka TABLETS TABLETS3386 Emar Pharma (Pvt) EUGLIM 4 1MG USP TABLETS GLIMEPIRIDE 1 GLIMIWEL Slim 3387 TABLETS 1MG USP TABLETS GLIMEPIRIDE TABLETS GLIPRIDE Sunshine 3388 Browns & Company 1MG USP TABLETS GLIMEPIRIDE TABLETS ORINASE3389 1MG USP TABLETS GLIMEPIRIDE Lifeline GLIMPRIDE B TABLETS TABLETS3390 CCL 1MG USP TABLETS GLIMEPIRIDE 2 GIMETAB Baur Life Sciences 3391 1MG USP TABLETS GLIMEPIRIDE VEXGLIM 1 TABLETS3392 1MG USP TABLETS GLIMEPIRIDE TABLETS Markss HLC (Pvt) 1 GLIMESTAR TABLETS Global Impex AV Hemas 3381 3MG GLIMEPIRIDE TABLETS GLIMEPIRIDE 3380 2MGTABLETS GLIMEPIRIDE DIAPRIDE TABLETS Micro Mega Lanka I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 287 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIA 31-May-17 Full INDIA 01-Nov-18 Full INDIAINDIA 29-Aug-15 Full INDIA 11-Nov-16 Full PAKISTAN 27-Sep-15 15-Mar-14 Full INDIA Full 25-Feb-14INDIA Full PAKISTAN 06-Jun-14 Full 13-Sep-15INDIA Full 24-Jan-18 Full U S V Ltd INDIAZim Laboratories Ltd U S V Ltd 10-May-16 Full INDIAWindlas Biotech (Pvt) Ltd Akums Drugs & 10-May-18Pharmaceuticals Ltd Full Aurochem Pharmaceuticals (India) Ltd CCL Pharmaceuticals (Pvt) Ltd MSN Laboratories Alembic Pvt Ltd for Pharmaceuticals - India Atra Pharmaceuticals (Pvt) Ltd India for Norvartis India Ltd Medizan Laboratories (Pvt) Ltd MMC Healthcare Ltd Akums Drugs & Pharmaceuticals Ltd (Contd.) Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Hemas Pharmaceuticals (Pvt) Ltd Pharmaceuticals Lanka (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Ltd Pharmaceuticals (Pvt) Ltd TABLETS SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP 3394 1MG USP TABLETS GLIMEPIRIDE 1 GP 3395 2MG USP TABLETS GLIMEPIRIDE 2 GLIMIRYLE 3396 TABLETS 2MG USP TABLETS GLIMEPIRIDE TABLETS 2 GP Hemas Tabrane 3397 2MG USP TABLETS GLIMEPIRIDE GLIPRIDE3398 TABLETS 2MG USP TABLETS GLIMEPIRIDE TABLETS VEXGLIM 2 Hemas 3399 2MG USP TABLETS GLIMEPIRIDE Lifeline TABLETS 2 GLIMESTAR 3400 UNCOATED 2MG USP TABLETS GLIMEPIRIDE Global Impex AV ORINASE3401 2MG USP TABLETS GLIMEPIRIDE GLISEN 2 TABLETS3402 CCL 2MG USP TABLETS GLIMEPIRIDE TABLETS GLIMPRIDE B Citihealth Imports TABLETS3403 2MG USP TABLETS GLIMEPIRIDE GLIMEX Baur Life Sciences 3404 2MG USP TABLETS GLIMEPIRIDE 2 GIMETAB TABLETS TABLETS Ceyline Markss HLC (Pvt) 3393 1MG USP TABLETS GLIMEPIRIDE 1 GLIMIWEL TABLETS Lotus 288 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIA 31-May-17 Full PAKISTAN 12-Apr-18INDIA Full PAKISTAN 12-May-15 15-Mar-14INDIA Full Full PAKISTAN 27-Sep-14 12-Apr-18 Full INDIA Full INDIA 01-Dec-17 Full INDIA 29-Aug-17 Full INDIA 01-Dec-17 Full INDIA 11-Nov-14 Full PAKISTAN 16-May-15 11-Mar-14 Full Full P T Kalbe FarmaT P INDONESIA 10-Jan-17Getz Pharma Pakistan (Pvt) Ltd Full Indoco Remedies India CCL Pharmaceuticals (Pvt) Ltd Aurochem Pharmaceuticals (India) Ltd Getz Pharma (Pvt) Ltd Cadila pharmaceuticals Ltd Windlas Biotech (Pvt) Ltd Cadila pharmaceuticals Ltd Akums Drugs & Pharmaceuticals Ltd Centaur Pharmaceutical (Pvt) Ltd CCL Pharmaceuticals (Pvt) Ltd Akums Drugs & Pharmaceuticals Ltd (Contd.) Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Ltd Pharmaceuticals Lanka (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Healthcare lanka Ltd Pharmaceuticals (Pvt) Ltd Healthcare lanka Ltd (Pvt) Ltd Health (Pvt) Ltd Pharmaceuticals Lanka (Pvt) Ltd Pharmaceuticals (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP 3411 3MG USP TABLETS GLIMEPIRIDE GETRYL TABLETS Hemas 3406 2MG USP TABLETS GLIMEPIRIDE METRIX3407 2MG USP TABLETS GLIMEPIRIDE GETRYL TABLETS3408 2MG USP TABLETS GLIMEPIRIDE Hemas PRICHEK TABLETS3409 3MG USP TABLETS GLIMEPIRIDE ORINASE Hemas TABLETS3410 3MG USP TABLETS GLIMEPIRIDE 3 GLIMESTAR TABLETS Emar Pharma (Pvt) TABLETS CCL Hemas 3412 4MG USP TABLETS GLIMEPIRIDE GLUCONORM-4 TABLETS3413 4MG USP TABLETS GLIMEPIRIDE GLIPRIDE 4 Sunshine 3414 4MG USP TABLETS GLIMEPIRIDE TABLETS GLUCONORM-4 TABLETS3415 4MG USP TABLETS GLIMEPIRIDE Lifeline VEXGLIM 4 Sunshine 3416 4MG USP TABLETS GLIMEPIRIDE TABLETS 4MG GLIMITAB TABLETS3417 4MG USP TABLETS GLIMEPIRIDE Global Impex AV ORINASE George Steuart TABLETS CCL 3405 2MG USP TABLETS GLIMEPIRIDE 2 GLIMIWEL TABLETS Lotus I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 289 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 AUSTRALIA 12-Sep-15 Full AUSTRALIA 12-Sep-15 Full INDIA 29-Apr-18 Full INDIA 28-May-14 Full INDIA 29-Apr-16 Full INDIAARGENTINA 20-Jun-17 20-Aug-15PAKISTAN Full Full 22-Oct-15 Full zer Italia SRL ITALY 27-Jan-17 Full fi Contract Manufacuring & Packging Services pty Ltd Contract Manufacuring & Packging Services pty Ltd MMC Healthcare Ltd Novo Nordisk DENMARKMMC Healthcare Ltd 11-Sep-17Years Two Bal Pharma Ltd INDIA 11-Jun-14 Full U S V Ltd INDIAZim Laboratories Ltd 01-Jul-18Years Two Quimica Montpellier SA Getz Pharma Pakistan (Pvt) Ltd P Akums Drugs & Pharmaceuticals Ltd (Contd.) Ltd Ltd Ltd Healthcare lanka Ltd Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Ceylon) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd TABLETS Alaris Lanka (Pvt) SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP OSTEOFLAM PLUS OSTEOFLAM BD CAPSULES Alaris Lanka (Pvt) CARTIPLUS TABLETS Markss HLC (Pvt) GLUCAGEN INJECTION Sunshine TABLETS 953MG TABLETS CAPSULES 750MG CHONDROITIN,METHYL SULFONYL SULFONYL CHONDROITIN,METHYL D3 METHANE CALCIUM & VITAMIN TABLETS INJECTION 1MG (Disposable Syr. INJECTION 1MG (Disposable Syr. for in) Water 3430 GLUCOSAMINE HYDEOCHLORIDE 3429 GLUCOSAMINE HYDEOCHLORIDE 3428 GLUCOSAMINE 3427 GLUCOSAMINE CAPSULES 750MG GSM FORTE CAPSULES Markss HLC (Pvt) 3424 5MG BP TABLETS GLIPIZIDE 3425 5MG BP TABLETS GLIPIZIDE EUGLIZIP3426 GLUCAGON HYDROCHLORIDE DIACON TABLETS TABLETS N/A International Yaden Astron (Pvt) Ltd SRI LANKA 04-Oct-15 Full 3422 5MG BP TABLETS GLIPIZIDE 3423 GLYNASE 5MG BP TABLETS GLIPIZIDE TABLETS GLIPIZIM 5 Hemas TABLETS Tabrane 3419 4MG USP TABLETS GLIMEPIRIDE GLEMAZ3420 4MG USP TABLETS GLIMEPIRIDE GETRYL TABLETS3421 5MG GLIPIZIDE TABLETS TABLETS Emerchemie NB MINIDIAB Hemas TABLETS Hemas 3418 4MG USP TABLETS GLIMEPIRIDE 4 GLIMIWEL TABLETS Lotus 290 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIA 21-Jul-15 Full INDIAINDIA 16-Mar-16MALAYSIA Full 07-Nov-17 27-Aug-18 Full Years Two CHINA 10-Aug-17 Full MALAYSIA 03-Feb-14 Full INDIA 11-Dec-17 Full INDIAINDIA 02-Jul-15 05-May-16 Full Full INDIA 31-Aug-16 Full INDIA 12-Jan-18 Full AUSTRALIA 12-Sep-16 Full PAKISTAN 15-May-17 Years Two Aculife Healthcare (Pvt) Ltd Aculife Healthcare (Pvt) Ltd B Braun Medical Industries Pharmaceutical Co. Ltd Ltd B Braun Medical Industries Jenburkt Pharmaceuticals Ltd Sciences Pvt Ltd Kniss Laboratories (Pvt) Ltd MMC Healthcare Ltd Kniss Laboratories (Pvt) Ltd Contract Manufacuring & Packging Services pty Ltd Hilton Pharma (Pvt) Ltd (Contd.) Sunshine Healthcare lanka Ltd Healthcare lanka Ltd Ltd Chamee Chemist Axa Parenterals Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Ltd (Pvt) Ltd Ltd Healthcare lanka Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP INFUSION INFUSION WIDA D10WIDA N/A INFUSION IV Aristons (Pvt) LtdN/A Widatra BhaktiT P INDONESIA INJECTION 16-Aug-15 Pharma Associates Sichuan Full Kelun VENOUS INTRA AXADEX INTRAVENOUS N/A INJECTION B Braun Lanka (Pvt) CARTIGEN TABLETS ODCARTISAFE TABLETS Harcourts (Pvt) Ltd Bioplus Life Hemas CARTICARE TABLETS Pharma Avenier CARTIPLUS TABLETS Markss HLC (Pvt) CARTICARE ODCARTICARE TABLETS Pharma Avenier NUFLAM CAPSULES Alaris Lanka (Pvt) GEVOLOX 500 CAPSULES Sunshine BP 5% BP BP 10% BP 5% BP INFUSION BP 5%W/V INFUSION BP INFUSION BP POTASSIUM CHLORIDE TABLETS TABLETS CHLORIDE POTASSIUM 1500MG 1500MG 750MG 750MG 1500MG CAPSULES 500MG CAPSULES 500MG 3443 INFUSION GLUCOSE INTRAVENOUS 3440 25% W.V GLUCOSE INJECTION BP N/A3441 50% w/v GLUCOSE INJECTION BP N/A3442 INFUSION GLUCOSE INTRAVENOUS INJECTION Sunshine INJECTION3444 INFUSION GLUCOSE INTRAVENOUS B Braun Lanka (Pvt) 3439 GLUCOSE INTERAVENOUS 3438 GLUCOSE 10% w/v INTRAVENOUS 3436 GLUCOSAMINE SULPHATE 3437 USP GLUCOSAMINE TABLETS 3435 TABLETS GLUCOSAMINE SULFATE 3434 TABLETS GLUCOSAMINE SULFATE 3433 TABLETS GLUCOSAMINE SULFATE 3432 GLUCOSAMINE SULFATE 3431 GLUCOSAMINE SULFATE I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 291 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 GERMANY 09-Apr-14 Full INDIA 06-Oct-16 Full INDIA 23-Sep-16 Full INDIABANGLADESH 18-Mar-15 02-Mar-16 Full Full INDIA 20-Aug-18 Provisional GERMANY 11-May-17 Full BANGLADESH 11-Mar-16 Full INDIA 10-Jun-14 Full INDONESIA 20-Nov-14 Full MALAYSIA 18-Nov-17 Full CHINA 10-Aug-17 Full Hameln Pharmaceuticals GmbH/Germany Hospira Australia (Pvt) Ltd Troikaa Troikaa Pharmaceuticals Ltd Troikaa Troikaa Pharmaceuticals Ltd Pharmaceuticals Ltd Modi Mundipharma Ltd Bliss GVS Pharma Ltd Micro Labs Ltd INDIAPharmaceuticals Ltd 22-Mar-18Years Two B Braun Melsungen A G Fresenius Kabi A.B Indonesia B Braun Medical Industries Pharmaceutical Co. Ltd (Contd.) Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Robert Hall & Co Ltd Healthcare lanka Ltd (Pvt) Ltd Ltd Pharmaceuticals (Pvt) Ltd Aristons (Pvt) Ltd Otsuka T P Ltd RELEASE TABLETS INFUSION SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP N/A INJECTION Akbar MYONIT 6.4MGMYONIT TABLETS Slim GLYSUP 1.15GLYSUP 2.6MYONIT PharmAce (Pvt) Ltd Square TABLETS Slim GLYSUP 2.3GLYSUP N/A PharmAce (Pvt) Ltd Square Sunshine N/A INJECTION B Braun Lanka (Pvt) GLUCOSE INJECTION Hemas N/A INTRA N/AN/A INJECTION Pharma Associates Sichuan Kelun INFUSION B Braun Lanka (Pvt) 1MG/ML CONTROLLED RELEASE TABLETS TABLETS CONTROLLED RELEASE 6.4MG 1.15G TAB CONTROLLED RELEASE 2.3G 1G BP 50% BP BP 5% w/v BP BP 5% w/v BP BP 5% BP BP 5% w/v BP 3457 INJECTION TRINITRATE GLYCERYL 3456 TRINITRATE GLYCERYL 3453 BP SUPPOSITORIES GLYCEROL 3454 2.6MG TRINITRATE GLYCERYL NITROCONTIN3455 2.6MG TRINITRATE GLYCERYL CONTROLLED 3450 CREAM 15 % W/W GLYCERIN 3451 BP SUPPOSITORIES GLYCERIN SECALIA3452 USP SUPPOSITORIES GLYCERIN CREAM Micro Mega Lanka 3449 INFUSION GLUCOSE INTRAVENOUS 3448 INFUSION GLUCOSE INTRAVENOUS 3447 INFUSION GLUCOSE INTRAVENOUS 3445 INFUSION GLUCOSE INTRAVENOUS 3446 INFUSION GLUCOSE INTRAVENOUS 292 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 06-Oct-18 Years Two 26-Jun-18 Full 10-Mar-18 Provisional 07-Feb-16 Full BANGLADESH 15-Feb-17 Full INDIAINDIA 08-Jun-16INDIA Full 10-Jun-15INDIA Full 06-Mar-14 Full 15-Sep-15 Full KINGDOM GERMANY 09-Aug-18GERMANY Years Two UNITED 25-Jul-18KINGDOM Years Two UNITED KINGDOM UNITED STATES CHINA 17-Aug-18 Years Two Laboratories (Pvt) Ltd Astra Lifecare (India) (Pvt) Ltd Fredun Pharmaceuticals Ltd Medopharm (PVT Ltd Glaxo Smithkiline Pakistan Ltd Astra Zeneca UNITED Birkerfeld Astra Zeneca UK Ltd Birkerfeld Macarthys Laboratories Ltd Martindale T/A Pharmaceuticals Baxter Pharmaceuticals Solution Jewim Pharmaceutical (Shandong) Co ltd (Contd.) Health (Pvt) Ltd Health (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticlas (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Ltd (Pvt) Ltd Emerchemie NB (Ceylon) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP INJECTION Hemas SPRAY ZIFOL NFZIFOL CAPSULES Kamazu (Pvt) Ltd Micro Labs Ltd INDIA 01-Apr-14 Full STERILE DEPOT N/ASIMPONI INJECTION Niix Holdings (Pvt) SOLUTION Pettah Pharmacy NITRIL SUBLINGUAL (DRIED FERROUS SULPHATE (DRIED FERROUS SULPHATE ACID 400MCG & ZINC 150MG+FOLIC 61.8MG) SULPHATE INJECTION PREFILLED PEN 50MG/0.5ML MCG ML SOLUTION FOR INJECTION MCG ML SUBLINGUAL SPRAY 0.4MG .200 SPRAY SUBLINGUAL DOSES 3466 500MG BP TABLETS GRISEOFULVIN GRISEBEN3467 500MG BP TABLETS TABLETS GRISEOFULVIN 500 ASFULVIN TABLETS3468 500MG BP TABLETS GRISEOFULVIN Ceyoka (Pvt) Ltd GRISEOFRED Leben TABLETS George Steuart 3469 500MG BP TABLETS GRISEOFULVIN N/A George Steuart 3470 WITH ZINC CAPSULES HAEMATINIC TABLETS Akbar 3465 500MGTABLETS GRISEOFULVIN GRISOVIN F.P TABLETS GlaxoSmithkiline 3464 GOSERELIN INJECTION 3.6MG ZOLADEX 3462 3.6MG GOSERELIN IMPLANT 3463 GOSERELIN INJECTION 10.8MG RESELIGO 3.6 ZOLADEX LA IMPLANTS INJECTIONAssociates Pharma AMW GmbH Hemas 3461 GOSERELIN 10.8 IMPLANT RESELIGO IMPLANTSAssociates Pharma AMW GmbH 3460 GOLIMUMAB SOLUTION FOR 3459 BROMIDE 200 GLYCOPYRRONIUM 3458 TRINITRATE GLYCERYL I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 293 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 MALAYSIA 16-May-17 Full KOREA 26-Feb-14 Full INDIAINDIA 17-Dec-14INDIA Full 25-Oct-18 Full 12-Jan-14 Full INDIASRI LANKA 15-Dec-17 Years Two 01-Jan-15PAKISTAN Full INDIA 21-Aug-18 Full PAKISTAN 06-Jul-18 21-Aug-14 Full Full INDIA 16-Mar-18 Years Two FRANCE 29-Apr-14 Full Pasteur fi Huniz Co. Ltd KOREAB Braun Medical Industries 26-Feb-14 Full Huniz Co. Ltd Dist. By HEMOCLEAN Co. Ltd PharmaceuticalS (Pvt) Ltd Claris Injectables Ltd Piramal Healthcare Ltd (Ceylon) (Pvt) Ltd Company Ltd Atoz Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Pharma Fabrikon INDIALaboratories (Pvt) Ltd 05-Jun-15 Full Maan Pharmaceutical Ltd S A (Contd.) Lanka Ltd Sano fi Ltd Ltd Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd P T C Medical (Pvt) T P Ltd INJECTION SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP ACT HIBACT INJECTION Sano ARISTON BARISTON HD 1A SOLUTION Shield Medical (Pvt) SOLUTION B Braun Lanka (Pvt) ARISTON CARISTON SOLUTION Shield Medical (Pvt) N/A INHALATION Euro Asian Pharma N/A INJECTION Novachem Lanka MANCALM 5 LIQUID TYPE B CONJUGATE VACCINE VACCINE TYPE B CONJUGATE 10MCG/0.5ML BICARBONATE DIALYSIS BICARBONATE BICARBONATE COMPONENT BICARBONATE BICARBONATE COMPONENT BICARBONATE INHALATIOON ML ML 3474 HAEMOPHILUS INFUENZAE 3473 SOLUTION FOR HAEMODIALYSIS 3472 CONCENTRATE HAEMODIALYSIS 3471 CONCENTRATE HAEMODIALYSIS 3483 5000IU/ML IINJECTION BP HEPARIN 25 OPARIN 3484 INJECTION 5000IU/ML HEPARIN INJECTION HEPAREN Ceyoka (Pvt) Ltd Ciron Drugs & INJECTION Akbar 3478 1.5MG BP TABLETS HALOPERIDOL N/A3479 1.5MGTABLETS HALOPERIDOL SERENACE3480 5MG BP TABLTETS HALOPERIDOL ZOCALM-5 TABLETS TABLETS3481 5MG BP TABLTETS HALOPERIDOL N/A TABLETS SERENACE Morison PLC3482 HALOTHANE LIQUID FOR Asian Pharma Euro TABLETS The Searle Morison PLC M S J Industries Searle-pakistan 3477 1.5MG BP TABLETS HALOPERIDOL 1.5 HALOSLIP TABLETS Ceyoka (Pvt) Ltd Leben 3476 5MG/ INJECTION BP HALOPERIDOL 3475 5MG/ INJECTION BP HALOPERIDOL 294 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 BELGIUM 20-Aug-18 Provisional BELGIUM 23-Oct-14 Full INDIA 23-Aug-17 Full MALAYSIA 04-Jul-17 Full INDIA 11-Feb-18 Years Two INDIA 23-Aug-17 Full BELGIUM 28-Aug-18 Full FRANCE 27-Oct-17 Years Two INDIA 25-Jun-17 Full BELGIUM 06-Mar-18 Full INDIA 05-Oct-17 Full FRANCE 29-Nov-15 Full Pasteur Pasteur fi fi Glaxo Smithkiline A Biologicals S Glaxo Smithkiline A Biologicals S LEO Pharma A SA LEO Pharma DENMARK 21-Jan-18Divine Laboratories (Pvt) Ltd Full Kotra pharma (M) Ltd Gland Pharma (Pvt) Ltd Divine Laboratories (Pvt) Ltd Sano Glaxo Smithkiline A Biologicals S S A Serum Institute of India (Pvt) Ltd Glaxo Smithkiline A Biologicals S Serum Institute of India (Pvt) Ltd S A (Contd.) Aventis Aventis Lanka Ltd Sano fi fi Sano Pharmaceuticlas (Pvt) Ltd Pharmaceuticlas (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Co Ltd Services Pvt. Ltd Pharmaceuticals (Pvt) Ltd Lanka Ltd Pharmaceuticlas (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP INJECTION INJECTION GlaxoSmithkiline AVAXIM SUAPE. HAVRIX INJECTION GlaxoSmithkiline TWINRIX ADULTTWINRIX INJECTION GlaxoSmithkiline HEPARIN LEOHEPARIN INJECTIONFLAGORIN 5000 Hemas INJECTION Slim VAXCEL INJECTION Delmege Forsyth & HEP 25HEP INJECTION ABC Pharma AVAXIM 80AVAXIM INJECTION Sano HAVRIX JUNIOR HAVRIX 720 N/A INJECTION Citihealth Imports ENGERIX-B INJECTION Smithkline Beecham N/A INJECTION Citihealth Imports (INACTIVATED & ADSORBED)160 & (INACTIVATED ANTIGEN UNITS/0.5ML UNITS IML INJECTION UNITS IML VACCINE I DOSE OF 1ML contain I DOSE OF 1ML VACCINE UNITS & ANTIGEN 720 ELISA HAV hb & ag 20mcg 5000 IU/ML IU/ML IU/ML 5ML (PAEDIATRIC) (INACTIVATED) UNITS/0.5ML UNITS/0.5ML (INACTIVATED) INJECTION RECOMBINANT (rDNA) 10 DOSE RECOMBINANT (ADULT) 20MCG/ML 10MCG/0.5ML ,PAEDIATRIC 10MCG/0.5ML 3492 A VACCINE HEPATITIS 3491 1440 ELISA VACCINE A HEPATITIS 3490 r DNA & B VACCINE A HEPATITIS 3489 SODIUM INJECTION IP HEPARIN 3488 SODIUM INJECTION 5000 HEPARIN 3487 SODIUM INJECTION 5000 HEPARIN 3486 25,000IU IN SODIUM BP HEPARIN 3485 1000IU/ML INJECTION BP HEPARIN FLAGORIN 1000 INJECTION Slim 3494 INACTIVATED VACCINE A HEPATITIS 3493 720 ELISA VACCINE A HEPATITIS 3497 B VACCINE HEPATITIS 3496 (R-DNA) B VACCINE HEPATITIS 3495 (r DNA) BP B VACCINE HEPATITIS I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 295 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 31-Aug-18 Full AUSTRIA 13-May-17 Years Two INDIA 06-Jul-18 Years Two KOREA 05-Jul-14 Full SWITZERLAND 10-Aug-18 Provisional GERMANY 26-Sep-17AUSTRIA Full KOREA 20-Aug-15CHINA Full 02-May-18 Provisional 23-Sep-17 Years Two UNITED STATES INDIA 24-Nov-14 Full CHINA 28-Oct-15 Full INDIA 24-Mar-16 Full Baxter AG AUSTRIA 23-Jun-15 Full Octapharma Pharmazeutika Vaccine Ltd Vaccine L G Life Sciences L Ltd CSL Behring CSL GmbH Octapharma Pharmazeutika SK Plasma Co. Ltd Sichuan Juanda Shuyang Pharmaceutical Co. Ltd Baxter AG AUSTRIA Behring CSL GmbH 07-Apr-18 Full Grifols Biological Inc Reliance Life Sciences (Pvt) Ltd Ashford Laboratories Ltd Serum Institute of India (Pvt) Ltd (Contd.) international Ltd Services Pvt. Ltd Ceyoka (Pvt) Ltd Bharat Serums & Services Pvt. Ltd Services Pvt. Ltd Services Pvt. Ltd Solutions Pharmaceuticals (Pvt) Ltd A J Medichem A international Ltd Services Pvt. Ltd (Pvt) Ltd Services Pvt. Ltd Ltd (Pvt) Ltd POWDER INJECTION ABC Pharma SOLUTION INFUSION SOLUTION ABC Pharma SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP OCTANATE-F INJECTION ABC Pharma HUCOG FREEZE DRIED IVF-C INJECTION ABC Pharma RHOPHYLAC INJECTION ABC Pharma OCTAPHARMA BAXTER HUMAN ALBU HUMAN ALBUMIN 20% ALBUTEINALBUREL INJECTION Mansel (Ceylon) INFUSION IV ABC Pharma HOMATROPINE EYE DROPS Ceylon (Pvt) Teastar N/A INJECTION Citihealth Imports FREEZE DRIED 100IU/ml GONADOTROPHIN INJECTION BP GONADOTROPHIN INJECTION BP 5000IU FREEZE DRIED (HIGHLY) GONADOTROPHIN (HCG) IM 5000IU IMMUNOGLOBULIN INJECTION 300MCG IN 2ML FOR INFUSION 200G/L,50ML and FOR INFUSION 200G/L,50ML 100ml BAXTER FOR INFUSION 200G/L,50ML and FOR INFUSION 200G/L,50ML 100ml BAXTER 20% SOLUTION FOR INJECTION INFUSION) (INTRAVENOUS USP EYE DROPS USP 2% EYE DROPS USP RECOMBINANT (Rdna) SINGLE RECOMBINANT DOSE (ADULT) 3511 VIII FACTOR HUMAN COAGULATION 250 IMMUNATE INJECTION J Medichem A 3510 IX, FACTOR HUMAN COAGULATION 3509 HUMAN CHORIONIC 3508 HUMAN CHORIONIC 3504ALBUMIN INJECTION 20% HUMAN ALBUMIN HUMAN 3505ALBUMIN SOLUTION 20% HUMAN ALBUMIN 20% SK INJECTION3506ALBUMIN SOLUTION 20% HUMAN SUYA-ALB Multi Pharma 3507ANTI D (Rho) SOLUTION HUMAN Slim 3503ALBUMIN 20%,SOLUTION HUMAN 3502ALBUMIN 20%,SOLUTION HUMAN 3501 ALBUMIN (NORMAL) IP HUMAN 3500ALBUMIN SOLUTION 5% HUMAN 3499 HYDROBROMIDE HOMATROPINE 3498 B VACCINE HEPATITIS 296 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 01-Jun-17 Full 08-May-17 Years Two KOREA 06-Apr-18 Provisional KOREA 28-Jan-15 Full STATES FRANCE 20-Jul-14 Full GERMANY 01-Jun-17 Full GERMANY 01-Jun-17 Full UNITED STATES INDIA 29-Sep-18 Years Two SWITZERLAND 13-Feb-16CHINA Full 20-Apr-14 Full SK Plasma Co. Ltd L G Life Sciences L Ltd Eli Lilly & Co UNITED Lilly France S.A.S France Eli Lilly & Company USA & Lilly Pharma Fertigung Und Distribution Eli Lilly & Company USA & Lilly Pharma Fertigung Und Distribution Vaccine Ltd Vaccine Kedrion SPA CHINAKamada Ltd ISRAELOrtho Clinical Diagnostcs Inc 27-Mar-15 Full 14-May-15 Full Biological Products Co. Ltd CSL Behring CSL GmbH (Contd.) Solutions Services Pvt. Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Celyon (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd Services Pvt. Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP LIV GAMMA INJECTION Multi Pharma IVF-M INJECTION ABC Pharma HUMULIN 70/30 INJECTION Hemas HUMULIN 70/30 INJECTION Hemas HUMULIN N INJECTION Hemas GAMMA IVGAMMA HUMULIN R INJECTION Ceyoka (Pvt) Ltd INJECTION Bharat Serums & Hemas N/AROSENGLOB INJECTION INJECTIONKamRho D I.M Associated Pharma Pharma Associates INJECTION Guizhou Taibang RHOGAM S J Enterprises INJECTION S J Enterprises SANDOGLOBULIN INJECTION ABC Pharma

IMMUNOGLOBULIN EUR PH FOR IV 500MG/10ML ADMINISTRATION GONADOTROPHIN HMG 75IU SUSPENSION 70%, HUMAN INSULIN 30% INJECTION 100IU/ml SUSPENSION 70%, HUMAN INSULIN 30% INJECTION 100IU/ml INJECTION rDNA 100IU/ML (R-DNA) 100IU/ML INJECTION rDNA INTRAVENOUS USE BP 0.5G/1ML USE BP INTRAVENOUS 100 UNIT in 150mcg /ML 300mcg (1500IU) Pre Filled Syringe INTRAVENOUS IMMUNOGLOBULIN INTRAVENOUS 5% FOR I.V INJECTION 5% NORMAL INJECTION NORMAL 3523 HUMAN NORMAL 3522 HUMAN MENOPAUSAL 3521 HUMAN INSULIN ISOPHANE 3520 HUMAN INSULIN ISOPHANE 3519 HUMAN INSULIN ISOPHANE 3517 HUMAN IMMUNOGLOBULIN, 3518 HUMAN INSULIN INJECTION USP 3515 HUMAN IMMUNOGLOBULIN (RHO(D) 3516 HUMAN IMMUNOGLOBULIN RHO(D) 3513 HUMAN IMMUNOGLOBULIN 3514 HUMAN IMMUNOGLOBULIN (PH4) 3512 HUMAN IMMUNOGLOBULIN I.V I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 297 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 11-May-15 Full 02-Dec-18 Provisional SRI LANKA 26-Mar-17SRI LANKAYears Two 17-Jan-17 Full INDIA 13-Feb-17 Full PAKISTAN 26-Apr-15 Full AUSTRIA 05-Aug-17 Full KOREA 20-Feb-18 Full BELGIUM 06-Nov-17 Full KOREA 20-Aug-17 Years Two Intermed INDIA 01-Nov-18 Years Two Kwality Pharmaceuticals Pvt Ltd (Ceylon) (Pvt) Ltd (Ceylon) (Pvt) Ltd SG Pharma (Pvt) Ltd Unijules Life Sciences Ltd Kamada Ltd ISRAELZafa 12-Oct-18Pharmaceuticals Provisional Laboratories (Pvt) Ltd Corporation Octapharma Pharmazeutika Glaxo Smithkiline A Biologicals S Guangzhon (Contd.) P T C Medical (Pvt) T P Ltd (Pvt) Ltd Pharmacy (Pvt) Ltd Pharmaceuticals (Pvt) Ltd S J Enterprises (Pvt) Ltd (Pvt) Ltd ABC Pharma Services Pvt. Ltd Pharmaceuticlas (Pvt) Ltd TABLETS INJECTION INJECTION SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP HIDREXN/A UNCOATED N/A TABLETS TABLETS N/A N/A M S J Industries M S J Industries N/A INJECTION The Esses N/A INJECTION Lifeline KAMRAB 150IU SOLUTION FOR ALBUMIN-GCC INJECTIONN/A Ceyoka (Pvt) Ltd Green Cross INJECTION International Yaden OCTAPLEX 500IUOCTAPLEX POWDER / GLOBULIN S INJECTION Ceyoka (Pvt) LtdCERVARIX Green Cros INJECTION GlaxoSmithkiline BP 25MG BP BP 25MG BP 50MG B.P INJECTION USP 20MG/ML INJECTION USP INJECTION USP 20MG/ML INJECTION USP INJECTION 20% NORMAL PASTEURIZED 150IU/ML 150IU/ML PASTEURIZED SOLUTION INJECTABLE 20MG/ML INJECTION USP POW. (FREEZE DRIED) & SOLVENT (FREEZE DRIED) & SOLVENT POW. FOR SOLUTION INJEC. II 280-760IU/FACTOR (FACTOR IX 500IU/ VII 180-480IU/FACTOR X 360 FACTOR IMMUNOGLOBULIN FOR INJECTION BP INTRAVENOUS 1000MG/20ML, 500MG/10ML 2500MG/50ML, 5000MG/100ML TYPE 16 & 18 3534 HYDROCHLOROTHIAZIDE TABLETS 3532 50MG B.P TABLETS HYDRALAZINE N/A3533 HYDROCHLOROTHIAZIDE TABLETS TABLETS3535 HYDROCHLOROTHIAZIDE TABLETS International Yaden 3531 HYDRALAZINE HYDROCHLORIDE 3530 HYDRALAZINE HYDROCHLORIDE 3528ALBUMIN HUMAN SERUM 3527 HUMAN RABIES IMMUNOGLOBULIN 3529 HYDRALAZINE HYDROCHLORIDE 3526 HUMAN PROTHROMBIN COMPLEX 3524 HUMAN NORMAL 3525 VACCINE HUMAN PAPILLOMAVIRUS 298 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIA 08-Jul-14 Full INDIA 14-Aug-17 Years Two INDIAINDIA 18-Aug-17INDIA Full 30-Jan-18INDIA Full 27-Apr-15 Full INDIA 29-Jun-18 Full 13-Feb-14 Full IRANINDIA 02-Mar-16 Full INDIA 26-Apr-18 Years Two 13-Feb-18 Years Two IRAN 02-Mar-16 Full INDIA 09-Jan-14 Full INDIA 17-Feb-18 Years Two B D H Industries Ltd Concept Pharmaceuticals Ltd (india) (Pvt) Ltd Pharmaceuticals (India) Ltd Laboratories (Pvt) Ltd Pharmaceuticals Agio Pharmaceuticals Ltd Laboratories (India) Ltd. Pharmaceuticals Aburaihan Pharmaceuticals Company Aburaihan Pharmaceuticals Company Agio Pharmaceuticals Ltd Unijules Life Sciences Ltd (Contd.) (Pvt) Ltd International (Pvt) Ltd (Pvt) Ltd Corporation (Pvt) Ltd Corporation (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP OINTMENT Pharma Associates Laborate CREAM Pharma Associates Laborate N/A OINTMENT Ravilux Company NETRACORT CREAMHYSOACE Ceyoka (Pvt) Ltd CREAMCORTILEB Galentic Pharma PharmAce (Pvt) Ltd CREAMLABOHYDRO Aurochem OINTMENT HYDROOEPT Ceyoka (Pvt) Ltd Leben OINTMENT Softcare HYSOACE CREAMLABOHYDRO CREAM 1%DROCORT PharmAce (Pvt) Ltd Aurochem CREAM Citihealth Imports HEMORCINE HC Glenford HEMORCAINE HC OINTMENT Glenford DROCORT-C CREAM Citihealth Imports HD Sone-C Cream CREAM Lifeline OINTMENT USP 1% USP OINTMENT CREAM BP 1%w/w CREAM BP 1%w/w CREAM BP 1% CREAM USP 1% w/w BP OINTMENT 1% w/w BP OINTMENT CREAM BP 0.5%w/w CREAM BP 1%w/w CREAM BP 1%w/w CREAM BP 5MG+LIDOCAINE 60MG+ALUMINUM 50MG+ZINC OXIDE SUBACETATE 400MG SUPPOSITAORY 0.275% +LIDOCAINE 3.5G 5G+ALUMUNIUM SUBACETATE + ZINC OXIDE 18G OINTMENT +CLOTRIMAZOLE 1% W/W CREAM CREAM BP 0.5% & 3% CREAM BP 3548 ACETATE HYDROCORTISONE 3543 ACETATE HYDROCORTISONE 3544 ACETATE HYDROCORTISONE 3545 ACETATE HYDROCORTISONE 3546 ACETATE HYDROCORTISONE 3547 ACETATE HYDROCORTISONE 3540 ACETATE HYDROCORTISONE 3541 ACETATE HYDROCORTISONE 3542 ACETATE HYDROCORTISONE 3539 ACETATE HYDROCORTISONE 3538 ACETATE HYDROCORTISONE 3537 1% HYDROCORTISONE 3536 & CLIOQUINOL HYDROCORTISONE I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 299 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIA 20-Oct-16 Full INDIAINDIA 25-Sep-17 Years Two 16-Feb-17 Full INDIA 11-Mar-15 Full INDIA 25-Sep-17 Years Two INDIA 20-Oct-16 Full INDIABANGLADESH 25-Sep-17 27-Apr-16 Years Two Full INDIAINDIA 25-Sep-17 Years Two INDIA 20-Oct-16 Full 05-Jun-14 Full MALAYSIA 11-Feb-18 Full Belco Pharma (Pvt) Ltd Ltd Unijules Life Sciences Ltd Vital Healthcare Vital (Pvt) Ltd Unijules Life Sciences Ltd Belco Pharma (Pvt) Ltd Pharmaceuticals Ltd Unijules Life Sciences Ltd (Pvt) Ltd & Co Ltd Unijules Life Sciences Ltd Pharmaceuticals SDN BHD (Contd.) Agency Pvt Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Agency Pvt Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd OINTMENT Lifeline OINTMENT Lifeline SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP CORAL CORTCORAL OINTMENTHYDRONONE Harcourts (Pvt) Ltd OINTMENT Coral Laboratories Leader Pharma UNICORT UNICORT OINTMENT VITACORT-H-OINT OINTMENT International Yaden LYCOR 1%LYCOR ASTROCORT CREAM CREAMASTROCORT Kamazu (Pvt) Ltd CREAM Micro Labs Ltd UNICORT N/AOINTMENT INDIA N/A 30-Jan-14 Astron (Pvt) Ltd SRI LANKA Full Astron (Pvt) Ltd SRI LANKA 24-Jul-17Years Two 24-Jul-17 Full TOPICORT CREAMHYDROSONE CREAM PharmAce (Pvt) Ltd Square Leader Pharma HYDROSONE CREAMN/A CREAMUNICORT Pharmatec (Pvt) Ltd CREAM Belco Pharma CREAM Lifeline Chamee Chemist Gopaldas Visram UNICORT CREAMUNICORT CREAM Lifeline 1% 1% 1% 1% 0.5% W/W 1% W/W 1% W/W W/W W/W W/W W/W W/W W/W 3562 BP OINTMENT HYDROCORTISONE 3563 BP OINTMENT HYDROCORTISONE 3561 BP OINTMENT HYDROCORTISONE 3560 BP OINTMENT HYDROCORTISONE 3557 CREAM USP HYDROCORTISONE 3558 CREAM USP HYDROCORTISONE 3559 BP OINTMENT HYDROCORTISONE 3556 1% CREAM B.P HYDROCORTISONE 3554 1% CREAM B.P HYDROCORTISONE 3555 1% CREAM B.P HYDROCORTISONE 3551 1% CREAM B.P HYDROCORTISONE 3552 1% CREAM B.P HYDROCORTISONE 3553 1% CREAM B.P HYDROCORTISONE 3550 1% CREAM B.P HYDROCORTISONE 3549 CREAM 1% HYDROCORTISONE H-CORT CREAM Indoscan (Pvt) Ltd Hoe 300 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 BANGLADESH 25-Nov-15 Full INDIAINDIA 26-May-14INDIA Full 07-May-14 Full 27-Apr-16 Full INDIAINDIA 09-Oct-16 Full 28-Mar-18 Years Two INDIA 16-Jun-16 Full INDIAINDIA 09-Oct-16 Full 23-Jun-15 Full INDIA 18-Aug-16 Full INDIA 31-Jul-14 Full MALAYSIA 01-Mar-17INDIA Full 08-May-15 Full Globe Pharmaceuticals Ltd Pharmaceuticals Ltd Pharmaceutica (Pvt) Ltd Neon Laboratories Ltd (Pvt) Ltd Macleods Pharmaceuticals Ltd Ambala Sarabhal Enterprises PharmaceuticalS (Pvt) Ltd Macleods Pharmaceuticals Ltd Galpha Laboratories Ltd Vital Healthcare Vital (Pvt) Ltd Pharmaceuticals SDN BHD & Co Ltd (Contd.) Tabrane Healthcare Tabrane (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd Co Ltd (Pvt) Ltd Ltd (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP INJECTION N/ASAMCORT INJECTION INJECTIONGLUCORT Pharmacare Ltd Chamee Chemist Troikaa Samrudh POWDER FOR HYDROCORT INJECTIONCORT-S PharmAce (Pvt) Ltd Belco Pharma INJECTION Ravilux Company PRIMACOR 100 INJECTION Pettah Pharmacy N/AN/A INJECTION Ceyoka (Pvt) Ltd INJECTION Ciron Drugs & Swedish Trading PRIMACOR 100 INJECTION Pettah Pharmacy GALCORT INJECTION Markss HLC (Pvt) H-CORTN/A OINTMENTASTROCORT Indoscan (Pvt) Ltd Hoe OINTMENT 100VITACORT-NS INJECTION OINTMENT N/A International Yaden Chamee Chemist Gopaldas Visram Astron (Pvt) Ltd SRI LANKA 20-May-15 Full SUCCINATE INJECTION 100MG/ML SUCCINATE 100MG INJECTION USP SUCCINATE POWDER INJECTION SUCCINATE 100MG/2ML SUCCINATE INJECTION 100MG SUCCINATE INJECTION 100MG SUCCINATE SUCCINATE INJECTION 100MG SUCCINATE SUCCINATE INJECTION 100MG SUCCINATE INJECTION 100MG SUCCINATE SUCCINATE INJECTION 100MG SUCCINATE SUCCINATE 100MG INJE SUCCINATE INJECTION B.P 100MG INJECTION B.P 1% 1% W/W 1% W/W 3575 SODIUM HYDROCORTISONE 3576 SODIUM HYDROCORTISONE 3577 SODIUM HYDROCORTISONE 3573 SODIUM HYDROCORTISONE 3574 SODIUM HYDROCORTISONE 3572 SODIUM HYDROCORTISONE 3570 SODIUM HYDROCORTISONE 3571 SODIUM HYDROCORTISONE 3569 SODIUM HYDROCORTISONE 3568 SODIUM HYDROCORTISONE 3567 SODIUM FOR HYDROCORTISONE 3564 BP OINTMENT HYDROCORTISONE 3565 USP OINTMENT HYDROCORTISONE 3566 USP OINTMENT HYDROCORTISONE I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 301 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIA 23-Jan-17 Full INDIA 02-Apr-16 Full INDIA 03-Aug-14 Full AUSTRALIA 16-Dec-17 Full INDIA 18-Aug-15 Full INDIA 21-Jul-17 Full INDIA 21-Sep-17 Years Two INDIA 13-Jun-18 Years Two INDIA 18-Oct-18 Full INDIAINDIA 04-Jun-18 Years Two 06-Jun-18 Years Two INDIAINDIA 18-Sep-14 Full 04-Jul-14 Full Centurion Laboratories Pvt Ltd Alice Pharma Private Ltd. SG Pharma (Pvt) Ltd Contract Manufacuring & Packging Services pty Ltd Neon Laboratories Ltd Vital Healthcare Vital (Pvt) Ltd Blossom Pharmaceuticals Indi Pharma (Pvt) Ltd PharmaceuticalS (Pvt) Ltd Ltd Mercury Laboratories Ltd Ltd (Pvt) Ltd (Contd.) (Pvt) Ltd Services Pvt. Ltd Pharmacy (Pvt) Ltd Alaris Lanka (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd Health (Pvt) Ltd Ltd Ceyoka (Pvt) Ltd Ciron Drugs & (Pvt) Ltd TABLETS SOLUTION SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP N/A TABLETS International Yaden HYQUIN TABLETS ABC Pharma N/A CAPSULES The Esses OZICAL CHEWABLE N/A INJECTION Ravilux Company VITA B12VITA INJECTION International Yaden COSMELITE CREAM George Steuart BRITE CREAM CREAM Emar Pharma (Pvt) N/AN/A TABLETS OPHTHALMIC Chamee Chemist Bajaj Healthcare N/AN/AN/A TABLETS TABLETS Chamee Chemist Bajaj Healthcare TABLETS Chamee Chemist Alvita Pharma International Yaden SULPHATE TAB 200MG BP/ TAB SULPHATE hydroxychloroquine SULPHATE TAB 200MG BP/ TAB SULPHATE hydroxychloroquine BP 500MG BP 600MG+VITAMIN D3 50IU TABLETS D3 50IU 600MG+VITAMIN BP 1000MCG in 1ML BP BP 1000MCG in 1ML BP +TRETINOIN USP 0.025% AND 0.025% +TRETINOIN USP 0.1% CREAM USP MOMENTASONE W/W,OXYBENZONE3.0% W/W & W/W,OXYBENZONE3.0% 5%W/W CREAM OCTINOXATE 5MG 0.3%W/V SOLUTION USP 10MG 10MG 5MG 3590 HYDROXYCHLOROQUINE 3589 HYDROXYCHLOROQUINE 3588 HYDROXYCARBAMIDE CAPSULES 3587 MILK CALCIUM HYDROXYAPATITE 3586 HYDROXOCOBALAMIN INJECTION 3585 HYDROXOCOBALAMIN INJECTION 3584 2% HYDROQUINONE USP 3583 HYDROQUINONE % 3581 USP TABLETS HYDROCORTISONE 3582 HYDROMELLOSE OPTHALMIC 3578 USP TABLETS HYDROCORTISONE 3579 USP TABLETS HYDROCORTISONE 3580 USP TABLETS HYDROCORTISONE 302 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 09-Dec-17 Years Two INDIA 26-Dec-15 Full 25-Feb-16 Full INDIAGERMANY 27-Apr-16 Full 28-Oct-14SWITZERLAND Full 05-Sep-14 Full PAKISTAN 05-Jun-17 Years Two INDIA 13-Jul-18 Provisional SG Pharma (Pvt) Ltd Cadila Healthcare Ltd Micro Labs Ltd INDIA LaboratoriesIPCA INDIA LaboratoriesIPCA INDIA 12-May-16 21-Oct-15Aculife Healthcare Full (Pvt) Ltd Full 24-Feb-14Fresenius Kabi Full A.B B Braun Medical Industries GA Bayer Pharma GERMANY 06-Jul-17 GA Bayer Pharma GERMANY Full 06-Jul-17Zafa Pharmaceuticals Laboratories (Pvt) Full Ltd (Pvt) Ltd Pharmaceuticals Ltd (Contd.) Pharmacy (Pvt) Ltd Healthcare lanka Ltd (Pvt) Ltd Ltd Ltd Healthcare lanka Ltd Hemas Pharmaceuticals (Pvt) Ltd Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP SOLUTION INJECTION Hemas INJECTION Hemas N/AZYQ 200 TABLETSWINFLAM TABLETS The Esses HCQS Sunshine TABLETSHCQS 400 Micro Mega Lanka TABLETSNIRHES 130 TABLETS Emar Pharma (Pvt) INJECTION Emar Pharma (Pvt) VOLUVEN Sunshine INFUSION 6%TETRASPAN INFUSION PROLUTON DEPOT B Braun Lanka (Pvt) PROLUTON DEPOT N/ALUTIN DEPOT INJECTION INJECTION International Yaden Pharmatec (Pvt) Ltd Belco Pharma H-KLOR TABLETS Pharma Associates Bafna SULPHATE TABLETS USP 200MG USP TABLETS SULPHATE 200MG USP TABLETS SULPHATE 200MG USP TABLETS SULPHATE 200MG USP TABLETS SULPHATE 400MG USP TABLETS SULPHATE WITH SODIUM 6%W/V ISOTONIC CHLORIDE IV INFUSION WITH SODIUM 6%W/V ISOTONIC CHLORIDE IV INFUSION W/V/ INFUSION INJECTION 250MG/ML CAPROATE (SOLUTION FOR INJECTION) INJECTION 250MG/ML CAPROATE (SOLUTION FOR INJECTION) 250MG/ INJECTION USP CAPROATE ML 250MG/ML INJECTION BP SULPHATE TABLETS USP 200MG USP TABLETS SULPHATE 3592 HYDROXYCHLOROQUINE 3593 HYDROXYCHLOROQUINE 3594 HYDROXYCHLOROQUINE 3595 HYDROXYCHLOROQUINE 3596 HYDROXYCHLOROQUINE 3597 (130/0.4) STARCH HYDROXYETHYL 3598 (130/0.4) STARCH HYDROXYETHYL 3599 IV 6% HYDROXYETHYLSTARCH 3600 HYDROXYPROGESTERONE 3601 HYDROXYPROGESTERONE 3602 HYDROXYPROGESTERONE 3603 HYDROXYPROGESTERONE 3591 HYDROXYCHLOROQUINE I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 303 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 20-Aug-18 Provisional INDIA 08-Apr-15 Full INDIA 08-Apr-15 Full BANGLADESH 08-Apr-15 03-Jun-14 Full INDIA Full BANGLADESH 07-Nov-16 18-Jun-16INDIA Full Full INDIA 01-Jan-15INDIA Full 04-Oct-14INDIA Full 07-Jun-18 Provisional SRI LANKA 04-Sep-18 Years Two 19-Dec-16 Full INDIA 02-Apr-16 Full Co. LLC UCB India (Pvt) Ltd UCB India (Pvt) Ltd UCB India (Pvt) Ltd Opsonin Pharma Ltd Macleods Pharmaceuticals Ltd Company Ltd B D H Industries Ltd Cadila Healthcare Ltd Pharmaceuticals Zim Laboratories Ltd (Ceylon) (Pvt) Ltd Ltd (Contd.) Healthcare lanka Ltd Healthcare lanka Ltd Healthcare lanka Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP GLUREA 500GLUREA CAPSULESATARAX PharmAce (Pvt) Ltd Global Pharma DROPATARAX TABLETS DROPS ORAL Sunshine Sunshine ATARAX INJECTION Sunshine ORASPAS TABLETSN/AHYOSPAM Pettah Pharmacy ZYCOPAN INJECTION INJECTION Ravilux Company INJECTIONHYOCIN 10 Hemas HYOZIM 10 TABLETS TABLETSAssociates Pharma N/A Essential Drugs Laborate Tabrane N/AN/A TABLETS TABLETS N/A TABLETS Kamazu (Pvt) Ltd Micro Labs Ltd Chamee Chemist INDIA M S J Industries Bajaj Healthcare 09-Jan-18 Full 500MG TABLETS BP 10MG BP TABLETS INJECTION BP 20MG/ML INJECTION BP 25MG 6MG/1ML SOLUTION FOR INJECTION 25MG/ ML B.P 20MG/ML INJECTION BP 20MG/ML INJECTION IP 10MG BP TABLETS 10MG BP TABLETS 10MG BP TABLETS 10MG BP TABLETS 3611 HYOSCINE BUTYLBROMIDE 3604 CAPSULES BP HYDROXYUREA 3617 HYOSCINE BUTYLBROMIDE 3605 HYDROXYZINE HYDRCHLORIDE 3606 HYDROXYZINE HYDRCHLORIDE 3607 HYDROXYZINE HYDRCHLORIDE 3608 HYOSCINE BUTYLBROMIDE 10MG HYSOMIDE 10 TABLETS3609 HYOSCINE BUTYLBROMIDE 10MG Biolife 3610 HYOSCINE BUTYLBROMIDE 3612 HYOSCINE BUTYLBROMIDE 3613 HYOSCINE BUTYLBROMIDE 3614 HYOSCINE BUTYLBROMIDE 3615 HYOSCINE BUTYLBROMIDE 3616 HYOSCINE BUTYLBROMIDE 304 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 04-Oct-16INDIA Full 02-Sep-15 Full 06-Aug-15PAKISTAN Full 15-Dec-14 Full BANGLADESH 05-Dec-17 Years Two SWITZERLAND 31-Jan-18 Full BANGLADESH 05-Dec-17 Years Two BANGLADESH 14-Mar-14 Full PAKISTAN 07-Nov-17INDIA Full 26-Feb-14 Full Cadila Healthcare Ltd Laboratories XL (Pvt) Ltd Sun Pharmaceutical industries Ltd Orion pharma Ltd BANGLADESH 02-Nov-17Incepta Years Two Pharmaceuticals Ltd F Hoffman-La Roche Ltd Cipla LtdIncepta Pharmaceuticals INDIALtd Healthcare Pharmaceuticals 13-May-14Orion pharma Ltd BANGLADESH Full 02-Nov-17Years Two Laboratories (Pvt) Ltd Zim Laboratories Ltd Abbott India Ltd INDIA 17-Jul-14 Full (Contd.) Pharmaceuticals (Pvt) Ltd Ltd Hemas Pharmaceuticals (Pvt) Ltd Co Ltd (Pvt) Ltd Ltd (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd Co Ltd Pharmaceuticals (Pvt) Ltd Healthcare lanka Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP SOLUTION ZYCOPAN TABLETSHAYOSPANVISCOMET Hemas TABLETS SMM Halcyon (Pvt) OPHTHALMIC IBANDRO 150 TABLETS CIC Holdings PLC PharmEvo (Pvt) TABLETS BP 10MG BP TABLETS TABLETS BP 10MG BP TABLETS OPTHALMIC SOLUTION 2%(HYDROXYPROPYL USP METHYLCELLULOSE OPTH. SOLUTION 150MG 3618 HYOSCINE BUTYLBROMIDE 3619 HYOSCINE BUTYLBROMIDE 3620 HYPROMELLOSE 3621 TABLETS SODIUM IBANDRONATE 3622 150MGTABLETS ACID IBANDRONIC BONCARE3623 150MGTABLETS ACID IBANDRONIC BONE GUARD TABLETS TABLETS3624 150MGTABLETS ACID IBANDRONIC Darley Butler & BONVIVA Citihealth Imports 3625 150MGTABLETS ACID IBANDRONIC 150 BONDRIA TABLETS3626 150MGTABLETS ACID TABLETS IBANDRONIC BONE GUARD Baur & Co (Pvt) A TABLETS Breathe Free Lanka 3627 150MGTABLETS ACID IBANDRONIC 150 BONDROVA Citihealth Imports TABLETS3628 150MGTABLETS ACID IBANDRONIC BONCARE Citihealth Imports 3629 150MGTABLETS ACID IBANDRONIC FILBONE TABLETS3630 150MG USP TABLETS IBERSARTAN Darley Butler & IRESART TABLETS3631 IP PharmAce (Pvt) LtdTABLETS IBUPROFEN 200MG Wilshire TABLETS BRUFEN 200MG TABLETS Tabrane Sunshine I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 305 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 PAKISTAN 18-Jan-18PAKISTAN Full 18-Jan-18INDIA Full INDIA 26-Dec-16 Full 17-May-18 Years Two INDIAINDIA 08-Feb-14INDIA Full 15-Dec-14 Full 29-Dec-17 Full IRANINDIA 29-Aug-14 Full INDIA 04-Jul-18 Years Two INDIA 04-Jun-18 Years Two 21-Oct-14 Full Abbott Laboratories Laboratories (Pvt) Ltd Unijules Life Sciences Ltd Cipla LtdFourrts (India) Laboratories Ltd INDIAParmax Labo. Ltd 13-Oct-14 Medicare Tirupathi Ltd Full Sanbe FarmaT P INDONESIA 21-Jan-14Zahravi Pharmaceutical Full Company Iran Medico Remedies (Pvt) Ltd Umedica Laboratories (Pvt) Ltd Axon Drugs (Pvt) Ltd Abbott Laboratories (Contd.) Healthcare lanka Ltd Lifeline Pharmaceuticals (Pvt) Ltd Breathe Free Lanka (Pvt) Ltd Sunshine Healthcare lanka Ltd Markss HLC (Pvt) Ltd Sunshine Healthcare lanka Ltd Lifeline Pharmaceuticals (Pvt) Ltd Corporation (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals Pvt Ltd Healthcare lanka Ltd Healthcare lanka Ltd SUSPENSION SUSPENSION SUSPENSION SUSPENSION SUSPENSION SUSPENSION SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP UFENIBUGESIC ORAL IBROFAN ORAL NAXBRU ORAL BRUFEN JUNIOR ORAL ORAL BUFECTADVIFEN ORAL CAPSULES Glenford B.P 100MG/5ml B.P 100MG/5ml B.P 100MG/5ml B.P 100MG/5ml B.P 100MG/5ml B.P 100MG/5ML USP CAPSULES 400MG 3633 IBUPROFEN CREAM 10% W/W BRUFEN3634 10% W/W BP IBUPROFEN GEL RUMAFEN 10% CREAM3635 SUSPENSION IBUPROFEN ORAL GEL Sunshine 3636 SUSPENSION IBUPROFEN ORAL Morison PLC3637 SUSPENSION IBUPROFEN ORAL ATCO 3638 SUSPENSION IBUPROFEN ORAL 3639 SUSPENSION IBUPROFEN ORAL 3640 SUSPENSION IBUPROFEN ORAL 3641 GELATIN IBUPROFEN SOFT 3642 200MG B.P TABLETS IBUPROFEN MEDIFEN 2003643 TABLETS 200MG B.P TABLETS IBUPROFEN 200 UBIMOL Akbar 3644 200MG B.P TABLETS IBUPROFEN TABLETS N/A Gamma TABLETS Sunshine 3632 IBUPROFEN CREAM 10% W/W BRUFEN CREAM Sunshine 306 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 14-Mar-15 Full INDIA 03-Dec-14INDIA Full 04-Aug-16INDIA Full 26-Oct-17 Years Two INDIA 25-Mar-16 Full INDIA 17-Nov-15 Full INDIA 10-Jun-14 Full INDIA 06-Jan-16 Full 07-Nov-15 Full INDIAINDIA 21-Jun-19 Full INDIA 21-Jun-14 Full 01-Apr-14 Full Medicamen Biotech Ltd Ltd Medopharm (PVT Ltd Pharmaceuticals Ltd Laboratories (Pvt) Ltd Healthcare (Pvt) Ltd Umedica Laboratories (Pvt) Ltd Laboratories (Pvt) Ltd Abbott India Ltd INDIAGetwell Pharmaceuticals 17-Jul-14Getwell Pharmaceuticals Full United Biotech (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Contd.) Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals Pvt Ltd Healthcare lanka Ltd Pharmacy (Pvt) Ltd Pharmacy (Pvt) Ltd Health (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP FOSFAFOSFA INJECTION The Esses IFOMID-M INJECTION The Esses INJECTION George Steuart USP 1G WITH MESNA INJECTION 1G WITH MESNA USP 200MG/2ML INJECTION 1G WITH MESNA USP 200MG/2ML INJECTION 1G MESNA 3646 200MG B.P TABLETS IBUPROFEN N/A3647 200MG B.P TABLETS IBUPROFEN N/A3648 200MG B.P TABLETS IBUPROFEN TABLETS PROMED 2003649 200MG TABLETS B.P TABLETS IBUPROFEN Slim TABLETS 200 TAMFEN Akbar 3650 200MG B.P TABLETS IBUPROFEN Kamazu (Pvt) Ltd TABLETS IBUT-200 B D H Industries Associates Pharma 3651 400MG B.P TABLETS IBUPROFEN Bafna ANAFLAM TABLETS3652 400MG B.P TABLETS IBUPROFEN Ceyoka (Pvt) Ltd 400 UBIMOL TABLETS Leben 3653 400MG B.P TABLETS IBUPROFEN TABLETS Ceyoka (Pvt) Ltd 400 IBUT Global Pharma 3654 Gamma 400MG IP TABLETS IBUPROFEN TABLETS BRUFEN 4003655 FOR INJECTION IFOSFAMIDE TABLETS Ceyoka (Pvt) Ltd Leben 3656 FOR INJECTION IFOSFAMIDE Sunshine 3657 WITH INJECTION USP IFOSFAMIDE 3645 200MG B.P TABLETS IBUPROFEN IBUCOL TABLETSAssociates Pharma Osaka I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 307 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIA 21-Dec-18 Years Two INDIAINDIA 21-Dec-15SWITZERLAND 24-Oct-17 Full 27-Aug-17 Years Two INDIA Years Two INDIA 01-Mar-18INDIA Full 06-Mar-14INDIA Full 06-Mar-14INDIA Full 20-Dec-18 Years Two INDIA 20-Dec-18 Years Two 02-Jan-19 Years Two INDIA 11-Oct-17 Years Two Natco Pharma Ltd INDIACipla Ltd 03-Aug-15Medmart Pharma (Pvt) Ltd Full INDIA(Pvt) Ltd Novartis Pharma 31-Jul-14A G Full Laboratories Ltd United Biotech (Pvt) Ltd United Biotech (Pvt) Ltd Jodas Expoim Pvt Ltd Jodas Expoim Pvt Ltd Getwell Pharmaceuticals Natco Pharma Ltd INDIA(Pvt) Ltd 25-Sep-17 Full Medmart Pharma (Pvt) Ltd (Contd.) Healthcare lanka Ltd (Pvt) Ltd Ltd Ltd Health (Pvt) Ltd Health (Pvt) Ltd International (Pvt) Ltd International (Pvt) Ltd Pharmacy (Pvt) Ltd Healthcare lanka Ltd Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP 3659 CAPSULES 100MG IMATINIB 3660 100MG VEENAT CAPSULES 100MG IMATINIB CAPSULES3661 CAPSULES 100MG IMATINIB Sunshine IMITAB3662 CAPSULES 100MG IMATINIB CELONIB 1003663 CAPSULES 100MG IMATINIB CAPSULES CAPSULES GLOMATINIB Breathe Free Lanka 3664 Celon Laboratories 400MG CAPSULES BP IMATINIB TABLETS GLIVEC 400 IMATINATE 3665 100MG CAPSULES IP IMATINIB PharmAce (Pvt) Ltd CAPSULES Globela Pharma 3666 UNITINIB 100 CAPSULES 400MG CAPSULES IP IMATINIB Ceyoka (Pvt) Ltd Baur & Co (Pvt) A Khandelwal CAPSULES3667 UNITINIB 400 100MGTABLETS IMATINIB George Steuart CAPSULES3668 400MGTABLETS IMATINIB JOGLIC 100 George Steuart 3669 TABLETS 400MGTABLETS IMATINIB JOGLIC 4003670 400MG Softcare TABLETS IMATINIB TABLETS 400 MATINIB 3671 400MG Softcare TABLETS IMATINIB 400MG TABLETS VEENAT TABLETS The Esses GLOMATINIB Sunshine TABLETS PharmAce (Pvt) Ltd Globela Pharma 3658 CAPSULES 100MG IMATINIB CELONIB 100 CAPSULES Celon Laboratories 308 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDONESIA 02-Nov-15 Full INDONESIA 25-Nov-17 Full INDIANETHERLANDS 28-Jun-15 13-Jan-15 Full INDIA Full INDIA 19-Jun-17INDIA Years Two 29-May-14INDIA Full 13-Oct-15 Full INDIA 17-Feb-17 Full INDIA 21-Oct-15 Full INDIA 28-Jun-14 Full 22-Feb-15 Full P T Tanabe Tanabe T P Indonesia for Mitsubishi Pharma Tanabe Corporation, Japan Tanabe T P Indonesia for Mitsubishi Pharma Tanabe Corporation, Japan GMH Organics india for Vexxa Life ciences (Pvt) Ltd India Merck Sharp & Dohme Pharma (Pvt) Ltd SG Pharma (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Sun Pharmaceutical industries Nitin Lifesciences Ltd GMH Organics india for Vexxa Life ciences (Pvt) Ltd India Pharmaceutical Pvt Ltd (Contd.) Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Global Impex AV (Pvt) Ltd Ltd Pharmacy (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Global Impex AV (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP INJECTION INJECTION TANATRIL TABLETS Hemas TANATRIL TABLETS Hemas VEXPINEM 250 POWDER TIENAM 500CIMISPECT INJECTION INJECTIONN/AAssociates Pharma Baur & Co (Pvt) A Chandra Bhagat CILIMERIGHT INJECTION INJECTIONCILANEM Chamee Chemist The Esses Zeiss IMEPEN-C 1G INJECTION INJECTION Hemas VEXPINEM 500 Slim POWDER LASTINEM INJECTION Ceyoka (Pvt) Ltd Kavbir TABLETS 10MG TABLETS TABLETS 5MG TABLETS 250MG POWDER FOR INJECTION VIAL 500MG 500MG INJECTION USP 500MG INJECTION USP 500MG INJECTION USP 500MG INJECTION USP 1G/VIAL INJECTION USP SODIUM FOR INJECTION 500MG PER VIAL SODIUM FOR INJECTION USP 500MG 3672 HYDROCHLORIDE IMIDAPRIL 3673 HYDROCHLORIDE IMIDAPRIL 3674 IMIPENAM 250MG+CILASTATIN 3675 IMIPENAM 500MG+CILASTATIN 3676 IMIPENAM 500MG+CILASTATIN 3677 IMIPENAM 500MG+CILASTATIN 3678 IMIPENAM 500MG+CILASTATIN 3679 IMIPENAM 500MG+CILASTATIN 3680 FOR AND CILASTATIN IMIPENAM 3681 IMIPENAM AND CILASTATIN 3682 IMIPENAM AND CILASTATIN I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 309 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIA 19-Aug-15 Full INDIASRI LANKA 29-Apr-16 09-Jan-15INDIA Full Full SWITZERLAND 26-Sep-18 21-Dec-17 Years Two Years Two INDIAFRANCE 08-Feb-14 Full 17-Sep-16 Full INDIA 24-Mar-17FRANCE Full 31-Dec-16 Full Pasteur fi Shamshree Lifesciences Ltd Sanbe FarmaT P INDONESIA 09-May-18Centurion Years Two Laboratories Pvt Ltd (Ceylon) (Pvt) Ltd Glenmark Pharmaceuticals Ltd Novartis Pharma Stein .AG LaboratoriesIPCA INDIA Torrent Pharmaceuticals 03-May-18Ltd Years Two Les Laboratories Servier Laboratories (Pvt) Ltd Celltrion Inc KOREAS A 09-Jan-18Years Two (Contd.) Lanka Ltd Sano fi (Pvt) Ltd Pharmaceuticals (Pvt) Ltd International Yaden (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Baur & Co (Pvt) A Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Health (Pvt) Ltd TABLETS FOR CAPSULES SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP IMICILASH 500 INJECTIONPELASTIN Omacx Healthcare INJECTION Lifeline CORTENOLULTRA DRY POWDER INDITOR-SR TABLETS SRLORVAS Hemas TABLETS SRNATRILIX Hemas TABLETSINDOS 25 Hemas INDOL CAPSULES lifeServ (Pvt) LtdREMSIMA Agog Pharma Ltd CAPSULES INDIAVAXIGRIP Ceyoka (Pvt) Ltd INJECTION Leben George Steuart INJECTION 31-Mar-16 Sano Full SODIUM FOR INJECTION USP SODIUM FOR INJECTION USP 500MG 25MG SODIUM FOR INJECTION USP SODIUM FOR INJECTION USP 500MG BROMIDE GLYCOPYRRONIUM 50MCG CAPSULES 1.5MG TABLETS 1.5MG TABLETS 1.5MG TABLETS 25MG INJECTION 100MG ,INACTIVATED) 3683 IMIPENAM AND CILASTATIN 3693 INDOMETHACIN CAPSULES B.P 3684 IMIPENEM AND CILASTATIN 3685 25MGTABLETS IMIPRAMINE N/A3686 25MG BP TABLETS IMIPRAMINE N/A3687 IMIQUIMOD CREAM 5% W/W FILM COA 3688 IMIQUADAND 110MCG INDACATEROL TABLETS3689 RELEASE SUSTAINED INDAPAMIDE CREAM N/A3690 Hemas RELEASE SUSTAINED INDAPAMIDE 3691 M S J Industries RELEASE SUSTAINED INDAPAMIDE 3692 INDOMETHACIN CAPSULES BP 3694 INFLIXIMAB POWDER FOR 3695 VIVION (SPLIT VACCINE INFLUENZA 310 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 GERMANY 17-May-16GERMANY Full 03-Aug-14GERMANY Full 15-Aug-17 Full Aventis Aventis Aventis Aventis fi fi fi Novo Nordisk DENMARKNovo Nordisk 30-Mar-16 DENMARK Full Novo Nordisk 28-Feb-18 DENMARK Provisional Novo Nordisk 17-Nov-14 DENMARK Full Novo Nordisk 13-Feb-14 DENMARK Full 13-Feb-14Novo Nordisk Full DENMARKNovo Nordisk 13-Feb-14 DENMARK Full Novo Nordisk 09-Dec-18 DENMARK Provisional Novo Nordisk 31-Aug-18 DENMARK Provisional 27-Jul-17 Full Deutschland Gmbh Deutschland Gmbh Deutschland Gmbh (Contd.) Lanka Ltd Sano Lanka Ltd Sano Lanka Ltd Sano fi fi fi Sunshine Healthcare lanka Ltd Sunshine Healthcare lanka Ltd Healthcare lanka Ltd Healthcare lanka Ltd Healthcare lanka Ltd Healthcare lanka Ltd Sunshine Healthcare lanka Ltd Sunshine Healthcare lanka Ltd Healthcare lanka Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP SUSPENSION INJECTION SUSPENSION INJECTION INJECTION Sunshine INJECTION Sunshine INJECTION Sunshine INJECTION Sunshine SOLUTION FOR INJECTION SOLUTION FOR INJECTION INJECTION Sunshine INJECTION Sano NOVOMIX 50 FLEXPEN NOVOMIX 50 PENFILL NOVOMIX 30 FLEXPEN NOVOMIX 30 PENFILL NOVO RAPID PLEXPEN NOVO RAPID INJECTIONNOVO RAPID PENFILL Swiss Biogenics Ltd Novo Nordisk TRESIBA FLEXTOUCH DENMARK100IU/1ML TRESIBA 09-Jun-17FLEXTOUCH Full LEVEMIR FLEX PEN LANTUS SOLOSTAR APIDRA INJECTION Sano INJECTION WITH PROTAMIN 50% INJECTION WITH PROTAMIN 100IU/ML DNA 100IU/ML DNA 100IU/ML INJECTION 100IU/1ML 70% (INS 30% PROTAM 100IU/ML INJECTION 100 IU/ML 100IU/ML DNA FOR INJECTION 100IU/ML FOR INJECTION 200IU/ML 100 IU/ML I.U/ML I.U/ML 3696 BIOPHASIC INSULIN ASPART 3702 RECOMBINANT INSULIN ASPART 3697 BIPHASIC rDNA ASPART INSULIN 3698 BIPHASIC( R-DNA) ASPART INSULIN 3699 INJECTION r-DNA ASPART INSULIN 3700 SOLUTION rDNA ASPART INSULIN 3701 RECOMBINANT INSULIN ASPART 3703 INSULIN DEGLUDEC SOLUTION 3704 INSULIN DEGLUDEC SOLUTION 3705 INJECTION INSULIN DETEMIR rDNA 3706 INSULIN GLARGINE 100IU/ML LANTUS INJECTION Sano 3707 INSULIN GLUSINE INJECTION 100 3708 INSULIN GLUSINE INJECTION 100 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 311 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 03-Jul-18 Provisional 02-Jul-18 Provisional 21-Jun-18 Provisional UNITED ARAB EMIRATES UNITED ARAB EMIRATES FRANCE 07-Aug-18 Years Two FRANCE 07-Aug-18 Full UNITED ARAB EMIRATES Gulf Pharmaceutical Industries (Julphar) Gulf Pharmaceutical Industries (Julphar) LtdWockhardt INDIALilly France S.A.S France Lilly France SAS 16-Apr-17 FRANCEYears Two Lilly France S.A.S 01-Sep-15France Full Lilly France SAS FRANCELilly France SAS 16-May-17 FRANCE Full Gulf 01-Mar-17Pharmaceutical Industries (Julphar) Full Novo Nordisk DENMARKNovo Nordisk 05-May-16 DENMARK Full 05-May-14 Full (Contd.) Access International (Pvt) Ltd Access International (Pvt) Ltd (Ceylon) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Morison PLC Biocon LimitedHealthcare lanka INDIALtd Healthcare lanka Ltd 31-Aug-18 Provisional INJECTION FOR INJECTION INJECTION Hemas FOR INJECTION INJECTION Sunshine SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP JUSLINE 30/70 SUSPENSION JUSLINE N SUSPENSION WOSULIN-RHUMALOG INJECTIONKWIKPEN Emerchemie NB HUMALOG INJECTIONMUMALOG MIX 25 INJECTION Hemas Hemas HUMALOG INJECTIONHUMALOG Hemas INJECTIONJUSLINE R Hemas I VIALINSUGEN R Access International SUSPENSION ACTRAPID PENFILL ACTRAPID INJECTION Sunshine origin) 30% AS SOLUBLE INSULIN origin) 30% AS INSULIN 100IU/1ML AND 70% SUSPENSION FOR INJECTION origin) ISOPHANE SUSPENSION 100IU/1ML INJECTION 100IU in 1ML 100IU/ML (Recombinant DNA Origin) (Recombinant DNA 100IU/ML FOR INJECTION 100IU/ML FOR INJECTION 100IU/ML SUSPENSION LISPRO PROTAMINE 75% INJ. SUSPENSION LISPRO PROTAMINE 75% INJ. SUSPENSION LISPRO PROTAMINE 50% INJ. origin) 100IU/1ML (Recombinant DNA SOLUTION FOR INJECTION INJECTION 100IU in 1ML INJECTION 100IU in 1ML 3711 INSULIN HUMAN INJECTIN USP 3709 INSULIN HUMAN (Recombinant DNA 3710 INSULIN HUMAN (Recombinant DNA 3718 INSULIN SOLUBLE HUMAN (r-DNA) 3712 INSULIN LISPRO (DNA) SOLUTION 3713 INSULIN LISPRO (DNA) SOLUTION 3714 INSULIN LISPRO 25% + 3715 INSULIN LISPRO 25% + 3716 INSULIN LISPRO 50%+INSULIN 3717 INSULIN REGULAR HUMAN 3719 INSULIN SOLUBLE HUMAN (r-DNA) 3720 INSULIN SOLUBLE HUMAN (r-DNA) 312 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 SWITZERLAND 26-Jan-14ITALY Full INDIA 29-Jun-15INDIA Full 20-Oct-17INDIA Full 07-May-15 Full IRELAND 25-Jan-18 Years Two 08-Feb-18IRELAND Full 07-Sep-17IRELAND Years Two 13-Jul-15IRELAND Full 23-Jul-15INDIA Full INDIA 15-Dec-17 Years Two INDIA 18-Feb-17 Full 18-Feb-17 Full F Hoffman-La F Hoffman-La Roche Ltd Merck Serono S P A Reliance Life Sciences (Pvt) Ltd Aculife Healthcare (Pvt) Ltd Aculife Healthcare (Pvt) Ltd G E Health Care Ireland Limited G E Health Care Ireland Limited G E Health Care Ireland Limited G E Health Care Ireland Limited Unijules Life Sciences Ltd Unique Pharmaceutical Labs Unique Pharmaceutical Labs GA Bayer Pharma GERMANY 05-Aug-14 Full (Contd.) Ltd Ltd ABC Pharma Services Pvt. Ltd Sunshine Healthcare lanka Ltd Healthcare lanka Ltd Healthcare lanka Ltd Healthcare lanka Ltd Healthcare lanka Ltd Healthcare lanka Ltd (Pvt) Ltd Health (Pvt) Ltd Health (Pvt) Ltd Pharmaceuticals (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP INJECTION INFUSION ROFERON AROFERON REBIF INJECTION Baur & Co (Pvt) A 30MCGRELIBETA SOLUTION FOR INJECTIONNIRPID 20% Baur & Co (Pvt) A VENOUS INTRA NIRPIDVISIPAQUE INJECTION INJECTION Sunshine VISIPAQUE Sunshine INJECTIONOMNIPAQUE Sunshine INJECTIONOMNIPAOUE Sunshine INJECTIONNIOSCAN Sunshine PAMIDOL INJECTION Novachem Lanka PAMIDOL INJECTION George Steuart ULTRAVIST INJECTION George Steuart INJECTION Hemas O3MIU/0.5ML /0.5ML PRE FILLED SYR /0.5ML 30MCG RECOMBINANT INFUSION INFUSION MEDIUM 270MG IODINE/ML CONTRAST INJECTION X-RAY MEDIUM 320MG 1/ML Contrast Media) MEDIUM CONTRAST "X" RAY 1ML GLASS BOTTLE POLYPROPYLENE BOTTLE TO 350MG ML(EQUIVALONT IODINE) 612.4MG (Equivalent to 300mg Iodine) 755.3MG (Equivalent to 370mg Iodine) 300MG INDINE IN TO (EQUIVALENT IML) (300MG/ML) 3721 -2A INTERFERON ALFA 3722 22MCG INTERFERON BETA-LA 3723 INJECTION INTERFERON BETA-LA 3724 EMULSION 20% FAT INTRAVENOUS 3725 EMULSION 10% FAT INTRVENOUS 3726 CONTRAST X-RAY IODIXANOL 3727 SOLUTION FOR IODIXANOL 3728 (X-Ray 350MG 1/ML IOHEXOL 3729 INJECTION 300MG IN IOHEXOL 3730 755MG/ INJECTION USP IOHEXOL 3731 INJECTION USP IOPAMIDOL 3732 INJECTION USP IOPAMIDOL 3733 IOPROMIDE INJECTION 0.623G/ML I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 313 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 GERMANY 28-Dec-15BANGLADESH Full 11-Oct-17CHINA Full BANGLADESH 17-Jan-14 13-Feb-18 Provisional Full SRI LANKA 24-Oct-16 Full INDIAINDIA 27-Jan-14 Full 12-Sep-17 Years Two PAKISTAN 15-Apr-17 Years Two INDIAINDIA 31-May-18 Years Two 01-Jun-18 Years Two Bayer Schering G Ltd A Pharma Pharmaceuticals Ltd Shandong Jewim Pharmaceutical Co. Ltd Pharmaceuticals Ltd Sciences (Pvt) Ltd Cipla LtdShandong Jewim Pharmaceutical INDIACo. Ltd Concept Pharmaceuticals Ltd 02-Feb-18Cipla Ltd Full Zafa INDIAPharmaceuticals Laboratories (Pvt) Ltd 15-Jun-15(Pvt) Ltd Full (Pvt) Ltd Cipla Ltd INDIA 29-Aug-14 Full (Contd.) Pharmaceuticals (Pvt) Ltd PharmAce (Pvt) Ltd Square (Ceylon) Ltd N/A(Pvt) Ltd Emergen Life (Ceylon) Ltd International (Pvt) Ltd Breathe Free Lanka (Pvt) Ltd (Pvt) Ltd Chamee Chemist Alvita Pharma (Pvt) Ltd NEBULIZING SOLUTION FOR INHALATION SOLUTION SOLUTION SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP ULTRAVIST-370 INJECTION Hemas SULPREX NEBULISER 40IPROMATE CAPSULESSULPREX Emerchemie NB IPRAHALE 40 INHALATION PharmAce (Pvt) Ltd Square POWDER DRY IPRAVENT 20IPROMATE POWDER DRY Breathe Free Lanka CAPSULES DPI 40IPRALET Emerchemie NB CAPSULES Softcare IPRAVENT RESPIRATOR TROPUM SOLUTIONIPRARIGHT International Yaden N/A NEBULIZING 20HFAIPRAVENT INHALER SOLUTION Breathe Free Lanka Chamee Chemist Alvita Pharma INJECTION 370MG 1/1ML SALBUTAMOL SULPHATE SULPHATE SALBUTAMOL NEBULISER SOLUTION DOSES POWDER FOR INHALATON SULPHAATE 20MCG+SALBUTAMOL 10MCG/PUFF BP POWDER FOR INHALATON DRY CAPSULES 40MCG 20MCG FOR INHALATIN CAPSULES BP FOR INHALATIN 40MCG SOLUTION 250MCG/ RESPIRATOR ML 0.025% SOLUTION BP 205MCG/ML SOLUTION BP 250MCG/ML SOLUTION BP 20MCG/DOSE BP INHALATION 3734 IOPROMIDE INTRAVASCULAR 3735 BROMIDE & IPRATROPIUM 3736 BROMIDE 40MCG/ IPRATROPIUM 3737 BROMIDE BP IPRATROPIUM 3738 40MCG BROMIDE BP IPRATROPIUM 3739 BROMIDE DP IPRATROPIUM 3740 BROMIDE POWDER IPRATROPIUM 3741 BROMIDE POWDER IPRATROPIUM 3742 BROMIDE IPRATROPIUM 3743 NEBULISER IPRATROPIUM 3744 NEBULISER IPRATROPIUM 3745 NEBULISER IPRATROPIUM 3746 PRESSURISED IPRATROPIUM 314 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 BANGLADESH 28-May-17 Full INDIAINDIA 31-Oct-16 Full INDIA 31-Oct-16 Full INDIA 16-Mar-15 Full INDIA 21-Aug-14 Full PAKISTAN 23-Sep-17 Years Two 23-Sep-17INDIA Years Two INDIA 16-Mar-15 Full PAKISTAN 31-May-18INDIA 06-Jul-18 Full Years Two INDIA 31-May-18INDIA Full 22-Dec-14 Full 21-Aug-15 Full Pharmaceuticals Ltd Alembic Pharmaceuticals Ltd Alembic Pharmaceuticals Ltd Sun Pharmaceutical industries Coast West Pharmaceurical works Ltd Sun Pharma Laboratories Ltd Nabiqasim Industries (Pvt) Ltd Sun Pharmaceutical industries Cadila Healthcare Ltd Ltd Cadila Healthcare Ltd Ltd Coast West Pharmaceurical works Ltd (Contd.) PharmAce (Pvt) Ltd Square (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd George Steuart Health (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Healthcare lanka Ltd Healthcare lanka Ltd (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP DOSE INHALER FIBRO SACHE IPREX 150IRBATAL-H METERED TABLETS 300IRBATAL-H Citihealth Imports TABLETS Citihealth Imports IROVEL-HCOLOSPAS TABLETS Hemas COLOSPAS INHALATION BP 20MCG/PUFF BP INHALATION HYDROCHLOROTHIAZIDE 150MG/12.5MG USP TABLETS HYDROCHLOROTHIAZIDE 300MG/12.5MG USP TABLETS HYDROCHLOROTHIAZIDE 12.5MG HYDROCHLOROTHIAZIDE 12.5MG 3747 PRESSURISED IPRATROPIUM 3748 & TABLETS IRBESARTAN 3749 & TABLETS IRBESARTAN 3750 150MGTABLETS IRBESARTAN 150 IROVEL 3751 150MGTABLETS IRBESARTAN TABLETS IRBEVEX 1503752 150MG + TABLETS IRBESARTAN Hemas TABLETS3753 150MG + TABLETS IRBESARTAN Global Impex AV 3754 300MGTABLETS IRBESARTAN 300 IROVEL 3755 300MGTABLETS IRBESARTAN TABLETS IRBEZYD 3003756 150MG USP TABLETS IRBESARTAN ARBI 150 Hemas TABLETS3757 150MG USP TABLETS IRBESARTAN IRBEZYD 150 Sunshine TABLETS TABLETS3758 150MG USP TABLETS IRBESARTAN 150 CORAVEL CIC Holdings PLC Sunshine PharmEvo (Pvt) 3759 300MG USP TABLETS TABLETS IRBESARTAN IRBEVEX 300 Harcourts (Pvt) Ltd TABLETS Coral Laboratories Global Impex AV I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 315 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 08-Apr-17INDIA Full 22-Dec-14INDIA Full 06-Jun-18 Years Two INDIA 08-Apr-17INDIA Full 02-Nov-18INDIA Full 21-Jun-18 Years Two 09-Mar-18INDIA Full INDIA 06-Apr-15INDIA Full 27-Sep-14INDIA Full 21-May-18INDIA Years Two 21-Jun-18INDIA Years Two 16-Jul-15ARGENTINA Full 24-Feb-18 22-Oct-14 Years Two Full Ltd Cadila Healthcare Ltd Zim Laboratories Ltd Limited Getwell Pharmaceuticals United Biotech (Pvt) Ltd Cipla LtdUnited Biotech (Pvt) Ltd INDIAFresenius Kabi Oncology Ltd 07-Sep-17Limited Years Two Getwell Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Bioprofarma SA Terrada Zim Laboratories Ltd (Contd.) Healthcare lanka Ltd Pharmaceuticals (Pvt) Ltd Pharmacy (Pvt) Ltd Health (Pvt) Ltd (Pvt) Ltd Health (Pvt) Ltd Ltd Ceyoka (Pvt) Ltd VENUS Remedies Pharmacy (Pvt) Ltd (Ceylon) Ltd Pharmaceuticals (Pvt) Ltd INJECTION The Esses INJECTION INJECTION The Esses SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP IRINOL RINOWEL 100MG/5ML TABLETSRINOTEC 5 Ceyoka (Pvt) Ltd 100INICIP INJECTION VENUS Remedies George Steuart RINOTEC 2 INJECTIONIRINOTEL Breathe Free Lanka INJECTION I.V George Steuart IRINOL INJECTION RINOWEL Markss HLC (Pvt) 40MG/2ML SOLUTION FOR IRINOTIN 40IRINOTIN 100 INJECTION Pharmatec (Pvt) Ltd INJECTIONIRINOGEN Belco Pharma Pharmatec (Pvt) Ltd Belco Pharma INJECTION Emerchemie NB 100MG in 5ML 100MG in 5ML 100MG in 5ML 100MG in 5ML INJECTION INJECTION INJECTION 40MG/2ML INJECTION 40MG/2ML INJ 100MG in 5ML TRIHYDRATE INJ 100MG in 5ML TRIHYDRATE 5ML 3761 300MG USP TABLETS IRBESARTAN 300 CORAVEL 3762 75MG USP TABLETS TABLETS IRBESARTAN IRBEZYD 75 Harcourts (Pvt) Ltd3763 75MG USP TABLETS IRBESARTAN Coral Laboratories TABLETS 75 IRESART Sunshine 3764 IRINOTECAN HYDROCHLORIDE TABLETS3765 IRINOTECAN HYDROCHLORIDE Tabrane 3766 IRINOTECAN HYDROCHLORIDE 3767 IRINOTECAN HYDROCHLORIDE 3768 IRINOTECAN HYDROCHLORIDE 3769 IRINOTECAN HYDROCHLORIDE 3770 IRINOTECAN HYDROCHLORIDE 3771 IRINOTECAN HYDROCHLORIDE 3772 IRINOTECAN HYDROCHLORIDE 3773 IRINOTECAN HYDROCHLORIDE 3774 IRINOTECAN INJECTION 100MG in 3760 300MG USP TABLETS IRBESARTAN 300 IRESART TABLETS Tabrane 316 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 PAKISTAN 19-Aug-18INDIA Full PAKISTAN 20-Jan-15 Full 27-May-17PAKISTAN Years Two 09-Nov-17PAKISTAN Full 30-Mar-16PAKISTAN Full 31-Mar-16PAKISTAN Full 02-Mar-15PAKISTAN Full 16-Feb-16INDIA Full INDIA 10-Mar-15 Full INDIA 01-Sep-17 Full INDIA 29-Aug-17 Full 10-Mar-15 Full Tabros Pharma Tabros (Pvt) Ltd Laboratories (Pvt) Ltd Hilton Pharma (Pvt) Ltd Platinum Pharmaceuticals (Pvt) Ltd & Well Well Pharma (Pvt) Ltd & Well Well Pharma (Pvt) Ltd Fynk Pharmaceuticals Pharmix Laborateries (Pvt) Ltd Laboratories (Pvt) Ltd Galpha Laboratories Ltd Glenmark Pharmaceuticals Ltd Emcure Pharmaceuticals Ltd (Contd.) Laboratories (Pvt) Ltd Healthcare lanka Ltd Health (Pvt) Ltd Laboratories (Pvt) Ltd Laboratories (Pvt) Ltd Ceyline Pharmaceuticals (Pvt) Ltd Lanka (Pvt) Tabrane Ltd Ltd Sunshine Healthcare lanka Ltd (Ceylon) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP TABLETS TABLETS TABLETS FERRY-FCHELFERRON CAPSULES CAPSULES Associated Ceyoka (Pvt) Ltd FAFEROSOFT- Leben TABLETSAPOFER-F Sunshine TABLETSFEROVEL George Steuart FEROVEL CAPSULES Associated MACIFAR-F CAPSULES Associated CHEWABLE POLYROLE CHEWABLE CHELFERRON LIQUID ORAL Ceyoka (Pvt) LtdCHOCOFER Leben LIQUIDMUMFER Markss HLC (Pvt) OROFER CHEWABLE DROPS ORAL Emerchemie NB COMPLEX 235MG+FOLIC ACID COMPLEX 235MG+FOLIC 0.35MG EQUIVALENT TO ELEMENTAL IRON ELEMENTAL TO EQUIVALENT ACID 1.5 MG+VIT.B 100MG+FOLIC COM. + Vit.C FOLIC ACID 0.35MG FOLIC ACID 0.75MG TABLETS ACID 100MG+FOLIC POLYMALTOSE 0.35MG TABLETS CHEWABLE ACID 100MG+FOLIC POLYMALTOSE 0.35MG TABLETS CHEWABLE COMPLEX POLYMALTOSE IRON 100MG+FOLIC EQ.ELEMENT ACID 0.35MG COMPLEX POLYMALTOSE IRON 100MG+FOLIC EQ.ELEMENT ACID 0.35MG COMPLEX & Folic POLYMALTOSE 50MG/5ML ACID SYRUP COMPLEX & Folic POLYMALTOSE 50MG/5ML ACID SYRUP COMPLEX POLYMALTOSE 100MG+FOLIC ACID 500MCG COMPLEX 200MG IN POLYMALTOSE DROPS ORAL 3775 IRON HYDROXIDE POLYMALTOSE 3776 COMPLEX IRON (III) POLYMALTOSE 3777 IRON (III) HYDROXIDE 100MG+ 3778 IRON (III) HYDROXIDE 100MG+ 3779 IRON (III) HYDROXIDE 3780 IRON (III) HYDROXIDE 3781 IRON (III) HYDROXIDE 3782 IRON (III) HYDROXIDE 3783 IRON (III) HYDROXIDE 3784 IRON (III) HYDROXIDE 3785 IRON (III) HYDROXIDE 3786 IRON (III) HYDROXIDE I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 317 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 PAKISTAN 27-Feb-18 Full INDIAINDIA 08-Mar-15 Full INDIA 10-Dec-17INDIA Full 24-Mar-15INDIA Full 24-Mar-17 Full PAKISTAN 06-Jun-17 Full 02-Aug-16PAKISTAN Full 18-Mar-16PAKISTAN Full 13-Sep-17PAKISTAN Years Two 10-Mar-14PAKISTAN Full 08-Aug-14 Full Nabiqasim Industries (Pvt) Ltd Sterling Lab INDIAGlenmark Pharmaceuticals 10-Apr-14Ltd Emcure Full Pharmaceuticals Ltd Apex Laboratories Ltd Apex Laboratories Ltd Glenmark Pharmaceuticals Ltd Platinum Pharmaceuticals (Pvt) Ltd Swiss Pharmaceuticals (Pvt) Ltd Hilton Pharma (Pvt) Ltd Hilton Pharma (Pvt) Ltd Medizan Laboratories (Pvt) Ltd (Contd.) Health (Pvt) Ltd Darley Butler & Co Ltd Healthcare lanka Ltd (Ceylon) Ltd Ltd Ltd Healthcare lanka Ltd Health (Pvt) Ltd Ltd Healthcare lanka Ltd Healthcare lanka Ltd Ceyline Pharmaceuticals (Pvt) Ltd ORAL ORAL SOLUTION SUSPENSION SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP IRPO-FA SYRUPFOLAID PLUS SYRUP George Steuart MUMFER SYRUP SYRUPOROFER Sunshine TRIFER CAPSULES Emerchemie NB TRIFER LIQUID ORAL MUMFER Baur & Co (Pvt) A SYRUP DROPS ORAL APOFER Sunshine Baur & Co (Pvt) A SYRUPFEROSOFT George Steuart TABLETSFEROSOFT Sunshine SYRUPZANTOSE Sunshine ORAL POLYMALTOSE COMPLEX POLYMALTOSE IRON 50MG+FOLIC ELEMENTAL ACID 0.35MG/5ML POLYMALTOSE COMPLEX POLYMALTOSE 50MG ELEMENTAL TO EQUIVALENT BP IRON WITH CYANOCOBALAMIN 5MG/5ML COMPLEX SYRUP POLYMALTOSE 50MG/5ML TABLETS COMPLEX POLYMALTOSE IRON) 100MG (ELEMENTAL DROPS 15ML 150ML SYRUP COMPLEX DROP POLYMALTOSE IRON TOELEMENTAL EUIVALENT 50MG/ML 50mg/5ml SYRUP 100MG 50mg/5ml 100MG OF TO EQUIVALENT Acid IRON +FOLIC ELEMENTAL 0.35mg TABLETS 3787 IRON (III) HYDROXIDE 3788 IRON (III) HYDROXIDE 3789 IRON (III) HYDROXIDE 3790 IRON (III) HYDROXIDE 3791 IRON HYDROXIDE POLYMALTOSE 3792 IRON HYDROXIDE POLYMALTOSE 3793 IRON III HYDROXIDE 3794 COMPLEX IRON III POLYMALTOSE 3795 SYRUP IRON PLUS VITAMINS VITAGLOBIN3796 COMPLEX IRON POLYMALTOSE SYRUP3797 COMPLEX IRON POLYMALTOSE Pharma (Pvt) Talex 3798 COMPLEX IRON POLYMALTOSE 318 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 04-Jan-18 Provisional INDIA 22-Oct-18 Years Two INDIA 12-Jul-18 Full INDIA 03-Jun-15INDIA Full 15-Jun-15PAKISTAN Full 29-Jul-17 Years Two 01-Jan-18PAKISTAN Full PAKISTAN 28-Nov-17 Years Two INDIA 28-Nov-17 Years Two ITALY 24-Feb-16 Full ITALY 06-Sep-15 Full INDIA 06-Sep-17INDIA Full 20-Apr-18 Full 13-Sep-14 Full Emcure Pharmaceuticals Ltd (Pvt) Ltd Cadila pharmaceuticals Ltd Claris Injectables Ltd Gland Pharma (Pvt) Ltd Pharmaceuticals Ltd Abbott Laboratories Merck Marker (Pvt). Ltd Martin Daw Marker Ltd Company Ltd Bayer Healthcare Manufacturing SRL Bayer Healthcare Manufacturing SRL Piramal Enterprises Ltd Parenteral Drugs Ltd INDIA (Contd.) (Ceylon) Ltd Healthcare lanka Ltd Pharmaceuticals (Pvt) Ltd Ltd Healthcare lanka Ltd (Ceylon) Ltd (Ceylon) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP TABLETS Sunshine ENCIFER 100MGUNIRAUT INJECTION INJECTION Emerchemie NB HAEM UP Klintas (Pvt) Ltd United Biotech N/A INJECTION Sunshine INCROS INJECTIONR.B.TONE INJECTION Akbar FOLIC IBERET CAPSULES Baur & Co (Pvt) A -500 GRADUMET PharmAce (Pvt) Ltd Medley FMSIDERFOL CAPSULESTRAVOCORTAssociates Pharma Raptakos Brett & CREAMTRAVOGEN Hemas CREAMISOPLAN Hemas LIQUID Omacx Healthcare 100MG 100MG 20G/ML 20G/ML 20G/ML CAPSULES B COMPLEX C & VITAMIN TABLETS CONTROLLED RELEASE 500 B6 & COPPER C+VITAMIN +VITAMIN CAPSULES VALERATE DIFLUCORTOLONE 1MG/1G CREAM 100ML INHALATION 3811 & 250ML ISOFLURANE 100ML N/A LIQUIDAsian Pharma Euro 3799 IRON SUCROSE INJECTION USP 3800 IRON SUCROSE INJECTION USP 3801 IRON SUCROSE INJECTION USP 3802 IRON SUCROSE INJECTION USP 3803 IRON SUCROSE INJECTION USP 3804 & MINERALS IRON, MULTIVITAMIN 3805 IRON,FOLIC ACID,VITAMIN 3806 IRON+ B COMPLEX3807 B COMPLEX SYRUP IRON+ VITAMIN SANGOBION3808ACID B12+FOLIC IRON+VITAMIN SYRUP SANGOBION3809 10MG+ ISOCONAZOLE NITRATE Emerchemie NB SYRUP3810 10MG/1G ISOCONAZOLE NITRATE Emerchemie NB 3812 ISOFLURANE ANESTHETIC I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 319 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 02-Jan-14 Full INDIAINDIA 01-Apr-16 Full 01-Oct-18 Years Two INDIASRI LANKA 28-Mar-18 17-Jun-18 Years Two Provisional MALAYSIA 15-Sep-15 Full CHINA 24-Oct-15 Full UNITED KINGDOM Mercury Laboratories Ltd Novo Nordisk DENMARKLilly France SAS FRANCE 05-May-14 Full LtdWockhardt 19-Jul-14 INDIANovo Nordisk Full DENMARK Healthcare Vital 16-Aug-17(Pvt) Ltd Years Two 05-May-15 Full Ltd Upha Pharmaceuticals (M) SDN for CCM Pharmaceuticals SDN BHD Astra Zeneca Pharmaceuticals Co Ltd Macleods Pharmaceuticals Ltd Aesica Queenborough Abbott Ltd UK for Laboratories UK (Contd.) (Pvt) Ltd Morison PLC Biocon LimitedHealthcare lanka INDIALtd Pharmaceuticals (Pvt) Ltd 31-Aug-18 Provisional (Ceylon) Ltd Healthcare lanka Ltd (Pvt) Ltd N/ALifeline Pharmaceuticals Rovik Lanka (Pvt) (Pvt) Ltd Hemas Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Healthcare lanka Ltd FOR INJECTION INJECTION Sunshine SOLUTION RELEASE TABLETS TABLETS SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP INSUGEN-N SUSPENSION INSULATARD PENFILL HUMULIN-N INJECTIONWOSULIN-N Hemas INSULATARD INJECTION Emerchemie NB INJECTIONISOVITA Sunshine ALCORUB INJECTION DISINFECTANT International Yaden IMDEX 60MG CR CONTROLLED IMDUR PROLONED RE FORANE INHALATION Sunshine (rDNA)) INJECTION 100IU/1ML (rDNA)) INJECTION 100IU/1ML (rDNA)) INJECTION 100IU/1ML (rDNA)) INJECTION 100IU/1ML BIOSYNTHETIC HUMAN INSULIN 100IU/ML 2MG/2ML 19.75 +GLYCERINE WATER +DISTIL ALCOHOLIC E 0.48, 3.5+ VITAMINE HAND RUB TA RELEASE 60MG CONTROL TABLETS PROLONGED RELEASE 60MG INHALATION 100ML INHALATION 3815 100MG BP TABLETS ISONIAZID N/A3816 ISOPHANE INSULIN , HUMAN 3817 ISOPHANE INSULIN , HUMAN TABLETS3818 ISOPHANE INSULIN , HUMAN International Yaden 3819 ISOPHANE INSULIN , HUMAN 3820 ISOPHANE INSULIN INJ. 3821 ISOPRENALINE INJECTION BP 3822 ALCOHOL 76.25% ISOPROPYL 3823 ISOSORBIDE 5-MONONITRATE 3824 ISOSORBIDE 5-MONONITRATE 3813 ISOFLURANE ANESTHETIC 3814 100MG BPTABLETS ISONIAZID SOLONEX 100 TABLETS Pettah Pharmacy 320 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 31-Aug-16INDIA Full 11-Jun-18 Provisional INDIA 30-Aug-18 Provisional INDIA 28-Feb-18 Years Two INDIA 31-Aug-15 Full INDIA 10-May-15 Full INDIA 19-Aug-17 Full INDIA 13-Aug-15 Full INDIA 05-Jul-14 Full SWITZERLAND 05-Dec-17 06-Jul-17 Years Two Full GERMANY 05-Dec-17 Full Cadila Healthcare Ltd Pharmaceuticals Wallace Pharmaceuticals Ltd Zim Laboratories Ltd Cadila Healthcare Ltd Sun Pharmaceutical industries Zim Laboratories Ltd Pharmaceuticals Ltd Sun Pharmaceutical industries Torrent Pharmaceuticals Ltd Catalent Germany Eberbach Gmbh,Germany for Cheplapharm Arineimittel Gmbh Germany Catalent German Eberbach Gmbh (Contd.) Sunshine Healthcare lanka Ltd Ltd Pharmaceuticals (Pvt) Ltd Healthcare lanka Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Ltd Ltd Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP EXT.REL. TABLETS TABLETS Sunshine TABLETSS.R Edna Medicals (Pvt) SOLOTRATE SR SOLOTRATE 60 20ISONIT MONICOR TABLETS TABLETSSORBIZIM 20Associates Pharma The Madras TABLETS Emar Pharma (Pvt) SR SOLOTRATE 30 Tabrane ODMONOTRATE TABLETSN/A Hemas N/A TABLETSMONOTRATE-20 TABLETS Tabrane TABLETS 60 VASOTRATE Hemas OD Pharma Associates Bafna TABLETS 60MG TABLETS TABLETS 20MG TABLETS 20MG BP TABLETS 20MG BP TABLETS 30MG TABLETS 50MG TABLETS 10MG B.P 5MG USP 20MG BP TABLETS TABLETS RELEASE SUSTAINED 60MG 3825 SR ISOSORBIDE MONONITRATE 3826 ISOSORBIDE MONONITRATE 3827 ISOSORBIDE MONONITRATE 3828 ISOSORBIDE MONONITRATE 3829 SR ISOSORBIDE 5 MONONITRATE 3830 SR ISOSORBIDE 5 MONONITRATE 3831 TABLET ISOSORBIDE DINITRATE 3832 TABLETS ISOSORBIDE DINITRATE 3833 ISOSORBIDE MONOHNITRATE 3834 ISOSORBIDE MONONITRATE 3835 ISOTRETINOIN CAPSULES 10MG ROACCUTANE CAPSULES Baur & Co (Pvt) A 3836 ISOTRETINOIN CAPSULES 20MG ROACCUTANE CAPSULES Baur & Co (Pvt) A I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 321 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 THAILANDTHAILAND 24-Aug-17 Years Two INDIA 05-Nov-14 Full PAKISTAN 17-Jul-18 Provisional INDIA 24-Apr-14 Full INDIA 03-Oct-16 Full 15-Aug-16INDIA Full INDIA 23-Apr-16 Full INDONESIA 18-Dec-16 18-May-15 Full ITALY Full 31-May-16 Full INDIA 14-Oct-15 Full Mega Lifesciences (Pvt) Ltd Mega Lifesciences (Pvt) Ltd Agio Pharmaceuticals Ltd Ferozsons Laboratories Ltd J Duncan Healthcare (Pvt) Ltd Cian Healthcare (Pvt) Ltd Hovid Berhard MALAYSIA Health Pell Tech Care (Pvt) Ltd 06-Apr-15Glenmark Full Pharmaceuticals Ltd T Dankos P Farma Janssen Cilag Spa ,Italy for Janssen Pharmaceutica Lda NV Belgium Micro Labs Ltd INDIAPharmaceuticals Ltd 31-May-14 Full (Contd.) Ltd Baur & Co (Pvt) A Ltd (Pvt) Ltd (Ceylon) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Lanka (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Healthcare lanka Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Ltd CAPSULES SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP ACNETREX 10 CAPSULESACNETREX 20 Baur & Co (Pvt) A GELETIN SOFT 5IVAB TABLETSAssociates Pharma Bafna CAPSULES USP 10MG CAPSULES USP CAPSULES USP 20MG CAPSULES USP 5MG TABLETS 3837 GELATINE ISOTRETINOIN SOFT 3838 GELATINE ISOTRETINOIN SOFT 3839 ITRACONAZOLE CAPSULES 100MG ITRASON 100 CAPSULES3840 ITRACONAZOLE CAPSULES 100MG ICON Citihealth Imports 3841 ITRACONAZOLE CAPSULES 100MG NETOJIT3842 CAPSULES ITRACONAZOLE CAPSULES 100MG CITROZ TABLETS Emerchemie NB 3843 ITRACONAZOLE CAPSULES 100MG Slim INOX 100MG CAPSULES3844 ITRACONAZOLE CAPSULES 100MG CAPSULES ITRAPELL Slim Hadley Bevan 3845 ITRACONAZOLE CAPSULES 100MG CANDITRAL CAPSULES Slim 3846 CAPSULES ITRACONAZOLE CAPSULES 100MG UNITRAC Sunshine 3847 ITRACONAZOLE CAPSULES 100MG SPORANOX CAPSULES Hemas CAPSULES3848 ITRACONAZOLE CAPSULES 100MG ITRACON 100 Pettah Pharmacy 3849 HYDROCHLORIDE IVABRADINE CAPSULES SMM Halcyon (Pvt) 322 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 BANGLADESH 13-Feb-16 Full FRANCE 05-Apr-17INDIA Full PAKISTAN 14-Oct-15INDIA 12-Jul-18 Full INDIA Full 25-Nov-14BANGLADESH Full 30-Dec-17 24-Dec-16 Full Full INDIAPAKISTAN 25-Nov-14INDIA 10-Jul-18 Full Full 30-Dec-17 Full KOREA 30-Jul-14 Full Pharmaceuticals Ltd Les Laboratories Servier Pharmaceuticals Ltd (Pvt ) Ltd Ltd Atoz Pharmaceuticals (Pvt) Ltd Pharmaceuticals Ltd Cadila Healthcare Ltd (Pvt ) Ltd Atoz Pharmaceuticals (Pvt) Ltd Biological E Ltd INDIABiological E Ltd 27-Feb-18 INDIAYears Two Guangzhon 27-Feb-18Years Two (Contd.) Pharmaceuticals (Pvt) Ltd Swiss Biogenics Ltd Cadila Healthcare (Pvt) Ltd Sunshine Healthcare lanka Ltd (Pvt) Ltd Healthcare lanka Ltd Healthcare lanka Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP TABLETS TABLETS INJECTION Ceyoka (Pvt) Ltd Green Cros IVANOR 5IVANOR CORALAN TABLETS PharmAce (Pvt) Ltd Square TABLETS 5IVAB Hemas TABLETSAssociates Pharma Bafna JEEVJEEV SUSPENSION Sunshine SUSPENSIONSTRAIN Sunshine 5MG TABLETS 5MG TABLETS 5MG TABLETS HUMAN VACCINE INACTIVATED ADSORBED 6MCG WHOLE CELL 0.5ML HUMAN VACCINE INACTIVATED ADSORBED 6MCG WHOLE CELL 0.5ML 3850 HYDROCHLORIDE IVABRADINE 3851 HYDROCHLORIDE IVABRADINE 3852 HYDROCHLORIDE IVABRADINE 3853 5MGTABLETS IVABRADINE 3854 5MGTABLETS IVABRADINE 5 IVAGEN 3855 5MGTABLETS IVABRADINE SIFTUS 5 TABLETS3856 7.5MG 5TABLETS IVADINE IVABRADINE Ceyoka (Pvt) Ltd FILM COA Genix Pharma 7.5 IVANOR 3857 TABLETS 7.5MGTABLETS IVABRADINE TABLETSAsian Pharma Euro SIFTUS 7.53858 7.5MGTABLETS IVABRADINE PharmAce (Pvt) Ltd Square 3859 FILM COA 7.5MGTABLETS IVABRADINE 7.5 IVAGEN 7.5 IVADINE 3860 TABLETS ENCEPHALITIS JAPANESE TABLETS Ceyoka (Pvt) Ltd3861 Genix Pharma ENCEPHALITIS JAPANESE Asian Pharma Euro 3862 ENCEPHALITIS VACCINE JAPANESE NAKAYAMA I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 323 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 THAILAND 02-May-18CHINA Provisional INDIA 04-May-15INDIA Full 01-Sep-16INDIA Full 08-Jun-16INDIA Full 18-Oct-18INDIA Full 06-Jul-18 Years Two INDIA 01-Mar-14 Full BANGLADESH 23-May-14 02-Apr-14 Full NEW ZEALAND Full 31-Oct-17Years Two INDIAINDIA 12-Mar-16INDIA Full 10-Apr-18 Years Two 26-Nov-17 Full Pharmaceutical Organ of Biological Products Healthcare Vital (Pvt) Ltd Neon Laboratories Ltd PharmaceuticalS (Pvt) Ltd Healthcare Vital (Pvt) Ltd Aculife Healthcare (Pvt) Ltd Glenmark Pharmaceuticals Ltd Incepta Pharmaceuticals Ltd Douglas Manufacturing Ltd Auckland New Zealand for Douglas Pharmaceuticals Ltd. & Co Ltd (india) (Pvt) Ltd Sava Healtheare Ltd (Contd.) Lanka Ltd Government fi Sano (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd Healthcare lanka Ltd Healthcare lanka Ltd (Pvt) Ltd Ltd (Pvt) Ltd POW INJECTION SHAMPOO Sunshine CREAM Ceyoka (Pvt) Ltd Galentic Pharma SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP IMOJEV LYOPHILIZED RS JEV 50KETAVIT INJECTIONANEKET INJECTION Ceyoka (Pvt) Ltd Chengdu Institute International Yaden INJECTIONKET INJECTION INJECTION Ceyoka (Pvt) Ltd Ravilux Company Ciron Drugs & PLUS KETO SHAMPOO CREAMGV KETO CREAMCREAM Chamee Chemist Gopaldas Visram LIVE ATTENUATED VACCINE, LIVE ATTENUATED ATTENUATED LIVE VACCINE, INJECTION 50MG/ML 500MG/10ML INJECTION USP 50MG/ML INJECTION USP PYRITHIONE 1% SHAMPOO CREAM 3863 ENCEPHALITIS VACCINE JAPANESE 3864 ENCEPHALITIS JAPANESE 3865 HYDROCHLORIDE BP KETAMINE 3866 HYDROCHLORIDE KETAMINE 3867 HYDROCHLORIDE KETAMINE 3868 10ML INJECTION BP KETAMINE 10 KETAVIT 3869 50MG/ML INJECTION BP KETAMINE KETANIR INJECTION3870 2% + ZINC KETOCONAZOLE International Yaden INJECTION Sunshine 3871 SHAMPOO 2% BP KETOCONAZOLE DANGEL3872 2% SHAMPOO KETOCONAZOLE SHAMPOO SEBIZOLE Citihealth Imports SHAMPOO3873 2% W/W USP KETOCONAZOLE Farnell Ceylon (Pvt) 3874 CREAM 2% W/W KETOCONAZOLE DERM KETA 3875 CREAM 2% W/W KETOCONAZOLE CON KETO CREAM Radiant Health Care 324 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIA 05-Nov-14INDONESIA Full 14-Sep-17 Years Two INDIAMALAYSIA 26-Nov-17 19-Sep-17INDIA Full Full THAILAND 21-Sep-17 Years Two 28-Nov-17MALAYSIA Full 18-Nov-16 Full BELGIUM 15-Nov-14INDIA Full INDIA 20-Mar-14 Full 20-Mar-14 Full P T Sanbe FarmaT P INDONESIA 14-Sep-17Years Two PharmaceuticalS (Pvt) Ltd Cipla Ltd Caprifamindo PT Laboratories for INDIA sanbe farma PT Sava Healtheare Ltd 24-Jun-18Pharmaniaga Years Two Manufacturing berhand Brassica Pharma Pvt Ltd Unison Laboratories Co Ltd Pharmaceuticals SDN BHD Kalbe FarmaT P INDONESIA 02-Sep-17Janssen Pharmaceuticals NV Full Pharm Products (Pvt) Ltd (Pvt) Ltd (Contd.) Pharmaceuticals (Pvt) Ltd Ceyoka (Pvt) Ltd Ciron Drugs & (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd (Ceylon) Ltd International (Pvt) Ltd Healthcare lanka Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Healthcare lanka Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP CREAM 3876 CREAM 2% W/W KETOCONAZOLE FORMYCO CREAM Lifeline 3877 CREAM 2% W/W KETOCONAZOLE N/A TOPICAL 3878 CREAM 2% W/W KETOCONAZOLE 200 KETO 3879 CREAM 2% W/W KETOCONAZOLE FORMYCO CREAM3880 CREAM 2% W/W KETOCONAZOLE CREAM CON KETO Breathe Free Lanka 3881 CREAM 2% W/W KETOCONAZOLE 2% ZICONAL Lifeline CREAM3882 CREAM 2% W/W KETOCONAZOLE CREAM SICAZOLE Radiant Health Care 3883 Emerchemie NB CREAM 2% W/W KETOCONAZOLE CREAM DIAZON3884 CREAM 2% W/W KETOCONAZOLE Softcare DEZOR CREAM3885 CREAM 2% W/W KETOCONAZOLE MYCORAL Sunshine CREAM3886 CREAM 20MG/G KETOCONAZOLE CREAM NIZORAL Indoscan (Pvt) Ltd Hoe 3887 LOTION 2% KETOCONAZOLE Hemas CREAM DANSEL-K3888 LOTION 2% KETOCONAZOLE Pettah Pharmacy LOTION DANSEL-K Sunshine LOTION Harcourts (Pvt) Ltd Pharm Products I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 325 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 PAKISTAN 23-Jan-18 Provisional INDIA 09-Nov-16 Full INDIAMALAYSIA 25-Mar-16 18-Nov-14 Full BELGIUM Full 01-Jan-17INDIA Full 06-Jan-14 Full THAILAND 23-Sep-18INDIA Full 17-May-18 Years Two Micro Labs Ltd INDIAEncube Ethicals (Pvt) Ltd 06-Feb-15Hovid SDN Bhd MALAYSIA Full 21-Oct-15Pharmaceuticals (India) Ltd Full Pharmaceuticals SDN BHD Janasen Pharmaceuticals N V Laboratories XL (Pvt) Ltd Kalbe FarmaT P INDONESIA 01-Jan-14Biolab Co Ltd THAILAND Full Unison Laboratories Co Ltd 18-Feb-14Unijules Life Full Sciences Ltd Sanbe FarmaT P INDONESIA 04-Apr-18 Full Laboratories (Pvt) Ltd (Contd.) Ltd Sunshine Healthcare lanka Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Ltd Pharmaceuticals (Pvt) Ltd Health (Pvt) Ltd Healthcare lanka Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd SOLUTION SHAMPOO Thorn SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP PHYTORALARCOLANE OINTMENT SMM Halcyon (Pvt) SCALP KETOVIT SHAMPOO 2% SEBIGONE SHAMPOODEZOR PharmAce (Pvt) Ltd Aurochem NIZORAL SHAMPOO Indoscan (Pvt) Ltd 200FUNGOTAB SHAMPOO Hoe TABLETS Pettah Pharmacy MYCORAL SMM Halcyon (Pvt) TABLETS Hemas W/W SOLUTION 2% W/V W/V 2% W/V USP W/V CONTAINS IN 1G 200MG 200MG 3890 2% OINTMENT KETOCONAZOLE 3891 SCALAP KETOCONAZOLE 3892 SHAMPOO 2% KETOCONAZOLE 3893 SHAMPOO 2% KETOCONAZOLE 3894 SHAMPOO 2% KETOCONAZOLE 3895 SHAMPOO 20MG KETOCONAZOLE 3896 USP TABLETS KETOCONAZOLE 3897 USP TABLETS KETOCONAZOLE 3898 2.5% GEL KETOPROFEN 3899 2.5G w/w BP GEL KETOPROFEN 2.5% LOLITA FASTUM3900 2.5G w/w BP GEL KETOPROFEN GEL KETOFAST GEL3901 2.5G w/w BP GEL KETOPROFEN GEL SANBEFLAM 2.5% Sunshine GEL George Steuart Lifeline Lifeline 3889 LOTION 2% KETOCONAZOLE CONAZ LOTION Morison PLC ATCO 326 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 04-Oct-16 Full INDIA 26-Apr-18 Years Two TURKEY 21-Mar-18 Years Two INDONESIA 13-Aug-15BANGLADESH Full 06-Oct-14BANGLADESH Full 12-Sep-14INDIA Full UNITED 21-Dec-14STATES Full IRELAND 29-Jun-17BANGLADESH 28-Jul-15 Full Full Renata Limited BANGLADESH Medicine World 12-Jan-15Ilac san ve Full Aristopharma Ltd BANGLADESH 02-May-14Renata Limited Full BANGLADESH T Ferron P 20-Aug-14Pharmaceutical, Indunesia /Dexa Full Medica Indonesia Healthcare Pharmaceuticals Healthcare Pharmaceuticals Allergan Sales LLC Allergan Sales LLC Cipla Ltd INDIASimpex Pharma (Pvt) Ltd 16-Feb-17 Full P T Kalbe FarmaT P INDONESIA 06-Oct-16 Full Allergan Pharmaceuticals Healthcare Pharmaceuticals (Contd.) eld fi (Ceylon) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Ceylon) Ltd Ltd (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Hemas Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP SOLUTION MEDROLGIN EYE DROPSORADOL Slim ROLAC 30 EYE DROPS Hemas REMOPAIN INJECTION Emerchemie NB INJECTIONKETORIX Baur & Co (Pvt) A KETORIX INJECTIONACULAR LS Citihealth Imports INJECTION EYE DROPS Citihealth Imports ACUVAIL Hemas OPHTHALMIC KALTROFEN INJECTIONKETOCAM-DT Hemas TABLETS Somer ACULARKETORIX EYE DROPS Hemas TABLETS Citihealth Imports INJECTION USP 60MG/ 2ML INJECTION USP DROPS 0.5% DROPS 0.5 % STERILE INJECTION 30MG IN 1ML (3%) 30MG IN 1ML INJECTION USP (3%) 30MG IN 1ML INJECTION USP OPTHALMIC SOLUTION 0.4% sterile OPTHALMIC SOLUTION 0.45% sterile 50MG/1ML OPTHALMIC SOLUTION 0.5% le TABLETS 10MG TABLETS 10MG TABLETS 3911 TROMETHAMINE KETOROLAC 3905 10MGTABLETS KETOROLAC 3906 EYE TROMETAMOL KETOROLAC ROLAC3907 TROMETHAMINE KETOROLAC EYE TABLETS3908 TROMETHAMINE KETOROLAC Emerchemie NB 3909 TROMETHAMINE KETOROLAC 3910 TROMETHAMINE KETOROLAC 3912 TROMETHAMINE KETOROLAC 3913 TROMETHAMINE KETOROLAC 3902 2.5G w/w BP GEL KETOPROFEN gel KETOGESIC GEL Breathe Free Lanka 3903 INJECTION KETOPROFEN 3914 TROMETHAMINE KETOROLAC 3904 DISPERSIBLE KETOROLAC 3915 TROMETHAMINE KETOROLAC I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 327 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 BANGLADESH 11-Oct-17 Years Two INDIABANGLADESH 27-Jul-18 31-Mar-17 Full Full BANGLADESH 14-Mar-15 Full BANGLADESH 11-Dec-15 Full INDIAPAKISTAN 25-May-18 18-Jun-16 Full Full BANGLADESH 20-Apr-14THAILAND Full 16-Oct-15BANGLADESH 25-Oct-17 Full INDONESIA Full 21-Jul-14 Full Formulation Ltd Zim Laboratories Ltd Globe Pharmaceuticals Ltd Popular Pharmaceuticals Ltd Pharmaceuticals Ltd Kopran Ltd Torrent INDIAPharmaceuticals Ltd Schazoo Pharmaceutical 06-Jul-17Laboratories (Pvt) Ltd Full Kalbe FarmaT P INDONESIA 21-Apr-18The ACME Laboratories Ltd Full Unison Laboratories Co Ltd The ACME Laboratories Ltd T Hexpharma P Jaya (Contd.) Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Services Pvt. Ltd Ltd Ltd Edna Medicals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Ltd Healthcare lanka Ltd Ltd Pharmaceuticals (Pvt) Ltd SOLUTION SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP TORAX 10TORAX KETROBID 10 SUSPENSION PharmAce (Pvt) Ltd TABLETS Square 10ROKET Tabrane TABLETS Healthcare Tabrane FRENASMA EYE DROPS 1MGKETOTIE PharmAce (Pvt) Ltd Square TABLETSASTHAFEN Alaris Lanka (Pvt) TABLETSKETOT Edna Medicals (Pvt) OPHTHALMIC TABLETS USP 10MG USP TABLETS TABLETS USP 10MG USP TABLETS 10MG USP TABLETS DROPS 0.025% 1MG 1MG 0.025% 3916 TROMETHAMINE KETOROLAC 3917 TROMETHAMINE KETOROLAC 3918 TROMETHAMINE KETOROLAC 3919 EYE DROPS 0.25MG/ML KETOTIFEN ZADIT3920 EYE FUMARATE KETOTIFEN EYE DROPS3921 TABLETS ABC Pharma FUMARATE KETOTIFEN 3922 TABLETS FUMARATE KETOTIFEN 3923 OPTHALMIC SOLUTION KETOTIFEN 3924 1MG/5ml SYRUP KETOTIFEN ASTIFEN3925 1MG/5ml SYRUP KETOTIFEN 3926 1MG/5ml SYRUP KETOTIFEN KEFEN SYRUP AMITOINE3927 1MGTABLETS KETOTIFEN Hemas SYRUP3928 1MG TABLETS KETOTIFEN SYRUP KEFEN Mega Pharma (Pvt) ASTIFEN Sunshine TABLETS TABLETS Mega Pharma (Pvt) Hemas 328 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 BANGLADESH 25-Oct-17THAILAND Full 24-Aug-15INDIA Full INDIA 17-May-18 Years Two INDIA 11-Oct-18INDIA Full 14-May-18 Years Two INDIA 26-Oct-18 Years Two INDIA 30-Apr-14INDIA Full 14-May-18INDIA Years Two 17-May-18 Years Two INDIA 25-Jun-18 Years Two INDIA 17-Mar-18 Years Two INDIA 11-Jun-18 Years Two INDIA 11-Jun-18 Years Two 11-Jun-18 Years Two Unison Laboratories Co Ltd (Pvt) Ltd PharmaceuticalS (Pvt) Ltd Human Verve Care Laboratories Pharmaceuticals Ltd SG Pharma (Pvt) Ltd Human Verve Care Laboratories (Pvt) Ltd Cadila Healthcare Ltd Ltd Cadila Healthcare Ltd Cadila Healthcare Ltd Cadila Healthcare Ltd The ACME Laboratories Ltd (Contd.) Healthcare lanka Ltd Agency Pvt Ltd Pharmacy (Pvt) Ltd Agency Pvt Ltd Healthcare lanka Ltd Healthcare lanka Ltd Healthcare lanka Ltd Healthcare lanka Ltd Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP TIPLAB 100N/A POWDER Klintas (Pvt) LtdLABEVER United Biotech INJECTIONN/A INJECTION Ceyoka (Pvt) Ltd Leader Pharma Ciron Drugs & LABESOL TABLETS TABLETS Pharma Associates Bafna The Esses INJECTION IP 100MG/20ML INJECTION IP 5MG/ML INJECTION USP 5MG/ML INJECTION USP 100MG USP TABLETS 100MG USP TABLETS 3930 1MG TABLETS KETOTIFEN 3931 HYDROCHLORIDE LABETALOL AMITOINE3932 HYDROCHLORIDE LABETALOL TABLETS3933 HYDROCHLORIDE LABETALOL Sunshine 3934 HYDROCHLORIDE LABETALOL 3935 HYDROCHLORIDE LABETALOL 3936 100MG BP TABLETS LABETALOL LABEVER3937 100MG IP TABLETS LABETALOL TIPLAB 1003938 100MGTABLETS LACOSAMIDE TABLETS 100 LACASA TABLETS Leader Pharma 3939 100MGTABLETS LACOSAMIDE TABLETS Klintas (Pvt) Ltd3940 COSAMIDE 100 150MGTABLETS LACOSAMIDE United Biotech TABLETS Sunshine 150 LACASA 3941 150MGTABLETS LACOSAMIDE Axia (Pvt) Ltd TABLETS 150 LACASA 3942 MSN Laboratories 50MGTABLETS LACOSAMIDE Sunshine TABLETS 50 LACASA Sunshine TABLETS Sunshine 3929 1MGTABLETS KETOTIFEN KEFEN TABLETS Mega Pharma (Pvt) I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 329 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIA 24-Feb-16 Full THAILAND 12-Jul-17PHILIPPINES Years Two 17-Nov-15BANGLADESH Full 22-Feb-14 Full PAKISTAN 16-Aug-18BANGLADESH Provisional 26-Oct-16INDIA Full INDIA 01-Nov-18 Years Two INDIA 24-Dec-17 Years Two 08-Feb-16INDIA Full INDIA 01-Oct-17 Years Two BANGLADESH 25-Feb-15 24-Apr-16 Full Full Patana Co Ltd Laboratories Philippines Ltd Globe Pharmaceuticals Ltd Pharmaceuticals (Pvt) Ltd Navana Pharmaceuticals Ltd Mercury Laboratories Ltd Panacea Biotec (Pvt) Ltd G S Pharmabutor (Pvt) Ltd Delta Pharma Ltd BANGLADESH 04-Dec-18Agio Years Two Pharmaceuticals Ltd Scott Edil Pharmacia Ltd Incepta Pharmaceuticals Ltd Fourrts (India) Laboratories Ltd (Contd.) (Pvt) Ltd CIC Holdings PLC Abbott India Ltd INDIACo Ltd 29-Jul-15 Full International Yaden (Pvt) Ltd Hemas Pharmaceuticals (Pvt) Ltd Robert Hall & Co Ltd Drugs (Pvt) Ltd Citihealth Imports (Pvt) Ltd Ltd Citihealth Imports (Pvt) Ltd Healthcare lanka Ltd ORAL ORAL SOLUTION SOLUTION SOLUTION SOLUTION SOLUTION Kandana Food & SOLUTION SOLUTION SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP LRIN/A INJECTIONLAXOLAC Sonali & Sudesh SOLUTION Thai Nakorn DUPHALAC SOLUTIONSOLUTION Indoscan (Pvt) Ltd Euromed Healthcare Tabrane DUPHRULZ SOLUTIONLAXOL Ceyoka (Pvt) Ltd Focus & Rulz LACLOS SOLUTIONLIVOLUK Darley Butler & ORAL OSMOWIN ORAL XYLOSE ORAL SOLUTION AGILEXLACON ORAL INOLAC SOLUTIONLAXOPEG C Medical (Pvt) T P ORAL SYRUP Sunshine USP CAL .CHl 20mg, Kcl 30MG, NaCl CAL USP 310MG 600MG, Na LCTATE USP HARTMANN'S FOR HARTMANN'S USP INF INTRAVENOUS BP 3.35G/5ML 3.35G/5ML 3.35G/5ML 10G/15ML 10G/15ML 10G/15ML 3.35G/5ML 3.35G/5ML 3.35G/5ML 3.35G/5ML 3.35G/5ML 3943 RINGER'S INJECTION LACTATED 3944 RNGER'S SOLUTION LACTATED 3945 SOLUTION LACTULOSE 3.4 MG/5ML 3946 SOLUTION LACTULOSE ORAL 3947 LACTULOSE SOLUTION BP 3948 LACTULOSE SOLUTION BP 3949 LACTULOSE SOLUTION USP 3950 LACTULOSE SOLUTION USP 3951 LACTULOSE SOLUTION USP 3952 LACTULOSE SOLUTION USP 3953 LACTULOSE SOLUTION USP 3954 LACTULOSE SOLUTION USP 3955 LACTULOSE SOLUTION USP 3956 LACTULOSE SOLUTION USP 330 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 SRI LANKA 30-Jan-18Years Two AUSTRIA 23-Dec-16BANGLADESH 06-Sep-14 Full Full MALAYSIAPAKISTAN 07-Dec-16 Full 27-Sep-17NETHERLANDS Years Two 21-Jan-17PAKISTAN Full 18-Jan-16PAKISTAN Full 24-Aug-16 Full INDIAINDIA 01-Jan-17 Full 15-Jul-16 Full Pharmaceuticals (Pvt) Ltd Sterling LabFresenius Kabi INDIAA.B Pharmaceuticals 23-Oct-14Ltd Full SDN BHD Opal Laboratories (Pvt) Ltd BV Hilton Pharma (Pvt) Ltd Nabiqasim Industries (Pvt) Ltd Hetero Labs Ltd INDIAHetero Labs Ltd INDIA 23-Jan-14Hetero Labs Ltd INDIA Full 06-Feb-18J Duncan Healthcare (Pvt) Full Ltd 17-Apr-14 Torrent Pharmaceuticals Ltd Full (Contd.) Co Ltd Hemas Pharmaceuticals (Pvt) Ltd PharmAce (Pvt) Ltd Square Indoscan (Pvt) Ltd Industries / S P Y Hemas Pharmaceuticals (Pvt) Ltd Healthcare lanka Ltd Health (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP SOLUTION SOLUTION ORAL SOLUTION SOLUTION RILACXECOLAC SOLUTIONB-LACT N/A SOLUTIONOSMOLAX Darley Butler & ORAL Gamma ORAL LACTUL SOLUTION LILAC SYRUP ORAL ZIDOLAMZIDOLAM-N TABLETS TABLETS Mansel (Ceylon) Mansel (Ceylon) 3.35G/5ML 3.4G/5ML 3.4G/5ML 3.4G/5ML 670MG/ML 67G/100ML 300MG 300MG+NEVIRAPINE 200MG TABLETS 3957 LACTULOSE SOLUTION USP 3958 LACTULOSE SOLUTION USP 3959 LACTULOSE SOLUTION USP 3960 LACTULOSE SOLUTION USP 3961 LACTULOSE SOLUTION USP 3962 LACTULOSE SOLUTION USP 3963 667g in 1 Liter LACTULOSE SYRUP DUPHALAC3964 68% BP LACTULOSE SYRUP SYRUP3965 HILAC 3.35G/5ML USP LACTULOSE SYRUP KLEENLAC CIC Holdings PLC Abbott Biological 3966 LAMIVUDINE 150MG+ZIDOVUDINE SYRUP SYRUP3967 LAMIVUDINE 150MG+ZIDOVUDINE George Steuart Sunshine 3968 150MGTABLETS LAMIVUDINE 3969 150 150MG HEPTAVIR LAMIVUDINE TABLETS TABLETS LOSIDE3970 LAMOTRIGINE DISPERSIBLE 25MG 25 LAMITOR Mansel (Ceylon) TABLETS TABLETS Slim Edna Medicals (Pvt) I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 331 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 10-Nov-14 Full 18-Dec-14 Full PAKISTAN 28-Jul-15 Full PAKISTAN 03-Aug-17INDIA Years Two INDIA 08-Dec-17 Years Two PAKISTAN 08-Apr-17INDIA 20-Dec-18 Full Years Two INDIA 08-Apr-17 Full 12-Aug-15 Full Sun Pharmaceutical industries Medochemie Ltd CYPRUSHilton Pharma 25-May-15(Pvt) Ltd Full Medochemie Ltd CYPRUSHilton Pharma 02-Mar-15(Pvt) Ltd Full (Pvt) Ltd Zim Laboratories Ltd Company Ltd Zim Laboratories Ltd Sun Pharmaceutical industries Sterling Lab INDIA 04-Oct-17 Full Medochemie Ltd CYPRUSSun 16-Aug-15Pharmaceutical industries Full (Contd.) (Ceylon) Ltd Laboratories (Pvt) Ltd Healthcare lanka Ltd Laboratories (Pvt) Ltd Healthcare lanka Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Ceylon) Ltd Darley Butler & Co Ltd Laboratories (Pvt) Ltd (Ceylon) Ltd CAPSULES SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP LAMOCARD 100 TABLETS Tabrane EUROPYL-KIT & TABLETS 100MG 30GM+TINIDAZOLE TABLETS. 500MG+CLARITHROMYCIN 250MG TABLETS 3973 25MGTABLETS LAMOTRIGINE LAMOSYN-253974 25MGTABLETS LAMOTRIGINE TABLETS LAMOTRIX 253975 25MG LAMOTRIGINE TABLETS Emerchemie NB TABLETS LOJIN3976 50MGTABLETS LAMOTRIGINE Associated LAMOTRIX 503977 50MG LAMOTRIGINE TABLETS TABLETS TABLETS LOJIN Sunshine 3978 100MG BP TABLETS LAMOTRIGINE Associated LAMICARE 1003979 TABLETS USP LAMOTRIGINE TABLETS TABLETS PharmAce (Pvt) Ltd3980 Swiss Pharma 50MG USP TABLETS LAMOTRIGINE Sunshine 50MG LAMNET 3981 TABLETS 50MG USP TABLETS LAMOTRIGINE LAMOCARD 50 TABLETS Morison PLC3982 50MG USP TABLETS LAMOTRIGINE LAMOSYN 50 Tabrane The Searle TABLETS3983 LANSOPRAZOLE CAP. Emerchemie NB 3971 100MGTABLETS LAMOTRIGINE LAMOTRIX 100MG TABLETS Associated 3972 100MGTABLETS LAMOTRIGINE LAMOSYN-100 TABLETS Emerchemie NB 332 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 12-Feb-15 Full PAKISTANINDIA 11-Mar-18 Full INDIA 04-Apr-14 Full UNITED KINGDOM 04-Apr-14 Full INDIAINDIA 23-Oct-18 Years Two INDIA 21-Aug-17 Years Two INDIA 17-May-18 Years Two BELGIUM 21-Aug-17 Years Two 02-Nov-15PAKISTAN Full 19-Aug-16 Full INDIA 05-May-14 Full INDIA 22-Dec-17 Years Two zer fi Cadila Healthcare Ltd Cadila Healthcare Ltd Glaxo Operations UK Ltd Pharmatec Pakistan (Pvt) Ltd Getwell Pharmaceuticals Sun Pharmaceutical Medicare Ltd Indoco Remedies India Unimed Ltd Technologles P Manufacturing NV/SA The Schazoo Pharmaceutucal Laboratories (Pvt) Ltd F D C Limited INDIASun Pharmaceutical industries 29-Apr-16Sun Full Pharmaceutical industries (Contd.) Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Ltd Plc The Esses Pharmacy (Pvt) Ltd Hemas Pharmaceuticals (Pvt) Ltd Hemas Pharmaceuticals (Pvt) Ltd Hemas Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Ltd Sunshine Healthcare lanka Ltd Hemas Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP INJECTION SOLUTION SOLUTION SOLUTION SOLUTION SOLUTION LANS-ODLANS-OD CAPSULES Hemas TYKERB CAPSULES Hemas TABLETS Baur & Co (Pvt) A L-GINASE 0.005%LATOCOM OPHTHALMIC POWDER / LATOCHEK-T OPHTHALMIC 0.005%LATOCOM OPHTHALMIC XALACOM EYE DROPS EYE DROPLATEP EYE DROPS Hemas Edna Medicals (Pvt) N/ALATOPROST OPHTHALMIC OPHTHALMIC LATOPROST EYE DROPS Hemas RELEASE CAPSULES 15MG USP RELEASE CAPSULES 30MG USP 250MG POWDER FOR INJECTION 10,000 IU MALEATE 0 5% OPTHALMIC MALEATE SOLUTION 0 5% OPTHALMIC MALEATE SOLUTION 0 5% OPTHALMIC MALEATE SOLUTION EYE DROPS 5ML/ML 50MCG/ML% SOLUTION 0.005% SOLUTION 0.005% SOLUTION 0.005% 3985 LANSOPRAZOLE DELAYED- 3986 LANSOPRAZOLE DELAYED- 3987 TABLETS DITOSYLATE LAPATINIB 3984 LANSOPRAZOLE CAPSULES 30MG LANZOLE 30 CAPSULES Browns & Company 3988 LYOPHILLSED L-ASPARAGINASE 3989 0..005 % +TIMOLOL LATANOPROST 3990 0..005 % +TIMOLOL LATANOPROST 3991 0..005 % +TIMOLOL LATANOPROST 3992 50MCG+TIMOLOL LATANOPROST 3993 EYE DROPS LATANOPROST 3994 EYE DROPS LATANOPROST 3995 OPTHALMIC LATANOPROST 3996 OPTHALMIC LATANOPROST I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 333 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 PAKISTANPAKISTAN 16-Dec-14 Full 08-Oct-15PAKISTAN Full INDIA 26-Sep-18 Years Two 01-Oct-18 Years Two INDIAINDIA 28-May-14PAKISTAN Full 05-Nov-18 12-Feb-14 Years Two Full INDIAPAKISTAN 28-May-14 14-Dec-17 Full INDIA Full INDIA 21-Jun-18SWITZERLAND 03-Jul-17 Full 21-Jun-18ARGENTINA Full Full 12-Nov-18INDIA Years Two INDIA 27-Nov-18 Years Two 18-Nov-17 Years Two Elko Organization (Pvt) Ltd Hilton Pharma (Pvt) Ltd (Pvt ) Ltd Mercury Laboratories Ltd Mercury Laboratories Ltd S J & G Fazul Ellahie (Pvt) Ltd Simpex Pharma (Pvt) Ltd Laboratories (Pvt) Ltd United Biotech (Pvt) Ltd United Biotech (Pvt) Ltd Novartis Pharma A G Laboratories Bago S A Corona Remedics (Pvt) Ltd (Pvt) Ltd Simpex Pharma (Pvt) Ltd (Contd.) eld eld fi fi (Ceylon) Ltd Healthcare lanka Ltd (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Health (Pvt) Ltd Health (Pvt) Ltd Ltd (Ceylon) Ltd Healthcare lanka Ltd Pharmaceuticals (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP VISLAT EYE DROPS Emerchemie NB SOLUTION 50MCG /ML 4011 2.5MG USP TABLETS LETROZOLE GLOTRAZ TABLETS PharmAce (Pvt) Ltd Globela Pharma 3997 OPTHALMIC LATANOPROST 3998 20MG LEFLUNOMIDE TABLETS LEFORA3999 10MG USP TABLETS LEFLUNOMIDE MOVELEF4000 10MG USP TABLETS LEFLUNOMIDE TABLETS N/A TABLETS4001 10MG USP TABLETS LEFLUNOMIDE Sunshine ARRESTO Ceyoka (Pvt) Ltd Genix Pharma TABLETS TABLETS International Yaden Somer 4002 20MG USP TABLETS LEFLUNOMIDE N/A4003 20MG USP TABLETS LEFLUNOMIDE CARTINA4004 20MG USP TABLETS LEFLUNOMIDE ARRESTO TABLETS TABLETS International Yaden TABLETS Pharma Tropical Somer 4005 20MG USP TABLETS LEFLUNOMIDE AIDRA4006 LENALIDOMIDE CAPSULES 10MG LENID 10 TABLETS4007 LENALIDOMIDE CAPSULES 5MG LENID 5 PharmAce (Pvt) Ltd4008 Wilshire CAPSULES 2.5MGTABLETS LETROZOLE George Steuart 4009 2.5MG USP TABLETS LETROZOLE FEMARA CAPSULES LUCIDEX 104010 2.5MG USP TABLETS LETROZOLE George Steuart STIMU-LET TABLETS TABLETS Emerchemie NB TABLETS Baur & Co (Pvt) A Sunshine 334 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 02-Sep-16BANGLADESH Full 31-Mar-14 26-Aug-15 Full Full INDIAINDIA 29-Jun-14INDIA Full 15-Dec-14INDIA Full 11-Oct-18INDIA Full 15-Dec-14INDIA Full 25-Jun-18INDIA Years Two 22-Jun-18INDIA Years Two 01-Aug-18INDIA Years Two 22-Mar-18 Years Two BANGLADESH 10-Jun-16 15-May-17 Years Two Full INDIA 23-Jun-17 Years Two United Biotech (Pvt) Ltd Sun Pharmaceutical industries Pharmaceuticals Ltd Cadila Healthcare Ltd Belco Pharma (Pvt) Ltd PharmaceuticalS (Pvt) Ltd Belco Pharma (Pvt) Ltd (Pvt) Ltd Getwell Pharmaceuticals Pharmaceuticals Ltd Vaccine Sun Pharmaceutical Medicare Ltd Chemical Industries Centurion Laboratories Pvt Ltd (Contd.) Health (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Agency Pvt Ltd Agency Pvt Ltd Pharmacy (Pvt) Ltd Ceyoka (Pvt) Ltd Bharat Serums & Pharmaceuticals (Pvt) Ltd (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP POWDER INJECTION Hemas ZOLETLETROZ TABLETSLEROZOL TABLETS George Steuart Hemas 2.5LETOV TABLETS PharmAce (Pvt) Ltd TABLETS Square N/A Hemas N/A INJECTIONN/A Leader Pharma INJECTIONN/A Ceyoka (Pvt) LtdLEUCOWEL INJECTION Ciron Drugs & BDSURE Leader Pharma INJECTION INJECTION The Esses LUPRODEX 3.75 Pharmatec (Pvt) Ltd Belco Pharma LYOPHILIZED INJECTION LUPRIDE DEPOT Pharma Associates3.75MG BDR ETRAXN/A TABLETS CIC Holdings PLC Advanced TABLETS International Yaden TABLETS TABLETS TABLETS TABLETS 10MG/ML USP 10MG/ML USP 10MG/ML USP 15MG/2ML USP 15MG/2ML USP INJECTION 3.75MG 3.75MG 3.75MG 40MG USP TABLETS 40MG USP TABLETS 4012 2.5MG USP TABLETS LETROZOLE 4013 2.5MG USP TABLETS LETROZOLE 4014 2.5MG USP TABLETS LETROZOLE 4015 2.5MG USP TABLETS LETROZOLE 4016 LEUCOVORIN CALCIUM INJECTION 4017 LEUCOVORIN CALCIUM INJECTION 4018 LEUCOVORIN CALCIUM INJECTION 4019 LEUCOVORIN CALCIUM INJECTION 4020 LEUCOVORIN CALCIUM INJECTION 4021 FOR LEUPROLIDE ACETATE 4022 INJECTION LEUPRORELIN ACETATE 4023 INJECTION LEUPRORELIN ACETATE 4024 HYDROCHLORIDE LEVAMISOLE 4025 HYDROCHLORIDE LEVAMISOLE I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 335 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 07-Jul-16BANGLADESH Full 01-Aug-17 07-Mar-18 Years Two Full INDIABANGLADESH 07-Mar-18 18-Jun-18 Years Two Full BANGLADESH 07-Mar-18 Full INDIABANGLADESH 27-Mar-18 10-Jun-16 Full INDIA Full INDIA 07-Aug-14 Full PAKISTAN 07-Mar-14 15-Jun-14 Full INDIA Full BANGLADESH 29-Jan-14 10-Jun-16 Full Full B D H Industries Ltd Sun Pharmaceutical industries Pharmaceuticals Ltd Co. LLC Pharmaceuticals Ltd Pharmaceuticals Ltd Sun Pharmaceutical industries Pharmaceuticals Ltd Torrent Pharmaceuticals Ltd Atoz Pharmaceuticals (Pvt) Ltd Hilton Pharma (Pvt) Ltd Sun Pharmaceutical industries Pharmaceuticals Ltd (Contd.) (Pvt) Ltd (Ceylon) Ltd Pharma Associates Global Pharma PharmAce (Pvt) Ltd Square (Ceylon) Ltd Ltd (Pvt) Ltd Healthcare lanka Ltd (Ceylon) Ltd INFUSION SOLUTION SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP LCARIS-40LEVIPIL TABLETS Ravilux Company IRACET INFUSION Emerchemie NB N/A INJECTIONIRACET PharmAce (Pvt) Ltd Square SOLUTION IRACET INJECTION PharmAce (Pvt) Ltd Square ORAL TABLETS USP 40MG USP TABLETS FOR INJECTION 100MG/ML 500MG/5ML 500MG/5ML 500MG/5ML 100MG/ML USP 4026 HYDROCHLORIDE LEVAMISOLE 4027 CONCENTRATE LEVETIRACETAM 4028 INJECTION LEVETIRACETAM 4029 INJECTION LEVETIRACETAM 4030 INJECTION LEVETIRACETAM 4031 SOLUTION ORAL LEVETIRACETAM 4032 1000MGTABLES LEVETIRACETAM LEVIPIL4033 250mgTABLES LEVETIRACETAM 250MG IRACET TABLETS4034 TABLETS 500MGTABLES LEVETIRACETAM Emerchemie NB 500 TORLEVA PharmAce (Pvt) Ltd Square 4035 500MG TABLETSTABLES LEVETIRACETAM 500 LEVITOZ Edna Medicals (Pvt) 4036 500MG TABLES LEVETIRACETAM TABLETS LERACEAsian Pharma Euro 4037 500MGTABLES LEVETIRACETAM 500 LEVIPIL TABLETS4038 500MGTABLES LEVETIRACETAM TABLETS Sunshine 500MG IRACET TABLETS Emerchemie NB PharmAce (Pvt) Ltd Square 336 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 27-Mar-18 Years Two INDIA 29-Apr-16 Full INDIA 27-Mar-18 Full INDIA 16-Mar-15 Full PAKISTAN 31-Jul-18 Years Two INDIA 06-Dec-18 Years Two INDIA 21-Aug-14 Full INDIA 16-Mar-15 Full INDIA 21-Aug-14 Full IRELAND 31-Dec-14 Full 01-Jan-18INDIA Years Two BANGLADESH 06-Jun-18 13-Feb-18 Years Two Full Torrent Torrent Pharmaceuticals Ltd Sun Pharmaceutical industries UCB India (Pvt) Ltd Sun Pharmaceutical industries Company Ltd Akums Drugs & Pharmaceuticals Ltd UCB India (Pvt) Ltd Akums Drugs & Pharmaceuticals Ltd UCB India (Pvt) Ltd Allergan Pharmaceuticals Inventia Healthcare (Pvt) Ltd Healthcare Pharmaceuticals Sun Pharmaceutical industries (Contd.) Ltd (Ceylon) Ltd Healthcare lanka Ltd (Ceylon) Ltd (Pvt) Ltd Healthcare lanka Ltd (Pvt) Ltd Healthcare lanka Ltd Hemas Pharmaceuticals (Pvt) Ltd (Ceylon) Ltd Citihealth Imports (Pvt) Ltd (Ceylon) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP SOLUTION SOLUTION LEVIPIL 250KEPPRA TABLETS TABLETS 250LIVIPIL Emerchemie NB Sunshine TABLETSLUMARK 250 Emerchemie NB TABLETSVEXLEV 250 Morison PLC TABLETS 250KEPPRA Global Impex AV The Searle TABLETSVEXLEV 500 Sunshine TABLETS 500KEPPRA Global Impex AV TABLETSBETAGAN Sunshine POTHALMIC GETCETALCET TABLETS Emerchemie NB ORAL 1000MG 1000MG 250MG 250MG 250MG 250MG 500MG 500MG OPTHALAMIC SOLUTION 0.5% W/V DIHYDROCHLORIDE MOUTH 5MG DISSOVING TABLETS DIHYDROCHLORIDE ORAL SOLUTION 2.5MG/5ML 4040 750MGTABLES LEVETIRACETAM 1000 TORLEVA TABLETS4041 USP TABLETS LEVETIRACETAM Edna Medicals (Pvt) 4042 USP TABLETS LEVETIRACETAM 4043 USP TABLETS LEVETIRACETAM 4044 USP TABLETS LEVETIRACETAM 4045 USP TABLETS LEVETIRACETAM 4046 USP TABLETS LEVETIRACETAM 4047 USP TABLETS LEVETIRACETAM 4048 USP TABLETS LEVETIRACETAM 4049 HYDROCHLORIDE LEVOBUNOLOL 4050 LEVOCETIRIZINE 4051 LEVOCETIRIZINE 4039 750MGTABLES LEVETIRACETAM LEVIPIL TABLETS Emerchemie NB I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 337 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAPAKISTAN 03-Jun-15 16-Feb-15INDIA Full Full INDIA 10-Mar-16PAKISTAN Full 03-Jun-15INDIA 11-Mar-17 Full Full INDIA 05-Feb-18 Provisional INDIA 14-Sep-17INDIA Full 05-Apr-14PAKISTAN Full 20-Nov-15 08-Dec-17PAKISTAN Full Full 30-Mar-16 Full INDIABANGLADESH 22-Feb-18 31-Jan-18 Years Two Full (Pvt) Ltd Hilton Pharma (Pvt) Ltd Unichem Laboratories (Pvt) Ltd Brookes Pharma (Pvt) Ltd Glenmark Pharmaceuticals Ltd Apex Laboratories Ltd Laboratories XL (Pvt) Ltd Healthcare Ltd Genome Pharmceuticals (Pvt) Ltd & Well Well Pharma (Pvt) Ltd UCB Pharma Ltd INDIAAnkur Drugs & Pharma (Pvt) Ltd 26-Feb-14Healthcare Full Pharmaceuticals (Contd.) Healthcare lanka Ltd Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Ltd Ltd Ltd Laboratories (Pvt) Ltd Healthcare lanka Ltd International (Pvt) Ltd Citihealth Imports (Pvt) Ltd TABLETS SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP LC-5LEOZIN 5 TABLETSLE ZYNCET TABLETS Harcourts (Pvt) LtdLC-5 TABLETS Sunshine Pharm Products 5MGLEVOCIT Baur & Co (Pvt) A TABLETSGLENOET TABLETS Mansel (Ceylon) Harcourts (Pvt) Ltd TABLETSTHERMAL Pharm Products LISINEX Hemas TABLETSCTZ- L Baur & Co (Pvt) A TABLETSLECET SMM Halcyon (Pvt) TABLETSALLERNO TABLETS Kamazu (Pvt) Ltd Syncom XYZAL TABLETS Lanka (Pvt) Tabrane Associated LEVOTRIN 5 TABLETS TABLETSALCET Sunshine Softcare FILM COA DIHYDROCHLORIDE TABLETS 5MG DIHYDROCHLORIDE TABLETS DIHYDROCHLORIDE TABLETS 5MG DIHYDROCHLORIDE TABLETS 5MG DIHYDROCHLORIDE TABLETS 5MG DIHYDROCHLORIDE TABLETS 5MG DIHYDROCHLORIDE TABLETS 5MG DIHYDROCHLORIDE TABLETS 5MG DIHYDROCHLORIDE TABLETS 5MG DIHYDROCHLORIDE TABLETS 5MG DIHYDROCHLORIDE TABLETS 5MG DIHYDROCHLORIDE TABLETS 5MG DIHYDROCHLORIDE TABLETS IP DIHYDROCHLORIDE TABLETS 5MG IP DIHYDROCHLORIDE TABLETS 5MG USP DIHYDROCHLORIDE TABLETS 5MG 4052 LEVOCETIRIZINE 4053 LEVOCETIRIZINE 4054 LEVOCETIRIZINE 4055 LEVOCETIRIZINE 4056 LEVOCETIRIZINE 4057 LEVOCETIRIZINE 4058 LEVOCETIRIZINE 4059 LEVOCETIRIZINE 4060 LEVOCETIRIZINE 4061 LEVOCETIRIZINE 4062 LEVOCETIRIZINE 4063 LEVOCETIRIZINE 4064 LEVOCETIRIZINE 4065 LEVOCETIRIZINE 338 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 23-Sep-16 Full INDIAINDIA 07-Mar-18INDIA Full 02-Apr-16INDIA Full 29-Jun-18INDIA Full 23-Jul-14 Full 27-Jul-16INDIA Full SWITZERLAND/ ITALY 06-May-16FINLAND Full 06-May-16PAKISTAN Full INDIA 23-Dec-15 Full INDIA 09-Aug-18 Full 04-Aug-17 Years Two Zim Laboratories Ltd Scences Scences SG Pharma (Pvt) Ltd Sun Pharmaceutical industries Orchid Healthcare INDIAOrian Corporation Orionate 09-Sep-14 Roche SpA Segrate Italy for F Hoffman Full Orian Corporation Orionate OBS Pakistan (Pvt) Ltd Sun Pharmaceutical industries Torrent Pharmaceuticals Ltd Cipla LtdRenata Limited INDIA BANGLADESHCipla Ltd 10-Dec-14 Full 21-Aug-16 INDIA Full 13-Aug-17Years Two (Contd.) Pharmaceuticals (Pvt) Ltd Pharmacy (Pvt) Ltd (Ceylon) Ltd (Pvt) Ltd Ltd Ltd Ltd (Pvt) Ltd (Ceylon) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd (Ceylon) Ltd (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP LEVOCET ODS 5LEVOCET ORALLY Tabrane PRANOSOL PLUSSYNDOPA TABLETS TABLETS The Esses LECARB PLUS Emerchemie NB TABLETS 100MGSTALEVO TABLETSAsian Pharma Euro HBSMADOPAR Baur & Co (Pvt) A CAPSULES 150MG Baur & Co (Pvt) STALEVO A TABLETSSINEMET Baur & Co (Pvt) A CRSYNDOPA TABLETS TABLETS FORTETIDOMET Mansel (Ceylon) TABLETS Emerchemie NB LEVOFLOX 250 Hemas TABLETSLEVOKING 500 Breathe Free Lanka TABLETSLEVOFLOX 500 TABLETS Emerchemie NB Breathe Free Lanka DISINTEGRATING STRIPS 5MG DISINTEGRATING 200MG 37.5MG + ENTACAPONE TABLETS 275MG BP 25MG TABLETS BP 25MG TABLETS TABLETS 200 25MG+ENTACAPONA 25MG CAPSULES 25MG TABLETS 50MG CON. RELE. TABLETS 25MG (CO-CARELDOPA 250/25MG) BP 250MG TABLETS 500MG TABLETS 500MG TABLETS 4066 LEVOCETIRIZINE ORALLY 4074 150MG + CARBIDOPA LEVODOPA 4067 5MG/5ML LEVOCETIRIZINE SYRUP SWICET-L4068 5MGTABLETS LEVOCETIRIZINE SYRUP SWICET-L4069 USP + CARBIDOPA LEVODOPA 4070 100MG + CARBIDOPA LEVODOPA PharmAce (Pvt) Ltd TABLETS Swiss Garnier Life PharmAce (Pvt) Ltd4071 100MG + CARBIDOPA Swiss Garnier Life LEVODOPA 4072 100MG + CARBIDOPA LEVODOPA 4073 100MG+BENSERAZIDE LEVODOPA 4075 250MG + CARBIDOPA LEVODOPA 4076 250MG + CARBIDOPA LEVODOPA 4077 250MG + CARBIDOPA LEVODPOA 4078 LEVOFLOXACIN HEMIHYDRATE 4079 LEVOFLOXACIN HEMIHYDRATE 4080 LEVOFLOXACIN HEMIHYDRATE I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 339 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 BANGLADESH 31-Jan-14 Full INDIAINDIA 18-Sep-18 Full INDIA 30-Apr-14PAKISTAN Full 16-Mar-16 09-May-16PAKISTAN Full Full 30-Jan-18 Years Two PAKISTAN 22-Mar-18BANGLADESH Years Two 04-Jan-18 Years Two PAKISTAN 15-Mar-14INDIA Full PAKISTAN 10-May-18 Years Two PAKISTAN 28-Jun-15 Full 09-Feb-14 Full Healthcare Pharmaceuticals Sanbe FarmaT P INDONESIA 10-Jul-17Aculife Healthcare Years Two (Pvt) Ltd Glenmark Pharmaceuticals Ltd Ltd Getz Pharma Pakistan (Pvt) Ltd Surge Laboratories (Pvt) Ltd, Pakistan for Nabiqasin Indu,s Pvt Ltd Pharmaceuticals Ltd CCL Pharmaceuticals (Pvt) Ltd Macleods Pharmaceuticals Ltd Ferozsons Laboratories Ltd Shrooq Pharmaceutical Pvt Ltd Laboratories (Pvt) Ltd (Contd.) (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Healthcare lanka Ltd Healthcare lanka Ltd Pharmaceuticals (Pvt) Ltd Health (Pvt) Ltd PharmAce (Pvt) Ltd Square Pharmaceuticals Lanka (Pvt) Ltd (Pvt) Ltd (Ceylon) Ltd (Pvt) Ltd INFUSION SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP RESQUIN TABLETSNIRLIV Citihealth Imports GLEVO IV IV INFUSION Sunshine AXA-LEVO INFUSION Sunshine LEFLOX INFUSION Chamee ChemistWARIOR INJECTION Axa Parenterals Hemas INJECTION George Steuart TREVOX 500IV INTRA LEVOCIL INJECTION CCL NEUMO 500 INJECTION PharmAce (Pvt) Ltd Wilshire INFUSION 5MG/ML INFUSION 500MG/100ML INFUSION 500MG/100ML TABLETS 500MG TABLETS 500MG/100ML 500MG/100ML 500MG/100ML 500MG/100ML INFUSION 500MG/100ML 4081 LEVOFLOXACIN HEMIHYDRATE 4082 LEVOFLOXACIN INFUSION 500MG LEVOCIN4083 LEVOFLOXACIN INFUSION INFUSION4084 LEVOFLOXACIN INFUSION Lifeline 4085 LEVOFLOXACIN INFUSION 4086 LEVOFLOXACIN INFUSION 4087 LEVOFLOXACIN INTRAVENOUS 4089 LEVOFLOXACIN INTRAVENOUS 4090 LEVOFLOXACIN INTRAVENOUS 4091 250MGTABLETS LEVOFLOXACIN LEVOMAC4092 250MGTABLETS LEVOFLOXACIN TABLETS LEFOXCIN4093 250MGTABLETS LEVOFLOXACIN LEFEXY Pettah Pharmacy TABLETS Emerchemie NB TABLETS Salveo Pharma 4088 LEVOFLOXACIN INTRAVENOUS 340 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 PAKISTAN 19-Aug-17INDIA Full 15-Nov-14INDIA Full INDIA 28-May-18 Provisional PAKISTAN 02-Nov-16 08-Sep-14 Full INDIA Full INDIA 03-Aug-16 Full PAKISTAN 03-Feb-15 25-Mar-15 Full PAKISTAN Full 09-Feb-14 Full PAKISTAN 23-May-14PAKISTAN Full 19-Aug-14 Full Simpex Pharma (Pvt) Ltd Hetero Labs Ltd INDIAMacleods Pharmaceuticals Ltd 15-Aug-14Emcure Pharmaceuticals Full Ltd Nabiqasim Industries (Pvt) Ltd for Surge Laboratories Lanark Laboratores (Pvt) Ltd Zim Laboratories Ltd Shaigan Pharmaceuticals (Pvt) Ltd Shrooq Pharmaceutical Pvt Ltd Kopran Ltd CCL INDIAPharmaceuticals (Pvt) Ltd Ferozsons Laboratories Ltd 16-Dec-17Years Two Shaigan Pharmaceuticals (Pvt) Ltd (Contd.) eld fi Pharmaceuticals (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd (Ceylon) Ltd Health (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Ltd Pharmaceuticals Lanka (Pvt) Ltd (Ceylon) Ltd Pharmaceuticals (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP 4095 250MG LEVOFLOXACIN TABLETS REMEDIA4096 250MGTABLETS LEVOFLOXACIN LEVIN 250 TABLETS4097 500MGTABLETS LEVOFLOXACIN LEVOMAC Somer TABLETS4098 500MGTABLETS LEVOFLOXACIN TABLETS 500 LOTOR Mansel (Ceylon) 4099 500MGTABLETS LEVOFLOXACIN Pettah Pharmacy TABLETS WARIOR Emerchemie NB 4100 500MGTABLETS LEVOFLOXACIN TABLETS LIVORIK 5004101 500MGTABLETS LEVOFLOXACIN George Steuart TABLETS LEVOC 5004102 Pharma Avenier 500MGTABLETS LEVOFLOXACIN TABLETS BEXUS 5004103 500MGTABLETS LEVOFLOXACIN Tabrane TABLETS LEFEXY4104 500MGTABLETS LEVOFLOXACIN Akbar 500MG LEVOKOP TABLETS TABLETS4105 500MG LEVOFLOXACIN TABLETS LEVOCIL Salveo Pharma Alaris Lanka (Pvt) 4106 500MGTABLETS LEVOFLOXACIN LEFOXCIN TABLETS CCL TABLETS Emerchemie NB 4094 250MGTABLETS LEVOFLOXACIN BEXUS 250 TABLETS Akbar I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 341 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 03-Dec-14INDIA Full 01-Apr-15INDIA Full 01-Jan-14INDIA Full 31-Dec-14INDIA Full 01-Jan-14PAKISTAN Full 31-Dec-14BANGLADESH 26-Apr-18 Full 31-Dec-15 Years Two Full PAKISTANPAKISTAN 03-Dec-17 Years Two 14-Jun-18PAKISTAN Full 08-Sep-16INDIA Full INDIA 17-Nov-17 Full INDIA 07-Dec-16 Full 05-Feb-18 Years Two Glenmark Pharmaceuticals Ltd (Pvt) Ltd Oasis Laboratories (Pvt) Ltd Oasis Laboratories (Pvt) Ltd Ltd Incepta Pharmaceuticals Ltd (Pvt ) Ltd Laboratories (Pvt) Ltd Nabiqasim Industries (Pvt) Ltd Sai Mirra Innopharm (Pvt) Ltd Pharmaceuticals Ltd Akriti pharmaceuticals Pvt Ltd Alkem Laboratories Ltd (Pvt) Ltd (Contd.) Healthcare lanka Ltd ltd Imports (Pvt ) Ltd (Pvt) Ltd Health (Pvt) Ltd Healthcare lanka Ltd Ltd (Ceylon) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP SPECTRIX 250MG TABLETSLEVOXIN 250 CIC Holdings PLC PharmEvo (Pvt) TABLETSS-FLOX Citihealth Imports NEUMO 250 TABLETS TABLETSWARIOR Ceyoka (Pvt) Ltd PharmAce (Pvt) Ltd Genix Pharma Wilshire N/A TABLETS George Steuart SYNOFLOX TABLETS TABLETSALFLOX 500 Sunshine Chamee Chemist TABLETS Synokem Alaris Lanka (Pvt) 250MG 250MG 250MG 250MG 250MG 250MG 250MG 500MG 4111 500MG IP TABLETS LEVOFLOXACIN LEVOTEC 500 TABLETS Klintas (Pvt) Ltd United Biotech 4110 500MG IP TABLETS LEVOFLOXACIN OLEFLOX 500 TABLETS RS Biogenics (Pvt) 4112 500MG IP TABLETS LEVOFLOXACIN OLEFLOX 500 TABLETS4113 USP LEVOFLOXACIN TABLETS Union Lanka 4114 USP LEVOFLOXACIN TABLETS 4115 USP LEVOFLOXACIN TABLETS 4116 USP LEVOFLOXACIN TABLETS 4117 USP LEVOFLOXACIN TABLETS 4118 USP LEVOFLOXACIN TABLETS 4119 USP LEVOFLOXACIN TABLETS 4108 500MG LEVOFLOXACIN TABLETS GLEVO4109 250MG IP TABLETS LEVOFLOXACIN LEVOTEC 250 TABLETS TABLETS Sunshine Klintas (Pvt) Ltd United Biotech 4120 USP LEVOFLOXACIN TABLETS 4107 500MGTABLETS LEVOFLOXACIN ALEVO 500 TABLETS Emerchemie NB 342 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 BANGLADESH 16-Nov-18 Years Two INDIAINDIA 09-Jan-17 Full PAKISTAN 16-Jan-16 23-Sep-17 Full INDIA Full PAKISTAN 08-Dec-17 26-Apr-17 Full Full INDIA 16-Jul-18 Provisional GERMANY 12-Nov-17 Years Two Incepta Pharmaceuticals Ltd Medibios Laboratories (Pvt) Ltd Pharmaceuticals Ltd Pharmix Laborateries (Pvt) Ltd Sai Mirra Innopharm (Pvt) Ltd Ltd FinlandBayer OY FINLANDUnicure Ramadies 31-Mar-18(Pvt) Ltd Years Two Ponds Chemicals THAILAND 14-Aug-17Ponds ChemicalsYears Two THAILAND 14-Aug-17 Bayer Weiner Years Two GmbH & Co. KC Germany for AG Bayer Pharma Germany (Contd.) (Pvt) Ltd (Ceylon) Ltd Ltd Healthcare lanka Ltd Pharmaceuticals (Pvt) Ltd Ltd Lanka Lanka Pharmaceuticals (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP IMPLANTS Hemas LEVOXIN 500 TABLETSLEVOBIOTIC 500 TABLETS Citihealth Imports SYNOFLOX Emerchemie NB TABLETS 500LEVOPAL TABLETS Chamee ChemistLF-500 Synokem Lanka (Pvt) Tabrane SPECTRIX 500MG TABLETS TABLETSJADELLE SINE CIC Holdings PLCINSERTER Sunshine PharmEvo (Pvt) FLORINAFEMINYL TABLETS Emar Pharma (Pvt) TABLETSFEMINYL Population Services TABLETSMICROGYNON TABLETS Population Services Hemas 500MG 500MG 500MG 500MG 500MG 500MG IMPLANTS 75MG 0.030MG ETHINYLESTRADIOL TABLETS 0.15MG+ETHINYLESTRADIOL OF FERROUS TABLETS 0.03MG & TABLETS 75MG BP FUMARATE 0.15MG+ETHINYLESTRADIOL OF FERROUS TABLETS 0.03MG & TABLETS 75MG BP FUMARATE 0.15MG+ETHINYLESTRADIOL OF FERROUS TABLETS 0.03MG & TABLETS 75MG BP FUMARATE 4121 USP LEVOFLOXACIN TABLETS 4122 USP LEVOFLOXACIN TABLETS 4123 USP LEVOFLOXACIN TABLETS 4124 USP LEVOFLOXACIN TABLETS 4125 USP LEVOFLOXACIN TABLETS 4126 USP LEVOFLOXACIN TABLETS 4127 SUBDERMAL LEVONORGESTREL 4128 0.150MG + LEVONORGESTREL 4129 LEVONORGESTREL 4130 LEVONORGESTREL 4131 LEVONORGESTREL I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 343 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 THAILAND 24-Jan-18 Provisional HUNGARY 08-Aug-17 Full PAKISTAN 02-Dec-15INDIA Full INDIA 09-Nov-18 Years Two INDIA 13-Jan-18INDIA Years Two 08-Jan-15INDIA Full 09-Nov-18 Years Two INDONESIA 07-Jul-18 13-May-14 Full PAKISTAN Full 16-May-16 Full Patana Co Ltd Gedeon Richter Ltd FinlandBayer OY FINLANDRenata Limited 29-Aug-18 BANGLADESH Full Renata Limited 15-Oct-17Years Two BANGLADESHZafa 15-Oct-17Pharmaceuticals Years Two Laboratories (Pvt) Ltd Corona Remedics (Pvt) Ltd Unicure Ramadies (Pvt) Ltd SG Pharma (Pvt) Ltd Corona Remedics (Pvt) Ltd Acme Formulation (Pvt) Ltd T Harsen P Yafefa (Dis. By Primarta) Zafa Pharmaceuticals Laboratories (Pvt) Ltd anning fl (Contd.) associatio Pharmaceuticals (Pvt) Ltd Lanka Lanka (Pvt) Ltd Healthcare lanka Ltd Ltd Pharmacy (Pvt) Ltd Healthcare lanka Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP R-DEN TABLETSPOSTINOR Sonali & SudeshMIRENA TABLETS Thai Nakorn The Family EMCON INTRAUTERINE Hemas EMCON TABLETSEMKIT TABLETS Population Services Population Services OPTION 2 TABLETS International Yaden LENOR 75 TABLETSSELECTOR Sunshine TABLETSOPTION 1 TABLETS Emar Pharma (Pvt) The Esses DEPREGDINA TABLETS TABLETS Sunshine PILKAB-FE Hemas TABLETS 28FAMILA Mansel (Ceylon) TABLETS International Yaden 0.15MG+ETHINYLESTRADIOL 0.15MG+ETHINYLESTRADIOL WITH USP TABLETS 0.03MG USP TAB FERROUS FUMARATE 75MG TABLETS 1.5MG INTRAUTERINE SYSTEM 20MCG/24th 0.75MG 0.75MG 0.75MG 0.75MG 0.75MG 0.75MG 1.5MG 1.5MG 0.15MG+ USP TABLETS ESTRADIOL 0.03MG 0.15MG+ USP TABLETS ESTRADIOL 0.03MG 4132 LEVONORGESTREL 4133 TABLETS LEVONORGESTREL 4134 52MG LEVONORGESTREL 4135 TABLETS LEVONORGESTREL 4136 TABLETS LEVONORGESTREL 4137 TABLETS LEVONORGESTREL 4138 BP TABLETS LEVONORGESTREL 4139 BP TABLETS LEVONORGESTREL 4140 BP TABLETS LEVONORGESTREL 4141 BP TABLETS LEVONORGESTREL 4142 BP TABLETS LEVONORGESTREL 4143 LEVONORGESTREL+ETHINYL 4144 LEVONORGESTREL+ETHINYL 344 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAARGENTINA 28-Dec-17 11-Oct-14ARGENTINA Full Full 03-Oct-18INDIA Full INDIA 11-Jul-18 Provisional BANGLADESH 14-May-18 01-Oct-17 Years Two Years Two BANGLADESH 01-Oct-15INDIA Full INDIA 15-Dec-17 Full INDIA 15-Dec-17 Full INDIA 28-Dec-17INDIA Full 12-Jul-17 Years Two INDIA 23-Nov-17 Full SRI LANKA 03-Mar-16 11-Dec-14 Full Full Ankur Drugs & Pharma (Pvt) Ltd Quimica Montpellier SA Quimica Montpellier SA Healthy Life Pharma (Pvt) Ltd Acme Formulation (Pvt) Ltd-india for Abbott India Ltd The ACME Laboratories Ltd The ACME Laboratories Ltd Ankur Drugs & Pharma (Pvt) Ltd Ankur Drugs & Pharma (Pvt) Ltd Ankur Drugs & Pharma (Pvt) Ltd (Pvt) Ltd Coast West Pharmaceurical works Ltd Macleods Pharmaceuticals Ltd (Ceylon) (Pvt) Ltd (Contd.) International (Pvt) Ltd (Ceylon) Ltd (Ceylon) Ltd Pharmaceuticals (Pvt) Ltd Healthcare lanka Ltd Ltd Ltd International (Pvt) Ltd International (Pvt) Ltd International (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP TABLETSTABLETS Emerchemie NB Emerchemie NB THYROLET 100THYROLET TABLETST4 100 Softcare MONTPELLIER T4 50 MONTPELLIER N/ATHYRONORM 25 TABLETS TABLETSTHYROMEGA Sunshine Slim TABLETSTHYROMEGA TABLETS Mega Pharma (Pvt) 50THYEROLET TABLETS Mega Pharma (Pvt) 50THYEROLET Softcare TABLETS 75THYROLET Softcare TABLETSTHYORIGHT Softcare THYVEX 0.05MG TABLETS TABLETS Chamee ChemistTHYROX Global Impex AV Alvita Pharma N/A TABLETS Pettah Pharmacy TABLETS N/A M S J Industries 100MCG TABLETS 100MCG TABLETS 50MCG TABLETS 0.05MG BP TABLETS 25MCG IP TABLETS 100MCG USP TABLETS 50MCG USP TABLETS 50MCG 50MCG 75MCG 0.05MG 0.05MG 100MCG (0.1MG) 100MCG (0.1MG) 4145 BP LEVOTHYROXINE TABLETS 4146 LEVOTHYROXINE SODIUM 4147 LEVOTHYROXINE SODIUM 4148 LEVOTHYROXINE SODIUM 4149 LEVOTHYROXINE SODIUM 4150 LEVOTHYROXINE SODIUM 4151 LEVOTHYROXINE SODIUM 4152 BP TABLET LEVOTHYROXINE 4153 BP TABLET LEVOTHYROXINE 4154 BP TABLET LEVOTHYROXINE 4155 BP LEVOTHYROXINE TABLETS 4156 BP LEVOTHYROXINE TABLETS 4157 BP LEVOTHYROXINE TABLETS 4158 BP LEVOTHYROXINE TABLETS I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 345 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 26-Aug-16 Full INDIA 30-Mar-18 Full INDIA 30-Mar-18 Years Two INDIA 03-Jun-14SWEDEN Full 21-Apr-14 19-Feb-18INDIA Full Full SWEDEN 26-Aug-15 08-Nov-16 Full SWEDEN Full 08-Nov-15INDIA Full INDIA 12-May-15INDIA Full 28-Sep-17 Years Two SWEDEN 26-May-17 Full 08-Nov-15 Full Macleods Pharmaceuticals Ltd Acme Formulation (Pvt) Ltd-india for Abbott India Ltd Acme Formulation (Pvt) Ltd-india for Abbott India Ltd Ambala Sarabhal Enterprises Neon Laboratories Ltd Recipharm Karlskoga AB for AB Astra Zeneca Pharmaceuticals (India) Ltd Recipharm Karlskoga AB for AB Astra Zeneca Recipharm Karlskoga AB for AB Astra Zeneca Indoco Remedies India Brassica Pharma Pvt Ltd Pharmafabrikon Unit Recipharm Karlskoga AB for AB Astra Zeneca (Contd.) (Pvt) Ltd Healthcare lanka Ltd Healthcare lanka Ltd Co Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Ltd International (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP INJECTION Swedish Trading THYROXTHYRONORM 100 TABLETS TABLETS Pettah Pharmacy Sunshine THYRONORM 50 TABLETS ANASICA Sunshine ADRENALINE 2% LOX 2% 5%EMLA INJECTIONCAINPLUS CREAM Ravilux Company CREAMXYLOPROCT Hemas OINTMENT PharmAce (Pvt) Ltd Aurochem XYLOPROCT Hemas SUPPOSITORY Hemas LIGNOX 2% INJECTION Emar Pharma (Pvt) N/AXYLOCAINE INJECTION JELLY Novachem Lanka Hemas 50MCG 100MCG 50MCG ADRENALINE 1:80.000 ADRENALINE 1:80.000 25MG/G CREAM CREAM 25MG USP 50MG+HYDROCORTISONE 2.5MG+ZINC OXIDE ACETATE 180MG OINTMENT 5MG 60MG+HYDROCORTISONE +ZINC OXIDE 400MG+ALU.SUBA 1:80,000 INJECTION BP ADRENALINE INJECTION BP AND 80.000 JELLY 4159 BP LEVOTHYROXINE TABLETS 4160 IP LEVOTHYROXINE TABLETS 4161 IP LEVOTHYROXINE TABLETS 4162AND LIDOCAINE 2% INJECTION BP 4163AND LIDOCAINE 2% INJECTION BP 4164 LIDOCAINE 25MG/G+PRELOCAINE 4165 LIDOCAINE 25MG+PRILOCAINE 4166 LIDOCAINE 4167 LIDOCAINE 4168 LIDOCAINE AND ADRENALINE 4169 2% W/V BP LIDOCAINE GEL 4170 SICA-NUMB LIDOCAINE HYDROCHLORIDE 2% GEL4171 LIDOCAINE HYDROCHLORIDE 2% Softcare 346 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 09-Apr-18INDIA Full 08-Aug-18INDIA Full 23-May-18INDIA Years Two 29-Apr-16INDIA Full 27-Apr-16SWEDEN Full 06-Mar-14 08-Nov-15BANGLADESH Full 14-Dec-16 Full Full INDIAINDIA 16-Jan-14INDIA Full 09-Sep-16 Full 22-May-16BANGLADESH Full 15-Dec-18 Full BANGLADESH 21-Dec-18 Years Two (india) (Pvt) Ltd Ltd Pharmafabrikon Unit Mackur Laboratories Ltd Mackur Laboratories Ltd Ambala Sarabhal Enterprises AB Astra Zeneca ,Sweden Pharmaceuticals Ltd Healthcare Vital (Pvt) Ltd PharmaceuticalS (Pvt) Ltd Healthcare Vital (Pvt) Ltd Astra Zeneca AUSTRALIA 08-Nov-16Cephalosporins Ltd Full Beximco Pharmaceuticals Ltd (Contd.) (Pvt) Ltd Pharmaceticals Pharmaceticals Co Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Ceylon) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP METACAIN JELLY Ceyoka (Pvt) Ltd Galentic Pharma XYLOCAINE SPRAYLIDO Hemas SYRUP GELCIROCATINE GEL PharmAce (Pvt) Ltd Square Ceyoka (Pvt) Ltd Ciron Drugs & JELLY USP JELLY SYRUP 10MG SYRUP 2% w/w IP GEL 4172 LIDOCAINE HYDROCHLORIDE 2% 4173 2% LIDOCAINE INJECTION BP 4174 2% ALCAINE LIDOCAINE INJECTION BP 4175 2% N/A LIDOCAINE INJECTION BP INJECTION4176 2% LIGNOMAK LIDOCAINE INJECTION BP PharmAce (Pvt) Ltd Alpa Laboratories 4177 2% LIGNOMAK LIDOCAINE INJECTION BP INJECTION INJECTION4178 10% (100MG/1G) 2% S P L ANASICA LIDOCAINE SPRAY Novachem Lanka INJECTION INJECTION S P L 4179 USP AEROSOL LIDOCAINE TOPICAL Trading Swedish 4180 2% (Sterile) BP LIGNOCAINE GEL N/A4181 LIGNOCAINE HYDROCHLORIDE 4182 2% LIGNOCAINE INJECTION BP GEL 20 LIGNOVIT 4183 2% LIGNOCAINE INJECTION BP INJECTION XYLOCAINE 2%4184 International Yaden 5MG INJECTIONTABLETS LINAGLIPTIN International Yaden Hemas 4185 LINITA 5MGTABLETS LINAGLIPTIN TRANETA TABLETS TABLETS PharmAce (Pvt) Ltd Square Emerchemie NB I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 347 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 21-Nov-18 Years Two 25-Oct-18 Years Two BANGLADESH 25-Jan-18 Years Two BANGLADESH 01-Jan-18 Provisional PAKISTAN 19-Dec-17BANGLADESH Years Two 26-Apr-18 Years Two BANGLADESH 25-Jan-18 Years Two NORWAY 28-Aug-14INDIA Full INDIA 15-May-16INDIA Full 19-Aug-16 Full 08-Apr-14 Full G D Laboratories (India) Pvt Ltd Aristopharma Ltd BANGLADESH 25-Jan-18 Provisional Nipro JMI Pharma Ltd The ACME Laboratories Ltd CCL Pharmaceuticals (Pvt) Ltd Incepta Pharmaceuticals Ltd Beximco Pharmaceuticals Ltd Fresenius kabi Korea Ltd for AB Fresenius kabi Sweden Ltd Glenmark Pharmaceuticals Ltd Zim Laboratories Ltd Micro Labs Ltd INDIA 25-Oct-18 Full Concept Pharmaceuticals Ltd (Contd.) Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Ltd Pharmaceuticals Lanka (Pvt) Ltd (Pvt) Ltd (Ceylon) Ltd Pharmaceuticals (Pvt) Ltd Healthcare lanka Ltd Pharmaceuticals (Pvt) Ltd Ltd International (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP AXAZOLIDLIZOLID INJECTION Chamee Chemist INJECTION Axa Parenterals Sunshine 200MG/100MG & 600MG/300ML 200mg/100ml 4187 5MGTABLETS LINAGLIPTIN 4188 GD LIP 5MG LINAGLIPTIN TABLETS 4189 LINAGLIP 5MGTABLETS LINAGLIPTIN TABLETS4190 5MGTABLETS LINAGLIPTIN 5 LIJENTA TABLETS Lifeline 4191 5MG LINAGLIPTIN TABLETS LINO Hemas TABLETS4192 LINA 5MGTABLETS LINAGLIPTIN Imedra Healthcare TABLETS4193 LINATAB LINEZOLID INJECTION 2MG/ML TABLETS Mega Pharma (Pvt) ARLIN4194 LINEZOLID INJECTION 2MG/ML TABLETS CCL ZYVOX Citihealth Imports IV INFUSION4195 LINEZOLID INJECTION Emerchemie NB INFUSION4196 LINEZOLID INJECTION Hemas 4197 600MG LINEZOLID TABLETS 4198 LINOSOBID 600MGTABLETS LINEZOLID TABLETS 500 LINOSEPT TABLETS Tabrane SMM Halcyon (Pvt) 4186 5MG LINAGLIPTIN TABLETS LINALIP TABLETS Softcare 348 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 PAKISTANINDIA 28-Sep-18 Full BANGLADESH 31-Oct-18 07-Mar-17 Years Two Full INDIAINDIA 08-Apr-14 Full INDIA 11-Oct-17 Full INDIA 22-Mar-15INDIA Full 02-Apr-18INDIA Full 18-Mar-14PAKISTAN Full 09-Mar-18 Years Two 25-May-15PAKISTAN Full 25-May-15 Full S J & G Fazul Ellahie (Pvt) Ltd Zim Laboratories Ltd Beximco Pharmaceuticals Ltd Zim Laboratories Ltd Macleods Pharmaceuticals Ltd Glenmark Pharmaceuticals Ltd Ltd Vaccine United Biotech (Pvt) Ltd Abbott Biological BV Abbott Laboratories Abbott Laboratories Novo Nordisk DENMARK LaboratoriesIPCA INDIA 04-May-17 Full 05-Apr-15 Full (Contd.) A V H Distributors A (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Ceylon) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Healthcare lanka Ltd Health (Pvt) Ltd Sunshine Healthcare lanka Ltd Sunshine Healthcare lanka Ltd Sunshine Healthcare lanka Ltd Healthcare lanka Ltd Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP TABLETS SUSPENSION SUSPENSION SUSPENSION AMPHOPONEX INJECTIONANILIP Ceyoka (Pvt) LtdCREMAFFIN Bharat Serums & INJECTION ORAL CREMAFFIN George Steuart ORAL CREMAFFIN ORAL VICTOZALISORETIC INJECTION Sunshine TABLETS Emar Pharma (Pvt) 20MG+HYDROCHLORIDE 12.5MG TABLETS INJECTION 50MG/20ML INJECTION (LYOPHILIZED) HYDROXIDE AND SODIUM SUSPENTION ORAL PICOSULFATE PER 15ML 11.25ML OF MAGNESIA PER 15ML 11.25ML OF MAGNESIA SUSPENTION ORAL INJECTION 6MG/ML 4211 LISINOPRIL 4199 600MGTABLETS LINEZOLID 600 NEZKIL FILM COA 4200 600MG LINEZOLID TABLETS 4201 LINOSOBID 600MGTABLETS LINEZOLID TABLETS4202 ARLIN 600MG LINEZOLID TABLETS Tabrane 4203 LINOSOBID 600MGTABLETS LINEZOLID TABLETS TABLETS4204 LIZOMAC 600 600MG LINEZOLID TABLETS Emerchemie NB Tabrane TABLETS4205 LIZOLID AMPHOTERICN LIPOSOMAL B Pettah Pharmacy 4206 AMPHOTERICN LIPOSOMAL B TABLETS4207 ,MAGNESIUM LIQUID PARAFFIN Sunshine 4208 3.75ML+ MILK IP LIQUID PARAFFIN 4209 3.75ML+ MILK IP LIQUID PARAFFIN 4210 LIRAGLUTIDE SOLUTION FOR I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 349 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 CHINACHINA 20-Jan-15 Full INDIA 24-Jan-16 Full 08-Apr-18 Years Two INDIA 08-Apr-18 Years Two BANGLADESH 02-Mar-16 Full INDIAINDIA 10-Jul-16BELGIUM Full 18-Jan-17 28-Dec-16 Full Full BANGLADESH 30-Dec-16MALAYSIA Full 27-May-15 Full Astra Zeneca Pharmaceuticals Co Ltd Torrent Pharmaceuticals Ltd LaboratoriesIPCA INDIA Torrent Pharmaceuticals Ltd 10-Apr-14 LaboratoriesIPCA INDIA Full Pharma Fabrikon INDIA 18-Apr-14Pharmaceuticals Ltd Full 12-Jul-15Aristopharma Ltd BANGLADESH Full 02-May-14 Laboratories XL Full (Pvt) Ltd Comed Chemical Ltd Lusomedicamenta Socie /Portugal Janssen Pharmaceutical NV Formulation Ltd SDN BHD Astra Zeneca Pharmaceuticals Co Ltd (Contd.) Pharmaceuticals (Pvt) Ltd Ltd Ltd Ltd Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Ltd Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP HYPNOLITH 250 TABLETSMEXLO 0.3% Novachem Lanka EYE DROPSLOMEFLOX PharmAce (Pvt) Ltd Square EYE DROPS Hemas IMODIUM 2MG CAPSULES Pettah Pharmacy 2IMOTIL LORAMIDE CAPSULES CAPSULES PharmAce (Pvt) Ltd Square Indoscan (Pvt) Ltd Industries / S P Y USP 250MG USP (3MG IN IML) EYE DROPS 0.3% W/V CAPSULES 2MG 2MG CAPSULES USP 2MG USP TABLETS 4213 5MG TABLETS LISINOPRIL 4214 10MG USP TABLETS LISINOPRIL ZESTRIL 10 LISTRIL 4215 10MG USP TABLETS LISINOPRIL TABLETS TABLETS 10 LISORIL 4216 5MG USP TABLETS LISINOPRIL Hemas Edna Medicals (Pvt) 5 LISTRIL TABLETS4217 5MG USP TABLETS LISINOPRIL Emar Pharma (Pvt) LISORIL-54218 TABLETS TABLETS LITHIUM CARBONATE 4219 Edna Medicals (Pvt) LOMEFLOXACIN EYE DROPS 0.3% TABLETS4220 Emar Pharma (Pvt) LOMEFLOXACIN HYDROCHLORIDE 4221 2MG LOPERAMIDE CAPSULES BP ABYDIUM4222 2MG LOPERAMIDE CAPSULES BP LOPMED4223 CAPSULES LOPERAMIDE HYDROCHLORIDE SMM Halcyon (Pvt) CAPSULES C Medical (Pvt) T P 4224 LOPERAMIDE HYDROCHLORIDE 4225 LOPERAMIDE HYDROCHLORIDE 4212 10MGTABLETS LISINOPRIL 10 ZESTRIL TABLETS Hemas 350 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 BANGLADESH 09-Apr-15INDIA Full INDIA 28-Dec-15INDIA Full 29-Aug-17 Years Two INDIA 16-Nov-17 Years Two BANGLADESH 18-Aug-17 12-Feb-15 Full INDIA Full SRI LANKA 11-Jan-17 19-Sep-14 Full PAKISTAN Full PAKISTAN 02-Jan-15 Full 31-Mar-17BANGLADESH 18-Oct-18 Full Provisional BANGLADESH 30-Nov-17 Full BANGLADESH 14-Oct-14BANGLADESH Full 30-Nov-17 Full Sava Healtheare Ltd Cadila Healthcare Ltd MMC Healthcare Ltd Agio Pharmaceuticals Ltd Pharmaceuticals Ltd Unique Pharmaceutical Labs Pharmaceuticals Pvt Ltd Pharmatec Pakistan (Pvt) Ltd Fozen Pharmaceutical Industries Pvt Ltd Eskayef Bangladesh Ltd The ACME Laboratories Ltd Incepta Pharmaceuticals Ltd Pharmaceuticals Ltd The ACME Laboratories Ltd (Contd.) Radiant Health Care (Pvt) Ltd Sunshine Healthcare lanka Ltd Markss HLC (Pvt) Ltd Citihealth Imports (Pvt) Ltd Harcourts (Pvt) Ltd General George Steuart Health (Pvt) Ltd N/A Health Care RCA (Pvt) Ltd Gamma Pharma Tropical (Pvt) Ltd Sunshine Healthcare lanka Ltd Mega Pharma (Pvt) Ltd (Pvt) Ltd CIC Holdings PLC Jayson Mega Pharma (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP TABLETS TABLETS SOLUTION SOLUTION SUSPENSION SOLUTION SOLUTION SOLUTION SOLUTION SUSPENSION SUSPENSION ORAL ORAL SUSPENSION SUSPENSION Z-TIN MDLORIDIN DISPERSIBLE ALLERDIN DISPERSIBLE LORITEX SYRUP ORAL ORAL LORINLORID ORAL LORYT ORAL PHILO-R ORAL LOR 60ML ORAL ORAL ORADINORIN ORAL ORAL ELADIN SUSPENTION ORIN ORAL TABLETS 10MG TABLETS 10MG TABLETS 5MG/ML 5MG/ML 5MG/5ML 5MG/5ML USP 5MG/5ML USP 5MG/5ML USP 5MG/5ML USP 5MG/5ML 5MG/5ML 5MG/5ML 5MG/5ML 4227 DISPERSIBLE LORATADINE 4228 DISPERSIBLE LORATADINE 4229 SOLUTION USP ORAL LORATADINE 4230 SOLUTION USP ORAL LORATADINE 4231 SUSPENSION ORAL LORATADINE 4232 SUSPENSION ORAL LORATADINE 4233 SUSPENSION ORAL LORATADINE 4234 SUSPENSION ORAL LORATADINE 4235 SUSPENSION ORAL LORATADINE 4236 SUSPENSION LORATADINE 4237 SUSPENSION LORATADINE 4238 SUSPENSION LORATADINE 4226 10MGTABLETS LORATADINE ENCILOR TABLETS Citihealth Imports 4239 SUSPENSION LORATADINE I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 351 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDONESIA 04-Aug-15SRI LANKA Full 09-Jan-14INDONESIA Full 04-Mar-14PAKISTAN Full 27-Jul-16INDONESIA Full 11-May-15CYPRUS Full 26-Jul-14BELGIUM Full BANGLADESH 21-Dec-14 06-Feb-18 Years Two Full BANGLADESH 28-Feb-18 Full BANGLADESH 24-Aug-17 Full THAILANDSRI LANKA 13-Sep-14 Full 04-Nov-17 Full (Ceylon) Ltd T Dankos P Farma Opal Laboratories (Pvt) Ltd Merck Sharp T P Dohme pharma Tbk Delobris Pharmaceuticals 01.06.18 Ltd-AT Yaden-LO42/17 Schering-Plough Lab N V Eskayef Bangladesh Ltd Pharmaceuticals Industry Ltd Beximco Pharmaceuticals Ltd Ltd. Pharmaceuticals Pvt Ltd P T Merck Sharp T P Dohme pharma Tbk (Contd.) Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Ltd (Pvt) Ltd Ltd Healthcare lanka Ltd (Ceylon) Ltd Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP 4241 5MG/5ML SYRUP LORATADINE 4242 HISTABAN 5MG/5ML USP SYRUP LORATADINE LOREZ SYRUP4243 SYRUP 5MG/5ML USP SYRUP LORATADINE ZEOS SYRUP4244 N/A 5MG/5ML USP SYRUP LORATADINE ALLERGET N/A SYRUP4245 10MGTABLETS LORATADINE SYRUP Hemas Astron (Pvt) Ltd CLARITYNE4246 Glaxo Wellcome 10MGTABLETS LORATADINE Hemas SRI LANKA TABLETS LORYTC 02-Apr-17Years Two 4247 10MGTABLETS LORATADINE Baur & Co (Pvt) A 4248 TABLETS 10MG USP TABLETS LORATADINE CLARITYNE ORADIN Access International TABLETS4249 10MG USP TABLETS LORATADINE SILORA TABLETS Baur & Co (Pvt) A 4250 10MG USP TABLETS LORATADINE Sunshine TABLET LOREZ 4251 TABLETS 10MG USP TABLETS LORATADINE TABLETS PRETIN Medinex (Pvt) Ltd N/A4252 10MG USP TABLETS LORATADINE The IBN SINA KALIDIN 10 TABLETS4253 10MG USP TABLETS LORATADINE LORYT TABLETS Emerchemie NB Astron (Pvt) Ltd PharmAce (Pvt) Ltd SRI LANKA Man Pharma T TABLETS 23-Dec-17 N/A Full Gamma 4240 1ML/ML SYRUP LORATADINE CLARITYNE SYRUP Baur & Co (Pvt) A 352 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 23-Dec-16 Full INDIA 07-Jun-14INDIA Full 14-Mar-16INDIA Full 06-Jul-15MALAYSIA Full 05-Apr-14 20-Apr-16 Full Full INDIAPAKISTAN 30-Jan-14 31-Mar-17INDIA Full Full INDIA 06-Dec-17INDONESIA Years Two 28-Jun-17 02-Mar-14INDIA Full Full PAKISTAN 21-Jan-16 22-Jul-15 Full Full Laborarories (Pvt) Ltd Laboratories XL (Pvt) Ltd Marksons Pharma Ltd Zim Laboratories Ltd SDN BHD IntermedMMC Healthcare Ltd INDIAFozen Pharmaceutical Industries Pvt Ltd 11-Jul-16Magbro Healthcare Full Zota Healthcare Ltd T Dankos P Farma Ltd Laboratories (Pvt) Ltd Agio Pharmaceuticals Ltd (Contd.) Ltd Plc Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Ltd (Pvt) Ltd Services Pvt. Ltd Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP 4255 10MG USP TABLETS LORATADINE LORIN4256 10MG USP TABLETS LORATADINE ALLOR 104257 TABLETS 10MG USP TABLETS LORATADINE LORAMARK TABLETS4258 Swiss Biogenics Ltd 10MG USP TABLETS LORATADINE Cassel Research LORAZIM TABLETS SMM Halcyon (Pvt) 4259 10MG USP TABLETS LORATADINE Browns & Company LORDAMIN TABLETS4260 10MG USP TABLETS LORATADINE LORAMED Tabrane TABLETS4261 10MG USP TABLETS LORATADINE ALLERDIN Indoscan (Pvt) Ltd TABLETS4262 10MG USP TABLETS LORATADINE Industries / S P Y N/A TABLETS Salveo Pharma 4263 10MG USP TABLETS LORATADINE N/A Markss HLC (Pvt) 4264 10MG USP TABLETS LORATADINE TABLETS LORGIC 104265 10MG USP TABLETS LORATADINE Pharma Tropical ZEOS TABLETS TABLETS4266 10MG USP TABLETS LORATADINE Alaris Lanka (Pvt) ABC Pharma ALLERBAN4267 10MG USP TABLETS TABLETS LORATADINE 10 ATCO-LOR TABLETS Hemas TABLETS Burhani Enterprises Saga laboratories Morison PLC ATCO 4254 10MG USP TABLETS LORATADINE LORITEX TABLETS Citihealth Imports I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 353 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIA 27-May-15INDIA Full INDIA 24-May-18 Years Two PAKISTAN 22-Dec-14 01-Feb-14 Full INDIA Full INDIA 16-May-18 Years Two BANGLADESH 18-Mar-15 25-Jun-14 Full INDIA Full INDIA 03-Apr-18 Full 19-Feb-15 Full PAKISTAN 11-Mar-14 Full Sterling Lab Human Verve INDIACare Laboratories Ltd 28-Jul-17Nabiqasim Industries (Pvt) Full Ltd Centaur Pharmaceutical (Pvt) Ltd Pharmaceuticals (India) Ltd Healthcare Pharmaceuticals Concept Pharmaceuticals Ltd Pharmaceuticals Ltd LaboratoriesIPCA INDIA CCL Pharmaceuticals 12-Jul-15(Pvt) Ltd Delta Pharma Ltd Full BANGLADESH 23-Apr-14 Full Unique Pharmaceutical Labs (Contd.) Co Ltd Agency Pvt Ltd Health (Pvt) Ltd Health (Pvt) Ltd (Pvt) Ltd International (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals Lanka (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Health (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP PRE PHASE H TABLETS Harcourts (Pvt) Ltd Coral Laboratories HLOSATRUST- TABLETSAUROZART-H George Steuart TABLETSBENEM PLUS PharmAce (Pvt) Ltd Aurochem TABLETSLOSACON H Citihealth Imports TABLETSZYLTAN-H Softcare TABLETSLOSANORM H 50 TABLETS Pharmacare LtdNORMOZIDE Hemas Troikaa TABLETSANIN PLUS CCL TABLETS Hyena HYDROCHLOROTHIAZIDE TABLETS HYDROCHLOROTHIAZIDE TABLETS USP HYDROCHLOROTHIAZIDE 2.5MG USP TABLETS 12.5mg USP+Hydrochlorothiazide BP TABLETS 12.5mg USP+Hydrochlorothiazide BP TABLETS 12.5mg USP+Hydrochlorothiazide BP TABLETS 50MG+Hydrochlorothiazide 12.5mg TABLETS 50MG+Hydrochlorothiazide 12.5mg TABLETS 50MG+Hydrochlorothiazide 12.5mg TABLETS 50MG+Hydrochlorothiazide 12.5mg TABLETS 4269 10MG USP TABLETS LORATADINE LORAX4270 1MG USP TABLETS LORAZEPAM VERALPAM4271 & POTASSIUM LOSARTAN TABLETS TABLETS Darley Butler & 4272 50MG POTASSIUM LOSARTAN Leader Pharma BEPSAR4273 50MG & POTASSIUM LOSARTAN TABLETS4274 50MG POTASSIUM LOSARTAN George Steuart 4275 50MG POTASSIUM LOSARTAN 4276 50MG POTASSIUM LOSARTAN 4277 POTASSIUM LOSARTAN 4278 POTASSIUM LOSARTAN 4279 POTASSIUM LOSARTAN 4280 POTASSIUM LOSARTAN 4268 10MG USP TABLETS LORATADINE LORID TABLETS George Steuart 354 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 GERMANY 12-Jul-17INDIA Years Two 08-Jul-14 Full INDIAINDIA 22-Jun-17INDIA Full 31-Jan-18 Years Two INDIA 27-Oct-19 Full INDIA 06-May-14 Full INDIA 27-Oct-14INDIA Full 22-Jun-17BANGLADESH Full 28-Sep-17 19-Mar-17 Years Two Years Two INDIA 02-Jun-14 Full Denk Pharma GmbH & Co. Cadila Healthcare Ltd Cipla LtdUnichem INDIALaboratories Cadila Healthcare Ltd 31-Aug-16Zim Laboratories Full Ltd Atoz Pharmaceuticals (Pvt) Ltd Zim Laboratories Ltd Unichem Laboratories Synmedic Laboratories (Pvt) Ltd Beximco Pharmaceuticals Ltd Scences (Contd.) Pharmaceuticals (Pvt) Ltd Healthcare lanka Ltd (Pvt) Ltd Ltd Healthcare lanka Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Ltd Pharmaceuticals (Pvt) Ltd (Ceylon) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP TABLETS Akbar COLOSA-DENK 50/12.5 LOSACAR-H TABLETSZAART-H Sunshine LOSAR 25 TABLETSN/A Breathe Free Lanka TABLETS 25COSART Baur & Co (Pvt) A TABLETS TABLETSLOZO 25 Sunshine Tabrane 25COSART TABLETS TABLETSAsian Pharma Euro LOSAR 25 Tabrane HYLOS 25 TABLETS CAPSULESPROSAN Baur & Co (Pvt) A Lifeline OROZART TABLETSASARTAN Emerchemie NB TABLETS PharmAce (Pvt) Ltd TABLETS Swiss Garnier Life N/A Astron (Pvt) Ltd SRI LANKA 03-Jun-14 Full 50MG+Hydrochlorothiazide 12.5mg TABLETS 50MG+Hydrochlorothiazide 12.5mg TABLETS 50MG+Hydrochlorothiazide 12.5mg TABLETS 25MG 25MG 25MG 25MG 25MG 25MG 25MG 25MG 25MG 25MG 4281 POTASSIUM LOSARTAN 4282 POTASSIUM LOSARTAN 4283 POTASSIUM LOSARTAN 4284 TABLETS POTASSIUM LOSARTAN 4285 TABLETS POTASSIUM LOSARTAN 4286 TABLETS POTASSIUM LOSARTAN 4287 TABLETS POTASSIUM LOSARTAN 4288 TABLETS POTASSIUM LOSARTAN 4289 TABLETS POTASSIUM LOSARTAN 4290 TABLETS POTASSIUM LOSARTAN 4291 TABLETS POTASSIUM LOSARTAN 4292 TABLETS POTASSIUM LOSARTAN 4293 TABLETS POTASSIUM LOSARTAN I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 355 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 PAKISTAN 23-May-14GERMANY Full 10-Dec-18INDIA Years Two INDIA 02-Dec-17INDIA Full 11-Sep-16INDIA Full 11-Apr-17 Full BANGLADESH 03-May-16 03-Apr-18 Full INDIA Full 22-Jun-17BANGLADESH 14-Nov-17 Full Years Two INDIAINDIA 27-Oct-16 Full PAKISTAN 04-Jan-17 03-Jan-18 Full INDIA Years Two 12-Jun-15 Full CCL CCL Pharmaceuticals (Pvt) Ltd Denk Pharma GmbH & Co. Unique Pharmaceutical Labs Dr Reddy's Laboratories Ltd Cadila Healthcare Ltd Torrent Pharmaceuticals Ltd Eskayef Bangladesh Ltd Unichem Laboratories Baximco Pharmaceuticals Zim Laboratories Ltd Windlas Biotech (Pvt) Ltd CCL Pharmaceuticals (Pvt) Ltd Scences (Contd.) Pharmaceuticals Lanka (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Health (Pvt) Ltd (Ceylon) Ltd Healthcare lanka Ltd Ltd Healthcare lanka Ltd Ltd (Ceylon) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals Lanka (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP MORNOPRESS TABLETSLOSARDENK 50 CCL TABLETS 25MYOTAN Akbar TABLETSRESILO 25 George Steuart LOSACAR TABLETS Emerchemie NB 25 TABLETSLOSATOR TABLETS Sunshine CARDON Edna Medicals (Pvt) LOSAR-50 TABLETSASARTAN Sunshine TABLETSPROSAN Baur & Co (Pvt) TABLETS A 50COSART N/A TABLETS TABLETSN/A Emerchemie NB Tabrane NORMOPRESS Astron (Pvt) Ltd SRI LANKA TABLETS TABLETS 50OROZART 07-Oct-17 CCL Lifeline Years Two TABLETS PharmAce (Pvt) Ltd Swiss Garnier Life 25MG 50MG 25MG 25MG 25MG 25MG 25MG 50MG 50MG 50MG 50MG 50MG 50MG 50MG 4294 TABLETS POTASSIUM LOSARTAN 4303 TABLETS POTASSIUM LOSARTAN 4295 TABLETS POTASSIUM LOSARTAN 4296 TABLETS POTASSIUM LOSARTAN 4297 TABLETS POTASSIUM LOSARTAN 4298 TABLETS POTASSIUM LOSARTAN 4299 TABLETS POTASSIUM LOSARTAN 4300 TABLETS POTASSIUM LOSARTAN 4301 TABLETS POTASSIUM LOSARTAN 4302 TABLETS POTASSIUM LOSARTAN 4304 TABLETS POTASSIUM LOSARTAN 4305 TABLETS POTASSIUM LOSARTAN 4306 TABLETS POTASSIUM LOSARTAN 4307 TABLETS POTASSIUM LOSARTAN 356 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 05-Nov-15 Full INDIAUNITED 02-Dec-17KINGDOM Full PAKISTANINDIA 24-Jun-17 Full 03-May-16INDIA Full INDIA 11-Sep-16INDIA Full 26-Jan-15SRI LANKA Full 22-Dec-14 06-Sep-17SRI LANKA Full Full 06-Nov-15SRI LANKA Full 06-Sep-16SRI LANKA Full 28-Aug-16INDIA Full INDIA 26-Nov-15 Full 27-Dec-17 Full Unique Pharmaceutical Labs Merck Sharp & Dohme Limiter U K for Merck Sharp & Dohme BV the Netherland Ltd Torrent Pharmaceuticals Ltd Cipla LtdDr Reddy's Laboratories Ltd INDIAPharmaceuticals Ltd 04-Jul-16Ltd Full Ltd (Ceylon) (Pvt) Ltd Ltd Pharmaceuticals Manufacturer Corporation Corona Remedics (Pvt) Ltd Centurion Laboratories Pvt Ltd (Contd.) Health (Pvt) Ltd Ltd Ltd (Pvt) Ltd (Ceylon) Ltd International (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP MYOTAN-50 TABLETSCOZAAR George Steuart TABLETS Baur & Co (Pvt) A TANSIN 50LOSATOR TABLETS TABLETSZAART-50 CIC Holdings PLC Edna Medicals (Pvt) PharmEvo (Pvt) RESILO 50 TABLETSZYLTAN TABLETS Breathe Free Lanka Emerchemie NB 25PRE PASE TABLETS TABLETSLOWPRESS 50 Pharmacare Ltd TABLETS Harcourts (Pvt) LtdN/A Troikaa Coral Laboratories N/AN/AN/A TABLETS Inter Pharm (Pvt) TABLETS N/AATOZAR TABLETS N/A 50NATRASOL TABLETS N/A TABLETS M S J Industries Sethma International Yaden Inter Pharm (Pvt) State 50MG 50MG 50MG 50MG 50MG 50MG 50MG 25MG BP 50MG BP 50MG BP 50MG BP 50MG BP 50MG BP 50MG BP 4311 TABLETS POTASSIUM LOSARTAN 4308 TABLETS POTASSIUM LOSARTAN 4309 TABLETS POTASSIUM LOSARTAN 4310 TABLETS POTASSIUM LOSARTAN 4312 TABLETS POTASSIUM LOSARTAN 4313 TABLETS POTASSIUM LOSARTAN 4314 TABLETS POTASSIUM LOSARTAN 4315 TABLETS POTASSIUM LOSARTAN 4316 TABLETS POTASSIUM LOSARTAN 4317 TABLETS POTASSIUM LOSARTAN 4318 TABLETS POTASSIUM LOSARTAN 4319 TABLETS POTASSIUM LOSARTAN 4320 TABLETS POTASSIUM LOSARTAN 4321 TABLETS POTASSIUM LOSARTAN I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 357 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 SRI LANKA 06-Sep-17INDIA Full 15-Dec-14SRI LANKA Full 18-Mar-17BANGLADESHYears Two 03-May-18 Full INDIAINDIA 16-May-18 Full INDIA 28-Jan-18PAKISTAN Full 06-Jun-14INDIA 19-Apr-18 Provisional Full INDIA 11-May-17 Full INDIA 05-Sep-15 Full INDIA 24-Oct-16 Full INDIA 19-Jul-16 Full 27-Jan-15 Full Ltd Stallion Laboratories Pvt Ltd Cipla Ltd(Pvt) Ltd INDIAIncepta Pharmaceuticals Ltd 04-Jul-16Centaur Pharmaceutical (Pvt) Ltd Full Theon Pharmaceuticals Ltd Bharat Parenterals Ltd (Pvt) Ltd Windlas Biotech (Pvt) Ltd Akums Drugs & Pharmaceuticals Ltd Laboratories (Pvt) Ltd Brussels Laboratories (Pvt) Ltd Health Care IVA (Pvt) Ltd (Contd.) (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd Health (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Supplies (Pvt) Ltd Pharmaceuticals (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP LOWPRESS 50 TABLETSLOSASTAL N/A TABLETSZAART-25 Siba Healthcare N/A TABLETS Inter Pharm (Pvt) OSARTIL Breathe Free Lanka TABLETS 25LOSATRUST TABLETS TABLETS N/A Citihealth Imports 25THEOSART George Steuart TABLETSBESARTAN-B Slim Unical Ceylon TABLETSOSAAR Baur Life Sciences LOSAKIND 25 TABLETS TABLETSLOSVEX 25 Ceyoka (Pvt) Ltd Hemas Lowitt Pharma TABLETS 25VAZORTAN TABLETS Global Impex AV 25LOSAVIN PharmAce (Pvt) Ltd Medley TABLETS 25IVASSRT Innovative Medical TABLETS Slim BP 50MG BP IP 25MG IP 25MG IP 50MG IP 25MG USP 25MG USP 25MG USP 25MG USP 25MG USP 25MG USP 25MG USP 25MG USP 25MG USP 25MG USP 4322 TABLETS POTASSIUM LOSARTAN 4323 TABLETS POTASSIUM LOSARTAN 4324 TABLETS POTASSIUM LOSARTAN 4325 TABLETS POTASSIUM LOSARTAN 4326 TABLETS POTASSIUM LOSARTAN 4327 TABLETS POTASSIUM LOSARTAN 4328 TABLETS POTASSIUM LOSARTAN 4329 TABLETS POTASSIUM LOSARTAN 4330 TABLETS POTASSIUM LOSARTAN 4331 TABLETS POTASSIUM LOSARTAN 4332 TABLETS POTASSIUM LOSARTAN 4333 TABLETS POTASSIUM LOSARTAN 4334 TABLETS POTASSIUM LOSARTAN 4335 TABLETS POTASSIUM LOSARTAN 358 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 06-Jun-14 Full INDIA 02-Sep-15 Full 26-Jul-16INDIA Full BANGLADESH 14-Jun-16 17-Mar-14BANGLADESH Full Full 08-Jun-16INDIA Full INDIA 25-Jan-16INDIA Full 10-May-18 Years Two INDIA 05-Feb-18 Years Two INDIA 22-Apr-18BANGLADESH Full 16-May-18 02-Jan-15 Full INDIA Full 29-May-18 Provisional Ankur Drugs & Pharma (Pvt) Ltd Macleods Pharmaceuticals Ltd Torrent Pharmaceuticals Ltd Micro Labs Ltd INDIASun Pharma Laboratories Ltd Eskayef 20-Jan-16Bangaladesh Ltd Full The ACME Laboratories Ltd Alkem Laboratories Ltd Macleods Pharmaceuticals Ltd Cadila Healthcare Ltd Lekar Pharma (Pvt) Ltd Centaur Pharmaceutical (Pvt) Ltd Globe Pharmaceuticals Ltd Agio Pharmaceuticals Ltd (Contd.) International (Pvt) Ltd (Pvt) Ltd Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Novex Pharmaceutical Ltd Ltd (Ceylon) Ltd (Pvt) Ltd Healthcare lanka Ltd Health (Pvt) Ltd Health (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP TABLETS BESARTAN-B TABLETS 25CZARTAN Softcare TABLETS 25TOZAAR Pettah Pharmacy TABLETSANGIZAAR-25 TABLETS Edna Medicals (Pvt) 25REPACE Micro Mega Lanka TABLETSCORDON Hemas 25LOSART FILM COA LARA TABLETSCZARTAN Mega Pharma (Pvt) TABLETSN/A TABLETS Emerchemie NB Pettah Pharmacy N/A TABLETS 50LOSATRUST TABLETS Sunshine TABLETSLOK 50 George Steuart George Steuart AGIACE 50 TABLETS TABLETS Tabrane Citihealth Imports USP 25MG USP USP 25MG USP 25MG USP 25MG USP 25MG USP 25MG USP 25MG USP 25MG USP 50MG USP 50MG USP 50MG USP 50MG USP 50MG USP 50MG USP 4336 TABLETS POTASSIUM LOSARTAN 4337 TABLETS POTASSIUM LOSARTAN 4338 TABLETS POTASSIUM LOSARTAN 4339 TABLETS POTASSIUM LOSARTAN 4340 TABLETS POTASSIUM LOSARTAN 4341 TABLETS POTASSIUM LOSARTAN 4342 TABLETS POTASSIUM LOSARTAN 4343 TABLETS POTASSIUM LOSARTAN 4344 TABLETS POTASSIUM LOSARTAN 4345 TABLETS POTASSIUM LOSARTAN 4346 TABLETS POTASSIUM LOSARTAN 4347 TABLETS POTASSIUM LOSARTAN 4348 TABLETS POTASSIUM LOSARTAN 4349 TABLETS POTASSIUM LOSARTAN I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 359 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIASRI LANKA 21-Jun-17 26-Dec-18INDIA Full Years Two INDIA 06-Jun-14BANGLADESH Full 25-Oct-18 02-Jun-18 Years Two INDIA Full INDIA 12-Jul-18 Full INDIA 19-Mar-17 Full INDIA 10-Apr-17 Full INDIA 06-Jun-14 Full INDIA 28-Jan-18 Years Two INDIA 27-Jan-15INDIA Full 14-Jun-15 Full 05-Sep-16 Full Akums Drugs & Pharmaceuticals Ltd (Pvt) Ltd Bharat Parenterals Ltd Pharmaceuticals (Pvt) ltd Incepta Pharmaceuticals Ltd Windlas Biotech (Pvt) Ltd Pharmaceuticals (India) Ltd Cadila Healthcare Ltd Ankur Drugs & Pharma (Pvt) Ltd Theon Pharmaceuticals Ltd Health Care IVA (Pvt) Ltd MMC Healthcare Ltd Akums Drugs & Pharmaceuticals Ltd (Contd.) Plc (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Healthcare lanka Ltd International (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Ltd (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP LOSAWEL 50LOSAWEL TABLETSBIPILO 50 Browns & Company BESARTAN-B TABLETS TABLETS 50LOCART N/A Baur Life Sciences TABLETSOSARTIL Algarash (Pvt) Ltd Surien LOSAKIND 50 Celogen Lanka TABLETS TABLETS Citihealth Imports 50AUROZART Hemas TABLETSLOSACAR PharmAce (Pvt) Ltd Aurochem TABLETSBESARTAN-B TABLETS Sunshine 50THEOSART Softcare TABLETS 50mgIVASSRT Slim TABLETS 50EMTAN Slim LOSVEX 50 TABLETS TABLETS Markss HLC (Pvt) Global Impex AV USP 50MG USP USP 50MG USP 50MG USP 50MG USP 50MG USP 50MG USP 50MG USP 50MG USP 50MG USP 50MG USP 50MG USP 50MG USP 50MG USP 4350 TABLETS POTASSIUM LOSARTAN 4351 TABLETS POTASSIUM LOSARTAN 4352 TABLETS POTASSIUM LOSARTAN 4353 TABLETS POTASSIUM LOSARTAN 4354 TABLETS POTASSIUM LOSARTAN 4355 TABLETS POTASSIUM LOSARTAN 4356 TABLETS POTASSIUM LOSARTAN 4357 TABLETS POTASSIUM LOSARTAN 4358 TABLETS POTASSIUM LOSARTAN 4359 TABLETS POTASSIUM LOSARTAN 4360 TABLETS POTASSIUM LOSARTAN 4361 TABLETS POTASSIUM LOSARTAN 4362 TABLETS POTASSIUM LOSARTAN 360 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 BANGLADESH 29-Mar-16INDIA Full INDIA 20-Jun-16 Full BANGLADESH 24-Oct-16 02-Jan-15 Full INDIA Full 19-Jul-15 Full BANGLADESH 04-Nov-14 Full INDIAINDIA 03-Jun-18 Full INDIA 21-Jun-17 Full 30-May-18INDIA Full 08-Aug-17 Full Healthcare Pharmaceuticals Intas Pharmaceuticals Ltd Pharmaceuticals Ltd Globe Pharmaceuticals Ltd Brussels Laboratories (Pvt) Ltd Innova Captab INDIAPharmaceuticals Industry Ltd 01-Oct-16Kopran Ltd Full Concept INDIAPharmaceuticals Ltd Akums Drugs & Pharmaceuticals 10-Oct-15Ltd Sun Full Pharmaceutical industries Micro Labs Ltd INDIACadila pharmaceuticals Ltd 20-Jan-17 Full (Contd.) (Pvt) Ltd Co Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Ltd International (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Healthcare lanka Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP BENEM 50 50LOSARTAS TABLETS TABLETS 50 Citihealth Imports VAZORTAN Darley Butler & TABLETSLOK 50 PharmAce (Pvt) Ltd Medley 50LOSAVIN TABLETS TABLETSLOSARIDE 50 Tabrane Innovate TABLETSLOSIUM Slim IOSAN TABLETSLOSACON 50 Medinex (Pvt) Ltd The IBN SINA TABLETS TABLETS 50LOSAWEL Alaris Lanka (Pvt) Softcare TABLETSREPACE-50 Lotus TABLETSANGIZAAR-50 Hemas TABLETSLOSIUM Micro Mega Lanka TABLETS Sunshine USP 50MG USP USP 50MG USP 50MG USP 50MG USP 50MG USP 50MG USP 50MG USP 50MG USP 50MG USP 50MG USP 50MG USP 50MG USP 50MG USP 4363 TABLETS POTASSIUM LOSARTAN 4364 TABLETS POTASSIUM LOSARTAN 4365 TABLETS POTASSIUM LOSARTAN 4366 TABLETS POTASSIUM LOSARTAN 4367 TABLETS POTASSIUM LOSARTAN 4368 TABLETS POTASSIUM LOSARTAN 4369 TABLETS POTASSIUM LOSARTAN 4370 TABLETS POTASSIUM LOSARTAN 4371 TABLETS POTASSIUM LOSARTAN 4372 TABLETS POTASSIUM LOSARTAN 4373 TABLETS POTASSIUM LOSARTAN 4374 TABLETS POTASSIUM LOSARTAN 4375 TABLETS POTASSIUM LOSARTAN I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 361 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 06-Feb-17 Full INDIAINDIA 07-Feb-16SWITZERLAND Full 28-Feb-15 03-May-14SPAIN Full Full INDIA 26-Feb-18 Years Two INDIA 11-May-16INDIA Full 30-Jan-18UNITED Full KINGDOM 30-Jan-18 Full MALAYSIA 23-Jan-18INDIA Full INDIA 24-Jul-14 Full 28-Apr-18 Years Two Alkem Laboratories Ltd Stallion Laboratories Pvt Ltd Merck Serono S A s Autovia De S L Logrono Alembic Pharmaceuticals Ltd J.B.Chemicals & Pharmaceuticals J.B.Chemicals & Pharmaceuticals Macarthys Laboratories Ltd Abbott India Ltd INDIAKotra pharma (M) Ltd 11-Mar-18 Full Marck Bio Sciences Ltd PharmaceuticalS (Pvt) Ltd (Contd.) (Ceylon) Ltd (Pvt) Ltd Ltd Ceyoka (Pvt) Ltd Casen Recordat Citihealth Imports (Pvt) Ltd George Steuart Health (Pvt) Ltd George Steuart Health (Pvt) Ltd Ltd Healthcare lanka Ltd Delmege Forsyth & Co Ltd Pharmaceuticals (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP SOLUTION TABLETS SUSPENSION SUSPENSION GEL ORAL Sunshine SUSPENSION LARA TABLETS Emerchemie NB CASENLAX 10MG POWDER ORAL ALEMBIC ULGEL CHEWABLE MASKACIDMASKACID ORAL ORAL N/A DIGENE GEL INJECTION STRAWBERRY FLAVOUR Niix Holdings (Pvt) EVILIN AXCEL FORTE N/AMAGCI 50 INJECTION INJECTION Akbar Ceyoka (Pvt) Ltd Ciron Drugs & +SIMETHICONE+SODIUM CARBOXYMETHLCELLULOSE+ DRIED ALU.HYD GEL USP 50MG USP ORAL SOLUTION IN SACHET 10G SOLUTION IN SACHET ORAL TABLETS SIMETHICONE 20MG 20MG/5ML SIMETHICONE USP 20MG/5ML SIMETHICONE USP SUSPENTION ORAL 16.265% W/ HEXAHYDRATE CHLORIDE 5.965% V+POTASSIUM WV+PROCAINE HYDROCHLORIDE 1.364% W/V INJECTION 400mg+ALUMINIUM HYDROXIDE 400MG+SIMETHICONE 40MG ORAL SUSPENSION USP 50 % INJECTION USP 50% W/V BP 4384 MAGNESIUM HYDROXIDE 4376 TABLETS POTASSIUM LOSARTAN 4377 50MG IP TABLETS LOSARTAN LOSASTAL4378 INJECTION 75IUALFA LUTROPIN LUVERIS TABLETS4379 4000 POWDER FOR MACROGOL Siba Healthcare SOLUTION4380 400MG & MAGALDRATE Baur & Co (Pvt) A 4381 400MG & MAGALDRATE 4382 400MG & MAGALDRATE 4383 MAGNESIUM CHLORIDE 4385 MAGNESIUM HYDROXIDE 4386 INJECTION MAGNESIUM SULFATE 4387 INJECTION MAGNESIUM SULPHATE 362 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 PAKISTAN 31-Dec-16INDIA Full 08-Mar-18INDIA Years Two CHINA 04-Jul-17 Years Two CHINA 08-Apr-17 Years Two MALAYSIA 05-Feb-16INDIA 23-Jan-18 Full Full INDIA 20-Oct-14INDIA Full 20-Oct-14 Full 17-Dec-16BELGIUM Full 21-Sep-14SRI LANKA Full 13-Jan-18BANGLADESH Provisional 08-Mar-18 Years Two Zafa Pharmaceuticals Laboratories (Pvt) Ltd Zota Healthcare Ltd Aculife Healthcare (Pvt) Ltd Hebei Tiancheng Pharmaceuticals Co Ltd Pharmaceutical Co. Ltd B Braun Medical Industries Serum Institute of India (Pvt) Ltd Serum Institute of India (Pvt) Ltd Serum Institute of India (Pvt) Ltd Glaxo Smithkiline A Biologicals S (Ceylon) (Pvt) Ltd Company Ltd (Contd.) (Pvt) Ltd Alaris Lanka (Pvt) Ltd Healthcare lanka Ltd Pharmaceuticals (Pvt) Ltd Ltd (Pvt) Ltd (Pvt) Ltd Citihealth Imports (Pvt) Ltd GlaxoSmithkiline Pharmaceuticlas (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP TABLETS INJECTION B Braun Lanka (Pvt) INJECTION INJECTION N/A CIDZOTA INJECTION International Yaden CHEWABLE N/AN/A INFUSIONN/A Sunshine INJECTIONOSMOFUNDIN 20 Slim % IV INJECTIONN/A Pharma AssociatesN/A Sichuan Kelun N/A INJECTION Citihealth Imports INJECTION Citihealth Imports POWDER FOR PRIORIXN/A POWDER N/A TABLETS TABLETS N/A M S J Industries Essential Drugs USP 500MG/1ML USP B.P 250MG,DRIED B.P ALUMINIUM HYDROXIDE B.P 120MH,COMPOUND MAGNESIUM BP TABLETS. TRISILICATE INFUSION BP W/V 20% INFUSION BP INFUSION - (MMR) VACCINE - (MMR) VACCINE ATTENUATED LIVE VACCINE CONTAINERS SINGLEDOSE 0.5ML VIRUS 5000 1000CCID MEASEL CCID MUMPS 1000CID OF RUBELLA VACC VIRUS VACCINE USP 500MG TABLETS 4388 INJECTION MAGNESIUM SULPHATE 4389 MAGNESIUM TRISILICATE 4390 20% INTRAVENOUS MANNITOL 4391 20% INJECTION USP MANNITOL 4392 INTRAVENOUS MANNITOL 4393 SOLUTION 20% IV MANNITOL 4394 MEASLES,MUMPS & RUBELLA 4395 MEASLES,MUMPS & RUBELLA 4396 MEASLES,MUMPS & RUBELLA 4397 LIVE MEASLES,MUMPS & RUBELLA 4398 100MG MEBENDAZOLE TABLETS 4399 MEBENDAZOLE CHEWABLE I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 363 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 20-Mar-17 Full BELGIUM 26-Jun-17INDIA Full INDIA 01-Jan-18 Provisional SRI LANKA 05-Jan-18 Years Two 06-Nov-17Years Two SRI LANKA 08-Mar-15INDIA Full INDIA 14-Jul-14 Full PAKISTAN 01-Nov-17 22-Feb-15 Full FRANCE/ NETHERLANDS Full PAKISTAN 25-Mar-14PAKISTAN Full FRNACE 12-Nov-15 Full 15-Oct-17 Years Two Janasen Pharmaceuticals N V Cadila pharmaceuticals Ltd Cadila pharmaceuticals Ltd Pharmaceuticals Manufacturer Corporation (Ceylon) (Pvt) Ltd Unique Pharmaceutical Labs Zim Laboratories Ltd Nabiqasim Industries (Pvt) Ltd Mylan Laboratories Ltd Shaigan Pharmaceuticals (Pvt) Ltd S J & G Fazul Ellahie (Pvt) Ltd Laboratories Ltd (Contd.) Pettah Pharmacy (Pvt) Ltd Sunshine Healthcare lanka Ltd Healthcare lanka Ltd Health (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Health (Pvt) Ltd Colombo Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP SOLUTION SUSPENSION CAPSULES CIC Holdings PLC Mylan VERMOXWORMIN ORAL WORMIN ORAL N/A TABLETS Sunshine N/A TABLETSVERMOREX N/A TABLETS TABLETSWERMOZIM 500 TABLETS George Steuart N/ACOLOSPAS State Tabrane TABLETSDUSPATALIN M S J Industries George Steuart TABLETSNEVIR 135 Chemical Industries ZEESPA TABLETS Kamazu (Pvt) LtdMEVRIN 135 TABLETS Micro Labs Ltd DUSPATALIN TABLETS INDIA Akbar 200 RETARD V H Distributors A 10-Jan-14 Full TABLETS BP 135MG BP TABLETS SUSPENSION 20MG/ML BP 135MG BP BP 135MG BP 100MG/5ML 100MG 500MG 500MG 100MG 500MG 135MG TABLETS 135MG BP TABLETS CAPSULES 200MG 4411 MEBEVERINE HYDROCHLORIDE 4409 MEBEVERINE HYDROCHLORIDE 4400 MEBENDAZOLE ORAL 4410 MEBEVERINE HYDROCHLORIDE 4401 MEBENDAZOLE SUSPENSION 4402 USP MEBENDAZOLE TABLETS 4403 USP MEBENDAZOLE TABLETS 4404 USP MEBENDAZOLE TABLETS 4405 USP MEBENDAZOLE TABLETS 4406 USP MEBENDAZOLE TABLETS 4407 MEBEVERINE HYDROCHLORIDE 4408 MEBEVERINE HYDROCHLORIDE 4412 MEBEVERINE HYDROCHLORIDE 364 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 24-Mar-18 Full INDIA 05-Jun-18 Full THAILAND 09-Nov-18 Years Two INDONESIA 01-Nov-14 09-Mar-15 Full BELGIUM Full 17-Oct-17INDIA Full INDIA 24-May-18 Years Two INDIA 01-Jan-15PAKISTAN Full 16-May-14MALAYSIA 03-Feb-15 Full Full 26-Mar-14 Full INDIA 23-Jun-17 Full INDIA 20-Jan-15 Full zer fi Sun Pharmaceutical industries Zim Laboratories Ltd Laboratories Ltd Drugs P T Laboratories T Harsen P Yafefa (Dis. By Primarta) P Manufacturing NV/SA Belco Pharma (Pvt) Ltd Laboratories Ltd Medico Remedies (Pvt) Ltd Adamjee Pharmaceuticals Kotra pharma (M) Ltd Agung T Pertivi P PAKISTAN 06-Jan-14Pharmaceuticals Ltd Full Blue Cross Laboratories Ltd (Contd.) (Ceylon) Ltd Pharmaceuticals (Pvt) Ltd Ceyoka (Pvt) Ltd Mylan Celyon (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Agency Pvt Ltd Pharmaceuticals (Pvt) Ltd Pvt Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharma Associates Bafna Hayleys Consume Produsts Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP SOLUTION INJECTION Mansel (Ceylon) CAPSULES Delmege Medical SUSPENSION SUSPENSION MEBIZ SRMENIN SR 200 CAPSULES CAPSULES Emerchemie NB N/A Tabrane DEPOTONE INJECTABLE DEPO INJECTIONPROGESTIN Associated Pharma DEPO PROVER INJECTIONN/A Hemas FAMY-DEPO INJECTIONN/A INJECTION Leader Pharma Ceyoka (Pvt) LtdDOLOR Mylan TABLETS AXCEL MEFENAMIC ACD TABLETS Akbar ASMEF Jayanetti & Sons P INPEL TABLETSMEFTAL-P Lifeline ORAL ORAL MODIFED RELEASE CAPSULES 200MG SR CAPSULES 200MG INJECTABLE ACETATE 150MG/ML SUSPENSION USP INJECTION 150MG/ML ACETATE INJECTION 150MG/ML ACETATE INJECTION 150MG/ML ACETATE 150MG/ INJECTION USP ACETATE ML INJECTION 150MG/ML ACETATE 250MG 250MG 250MG 500MG TABLET SUSPENSION 100MG IN 5ML 100MG IN 5ML 4413 MEBEVERINE HYDROCHLORIDE 4414 MEBEVERINE HYDROCHLORIDE 4415 MEDROXYPROGESTERONE 4416 MEDROXYPROGESTERONE 4417 MEDROXYPROGESTERONE 4418 MEDROXYPROGESTERONE 4419 MEDROXYPROGESTERONE 4420 MEDROXYPROGESTERONE 4421 MEFENAMIC ACID BP TABLETS 4422 MEFENAMIC ACID BP TABLETS 4423 ACID CAPSULES BP MEFENAMIC 4424 ACID FILM COATED MEFENAMIC 4425 MEFENAMIC ACID ORAL 4426 MEFENAMIC ACID SUSPENSION I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 365 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 SRI LANKA 26-Mar-16INDIA Full SRI LANKA 11-Dec-15 11-Nov-17INDIAYears Two Full INDIA 15-Jan-15 Full INDIA 02-Apr-18INDIA Full 09-Mar-18INDIA Full 05-Jan-16 Full INDIA 28-Mar-14INDIA Full 27-May-16SRI LANKA Full 05-Jan-16 03-Mar-15INDIA Full Full 11-May-16 Full INDIA 25-May-15 Full Ltd Blue Cross Laboratories Ltd Ltd Pharmaceuticals Ltd Pondchy Pharmaceuticals Unicure Ramadies (Pvt) Ltd Pharmaceuticals Ltd Fourrts (India) Laboratories Ltd Lincolin Pharmaceuticals Pharmaceuticals Ltd Ltd Alembic Pharmaceuticals Ltd Orion pharma Ltd BANGLADESH 11-Apr-18Years Two United Biotech (Pvt) Ltd (Contd.) Produsts Ltd Pharmaceuticals (Pvt) Ltd Ltd Healthcare lanka Ltd Imports (Pvt) Ltd Citihealth Imports (Pvt) Ltd Darley Butler & Co Ltd Health (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP SUSPENSION ORAL SOLUTION MEFEN P SUSPENSION N/AN/AINPEL Inter Pharm (Pvt) TABLETSMEFI 500 INJECTION N/A Pharma AssociatesMEPEN 500 TABLETS Bafna INPEL TABLETS Neon Inter Pharm (Pvt) Emar Pharma (Pvt) MEFER TABLETSMEFLIN 500 Pharma Associates TABLETS Bafna INPEL TABLETS Sunshine & J Pharma T MEFEN TABLETSALEMIC ULGEL Pharma Associates ORAL TABLETS Bafna NOVELTA SUSPENTION N/AONISTROL TABLETS Inter Pharm (Pvt) George Steuart 50MG/5ML 250MG 250MG 500MG 500MG 500MG 500MG 500MG 500MG 500MG SIMETHICONE 20MG ORAL SUSPENSION SIMETHICONE 20MG ORAL SUSPENSION 40MG 4427 ACID SUSPENSION BP MEFENAMIC 4428 100MGTABLETS ACID MEFENAMIC MEFTAL-P4429 MEFENAMIC ACID BP TABLETS TABLETS4430 MEFENAMIC ACID BP TABLETS Hayleys Consume 4431 MEFENAMIC ACID BP TABLETS 4432 MEFENAMIC ACID BP TABLETS 4433 MEFENAMIC ACID BP TABLETS 4434 MEFENAMIC ACID BP TABLETS 4435 MEFENAMIC ACID BP TABLETS 4436 MEFENAMIC ACID BP TABLETS 4437 MEFENAMIC ACID BP TABLETS 4438 400MG & MEGALDRATE 4439 480MG & MEGALDRATE 4440 IP TABLETS ACETATE MEGESTROL 366 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 22-Jun-17PAKISTAN Full 26-Jul-17INDIA 14-Nov-16 Full Full 23-Aug-16INDIA Full 27-Oct-17 Years Two INDIAINDIA 27-Oct-17 Years Two INDIA 02-Feb-18 Years Two INDIA 05-Jul-17 Full INDIA 10-Feb-19INDIA Full 08-Jun-18INDIA Years Two 17-Dec-14 Full 10-Feb-14 Full Agio Pharmaceuticals Ltd Pharmatec Pakistan (Pvt) Ltd Cadila Healthcare Ltd Cipla LtdSunrise International LabS INDIALtd Cipla Ltd 12-Sep-18Sunrise Years Two International LabS INDIALtd Sun Pharmaceutical industries 12-Sep-18Years Two Cadila pharmaceuticals Ltd Zim Laboratories Ltd Aurobindo Pharam Ltd Laboratories XL (Pvt) Ltd Zim Laboratories Ltd Unichem Laboratories (Contd.) (Pvt) Ltd Pharmaceuticals Healthcare lanka Ltd (Pvt) Ltd Pharmaceutical (Pvt) Ltd (Pvt) Ltd Pharmaceutical (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Healthcare lanka Ltd Pharmaceuticals (Pvt) Ltd Ltd Ltd Pharmaceuticals (Pvt) Ltd Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP 4442 15MG MELOXICAM CAPSULES BP 15 LOXINOL 4443 15MG MELOXICAM CAPSULES BP TABLETS APOCAM4444 15MG MELOXICAM CAPSULES BP Citihealth Imports N/A TABLETS4445 15MGTABLET MELOXICAM Brown & Burk 4446 7.5MGTABLETS MELOXICAM MELOX TABLETS SUNFLAM4447 7.5MGTABLETS MELOXICAM Sunshine TABLETS4448 7.5MG TABLETSTABLETS MELOX 7.5 MELOXICAM Breathe Free Lanka SUNFLAM Kent 4449 TABLETS 7.5MGTABLETS MELOXICAM Breathe Free Lanka TABLETS MUVERA4450 7.5MGTABLETS MELOXICAM Kent MUVIK 7.5 TABLETS4451 15MG BP TABLETS MELOXICAM LOXICAM 15 Hemas TABLETS4452 15MG BP TABLETS MELOXICAM TABLETS Sunshine AROXICAM 154453 15MG BP TABLETS MELOXICAM Tabrane TABLETS MELCOM 154454 15MG BP TABLETS MELOXICAM Alaris Lanka (Pvt) LOXICAM 15 TABLETS TABLETS SMM Halcyon (Pvt) Tabrane 4441 MELOXICAM CAPSULES 7.5MG M-CAM TABLETS Baur & Co (Pvt) A I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 367 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIA 26-Jul-18 Years Two INDIAINDIA 04-Jan-16 Full INDIA 12-Jul-17 Years Two INDIA 26-Jul-17INDIA Full 18-Sep-17 Years Two INDIA 16-May-17 Full 12-Sep-15 Full INDIA 28-Mar-18 Full Medochemie Ltd CYPRUSMacleods 23-Nov-18Pharmaceuticals Ltd Years Two Medico Remedies (Pvt) Ltd Agio Pharmaceuticals Ltd Laboratories XL (Pvt) Ltd Unique Pharmaceutical Labs Zim Laboratories Ltd Sanbe FarmaT P INDONESIA 16-Nov-17G D Laboratories Years Two (India) Pvt Ltd Medochemie Ltd CYPRUS Sanbe FarmaT P INDONESIA 23-Nov-16 16-Nov-17 Full Agio Years Two Pharmaceuticals Ltd (Contd.) Laboratories (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Ltd Health (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Laboratories (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP 4459 7.5MG BP TABLETS MELOXICAM MEDOXICAM4460 7.5MG BP TABLETS MELOXICAM TABLETS MELOCAM 7.54461 Associated 7.5MG BP TABLETS MELOXICAM TABLETS CAMOLA Pettah Pharmacy 4462 7.5MG BP TABLETS MELOXICAM 7.5 LOXINOL TABLETS4463 7.5MG BP TABLETS MELOXICAM TABLETS Akbar MELCOM 7.54464 7.5MG BP TABLETS MELOXICAM Citihealth Imports TABLETS UNIMELO 7.54465 7.5MG BP TABLETS MELOXICAM TABLETS SMM Halcyon (Pvt) LOXICAM4466 George Steuart 15MG USP TABLETS MELOXICAM OSTELOX TABLETS4467 15MG USP TABLETS MELOXICAM Tabrane OXICHEM 15 TABLETS TABLETS Lifeline Lifeline 4457 7.5MG BP TABLETS MELOXICAM OSTELOX4458 7.5MG BP TABLETS MELOXICAM 7.5 LOXINOL TABLETS TABLETS Lifeline Citihealth Imports 4455 15MG BP TABLETS MELOXICAM 4456 MOZTA 15MG BP TABLETS MELOXICAM MEDOXICAM TABLETS TABLETS Ceyoka (Pvt) Ltd Associated ENGLISH PAKISTAN 13-Jul-18 Full 368 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 PAKISTAN 24-Mar-18INDIA Full PAKISTAN 05-Feb-17 12-Jul-16 Full PAKISTAN Full 24-Mar-18INDIA Full 31-Aug-17 Full INDIA 20-Sep-17 Years Two PAKISTANINDIA 04-Oct-17 Years Two PAKISTAN 12-Jan-18PAKISTAN 14-Dec-17 Provisional Years Two 22-Feb-18INDIA Full 03-Aug-17 Full Sun Pharmaceutical industries Hilton Pharma (Pvt) Ltd Laboratories (Pvt) Ltd G D Laboratories (India) Pvt Ltd Natco Pharma Ltd INDIACelon Laboratories Ltd 24-Jan-14Medochemie Ltd CYPRUS Full MASS Pharma 28-Jun-18Pvt Ltd Pharmafabrikon Full Unit MASS Pharma Pvt Ltd Laboratories (Pvt) Ltd Sun Pharmaceutical industries Laboratories (Pvt) Ltd (Contd.) Pharmaceuticals (Pvt) Ltd Healthcare lanka Ltd Pharmaceuticals (Pvt) Ltd Healthcare lanka Ltd (Pvt) Ltd Laboratories (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd Emerchemie NB (Ceylon) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP TABLETS MANTOMED 10MANTOMED TABLETSXANTOL Associated MENDIN 10 TABLETSXANTOL TABLETS V H Distributors A 10FOLIANT Novachem Lanka TABLETS TABLETS 10ADMENTA V H Distributors A PharmAce (Pvt) Ltd FILM COA Wilshire TABLETS 10MG TABLETS 10MG TABLETS 10MG TABLETS 10MG TABLETS 10MG TABLETS 10MG TABLETS 4469 15MG USP TABLETS MELOXICAM MUVERA4470 15MG USP TABLETS MELOXICAM XOBIX TABLETS4471 7.5MG USP TABLETS MELOXICAM Hemas M.COM 7.5 TABLETS4472 7.5MG USP TABLETS MELOXICAM TABLETS OXICHEM 7.5 Sunshine 4473 TABLETS 5MG BP PharmAce (Pvt) LtdTABLETS MELPHALAN Wilshire ALPHALAN 5 Lifeline 4474 2MG USP TABLETS MELPHALAN TABLETS ALKACEL4475 MEMANTINE HYDROCHLORIDE Sunshine TABLETS4476 MEMANTINE HYDROCHLORIDE Medmart Pharma 4477 MEMANTINE HYDROCHLORIDE 4478 MEMANTINE HYDROCHLORIDE 4479 MEMANTINE HYDROCHLORIDE 4480 MEMANTINE HYDROCHLORIDE 4468 15MG USP TABLETS MELOXICAM MELBON 15 TABLETS PharmAce (Pvt) Ltd Wilshire I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 369 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 PAKISTAN 12-Jul-17INDIA Years Two INDIA 03-Aug-17INDIA Full 22-Feb-15PAKISTAN Full 16-Nov-17 Years Two 12-Jul-17INDIA Years Two BELGIUM 22-Feb-18 Years Two 20-Jan-14INDIA Full INDIA 09-Nov-18 Years Two 08-Nov-18 Years Two SINGAPORE 09-Jan-18INDIA Full 11-Mar-15 Full Medochemie Ltd CYPRUSGenome 28-Jun-18Pharmceuticals (Pvt) Ltd Full Sun Pharmaceutical industries Pvt Ltd Cadila Healthcare Ltd Genome Pharmceuticals (Pvt) Ltd Pvt Ltd Glaxo Smithkiline A Biologicals S Ltd Vaccine Ltd Vaccine Leung Kai Fook Medical Co Ltd Cadila Healthcare Ltd (Contd.) Laboratories (Pvt) Ltd (Pvt) Ltd Emerchemie NB (Ceylon) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Ceyoka (Pvt) Ltd Bharat Serums & Ceyoka (Pvt) Ltd Bharat Serums & Singha Holdings (Pvt) Ltd Pharmaceuticals (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP TABLETS INJECTION Hemas POW INJECTION POW INJECTION MEDICATED OIL MANTOMED 20MANTOMED TABLETSDEMANTIN 20 Associated TABLETS 5ADMENTA Healthcare Tabrane FILM COA ALZITIN 10 10MENTRA TABLETS TABLETS PharmAce (Pvt) LtdDEMANTIN 10 Consern Pharma Hemas TABLETSALZITIN Healthcare Tabrane MENCEVAX ACWY TABLETSHUMOG-150IU PharmAce (Pvt) Ltd Consern Pharma LYOPHILIZED HUMOG-75HP LYOPHILIZED PAMOLAXE BRAND LINIMENT OIL UNIVERSAL N/A6-MP Holychems TABLETS SRI LANKA Hemas 23-Sep-16 Full TABLETS 20MG TABLETS SALICYLATE 15%+ EUCALYPTUS 15%+ EUCALYPTUS SALICYLATE OIL 15% MEDUCATED TABLETS 20MG TABLETS 5MG TABLETS 10MG USP TABLETS 10MG USP TABLETS 10MG TABLETS 10MG USP TABLETS ACWY) 150 IU 75 IU BP 20%+THYMOL SALICYLATE 0.5% 0.5% + EUCALIPTUS OIL 0.5% LINIMENT +TURPENTINE OIL 50MG 4481 MEMANTINE HYDROCHLORIDE 4492 20%+ METHYL MENTHOL 4482 MEMANTINE HYDROCHLORIDE 4483 MEMANTINE HYDROCHLORIDE 4484 MEMANTINE HYDROCHLORIDE 4485 MEMANTINE HYDROCHLORIDE 4486 MEMENTINE HYDROCHLORIDE 4487 MEMENTINE HYDROCHLORIDE 4488 ( VACCINE MENINGOCOCCAL 4489 MENOTROPHIN FOR INJECTION BP 4490 MENOTROPHIN FOR INJECTION 4491 2.5%+ METHYL MENTHOL 4493 IP TABLETS MERCAPTOPURINE 370 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 04-May-18 Provisional INDIA 24-Jun-16 Full INDIA 25-Jul-18 Years Two BANGLADESH 13-Jun-18 02-Dec-17BANGLADESH Full Full 07-Jul-15INDIA Full 13-Jun-17 Full INDIAGERMANY 25-Apr-18 12-Apr-17 Years Two Full INDIAINDONESIA 26-Nov-15 04-May-15 Full Full INDIA 09-Mar-18 Years Two Macleods Pharmaceuticals Ltd Advance Scott Edil Research Laboratories Macleods Pharmaceuticals Ltd Akums Drugs & Pharmaceuticals Ltd The Acme Laboratories Ltd Pharmaceuticals Ltd Akums Drugs & Pharmaceuticals Ltd (Pvt) Ltd Excella GmbH Germany for Glaxo Smith Kline GmbH Biolab Co Ltd THAILANDShamshree Lifesciences Ltd 13-May-18 T Dankos P Farma Full Renata Limited BANGLADESHSanjivani 01-Apr-15Parentaral Ltd Full (Contd.) (Pvt) Ltd Ltd (Pvt) Ltd Browns & Company Plc Mega Pharma (Pvt) Ltd PharmAce (Pvt) Ltd Square Lotus Pharmaceuticals (Pvt) Ltd Pharmaceuticlas (Pvt) Ltd Health (Pvt) Ltd (Pvt) Ltd Hemas Pharmaceuticals (Pvt) Ltd (Ceylon) Ltd Canoe Medical (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP INJECTION INJECTION INJECTION INJECTION INJECTION INJECTION MEROMAC 0.5 I VIALN/A Pettah Pharmacy MEROMAC 1 INJECTION INJECTIONAKUMERO 1000 C Medical (Pvt) T P Pettah Pharmacy POWDER / FULSPECSPECBAC 1GM POWDER / POWDER FOR AKUMERO 1000 POWDER / N/APURI NETHOL TABLETS TABLETSMONEM GlaxoSmithkiline PharmAce (Pvt) Ltd Globela Pharma MERONASH INJECTIONMEROFEN 1 INJECTION George Steuart Omacx Healthcare POWDER FOR MEROPENPENEM 500MG INJECTION POWDER / Emerchemie NB 500MG 1000MG 1G 1G 1G 1G 1G 50MG 50MG 1000MG(1g) 1000MG(1g) 1000MG(1g) 1000MG(1g) 500MG 4494 BP TABLETS MERCAPTOPURINE 4495 BP TABLETS MERCAPTOPURINE 4496 MEROPENEM INJECTION USP 4497 MEROPENEM INJECTION USP 4498 MEROPENEM INJECTION USP 4499 MEROPENEM INJECTION USP 4500 MEROPENEM INJECTION USP 4501 MEROPENEM INJECTION USP 4502 MEROPENEM FOR INJECTION USP 4503 MEROPENEM FOR INJECTION USP 4504 MEROPENEM FOR INJECTION USP 4505 MEROPENEM FOR INJECTION USP 4506 MEROPENEM FOR INJECTION USP 4507 MEROPENEM FOR INJECTION USP I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 371 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIA 17-Mar-16 Full INDIAINDIA 19-Aug-14BANGLADESH Full 30-Jan-18 11-Dec-15INDIA Full Full 19-Aug-14 Full INDIAINDONESIA 02-Jun-17 04-May-15 Full INDIA Full 07-Jun-17JAPAN Full 03-Mar-14 Full Danna Pharma Co IRANPharmaceuticals 11-Jul-16(Pvt) Ltd Full The ACME Laboratories Ltd Zeiss Pharmaceuticals (Pvt) Ltd Biolab Co Ltd THAILANDRenata Limited BANGLADESH 16-Mar-18Injectcare 01-Apr-15Parenterals (Pvt) Full Ltd Full T Dankos P Farma Injectcare Parenterals (Pvt) Ltd Dexa MedicaT P INDONESIADainippon 18-Sep-15Sumitomo Phar'cals -Japan for Astra Full Zeneca UK Nitin Lifesciences Ltd Shamshree Lifesciences Ltd (Contd.) Corporation (Pvt) Ltd Chamee Chemist Zeiss Mega Pharma (Pvt) Ltd Medimex Pharma (Pvt) Ltd Health (Pvt) Ltd (Ceylon) Ltd International Yaden (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Access International (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd INJECTION INJECTION POWDER FOR INJECTION INJECTION INJECTION SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP MEROXAN 1G INJECTION 1GMERORIGHT Glenford POWDER FOR FULSPEC MERORIGHT 500MG POWDER FOR MONEM 500MEROPEN INJECTION George Steuart N/A INJECTION Emerchemie NB MEROFEN 0.5 INJECTION POWDER FOR Hemas TRIPENEMMERONEM POWDER FOR INJECTION Hemas NEOPENEM INJECTION Slim MERONASH INJECTION Omacx Healthcare 1G 1G 500MG 500MG 500MG 500MG 500MG 500MG INJECTION 1G INJECTION 1G 1G 500MG 4511 MEROPENEM FOR INJECTION USP 4509 MEROPENEM FOR INJECTION USP 4510 MEROPENEM FOR INJECTION USP 4512 MEROPENEM FOR INJECTION USP 4513 MEROPENEM FOR INJECTION USP 4514 MEROPENEM FOR INJECTION USP 4515 MEROPENEM FOR INJECTION USP 4516 MEROPENEM FOR INJECTION USP 4517 MEROPENEM FOR INJECTION USP 4518 1G MEROPENEM INJECTION USP N/A4519 MEROPENEM POWDER FOR 4520 MEROPENEM POWDER FOR INJECTION International Yaden 4508 MEROPENEM FOR INJECTION USP 372 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 JAPAN 03-Mar-14INDIA Full INDIA 26-Sep-14 Full INDIA 28-Feb-18 Years Two INDIA 26-Dec-17 Full SWITZERLAND 13-Jun-18 11-Jan-16 Years Two Full INDIAGERMANY 22-Jun-18 25-Jan-14 Years Two INDIA Full INDIA 08-Sep-18INDIA Provisional 23-Aug-18INDIA Years Two 30-Apr-14FRANCE Full 19-Mar-14 01-Feb-18 Full Full Dainippon Sumitomo Phar'cals -Japan for Astra Zeneca UK Cadila Healthcare Ltd Cadila Healthcare Ltd Sun Pharmaceutical industries Mercury Laboratories Ltd Ferring International center SA Getwell Pharmaceuticals Bayer Schering G Ltd A Pharma Human Verve Care Laboratories Mercury Laboratories Ltd SG Pharma (Pvt) Ltd S Kant Healthcare Ltd Merck Serono S A s (Contd.) Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd International Yaden (Pvt) Ltd Healthcare lanka Ltd The Esses Pharmacy (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Agency Pvt Ltd (Pvt) Ltd Pharmacy (Pvt) Ltd Co Ltd (Ceylon) Ltd COATED COATED TABLETS INJECTION SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP MERONEM INJECTION Hemas 1.2IBSOL 800IBSOL TABLETS Hemas TABLETS Hemas N/APENTASA ENTERIC TABLETS Sunshine METAVERN/A INJECTIONN/A Leader Pharma XR 500DELMET INJECTION TABLETSGLUCOPHAGE International Yaden INJECTION Delmege Forsyth & TABLETS The Esses Emerchemie NB TABLETS 1.2G TABLETS 800MG USP TABLETS 400MG BP TABLETS 500MG RELEASE TABLETS 10MG/ML INJECTION BP ML ML 500MG USP TABLETS 500MG TABLETS INJECTION 500MG 4522 RELEASED MESALAMINE DELAYED 4523 RELEASE MESALAMINE DELAYED 4524 400MG MESALAMINE TABLETS MESACOL4525 MESALAZINE GASTRO-RESISTANT TABLETS4526 MESALAZINE PROLONGED Hemas 4527 INJECTION 200MG/2ML MESNA 4528 N/A 25MGTABLETS MESTEROLONE PROVIRON4529 BHARTRATE METARMINOL TABLETS SOLUTION FOR 4530 10MG/ INJECTION BP METARMINOL Hemas 4531 10MG/ INJECTION BP METARMINOL 4532 METFORMIN EXTENDED RELEASE 4533 METFORMIN HYDROCHLORIDE 4521 MEROPENEM POWDER FOR I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 373 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIA 30-Jan-14 Full INDONESIA 12-Jun-18 Years Two BANGLADESH 28-Aug-16 Full INDIAINDIA 19-Jun-15 Full INDIA 02-Mar-14 Full 27-Oct-15PAKISTAN Full INDIA 17-Jun-15 Full 05-Mar-14 Full P T Kalbe FarmaT P INDONESIA 15-Dec-15Hovid Berhard MALAYSIA Full Hovid Berhard 06-Oct-14 MALAYSIA Full T Ferron P Pharmaceutical 06-Oct-14 Full The Acme Laboratories Ltd Renata Limited BANGLADESHFourrts (India) 04-Oct-17Laboratories Ltd Years Two Aristo Pharmaceuticals Ltd Ambala Sarabhal Enterprises U S V Ltd INDIAMartin Daw Marker Ltd Indoco Remedies India 18-Nov-15Micro Labs Ltd Full INDIA 01-Mar-14 Full Cadila Healthcare Ltd (Contd.) Hemas Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Lanka (Pvt) Ltd Ltd Ltd (Ceylon) Ltd Healthcare lanka Ltd Co Ltd Co Ltd Pharmaceuticals (Pvt) Ltd (Ceylon) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Healthcare lanka Ltd TABLETS TABLETS Thorn TABLETS Hadley Bevan SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP NEVOX XR EXT.REL. DIABETMIN XR 500 DIABETMIN XR 500 GLUMIN XR 500 TABLETSDAOMIN Baur & Co (Pvt) A 500BIGMET TABLETSMETFIL TABLETS Mega Pharma (Pvt) Emerchemie NB 500BIGOMET TABLETS TABLETS 500METICA Sunshine Darley Butler & GLYCOMET-500 TABLETS TABLETS Trading Swedish GLUCOPHAGE Hemas TABLETSMETCHECK Emerchemie NB TABLETS 500MELMET Hemas TABLETS Micro Mega Lanka BIGSENS-XR 500 TABLETS Sunshine EXTENDED RELEAS TABLETS TABLETS EXTENDED RELEAS 500MG TABLETS EXTENDED RELEAS 500MG TABLETS EXTENDED RELEAS 500MG TABLETS EXTENDED RELEAS 500MG 500MG 500MG 500MG 500MG 500MG 500MG 500MG 500MG 500MG EXTENDED RELEAS TABLETS TABLETS EXTENDED RELEAS 500MG 4535 METFORMIN HYDROCHLORIDE 4536 METFORMIN HYDROCHLORIDE 4537 METFORMIN HYDROCHLORIDE 4538 METFORMIN HYDROCHLORIDE 4539 METFORMIN HYDROCHLORIDE BP 4540 METFORMIN HYDROCHLORIDE BP 4541 METFORMIN HYDROCHLORIDE BP 4542 METFORMIN HYDROCHLORIDE BP 4543 METFORMIN HYDROCHLORIDE BP 4544 METFORMIN HYDROCHLORIDE BP 4545 METFORMIN HYDROCHLORIDE BP 4546 METFORMIN HYDROCHLORIDE BP 4547 METFORMIN HYDROCHLORIDE BP 4534 METFORMIN HYDROCHLORIDE 374 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 MALAYSIA 31-Jan-14INDIA Full 16-Dec-16PAKISTAN Full GERMANY 23-Mar-17 Full 03-Dec-17INDIA Full SRI LANKA 02-Mar-18 18-Jun-18INDIAYears Two Full INDIA 22-Oct-18 Full INDIA 17-Dec-15 Full INDIA 24-Feb-15 Full INDIA 12-May-15 Full 31-Dec-14BANGLADESH Full 04-Sep-15 Full Pharmaniaga International Corporation Sdn Bhd Fredun Pharmaceuticals Ltd Micro Labs Ltd INDIAMartin Daw Marker Ltd Denk Pharma GmbH & Co. 16-Jun-16 Full (Pvt) Ltd Ltd Concept Pharmaceuticals Ltd Torrent Pharmaceuticals Ltd Glenmark Pharmaceuticals Ltd Akums Drugs & Pharmaceuticals Ltd Inventia Healthcare (Pvt) Ltd Sterling LabHealthcare INDIAPharmaceuticals 30-Oct-17Years Two (Contd.) (Ceylon) Ltd Health (Pvt) Ltd (Pvt) Ltd (Ceylon) Ltd Pharmaceuticals (Pvt) Ltd Softcare International (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd (Ceylon) Ltd Co Ltd (Pvt) Ltd TABLETS Akbar COA.) SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP GLUMET-FORTS TABLETS Emerchemie NB SRIMET 850MELMET TABLETS TABLETSGLUCOPHAGE George Steuart TABLETSMETFORMIN- Micro Mega Lanka DENK Emerchemie NB 500 SRAMET TABLETSN/AAssociates Pharma SR 500CONMET AMN Life Science (EN. TABLETS TABLETS SRDIBETA N/A TABLETS ER 500XMET Hemas TABLETS XRVEXMET Inter Pharm (Pvt) Hemas TABLETS 500PROGLUTROL TABLETS Global Impex AV Emerchemie NB SR 500GENMET TABLETS XRGLYMIN Darley Butler & TABLETS Citihealth Imports 850MG 850MG 850MG 850MG 500MG USP TABLETS EXTE. RELE 500MG USP TABLETS EXTE. RELE 500MG USP TABLETS EXTE. RELE 500MG USP TABLETS EXTE. RELE 500MG USP TABLETS EXTE. RELE 500MG USP TABLETS EXTE. RELE 500MG USP TABLETS EXTE. RELE 500MG USP TABLETS EXTE. RELE 500MG USP TABLETS EXTE. RELE 850MG 4549 METFORMIN HYDROCHLORIDE BP 4550 METFORMIN HYDROCHLORIDE BP 4551 METFORMIN HYDROCHLORIDE BP 4552 METFORMIN HYDROCHLORIDE BP 4553 METFORMIN HYDROCHLORIDE 4554 METFORMIN HYDROCHLORIDE 4555 METFORMIN HYDROCHLORIDE 4556 METFORMIN HYDROCHLORIDE 4557 METFORMIN HYDROCHLORIDE 4558 METFORMIN HYDROCHLORIDE 4559 METFORMIN HYDROCHLORIDE 4560 METFORMIN HYDROCHLORIDE 4561 METFORMIN HYDROCHLORIDE 4548 METFORMIN HYDROCHLORIDE BP I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 375 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIA 04-Mar-15INDIA Full 08-May-14 Full INDIAINDIA 13-Oct-17 Full INDIA 07-May-18 Full INDIA 08-Apr-17 Full INDIA 24-Feb-15 Full INDIA 17-Jan-15 Full INDIA 28-Jan-18 Full INDIA 21-Jun-17 Full 21-Jul-17 Years Two India Ltd INDIA 04-Sep-17Years Two fi Micro Labs Ltd INDIAInventia Healthcare Pvt Ltd for Mega Lifesciences (Pvt) 09-Jun-14Ltd Full U S V Ltd INDIAFourrts (India) Laboratories Ltd 25-Jan-15 Full Fredun Pharmaceuticals Ltd Akums Drugs & Pharmaceuticals Ltd Health Pell Tech Care (Pvt) Ltd Akums Drugs & Pharmaceuticals Ltd Health Care IVA (Pvt) Ltd Theon Pharmaceuticals Ltd Akums Drugs & Pharmaceuticals Ltd Scott Edil Pharmacia Ltd (Contd.) Lanka Ltd Sano fi (Pvt) Ltd Ltd Pharmaceuticals (Pvt) Ltd Healthcare lanka Ltd Health (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Ltd TABLETS Hemas SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP MELMET 500MELMET TABLETS SR 500PANFOR TABLETS Micro Mega Lanka Baur & Co (Pvt) A CETSPIN XRTABLETS S.R Sano GLYCOMET SR GLYCOMET 500 OBMET S.R TABLETS Sunshine SRIMET SR 500SRIMET TABLETS 500METATIME George Steuart TABLETSPELLFORMIN 500 TABLETS Hemas 500VEXMET Slim TABLETS 500ICOMET Global Impex AV TABLETS 500THEOMET TABLETS Slim DIBETIN Slim N/A TABLETS Lotus TABLETS C Medical (Pvt) T P SUSTAINED RELE 500MG SUSTAINED RELE 500MG SUSTAINED 500MG TABLETS RELE SUSTAINED SUSTAINED RELE 500MG SUSTAINED SUSTAINED RELE 500MG SUSTAINED SUSTAINED RELE TABLETS 500MG TABLETS RELE SUSTAINED 500MG USP TABLET 500MG USP TABLET 500MG USP TABLET 500MG USP TABLET 500MG USP TABLET 500MG USP TABLET 500MG USP TABLET 4564 METFORMIN HYDROCHLORIDE 4565 METFORMIN HYDROCHLORIDE 4566 METFORMIN HYDROCHLORIDE 4562 METFORMIN HYDROCHLORIDE 4563 METFORMIN HYDROCHLORIDE 4567 METFORMIN HYDROCHLORIDE 4568 METFORMIN HYDROCHLORIDE 4569 METFORMIN HYDROCHLORIDE 4570 METFORMIN HYDROCHLORIDE 4571 METFORMIN HYDROCHLORIDE 4572 METFORMIN HYDROCHLORIDE 4573 METFORMIN HYDROCHLORIDE 4574 METFORMIN HYDROCHLORIDE 376 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAPAKISTAN 20-Oct-17 17-Jun-18 Full Full INDIAFRANCE 28-Jan-18INDIA Full 01-Feb-18 Full INDIA 25-Nov-14 Full INDIA 01-Feb-15 Full BANGLADESH 26-Nov-16 02-Aug-18 Years Two Full INDIASRI LANKA 15-Oct-14INDIA 28-Jul-18 Full Years Two 06-Mar-18 Provisional INDIA 13-May-16 Full Cadila Healthcare Ltd Merck Serono S A s Renata Limited BANGLADESHTheon 05-Jul-18Pharmaceuticals Provisional Ltd Merck Serono S A s Akums Drugs & Pharmaceuticals Ltd Health Care IVA (Pvt) Ltd Cadila Healthcare Ltd Pharmaceuticals Ltd Centaur Pharmaceutical (Pvt) Ltd Ltd. Fourrts (India) Laboratories Ltd Windlas Biotech (Pvt) Ltd (Contd.) Healthcare lanka Ltd (Ceylon) Ltd (Ceylon) Ltd Pharmaceuticals (Pvt) Ltd (Ceylon) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Healthcare lanka Ltd Health (Pvt) Ltd Sunshine Healthcare lanka Ltd Pharmaceuticals (Pvt) Ltd TABLETS Emerchemie NB COA.) SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP BIGSENS 500 TABLETSGLUCOPHAGE Sunshine TABLETS 850BIGMET Emerchemie NB 850THEOMET TABLETS TABLETS Emerchemie NB GLUCOPHAGE 850 Slim 850VEXMET TABLETS 850ICOMET Global Impex AV TABLETSBIGSENS 850 Slim TABLETS XR 500COMET Sunshine TABLETS PharmAce (Pvt) Ltd Square TABLETS BP 500MG BP TABLETS 850MG BP TABLETS 850MG USP TABLETS 850MG USP TABLETS 850MG USP TABLETS 850MG USP TABLETS 850MG USP TABLETS 500MG BP TABLETS RELEASE TABLET USP 500MG USP TABLET 4576 METFORMIN HYDROCHLORIDE 4577 METFORMIN HYDROCHLORIDE 4578 METFORMIN HYDROCHLORIDE 4579 METFORMIN HYDROCHLORIDE 4580 METFORMIN HYDROCHLORIDE 4581 METFORMIN HYDROCHLORIDE 4582 METFORMIN HYDROCHLORIDE 4583 METFORMIN PROLONGED 4584 850MGTABLETS METFORMIN 850 BIGUAL 4585 500MG BP TABLETS METFORMIN DIABEMET TABLETS4586 500MG BP TABLETS METFORMIN OBMET TABLETS George Steuart 4587 500MG BP TABLETS METFORMIN N/A EUGLIMET4588 500MG BP TABLETS METFORMIN (EN. TABLETS METAFOR TABLETS TABLETS CIC Lifesciences N/A Lifeline Astron (Pvt) Ltd SRI LANKA 31-Oct-17 Full 4575 METFORMIN HYDROCHLORIDE I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 377 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 28-Sep-15 Full BANGLADESH 28-Sep-17 20-Feb-15 Full INDIA Full INDIA 24-Jan-17SRI LANKA Full 05-Mar-16 06-Feb-18SRI LANKA Full Provisional CYPRUS 18-Jul-14 Full 26-Jul-14INDIA Full INDIA 06-Aug-15INDIA Full 12-Feb-16 Full INDIA 22-Feb-18 Full INDIA 16-Jul-15 Full 23-Feb-16 Full Synmedic Laboratories (Pvt) Ltd Globe Pharmaceuticals Ltd Ltd Centurion Laboratories Pvt Ltd Priivate Limited Ltd Delobris Pharmaceuticals 01.06.18 Ltd-AT Yaden-LO42/17 S Kant Healthcare Ltd Ratnamani Healthcare (Pvt) Ltd Centaur Pharmaceutical (Pvt) Ltd Medico Remedies (Pvt) Ltd Macleods Pharmaceuticals Ltd Synmedic Laboratories (Pvt) Ltd (Contd.) Pharmaceuticals (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd Co Ltd Ltd Health (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Lifeline Pharmaceuticals (Pvt) Ltd TABLETS SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP 4590 500MG BP TABLETS METFORMIN MEFOR 5004591 500MG BP TABLETS METFORMIN TABLETS 500 SUCOMET 4592 TABLETS 500MG BP Lifeline TABLETS METFORMIN NEFORT4593 Healthcare Tabrane 500MG BP TABLETS METFORMIN N/A TABLETS4594 500MG BP TABLETS METFORMIN N/A Burhani Enterprises4595 500MG BP Saga laboratories TABLETS METFORMIN TABLETS DIABX4596 500MG BP TABLETS METFORMIN International Yaden NEOMID TABLETS TABLETS4597 500MG BP TABLETS METFORMIN N/A TABLETS 500 DELMET N/A4598 500MG BP TABLETS METFORMIN Access International TABLETS N/A4599 500MG BP TABLETS METFORMIN Celogen Lanka Delmege Forsyth & GLUCOTRUST Inter Pharm (Pvt) 4600 TABLETS 500MG BP TABLETS METFORMIN TABLETS N/A George Steuart Lanka (Pvt) Tabrane 4601 500MG BP TABLETS METFORMIN MEFOMIN 500 TABLETS TABLETS Pettah Pharmacy Akbar 4589 500MG BP TABLETS METFORMIN MEFOR 850 FILM COA 378 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 BANGLADESH 25-Jul-14INDIA Full 03-May-17GERMANY Years Two 06-Jul-17INDIA Years Two 19-Mar-18 Full INDIAINDIA 25-Feb-15 Full 05-Dec-14CYPRUS Full 26-Jul-14INDIA Full BANGLADESH 05-Mar-16 31-Oct-15INDIA Full Full 26-Dec-17 Full IntermedHealthcare Pharmaceuticals INDIAState Pharmaceuticals Manufacturing Till Corporation at 08-Jun-15Heathcare Pvt Ltd Full Denk Pharma GmbH & Co. Pharmaceuticals (India) Ltd U S V Ltd INDIAAristo Pharmaceuticals Ltd 16-Jul-18(Pvt) Ltd Sterling Lab Full Delobris INDIAPharmaceuticals 01.06.18 Ltd-AT Yaden-LO42/17 Centurion 28-Aug-14Laboratories Pvt Ltd Full Healthcare Pharmaceuticals S K Healthcare Formulations Pvt Ltd (Contd.) (Pvt) Ltd (Pvt) Ltd Pharmaceuticals Manufacturer Corporation Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Co Ltd Co Ltd (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd Co Ltd TABLETS Akbar SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP DENK 500 4611 850MG BP TABLETS METFORMIN NEOMID TABLETS Access International 4603 500MG BP TABLETS METFORMIN GLYMIN4604 500MG BP TABLETS METFORMIN N/A TABLETS4605 500MG BP TABLETS METFORMIN Citihealth Imports METFORMIN- TABLETS4606 850MG BP TABLETS METFORMIN State AUROMET4607 850MG BP TABLETS METFORMIN TABLETS 850 GLYCOMET TABLETS4608 850MG BP TABLETS METFORMIN PharmAce (Pvt) Ltd Aurochem 850 BIGOMET Hemas 4609 850MG BP TABLETSTABLETS METFORMIN 850 AMET 4610 850MG BP TABLETS METFORMIN Darley Butler & 850 GENIMET TABLETS TABLETSAssociates Pharma AMN Life Science Darley Butler & 4612 850MG BP TABLETS METFORMIN N/A4613 850MG BP TABLETS METFORMIN GLYMIN4614 850MG BP TABLETS METFORMIN TABLETS 850 DELMET TABLETS International Yaden TABLETS Citihealth Imports Delmege Forsyth & 4602 500MG BP TABLETS METFORMIN GLUCOSHA TABLETS Salveo Pharma I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 379 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 06-Mar-17INDIA Full 16-Jul-16INDIA Full 28-Feb-14 Full INDIA 17-Apr-15 Full INDIA 03-Nov-14 Full INDIA 11-Oct-17 Years Two SRI LANKA 10-Feb-15 11-Dec-17 Full Years Two INDIAMALAYSIA 30-Mar-14 04-Jan-17INDIA Years Two Full SRI LANKA 24-Oct-16 15-Jul-15 Full Full Indoco Remedies India Pharmaceuticals Ltd Kausikh Therapeutics (Pvt) Ltd Fredun Pharmaceuticals Ltd Pharmaceuticals (India) Ltd Concept Pharmaceuticals Ltd (Ceylon) (Pvt) Ltd Laboratories XL (Pvt) Ltd Pharmaniaga Manufacturing berhand SG Pharma (Pvt) Ltd (Ceylon) (Pvt) Ltd Intermed INDIA 01-Nov-18 Years Two Fourrts (India) Laboratories Ltd (Contd.) Ltd Pvt Ltd Health (Pvt) Ltd International (Pvt) Ltd Ltd (Ceylon) Ltd Pharmacy (Pvt) Ltd Ltd Healthcare lanka Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP INTERMETO TABLETS C Medical (Pvt) T P 2.5MG 4616 850MG BP TABLETS METFORMIN METCHECK4617 500MG BP TABLETS METFORMIN METMIN 500 TABLETS4618 500MG BP TABLETS METFORMIN TABLETS Emar Pharma (Pvt) METKARE 5004619Associates Pharma TABLETS 500MG BP TABLETS METFORMIN Bafna SRIMET Jayanetti & Sons P 4620 500MG BP TABLETS METFORMIN AUROMET TABLETS4621 500MG BP TABLETS METFORMIN TABLETS George Steuart CONMET4622 500MG BP TABLETS METFORMIN PharmAce (Pvt) Ltd Aurochem N/A TABLETS4623 500MG BP TABLETS METFORMIN METZ4624 Softcare 500MG BP TABLETS METFORMIN METFORMIN-XL4625 TABLETS 500MG BP TABLETS METFORMIN TABLETS DC GLUMET TABLETS N/A SMM Halcyon (Pvt) 4626 5MG USP TABLETS METHIMAZOLE TABLETS 5 TAPEL Kamazu (Pvt) Ltd4627 Micro Labs Ltd 5MG USP TABLETS METHIMAZOLE Emerchemie NB N/A INDIA4628 TABLETS M S J Industries BP TABLETS METHOTREXATE The Esses 01-Mar-14 TABLETS Full N/A M S J Industries 4615 850MG BP TABLETS METFORMIN 850 OBIMET TABLETS Sunshine 380 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 KOREAINDIA 08-Mar-18 Years Two 24-Dec-17INDIA Full INDIA 07-Jun-15INDIA Full 21-Jan-15INDIA Full 20-Jul-16INDIA 29-May-18 Full INDIA Years Two 26-Mar-14INDIA Full 14-Sep-14INDIA Full 26-Mar-14INDIA Full 11-Mar-18 Full INDIA 04-Jun-18 Provisional GERMANY 24-Feb-14 12-Sep-15 Full GERMANY Full 08-Sep-15 Full Hankook Korns Pharma Co. Ltd Co. LLC Cipla Ltd(Pvt) Ltd INDIAPharmaceutical Pvt Ltd 22-Feb-15Laboratories Ltd Full Limited B D H Industries Ltd Laboratories Ltd B D H Industries Ltd Cadila Healthcare Ltd Centurion Laboratories Pvt Ltd Inga Laboraories (Pvt) Ltd Roche Diagnostics GmbH, Germany, La /F Hoffman Roche Ltd Roche Diagnostics GmbH (Contd.) (Pvt) Ltd (Pvt) Ltd Services Pvt. Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Co Ltd Ltd Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP KORNS NTX 2.5 TABLETSTREXGLO International Yaden IMUTREX 2.5 TABLETS TABLETSMETHOWIN PharmAce (Pvt) Ltd Global Pharma TREXOL Breathe Free Lanka INJECTION Pharmatec (Pvt) Ltd Belco Pharma EMTHEX 50 INJECTIONTREXOL INJECTION Ceyoka (Pvt) Ltd Kavbir Ceyoka (Pvt) LtdCYTOTREX Khandelwal INJECTIONEMTHEX 2.5 TABLETS Ceyoka (Pvt) Ltd TABLETS VENUS Remedies CYTOTREX ABC Pharma METHOREX Ceyoka (Pvt) Ltd TABLETS Khandelwal TABLETS Ravilux Company Hemas MIRCERA INJECTIONMIRCERA Baur & Co (Pvt) A INJECTION Baur & Co (Pvt) A 2.5MG 2.5MG 25MG/ML 50MG/2ML 50MG/2ML GLASS VIAL 500MG/5ML 2.5MG 2.5MG 2.5MG 2.5MG INJECTION BETA GLYCOL-EPOETIN 100MCG/0.3ML INJECTION BETA GLYCOL-EPOETIN 50MCG/0.3ML 2.5MG 4630 BP TABLETS METHOTREXATE 4631 BP TABLETS METHOTREXATE 4632 INJECTION BP METHOTREXATE 4633 INJECTION BP METHOTREXATE 4634 INJECTION BP METHOTREXATE 4635 INJECTION USP METHOTREXATE 4636 BP TABLETS METHOTREXATE 4637 BP TABLETS METHOTREXATE 4638 BP TABLETS METHOTREXATE 4639 IP TABLETS METHOTREXATE 4640 10MGTABLETS METHOXSALEN N/A4641 10MG METHOXSALEN TABLETS MELADERM4642 METHOXYPOLYETHYLENE TABLETS TABLETS4643 International Yaden METHOXYPOLYETHYLENE Swedish Trading 4629 BP TABLETS METHOTREXATE I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 381 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 12-Sep-14 Full GERMANY/ SWITZERLAND SPAIN 11-Mar-16INDIA Full SPAIN 16-May-17 Full INDIA 04-Jun-15 Full THAILAND 20-May-14MALAYSIA 27-Jun-18 Full Years Two 20-Nov-17 Full INDIAPAKISTAN 11-Jan-18 Full 08-Nov-15INDIA Full 08-Oct-18 Full Novartis pharmaceuticals SA, Spain for Novartis Pharma AG Switzertland Human Verve Care Laboratories Laboratoires Rubio S.A Sun Pharmaceutical industries Ltd. Pharmaceuticals SDN BHD Jenburkt Pharmaceuticals Ltd Pharmix Laborateries (Pvt) Ltd Zim Laboratories Ltd Roche Diagnostics GmbH, Germany, La /F Hoffman Roche Ltd (Contd.) Ltd Agency Pvt Ltd Pharmaceuticals (Pvt) Ltd (Ceylon) Ltd Pharmaceuticals (Pvt) Ltd Ltd Pharmaceuticals (Pvt) Ltd Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP RITALIN 10RITALIN TABLETSMETPHEN Baur & Co (Pvt) A TABLETSRUBIFEN Leader Pharma ADDWIZE TABLETS Slim NOX-PAIN TABLETSMENZZA Emerchemie NB CREAM CREAMANALEP CREAM PharmAce (Pvt) Ltd CREAM Man Pharma T Indoscan (Pvt) LtdZIX STRONG RUB N/A Hoe GEL TOPICAL Hemas MENWIN Panacea Medicals SRI LANKAMCAMINE 1500 TABLETS 11-Aug-17 ORALLY Years Two Lanka (Pvt) Tabrane Tabrane MIRCERA INJECTION Baur & Co (Pvt) A HYDROCHLORIDE TABLETS 10MG HYDROCHLORIDE TABLETS USP HYDROCHLORIDE TABLETS 10MG USP HYDROCHLORIDE TABLETS 10MG USP HYDROCHLORIDE TABLETS 10MG 1.36% 5.44% + EUGENOL MENTHOL 5% MENTHOL SALICYLATE CREAM METHYL 0.5 THYMOL 2.5% 16% MENTHOL 0.5% CAPSULES OIL EUCALYPTUS 8%+ EUCALIPTUS OIL +MENTHOL 1.47% OIL TERPANTINE 1.97% & GEL 25MG USP STRIPS 1500MCG DISINTEGRATING GLYCOL-EPOETIN BETA INJECTION BETA GLYCOL-EPOETIN 75MCG/0.3ML 4645 PHENIDATE METHYL 4646 PHENIDATE METHYL 4647 PHENIDATE METHYL 4648 PHENIDATE METHYL 4649 10.2% + SALICYLATE METHYL 4650 25% SALICYLATE METHYL 4651 COMPOUND SALICYLATE METHYL 4652 15.% SALUCYLATE METHYL 4653 TABLETS TESTOSTERONE METHYL 4654 METHYLCOBALAMINE ORALLY 4644 METHOXYPOLYETHYLENE 382 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 08-Mar-18 Full INDIA 12-Mar-14PAKISTAN Full 12-Jul-18 11-May-15 Years Two INDIA Full INDIA 21-Mar-18 Provisional INDIA 17-Dec-14INDIA Full 04-Jul-17 Full 28-Feb-18 Years Two INDIA 07-May-16 Full INDIAINDIA 17-Apr-15 Full 28-Feb-18 Years Two Zim Laboratories Ltd Medopharm (PVT Ltd (Pvt) Ltd OBS Pakistan (Pvt) Ltd Kwality Pharmaceuticals Pvt Ltd SG Pharma (Pvt) Ltd Human Verve Care Laboratories (Pvt) Ltd Sanbe FarmaT P INDONESIA 26-Oct-17United Biotech Years Two (Pvt) Ltd Sanbe FarmaT P INDONESIA 26-Oct-17Years Two Sciences (Pvt) Ltd (Pvt) Ltd (Contd.) Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd Pharmacy (Pvt) Ltd Agency Pvt Ltd Pharmaceuticals (Pvt) Ltd (Pte) Ltd Pharmaceuticals (Pvt) Ltd Pharma Associates Samarth Life INJECTION R & D Intertrades INJECTION SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP MCAMINE 1500 ORALLY Tabrane N/AN/A INJECTIONVERBLUE International Yaden MEPRELON INJECTION INJECTIONSANEXON 125 The Esses TABLETS Leader Pharma INJECTION PharmAce (Pvt) LtdSOL-U-PRED Swiss Pharma Lifeline 500MG SANEXON INJECTIONMYPRED 50 Lifeline POWDER MEPRELON TABLETS PharmAce (Pvt) Ltd Swiss Paranterals 1% W/V 10MG/ML 10MG/ML 2MG BP FOR INJECTION USP SUCCINATE 125MG FOR INJECTION USP SUCCINATE 500MG/VIAL FOR INJECTION USP SUCCINATE 500MG/VIAL FOR INJECTION USP SUCCINATE 500MG/VIAL 4MG BP DISINTEGRATING STRIPS 1500MCG DISINTEGRATING 4656 250MG BP METHYLDOPA 4657 250MGTABLETS METHYLDOPA N/A N/A4658 250MGTABLETS METHYLDOPA ALDOMET4659 250MGTABLETS METHYLDOPA TABLETS4660 N/A METHYLENE BLUE INJECTION USP TABLETS TABLETS Akbar 4661 Chamee Chemist Mansel (Ceylon) METHYLENE BLUE INJECTION USP Alvita Pharma TABLETS4662 METHYLENE BLUE INJECTION USP 4663 Kamazu (Pvt) Ltd METHYLPRDNISOLONE TABLETS Micro Labs Ltd4664 METHYLPREDNISOLONE SODIUM INDIA4665 METHYLPREDNISOLONE SODIUM 27-Sep-174666 Full METHYLPREDNISOLONE SODIUM 4667 METHYLPREDNISOLONE SODIUM 4668 METHYLPREDNISOLINE TABLETS 4655 METHYLCOBALAMINE ORALLY I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 383 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 14-Dec-17 Full 14-Dec-17INDIA Full INDIA 06-Aug-17 Full BELGIUM 06-Aug-15 10-Jun-17 Full BELGIUM Full 06-Jan-14INDIA Full INDONESIA 03-Apr-18 16-Oct-14INDIA Full Full INDIA 11-Jul-17 Full 30-Jun-16 Full INDIA 16-Jul-17 Full c Stridden fi zer zer zer Italia SRL ITALY 16-Jan-14 Full fi fi fi Ltd Micro Labs Ltd INDIA Coast West Pharmaceurical works Ltd Coast West 08-Dec-15Pharmaceurical works Ltd Full P Manufacturing NV/SA P Manufacturing NV/SA Swiss Paranterals (Pvt) Ltd T Pharos P Indonesia for PT Dexa Medica Advance Scott Edil Research Laboratories GU Biopharma Pvt ltd Dexa MedicaT P INDONESIAP 29-Aug-14 Full Alice Pharma Private Ltd. Ltd (Contd.) (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Ltd Ltd C Medical (Pvt) T P Ltd Pharmaceuticals (Pvt) Ltd Ltd Pharmaceuticals (Pvt) Ltd Services Pvt. Ltd INJECTION SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP MEPRELONPREDACE TABLETSPREDNIVEX 4 PharmAce (Pvt) Ltd TABLETS Swiss Biogenics TABLETSPREDNIVEX 16 Micro Mega Lanka Global Impex AV TABLETSSOLU MEDROL Global Impex AV INJECTIONDEPO MEDROL Hemas INJECTIONN/A Hemas MEDIXON 500 INJECTION INJECTIONN/A Baur & Co (Pvt) A C Medical (Pvt) T P METRITE POWDER / MEDIXON INJECTION Slim MEDROL TABLETSMYSOL-16 Baur & Co (Pvt) A TABLETS Hemas TABLETS ABC Pharma MEPRELON TABLETS PharmAce (Pvt) Ltd Swiss Biogenics BP 8MG BP 4MG IP 4MG USP 16MG USP INJECTION 1000MG 40MG/1ML INJECTION BP 1000MG FOR INJECTION USP 500MG FOR INJECTION USP FOR INJECTION USP SUCCINATE 500MG FOR INJECTION USP SUCCINATE 500MG 16MG 4MG 16MG BP BP 8MG BP 4670 METHYLPREDNISOLINE TABLETS 4671 METHYLPREDNISOLINE TABLETS 4672 METHYLPREDNISOLINE TABLETS 4673 METHYLPREDNISOLINE TABLETS 4674 METHYLPREDNISOLONE 4675 METHYLPREDNISOLONE ACETATE 4676 METHYLPREDNISOLONE SODIUM 4677 METHYLPREDNISOLONE SODIUM 4678 METHYLPREDNISOLONE 4679 METHYLPREDNISOLONE 4680 METHYLPREDNISOLONE TABLETS 4681 METHYLPREDNISOLONE TABLETS 4682 METHYLPREDNISOLONE TABLETS 4669 METHYLPREDNISOLINE TABLETS 384 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 14-Dec-17 Full 16-Jul-16 Full INDONESIA 08-Feb-14 Full INDONESIA 31-Jan-18 Years Two INDONESIA 28-Nov-17INDIA Full INDIA 27-Apr-16INDIA Full 25-Feb-15INDIA Full 07-Feb-14 Full 25-Feb-15 Full zer Italia SRL ITALY 16-Jan-14 Full fi (Pvt) Ltd Alice Pharma Private Ltd. Micro Labs Ltd INDIAMicro Labs Ltd INDIAP 27-Oct-15 Full T Dankos P 27-Oct-17Farma Full Sanbe FarmaT P INDIA T Dankos P Farma 16-Nov-17Years Two Sanbe FarmaT P INDONESIA 23-Mar-18 T Otto P Years Two Pharmaceuticals Industries Mackur Laboratories Ltd Belco Pharma (Pvt) Ltd Neon Laboratories Ltd Belco Pharma (Pvt) Ltd Pharma Fabrikon INDIA 30-Mar-16 Full (Contd.) Services Pvt. Ltd (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceticals Agency Pvt Ltd (Pvt) Ltd Agency Pvt Ltd (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP MEPRELONMYSOL-4 TABLETSPREDACE 16 PharmAce (Pvt) Ltd Swiss Pharma TABLETS TABLETSPREDACE ABC Pharma Micro Mega Lanka MEDROL TABLETSHEXILON 1G Micro Mega Lanka TABLETS TABLETS Hemas SANEXON Hemas TABLETSHEXILON 4G TABLETS Lifeline SANEXON Hemas TABLETSPREDNICORT-8 TABLETS Lifeline N/A Lifeline BETANORMDONMET INJECTION INJECTION Leader Pharma BETANORM S P L INJECTIONN/A INJECTION Ravilux Company Leader Pharma INJECTION Novachem Lanka BP 4MG BP 16MG IP 8MG IP 16MG USP 16MG USP 16MG USP 4MG USP 4MG USP 8MG USP 5MG/ML 10MG/2ML 10MG/2ML 10MG/2ML 5MG/ML BP 16MG BP 4684 METHYLPREDNISOLONE TABLETS 4685 METHYLPREDNISOLONE TABLETS 4686 METHYLPREDNISOLONE TABLETS 4687 METHYLPREDNISOLONE TABLETS 4688 METHYLPREDNISOLONE TABLETS 4689 METHYLPREDNISOLONE TABLETS 4690 METHYLPREDNISOLONE TABLETS 4691 METHYLPREDNISOLONE TABLETS 4692 METHYLPREDNISOLONE TABLETS 4693 INJECTION B.P METOCLOPRAMIDE 4694 INJECTION BP METOCLOPRAMIDE 4695 INJECTION BP METOCLOPRAMIDE 4696 INJECTION BP METOCLOPRAMIDE 4697 INJECTION BP METOCLOPRAMIDE 4683 METHYLPREDNISOLONE TABLETS I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 385 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 20-Sep-15PAKISTAN Full 12-Mar-17INDIA 24-Mar-16 Full Full 07-Jan-14INDIA Full INDIA 18-Nov-15 Full INDIA 18-Feb-17INDIA Full 18-Jun-18 Years Two SWEDEN 18-Feb-18 Full 14-Jan-14INDIA Full INDIA 01-Dec-18 Full INDIA 01-Dec-15 Full INDIA 01-Dec-18 Full 26-Dec-18 Full Sciences (Pvt) Ltd S J & G Fazul Ellahie (Pvt) Ltd Wallace Pharmaceuticals Ltd Laboratories (Pvt) Ltd Centaur Pharmaceutical (Pvt) Ltd (Pvt) Ltd Centaur Pharmaceutical (Pvt) Ltd AB Astra Zeneca ,Sweden Sun Pharmaceutical industries Sun Pharmaceutical industries Sun Pharmaceutical industries Zen Pharma (Pvt) Ltd PharmaceuticalS (Pvt) Ltd (Contd.) (Pvt) Ltd Ltd Health (Pvt) Ltd Health (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Care (Pvt) Ltd ER TABLETS Hemas SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP MICOVINDIGESTINE INJECTIONMAXERON CAPSULESAssociates Pharma Steril Gene Life V H Distributors A TABLETSN/A Emar Pharma (Pvt) REGURG TABLETS TABLETS Chamee Chemist Ceyoka (Pvt) Ltd Oboi Laboratories INDIA Leben 22-May-14 ZOKBETALOC Full TABLETS XL PROLOMET Hemas 100 25 XL PROLOMET TABLETS ER Hemas 50 XL PROLOMET TABLETS Hemas ZULAN INJECTION Radiant Health XYPROL-T INJECTION Ceyoka (Pvt) Ltd Ciron Drugs & USP 5MG/ML USP CAPSULES 40MG 10MG 10MG 10MG SUCCINATE 100MG USP TABLETS RELEASE 25MG USP TABLETS RELEASE 50MG USP TABLETS RELEASE USP 5MG/ML USP ML 4711 1MG/ INJECTION BP METOPROLOL 4699 INJECTION METOCLOPRAMIDE 4700 RESINATE METOCLOPRAMIDE 4701 B.P TABLETS METOCLOPRAMIDE 4702 B.P TABLETS METOCLOPRAMIDE 4703 B.P TABLETS METOCLOPRAMIDE 4704 2.5MG USP TABLETS METOLAZONE 2.5 METOZ 4705 5MG USP TABLETS METOLAZONE TABLETS LAZON 54706 5MG USP TABLETS METOLAZONE George Steuart 5 METOZ TABLETS4707 TABLETS 50MG METOPROLOL TABLETS Klintas (Pvt) Ltd4708 EXTENDED United Biotech METOPROLOL George Steuart 4709 EXTENDED METOPROLOL 4710 EXTENDED METOPROLOL 4698 INJECTION METOCLOPRAMIDE 386 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 11-Jul-18 03-May-17 Full Full INDIASWEDEN 13-Nov-18 Provisional 14-Jan-14INDIA Full INDIA 26-Feb-17CHINA Full 27-Mar-16 Full INDIA 18-Feb-17INDIA Full 20-Nov-14INDIA Full 06-Sep-16 Full 16-Dec-16 Full Verve Human Verve Care Laboratories Healthcare Vital (Pvt) Ltd Astra Zeneca SWEDEN LaboratoriesIPCA INDIA 18-May-14 LaboratoriesIPCA Full INDIA 14-Jun-16Ajantha Pharma Full Ltd 14-Jun-16AB Astra Zeneca Full ,Sweden SG Pharma (Pvt) Ltd Centurion Laboratories Pvt Ltd Astra Zeneca Pharmaceuticals Co Ltd Ltd Unique Pharmaceutical Labs Unique Pharmaceutical Labs (Contd.) Leader Pharma Agency Pvt Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Baur & Co (Pvt) A Ltd Hemas Pharmaceuticals (Pvt) Ltd Pharmacy (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Health (Pvt) Ltd Health (Pvt) Ltd SOLUTION TABLETS REL) GEL Harcourts (Pvt) Ltd Coral Laboratories SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP VERPROLOL INJECTABLE VITAPRO INJECTION International Yaden 100 XL REVELOL TABLETS ER Hemas 25 XL REVELOL TABLETS 50METXL Hemas ZOKBETALOC EXT.REL. (CON. TABLETS N/AN/A INJECTION The Esses TABLETS GEL DENTA International Yaden V GELMETROGYL GEL George Steuart ML TABLETS EXTENDED RELEASE 100MG USP TABLETS EXTENDED RELEASE 25MG USP TABLETS EXTENDED RELEASE 50MG USP to METOPRLOL CORRESP TABLETS 100mg 5MG/5ML INJECTION USP 50MG BP WITH APPLICAT0R ML 4713 1MG/ INJECTION BP METOPROLOL 4714 25MG SUCCINATE METOPROLOL ZOK BETALOC TABLETS4715 SUCCINATE METOPROLOL Hemas 4716 SUCCINATE METOPROLOL 4717 SUCCINATE METOPROLOL 4718 SUCCINATE METOPROLOL 4719 TARTRATE METOPROLOL 4720 TABLETS TARTRATE METOPROLOL 4721 50MGTRATRATE METOPROLOL 50MG BETALOC TABLETS4722 BP METRONIDAZOLE 1% GEL 4723 Hemas U S P METRONIDAZOLE 1% GEL CORNIZOLE 4724 USP METRONIDAZOLE 1% GEL METROGYL GEL George Steuart 4712 1MG/ INJECTION BP METOPROLOL I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 387 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 14-Dec-17 Full MALAYSIA 09-Apr-18 Provisional CHINA 11-May-16 Full 24-Mar-18 Provisional BANGLADESH 07-Jan-18 Years Two INDIAINDIA 18-Feb-17INDIA Full 16-Jun-16INDIA Full 09-Mar-17 Full BANGLADESH 21-Apr-15 15-Feb-18 Full INDIA Full INDIA 21-May-18INDIA Years Two 21-May-18INDIA Years Two 21-May-18 Years Two 09-Mar-16 Full

fi Unique Pharmaceutical Labs SDN BHD Hebei Tiancheng Pharmaceuticals Co Ltd Laboratories (India) Ltd. Bangaladesh Ltd Fresenius Kabi India Pvt Ltd Ltd Unique Pharmaceutical Labs Aculife Healthcare (Pvt) Ltd Cephalosporins Ltd Mercury Laboratories Ltd Mercury Laboratories Ltd Mercury Laboratories Ltd Unique Pharmaceutical Labs (Contd.) Lanka Ltd Sano fi Health (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Health (Pvt) Ltd Healthcare lanka Ltd PharmAce (Pvt) Ltd Square International Yaden (Pvt) Ltd International Yaden (Pvt) Ltd International Yaden (Pvt) Ltd Health (Pvt) Ltd GEL George Steuart INFUSION SUSPENSION SUSPENSION SUSPENSION SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP DENTA FROTINN/A TABLETSFLAGYL Indoscan (Pvt) Ltd Industries / S P Y INFUSION INJECTION Slim Sano COVINEX GEL PharmAce (Pvt) Ltd Aurochem N/AAXAGYL INJECTIONMETROGYL INFUSION Hemas INJECTIONNIRMET Chamee Chemist George Steuart Axa Parenterals AMODIS 500 INJECTION INTRA Sunshine N/AN/AN/A ORAL METROGYL ORAL SUSPENSION ORAL George Steuart TABLETS USP 200MG USP TABLETS 0.5% W/V 500MG/100ML CHLORHEXIDINE GLUCONATE CHLORHEXIDINE GLUCONATE 2.5MG/G GEL 0.5% 500MG/100ML 500MG/100ML 0.5% INFUSION BP 0.5% INFUSION BP SUSPENSION 200MG/ 5ML 200MG/5ML SUSPENSION BP 200MG/5ML SUSPENSION BP 200MG/5ML SUSPENSION BP 4726 METRONIDAZOLE 10MG/G GEL METROGYL 4727 METRONIDAZOLE FILM COATED 4728 METRONIDAZOLE INJECTION BP 4729 METRONIDAZOLE INJECTION BP 4725 METRONIDAZOLE 10MG + 4730 METRONIDAZOLE INJECTION USP 4731 METRONIDAZOLE INJECTION USP 4732 METRONIDAZOLE INJECTION USP 4733 METRONIDAZOLE INTRAVENOUS 4734 METRONIDAZOLE INTRAVENOUS 4735 METRONIDAZOLE ORAL 4736 METRONIDAZOLE ORAL 4737 METRONIDAZOLE ORAL 4738 METRONIDAZOLE ORAL 388 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 BANGLADESH 16-Jan-15INDIA Full 18-Nov-17 Years Two BANGLADESH 07-Feb-14SRI LANKA Full INDIA 06-Jul-14 Full INDIA 20-Jun-14INDIA Full 28-May-15SRI LANKA Full 18-Feb-14 31-Oct-15BANGLADESH Full 17-Dec-15 Full Full INDIAINDIA 09-Mar-15 Full 04-Aug-16 Full BANGLADESH 17-Oct-14INDIA Full INDIA 18-Feb-14 Full 09-Mar-16 Full

Aventis Aventis fi fi Pharmaceuticals Ltd Laboratories (Pvt) Ltd Bangaladesh Ltd Ltd Ltd Astra Lifecare (India) (Pvt) Ltd Laboratories (Pvt) Ltd Ltd Pharmaceuticals Ltd Unique Pharmaceutical Labs Ltd Bangaladesh Ltd Laboratories (Pvt) Ltd Unique Pharmaceutical Labs (Contd.) Lanka Ltd Sano Lanka Ltd Sano fi fi Health (Pvt) Ltd N/A Inter Pharm (Pvt) Health (Pvt) Ltd Health (Pvt) Ltd TABLETS Ceyoka (Pvt) Ltd Leben TABLETS SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP AMODIS 400 TABLETSMETROLEB 400 TABLETS PharmAce (Pvt) Ltd Square FLAGYL400 Ceyoka (Pvt) Ltd Leben TABLETS Sano ANABACN/A TABLETSASTROGYL N/AReg.failed- TABLETS TABLETSMETROLEB George Steuart Chamee ChemistN/A Bajaj Healthcare Inter Pharm (Pvt) AMODIS 200 TABLETS FILM COA METROGYL-200 TABLETS PharmAce (Pvt) Ltd Square METAZOLE George Steuart 200FLAGYL TABLETS TABLETS Kamazu (Pvt) Ltd B D H Industries Sano METROLEB-200 TABLETSMETROGYL-400 Ceyoka (Pvt) Ltd TABLETS Leben George Steuart 400MG 400MG 400MG 200MG 200MG 200MG 200MG 200MG 200MG 200MG 200MG 200MG 200MG 400MG 4740 BP TABLETS METRONIDAZOLE 4741 BP TABLETS METRONIDAZOLE 4739 BP TABLETS METRONIDAZOLE 4742 BP METRONIDAZOLE TABLETS 4743 BP METRONIDAZOLE TABLETS 4744 BP METRONIDAZOLE TABLETS 4745 BP METRONIDAZOLE TABLETS 4746 BP METRONIDAZOLE TABLETS 4747 BP METRONIDAZOLE TABLETS 4748 BP METRONIDAZOLE TABLETS 4749 BP METRONIDAZOLE TABLETS 4750 BP METRONIDAZOLE TABLETS 4751 BP METRONIDAZOLE TABLETS 4752 BP METRONIDAZOLE TABLETS I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 389 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIA 23-Jan-14MALAYSIA Full 04-May-15 Full INDIAINDIA 26-Dec-15INDIA Full 28-Mar-15INDIA Full 10-Jun-15MALAYSIA Full 17-Feb-14 11-Dec-14 Full INDIA Full BANGLADESH 27-Apr-15 22-Jan-14INDIA Full Full SRI LANKA 22-Aug-16 06-Jul-17BELGIUM Full Full 26-Jun-17INDIA Years Two 20-Oct-16 Full Kotra pharma (M) Ltd Scottish Pharma INDIASG Pharma (Pvt) Ltd SG Pharma (Pvt) 29-May-16Ltd Full SG Pharma (Pvt) Ltd Unijules Life Sciences Ltd Kotra pharma (M) Ltd Healthcare Vital (Pvt) Ltd Pharmaceuticals Ltd Medicare Yash (Pvt) Ltd Pharmaceuticals Pvt Ltd Janssen Pharmaceuticals NV Belco Pharma (Pvt) Ltd Pharmaceuticals Ltd (Contd.) Co Ltd Ltd Pharmacy (Pvt) Ltd Pharmacy (Pvt) Ltd Pharmacy (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Co Ltd (Pvt) Ltd Himan Group (Pvt) Ltd (Pvt) Ltd Agency Pvt Ltd CREAM Delmege Forsyth & CREAM SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP N/AN/A TABLETS TABLETS N/A Delmege Forsyth & MEXILATE INJECTION The Esses MICONAZOLE CREAM SRI LANKA 14-Nov-16 Full DAKTACORT CREAMNEOZOLE Pettah Pharmacy CREAM Leader Pharma ETZOLE 200 TABLETSAssociates Pharma Bafna 200MG 400MG ML 10MG/G G+HYDROCORTISONE CREAM B.P 200MG 4754 USP METRONIDAZOLE TABLETS 4755 USP METRONIDAZOLE TABLETS 4756 500MG BP TABLETS METFORMIN N/A4757 150MG MEXILETINE CAPSULES BP N/A4758 50MG MEXILETINE CAPSULES BP N/A TABLETS4759 25MG/ MEXILETINE INJECTION BP CAPSULES4760 Alaris Lanka (Pvt) 2% W/W MICONAZOLE CREAM BP N/A The Esses CAPSULES4761 2% W/W MICONAZOLE CREAM BP The Esses AXCEL CREAM4762 2% W/W MICONAZOLE CREAM BP ZOLOVIT4763 2% W/W MICONAZOLE CREAM BP Lifeline FUNGIDAL CREAM4764 2% W/W MICONAZOLE CREAM BP CREAM MICOVIN International Yaden 4765 2% W/W MICONAZOLE CREAM BP N/A PharmAce (Pvt) Ltd Square TOPICAL 4766 MICONAZOLE 20MG/ CREAM4767 2% CREAM MICONAZOLE NITRATE N/A Gamma 4753 IP METRONIDAZOLE TABLETS 390 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAMALAYSIA 07-Apr-16 07-Feb-18BELGIUM Full Full 22-Jun-18BELGIUM Provisional 22-Jun-17MALAYSIA Full 07-Jul-15 Full INDIAINDIA 08-Feb-17INDIA Full 26-Jun-16INDIA Full 25-Mar-16BANGLADESH Full 25-Jun-15 22-Apr-18 Years Two INDIA Full MALAYSIA 25-Jan-18 01-Dec-15 Full Full Hovid SDN Bhd MALAYSIAPharmaceutical 10-Jun-14Pharmaceuticals Full SDN BHD Janssen Pharmaceuticals NV Janssen Pharmaceuticals NV Pharmaceuticals SDN BHD Cipla LtdAgio Pharmaceuticals INDIALtd & Co Ltd 01-Sep-15Pharmaceuticals Full (India) Ltd Pharmaceutical Pharmaceuticals Ltd Centaur Pharmaceutical (Pvt) Ltd Pharmaceuticals SDN BHD (Contd.) Lanka (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd Health (Pvt) Ltd ORAL GELORAL PharmAce (Pvt) Ltd Square SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP TINACORTEMZOLE-F CREAMDECOCORT OINTMENT Hadley Bevan CREAMAssociates Pharma DAKTATIN Central drugs and Indoscan (Pvt) Ltd CREAMDAKTATIN Hoe Pettah Pharmacy CREAMDECOZOLE CREAM Pettah Pharmacy MICOGELMICOSON 2% Indoscan (Pvt) Ltd CREAM Hoe CREAMGVMICON Breathe Free Lanka Citihealth Imports CREAMEMZOLE Chamee Chemist Gopaldas Visram ORAL GELORA GEL CREAM oralMICONA Associates Pharma Central drugs and GELDECOZOLE GEL ORAL George Steuart Indoscan (Pvt) Ltd Hoe 2%+FLUOCINOLONE 0.01% 2% HYDROCHLORIDE CREAM B.P 20MG IN 1G 20MG IN 1G 2% 2% 2% W/W USP 2% W/W USP CREAM 2%W/W BP 2%W/W BP 2%W/W BP HYDROCORTISONE 1% HYDROCORTISONE 4769 MICONAZOLE NITRATE 4770AND BP MICONAZOLE NITRATE 4771 CREAM MICONAZOLE NITRATE 4772 CREAM MICONAZOLE NITRATE 4773 CREAM BP MICONAZOLE NITRATE 4774 CREAM BP MICONAZOLE NITRATE 4775 CREAM MICONAZOLE NITRATE 4776 CREAM MICONAZOLE NITRATE 4777 20mg/g GEL MICONAZOLE NITRATE MICOTRATE4778 GEL 2% IP MICONAZOLE NITRATE 4779 GEL MICONAZOLE OROMUCOSAL PharmAce (Pvt) Ltd Aurochem 4780 GEL MICONAZOLE OROMUCOSAL 4781 GEL MICONAZOLE OROMUCOSAL 4768 2% WITH MICONAZOLE NITRATE I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 391 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIABELGIUM 05-Jun-15 30-Jan-17 Full SWITZERLAND Full 07-Nov-17 Years Two INDIAFRANCE 07-Jun-18 14-Nov-17INDIA Full Years Two SWITZERLAND 24-Aug-18 21-Apr-14 Full Full BANGLADESH 26-Jan-16INDIA Full INDIA 17-May-18INDIA Full 14-May-14INDIA Full 31-Mar-15 Full 19-Apr-18 Provisional Lusomedicamenta Socie /Portugal Janssen Pharmaceutical NV Cenexi SAS Fontenay France for F Hoffmann-La roche ltd-Swit Human Verve Care Laboratories Cenexi SAS Fontenay Sous Bois Neon Laboratories Ltd Products Roche Mexico for A S F Hoffman-La Roche Ltd. Switzerland Pharmaceuticals Ltd Unijules Life Sciences Ltd SG Pharma (Pvt) Ltd United Biotech (Pvt) Ltd Kwality Pharmaceuticals Pvt Ltd Micro Labs Ltd INDIA 01-Dec-14 Full (india) (Pvt) Ltd (Contd.) Pettah Pharmacy (Pvt) Ltd Ltd Agency Pvt Ltd Ltd (Pvt) Ltd Ltd Lifeline Pharmaceuticals (Pvt) Ltd Pharmacy (Pvt) Ltd (Pte) Ltd (Pvt) Ltd (Pvt) Ltd TINCTURE SUSPENSION GEL Ceyoka (Pvt) Ltd Galentic Pharma SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP MAGAFIN ORAL MILRONN/A INJECTIONMINOLIN 100 R & D Intertrades INJECTION TABLETS International Yaden Micro Mega Lanka OROMUCORAL OROMUCORAL GEL +LIQUID PARAFIN 3.75ML/15ML +LIQUID PARAFIN 10MG/10ML 1MG/1ML 100MG USP TABLETS BP 40G BP 4783 MICONAZOLE TINCTURE 20MG/ML DAKTARIN TOPICAL 4784 MIDAZOLAM INJECTION 5MG/ML DORMICUM4785 5MG/ML MIDAZOLAM INJECTION BP INJECTION 5 VERZOL 4786 Baur & Co (Pvt) A 5MG/ML MIDAZOLAM INJECTION BP DORMICUM INJECTION4787 INJECTION Leader Pharma 5MG/ML MIDAZOLAM INJECTION BP MEZOLAM Baur & Co (Pvt) A 4788 7.5MGTABLETS MIDAZOLAM INJECTION DORMICUM Ravilux Company 4789 7.5MGTABLETS MIDAZOLAM TABLETS DORMITOL4790 Baur & Co (Pvt) A 11.25ML IP MILK OF MAGNESIA TABLETS4791 MILRINONE INJECTION 10MG/10ML NEFRISOL PharmAce (Pvt) Ltd4792 Square INJECTION MILRINONE LACTATE INJECTION4793 INJECTION MILRINONE LACTATE The Esses 4794 MINOCYCLINE HYDROCHLORIDE 4782 GEL MICONAZOLE OROMUCOSAL 392 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIA 15-Sep-17INDIA Years Two INDIA 30-Apr-14INDIA Full 15-Sep-17PAKISTAN Years Two 30-Apr-14PAKISTAN 26-Jul-18 Full Full 24-Feb-14PAKISTAN Full PAKISTAN 26-Jul-18 Full 28-Aug-14INDIA Full INDIA 10-Sep-18INDIA Years Two 10-Sep-18INDIA Years Two 23-Sep-14PAKISTAN Full 17-Dec-14 12-Nov-18 Full Years Two Wings Biotech INDIAPharmaceuticals Wings Biotech 28-Feb-18 INDIAYears Two SG Pharma (Pvt) Ltd Pharmaceuticals 22-Feb-18Years Two SG Pharma (Pvt) Ltd Elko Organization (Pvt) Ltd Hemas Pharmaceuticals (Pvt) Ltd Elko Organization (Pvt) Ltd Brookes Pharma (Pvt) Ltd Aurobindo Pharam Ltd Aurobindo Pharam Ltd India Ltd Sun Pharmaceutical industries OBS Pakistan (Pvt) Ltd (Contd.) (Pvt) Ltd (Pvt) Ltd Pharmacy (Pvt) Ltd Pharmacy (Pvt) Ltd Emerchemie NB (Ceylon) Ltd Mansel (Ceylon) (Pvt) Ltd Emerchemie NB (Ceylon) Ltd Pharmaceuticals (Pvt) Ltd Ltd Ltd (Ceylon) Ltd (Ceylon) Ltd SOLUTION SOLUTION SOLUTION TABLETSTABLETS Alaris Lanka (Pvt) Alaris Lanka (Pvt) SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP MINOXINHAIR MAX PLUS TOPICAL TOPICAL MINOXIN plus PLASTIC JARAUROZAPINE Hemas OD 15 AUROZAPINE OD 30 USP 2% USP 5% 5% USP 15MG TABLETS 30MG TABLETS 4796 5MGTABLETS MINOXIDIL 4797 2.5MG USP TABLETS MINOXIDIL N/A MINOXIN4798 2.5MG USP TABLETS MINOXIDIL N/A4799 2.5MG USP TABLETS MINOXIDIL TABLETS N/A4800 TABLETS 5MG USP TABLETS MINOXIDIL International Yaden 4801Associates Pharma N/A TABLETS SOLUTION 2%TOPICAL MINOXIDIL The Madras HAIR MAX4802 TABLETS The Esses SOLUTION TOPICAL MINOXIDIL TOPICAL Associates Pharma TABLETS4803 The Madras SOLUTION TROPICAL MINOXIDIL 4804 The Esses SOLUTION TROPICAL MINOXIDIL 4805 ORO DISPERSIBLE MIRTAZAPINE 4806 ORO DISPERSIBLE MIRTAZAPINE 4807 15MG USP TABLET MIRTAZAPINE 15 MITRAPIL 4808 15MG USP TABLET MIRTAZAPINE 15 TABLETS MIRTAZ 4809 30MG USP TABLET MIRTAZAPINE PharmAce (Pvt) Ltd TABLETS Psychotropine MEZERON Emerchemie NB TABLETS Emerchemie NB 4795 5MGTABLETS MINOXIDIL MINOXIN TABLETS International Yaden I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 393 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIA 17-Jul-15INDIA Full INDIA 02-Jul-18INDIA Provisional 28-Jun-17BANGLADESH Years Two 22-Mar-18 02-Jul-18 Years Two Provisional INDIAINDIA 21-Sep-17 Years Two TURKEY 29-Jun-18 Years Two 27-Feb-18INDIA Full INDIA 06-Sep-17 Years Two BELGIUM 15-Aug-15INDIA 01-Aug-16 Full Full INDIA 08-Mar-15 Full 11-Jul-15 Full Acme Formulation (Pvt) Ltd Mercury Laboratories Ltd Beximco Pharmaceuticals Ltd Concept Pharmaceuticals Ltd Sava Healtheare Ltd Medicine World Ilac san ve Concept Pharmaceuticals Ltd Wallace Pharmaceuticals Ltd Schering-Plough Lab N V Glenmark Pharmaceuticals Ltd Laboratories (Pvt) Ltd Sun Pharmaceutical industries Mercury Laboratories Ltd (Contd.) Lanka (Pvt) Ltd (Ceylon) Ltd International (Pvt) Ltd (Ceylon) Ltd Pharmaceuticals (Pvt) Ltd International (Pvt) Ltd Ltd Ltd Healthcare lanka Ltd (Ceylon) Ltd (Pvt) Ltd NASAL SPRAYNASAL Emerchemie NB SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP NASOMET SPRAY NASAL METALET Emerchemie NB NS MOMENAP SPRAY NASAL 0.05 Softcare ETACIDMOMETACON SPRAY NASAL Slim CREAM CREAMMTAZ Softcare CREAM Emar Pharma (Pvt) MOMSON CREAM Ceyoka (Pvt) Ltd Leben SPRAY BP 50MCG BP SPRAY 50MCG BP SPRAY 0.05% W/V BP SPRAY 0.05% W/V BP SPRAY W/W W/W 0.1% W/W 4811 15MGTABLETS MIRTAZAPINE MIRAZEP TABLETS Micro Labs Ltd Micro Labs Ltd INDIA 08-Mar-15 Full 4813 200MCGTABLETS MISOPROSTOL MISOCLEAR4814 25MCGTABLETS MISOPROSTOL TABLETS N/A4815 AQUEOUS NASAL MOMETASONE Population Services 4816 AQUEOUS NASAL MOMETASONE TABLETS4817 AQUEOUS NASAL MOMETASONE International Yaden 4818 AQUEOUS NASAL MOMETASONE 4819 0.1% CREAM BP MOMETASONE 4820 0.1% CREAM IP MOMETASONE 4821 0.1% USP FUROATE MOMETASONE ELOMET4822 0.1% USP FUROATE MOMETASONE CREAM MOMATE CREAM CREAM4823 CREAM FUROATE MOMETASONE Sunshine Baur & Co (Pvt) A 4810 30MG USP TABLET MIRTAZAPINE 30 MIRTAZ TABLETS4812 200MCGTABLETS MISOPROSTOL N/A Emerchemie NB TABLETS International Yaden 394 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 MALAYSIA 14-Nov-17INDIA Full INDIA 17-Sep-14PAKISTAN Full 19-Mar-16PAKISTAN 14-Mar-17 Full Full BANGLADESH 16-Jan-15 12-Aug-18 Full Full INDIAINDIA 29-Apr-15 Full INDIA 21-Sep-17 Years Two 14-Mar-17 Years Two INDIABELGIUM 26-Sep-18BANGLADESH 20-Mar-15 Full 12-May-16 Full Full Pharmaceuticals SDN BHD ZYG Pharma (Pvt) Ltd Glenmark Pharmaceuticals Ltd Pharmatec Pakistan (Pvt) Ltd Caraway Pharmaceuticals Incepta Pharmaceuticals Ltd Torrent Torrent Pharmaceuticals Ltd Brassica Pharma Pvt Ltd Centaur Pharmaceutical (Pvt) Ltd Cipla LtdCipla Ltd INDIAGlenmark INDIAPharmaceuticals Ltd 09-May-16Schering-Plough Full Lab N V 05-Apr-18Incepta Full Pharmaceuticals Ltd (Contd.) Ltd Healthcare lanka Ltd Plc Health (Pvt) Ltd (Pvt) Ltd Ltd International (Pvt) Ltd Health (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Ltd (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP BITVIOMOMESICA CREAM CREAMMOMTAS Mega Pharma (Pvt) Softcare TOPCORT CREAMMETASPRAY CREAM George Steuart DROPS NASAL Breathe Free Lanka MOMATE Breathe Free Lanka NASONEX SPRAY NASAL Hemas MOMESON SPRAY NASAL Baur & Co (Pvt) A SPRAY NASAL Citihealth Imports ELOSONE OINTMENTBITVIO Indoscan (Pvt) LtdMOMATE Hoe OINTMENT OINTMENT Mega Pharma (Pvt) Sunshine OINTMENT 0.1% W/W OINTMENT 0.1% W/W OINTMENTUSP 0.1% W/W OINTMENTUSP USP 0.1% W/W USP 0.1% W/W USP 0.1% W/W USP DROPS NASAL MONOHYDRATE 50mcg/dose SPRAY NASAL MONOHYDRATE 50mcg/SPRAY 0.05% SPRAY 50 MCG SPRAY USP 0.1% W/W USP 4832 FUROATE MOMETASONE 4833 FUROATE MOMETASONE 4834 FUROATE MOMETASONE 4835 10MGTABLETS MONTELUKAST MONTEC 104836 10MGTABLETS MONTELUKAST CARAMONT TABLETS4837 10MGTABLETS MONTELUKAST VENTELUCAST TABLETS Browns & Company TABLETS George Steuart Citihealth Imports 4825 CREAM FUROATE MOMETASONE 4826 CREAM FUROATE MOMETASONE 4827 CREAM FUROATE MOMETASONE 4828 FUROATE MOMETASONE 4829 FUROATE MOMETASONE 4830 NASAL FUROATE MOMETASONE 4831 NASAL FUROATE MOMETASONE 4824 CREAM FUROATE MOMETASONE I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 395 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 BANGLADESH 06-Aug-15 Full BANGLADESH 19-Mar-14 Full INDIAPAKISTAN 02-May-14 15-Mar-14 Full PAKISTAN Full PAKISTAN 16-Jan-15 Full 07-Aug-14BANGLADESH 09-Sep-15 Full Full INDIAPAKISTAN 18-Sep-15 22-Jul-17 Full Full BANGLADESH 05-Dec-17PAKISTAN Full PAKISTAN 26-Jan-16 Full 14-Mar-18 Full Beximco Pharmaceuticals Ltd Pharmaceuticals Ltd Glenmark Pharmaceuticals Ltd CCL Pharmaceuticals (Pvt) Ltd Caraway Pharmaceuticals Genome Pharmceuticals (Pvt) Ltd Healthcare Pharmaceuticals Hovid Berhard MALAYSIA 14-Nov-14 Full Unichem Laboratories Pharmaceuticals Pvt Ltd Innova Captab INDIA 24-Aug-16 Full The ACME Laboratories Ltd PharmEvo (Pvt) Ltd Pharmatec Pakistan (Pvt) Ltd (Contd.) (Ceylon) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals Lanka (Pvt) Ltd Health (Pvt) Ltd Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Ltd Pharmaceuticals (Pvt) Ltd Ltd Colombo Ltd Plc SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP 4838 10MGTABLETS MONTELUKAST 10 MONOCAST TABLETS Emerchemie NB 4839 10MGTABLETS MONTELUKAST MONTENE 104840 10MGTABLETS MONTELUKAST TABLETSTR 10 GLEMONT TABLETS PharmAce (Pvt) Ltd4841 10MGTABLETS MONTELUKAST Square MONTELUK Hemas 4842 10MGTABLETS MONTELUKAST TABLETS CARAMONT4843 10MGTABLETS MONTELUKAST CCL 10 MEKAST TABLETS4844 10MGTABLETS MONTELUKAST TABLETS George Steuart AERON4845 10MGTABLETS MONTELUKAST Lanka (Pvt) Tabrane MONTELAIR 10MG TABLETS TABLETS Thorn Citihealth Imports 4846 10MGTABLETS MONTELUKAST 10 ZOKAST TABLETS Baur & Co (Pvt) A 4847 10MGTABLETS MONTELUKAST PULMIKAST4848 10MGTABLETS MONTELUKAST TABLETS 10 VENTOKAST TABLETS Klintas (Pvt) Ltd Hansel Slim 4849 10MGTABLETS MONTELUKAST MONAS 10 TABLETS Mega Pharma (Pvt) 4850 10MGTABLETS MONTELUKAST AIREEZ 104851 5MGTABLETS MONTELUKAST MONTEC 5 TABLETS Chemical Industries TABLETS Browns & Company 396 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 PAKISTAN 23-Aug-17BANGLADESH 08-Nov-14 Full Full BANGLADESH 19-Mar-17 Full BANGLADESH 12-Sep-14 Full PAKISTAN 15-Mar-14PAKISTAN Full 07-Aug-14INDIA Full PAKISTAN 26-Nov-18INDIA Years 16-Jul-14 Two Full INDIA 02-Sep-17 Years Two INDIA 24-Jan-15 Full BANGLADESH 01-Oct-17 23-Feb-15 Years Two Full PAKISTAN 22-Oct-14 Full Pharmaceuticals Ltd Pharmaceuticals Pvt Ltd Incepta Pharmaceuticals Ltd Beximco Pharmaceuticals Ltd CCL Pharmaceuticals (Pvt) Ltd Genome Pharmceuticals (Pvt) Ltd Aurobindo Pharam Ltd (Pvt ) Ltd Cadila Healthcare Ltd MSN Laboratories Alembic Pvt Ltd for Pharmaceuticals - India Glenmark Pharmaceuticals Ltd Globe Pharmaceuticals Ltd Nabiqasim Industries (Pvt) Ltd (Contd.) Klintas (Pvt) Ltd Hansel (Pvt) Ltd (Ceylon) Ltd Pharmaceuticals Lanka (Pvt) Ltd Ltd Ltd Ceyoka (Pvt) Ltd Genix Pharma Hemas Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Hemas Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Health (Pvt) Ltd TABLETS TABLETS TABLETS TABLETS SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP M KAST 4M KAST LEUGEN TABLETSMONTEZYD 4 Alaris Lanka (Pvt) CHEWABLE CHEWABLE 4MORAL TABLETS 4 CT GLEMONT CHEWABLE Citihealth Imports 4MONTIFAST TABLETSLUNGAIR Healthcare Tabrane TABLETS George Steuart TABLETS 4MG TABLETS 4MG TABLETS 4MG TABLETS 4MG TABLETS 4MG TABLETS 4MG TABLETS 4MG TABLETS 4853 5MGTABLETS MONTELUKAST 5 VENTELUCAST TABLETS4854 5MGTABLETS MONTELUKAST MONTENE 5 Citihealth Imports 4855 5MGTABLETS MONTELUKAST TABLETS 5 MONOCAST 4856 5MGTABLETS MONTELUKAST PharmAce (Pvt) Ltd TABLETS Square MONTELUK4857 5MG Emerchemie NB TABLETS MONTELUKAST TABLETS 5 MEKAST 4858 CHEWABLE MONTELUKAST CCL TABLETS4859 CHEWABLE MONTELUKAST Lanka (Pvt) 4860 Tabrane CHEWABLE MONTELUKAST 4861 CHEWABLE MONTELUKAST 4862 CHEWABLE MONTELUKAST 4863 CHEWABLE MONTELUKAST 4864 CHEWABLE MONTELUKAST 4852 5MGTABLETS MONTELUKAST PULMIKAST CHEWABLE I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 397 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 BANGLADESH 30-Nov-17INDIA Full INDIA 26-Nov-18 Years Two INDIA 01-Oct-17 Years Two INDIA 30-Oct-14 Full BANGLADESH 24-Jan-15 23-Feb-15 Full Full BANGLADESH 05-Dec-17INDIA Full BANGLADESH 24-Jan-15 23-Feb-15 Full Full PAKISTANPAKISTAN 27-Jan-16 Full 30-Dec-15INDIA Full 21-Mar-18PAKISTAN Years Two 22-Jan-17 Full Ltd The Acme Laboratories Ltd Aurobindo Pharam Ltd Glenmark Pharmaceuticals Ltd Cadila Healthcare Ltd MSN Laboratories Alembic Pvt Ltd for Pharmaceuticals - India Globe Pharmaceuticals Ltd The ACME Laboratories Ltd MSN Laboratories Alembic Pvt Ltd for Pharmaceuticals - India Globe Pharmaceuticals Ltd Hemis NOA Pharmaceuticals Hilton Pharma (Pvt) Ltd Cipla Ltd Hemis NOA Pharmaceuticals INDIA 05-Jul-18 Full (Contd.) Ltd Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd Mega Pharma (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd Sunshine Healthcare lanka Ltd Breathe Free Lanka (Pvt) Ltd (Pvt) Ltd TABLETS POWDER Negolec Lifescience FOR ORAL SOLUTION TABLETS SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP M KAST 5M KAST 5 CT GLEMONT TABLETS TABLETSMONTEZYD 5 Alaris Lanka (Pvt) Hemas TABLETS 5MORAL Hemas TABLETS 5MONTIFAST TABLETS Citihealth Imports MONAS 5 Healthcare Tabrane 10MORAL CHEWABLE TABLETS 10MONTIFAST TABLETS Citihealth Imports Healthcare SACHETS Tabrane MYTEKA CW 5BREATHEZY TABLETS POWDER MONTAIR-5 Axia (Pvt) Ltd CHEWABLE MSN Laboratories MONAS 4 TABLETS Mega Pharma (Pvt) MONAKA TABLETS Negolec Lifescience TABLETS 5MG TABLETS 5MG TABLETS 5MG TABLETS 5MG TABLETS 5MG TABLETS 5MG TABLETS 10MG TABLETS 10MG TABLETS SACHET 5MG TABLETS CHEWABLE 5MG TABLETS 4MG TABLETS 5MG 4866 CHEWABLE MONTELUKAST 4867 CHEWABLE MONTELUKAST 4868 CHEWABLE MONTELUKAST 4869 CHEWABLE MONTELUKAST 4870 CHEWABLE MONTELUKAST 4871 CHEWABLE MONTELUKAST 4872 CHEWALBE MONTELUKAST 4873 CHEWALBE MONTELUKAST 4874 SACHETS 4MG MONTELUKAST MONAKA 4875 SACHETS 4MG/ MONTELUKAST 4876 SODIUM MONTELUKAST 4877 TABLETS SODIUM MONTELUKAST 4865 CHEWABLE MONTELUKAST 4878 TABLETS SODIUM MONTELUKAST 398 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 PHILIPPINES 22-May-15 Full INDIAINDIA 10-Nov-16 Full PAKISTAN 16-Feb-18 Years Two 19-Apr-16BANGLADESH 26-Apr-17 Full PAKISTAN Full 03-Mar-15 Full INDIAPAKISTAN 20-Jul-17 03-Mar-15INDIA Full Full INDIA 18-Dec-14PAKISTAN Full 17-Dec-15 02-Dec-15 Full Full Micro Labs Ltd INDIAAmherst Laboratories 07-Feb-14Sun Full Pharmaceutical industries Zim Laboratories Ltd Getz Pharma Pakistan (Pvt) Ltd Beximco Pharmaceuticals Ltd Indus Pharma (Pvt) Ltd PharmaMBL PAKISTANCelogen Pharma Pvt 03-May-18Indus Pharma (Pvt) Ltd Full Sun Pharmaceutical industries Laboratories XL (Pvt) Ltd Zafa Pharmaceuticals Laboratories (Pvt) Ltd (Contd.) Ltd Health (Pvt) Ltd Emerchemie NB (Ceylon) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Emerchemie NB (Ceylon) Ltd Pharmaceuticals (Pvt) Ltd Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Ceylon) Ltd Ltd International Yaden (Pvt) Ltd TABLETS TABLETS TABLETS SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP PULMINAIR 5 TABLETSMONTEK-4 PharmAce (Pvt) Ltd Kopran Ltd CHEWABLE LEUKO 4 INDIAMONTIGET TABLETS TABLETS Tabrane 4MONOCAST 10-Oct-17Years Two CHEWABLE Hemas INDOKAST TABLETSMONTI 5 Lotus TABLETS 5INDOKAT Markss HLC (Pvt) TABLETSMONTEK-5 Lotus TABLETSASMAACT Emerchemie NB MONTAZA TABLETS CHEWABLE SMM Halcyon (Pvt) MONEST 5MONEST EZKASTAIR TABLETS TABLETS SMM Halcyon (Pvt) George Steuart MONTEGEN 5 TABLETS Pharma Villorgen 5MG 4MG TABLETS CHEWABLE 4MG TABLETS CHEWABLE 4MG TABLETS CHEWABLE 4MG TABLETS CHEWABLE 10MG TABLETS CHEWALBE 5MG TABLETS CHEWALBE 5MG TABLETS CHEWALBE 5MG TABLETS CHEWALBE 5MG TABLETS CHEWALBE 5MG TABLETS CHEWALBE 5MG 5MG 5MG TABLETS CHEWALBE 4881 TABLETS SODIUM MONTELUKAST 4882 SODIUM MONTELUKAST 4883 SODIUM MONTELUKAST 4884 SODIUM MONTELUKAST 4885 SODIUM MONTELUKAST 4886 SODIUM MONTELUKAST 4887 SODIUM MONTELUKAST 4889 SODIUM MONTELUKAST 4890 SODIUM MONTELUKAST 4891 SODIUM MONTELUKAST 4892 SODIUM MONTELUKAST 4879 TABLETS SODIUM MONTELUKAST 4880 TABLETS SODIUM MONTELUKAST 4888 SODIUM MONTELUKAST I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 399 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 05-Jun-15 Full PAKISTAN 19-Apr-16INDIA Full UNITED KINGDOM 30-Jun-17 Years Two PAKISTANBANGLADESH 25-Jan-17 24-Aug-17 Full PAKISTAN Full 04-Jul-18BANGLADESH Years Two 06-Oct-14 Full PAKISTAN 30-Aug-18PAKISTAN Years Two INDIA 10-Apr-17 Full INDIA 27-Oct-14 Full PAKISTAN 10-Nov-14TURKEY 27-Jan-17 Full Full 23-Dec-14 Full Getz Pharma Pakistan (Pvt) Ltd Cadila pharmaceuticals Ltd Merck Sharp & Dohme Ltd Company Ltd Healthcare Pharmaceuticals Getz Pharma Pakistan (Pvt) Ltd Healthcare Pharmaceuticals PharmaMBL PAKISTANNabiqasim Industries (Pvt) Ltd 03-May-18 Provisional Zim Laboratories Ltd Sun Pharmaceutical industries Hemis NOA Pharmaceuticals Deva Holding A.S.Organize Sanayl (Contd.) Pharmaceuticals (Pvt) Ltd Healthcare lanka Ltd Baur & Co (Pvt) A Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Markss HLC (Pvt) Ltd Health (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Ceylon) Ltd (Pvt) Ltd Sciences (Pvt) Ltd TABLETS TABLETS SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP MONTELAST-5 TABLETSSINGULAIR Sunshine CHEWABLE MONTIGET TABLETS Hemas AIREEZ 5 TABLETS CIC Holdings PLC PharmEvo (Pvt) AERON FT 5AERON FT MONTIGET TABLETS Citihealth Imports GRANULES 4AERON FT Hemas MONTI 10 TABLETS Citihealth Imports FILM COA VENTEKLEUKO 10 TABLETS TABLETSMONTEK-10 Morison PLC TABLETS Tabrane MONAKA The Searle Emerchemie NB 10LUXAT TABLETS TABLETS Negolec Lifescience Synergos Life LUNGAIR TABLETS George Steuart CHEWALBE TABLETS 5MG TABLETS CHEWALBE 5MG TABLETS CHEWALBE CHEWALBE TABLETS 5MG TABLETS CHEWALBE 5MG TABLETS CHEWALBE DISPERSIBLE TABLETS 5MG TABLETS DISPERSIBLE GRANULES 4MG PAEDISTRIC 4MG 10MG 10MG 10MG 10MG 10MG 10MG 10MG 4894 SODIUM MONTELUKAST 4895 SODIUM MONTELUKAST 4893 SODIUM MONTELUKAST 4896 SODIUM MONTELUKAST 4897 SODIUM MONTELUKAST 4898 SODIUM MONTELUKAST 4899 TABLETS SODIUM MONTELUKAST 4900 TABLETS SODIUM MONTELUKAST 4902 TABLETS SODIUM MONTELUKAST 4903 TABLETS SODIUM MONTELUKAST 4904 TABLETS SODIUM MONTELUKAST 4905 TABLETS SODIUM MONTELUKAST 4906 TABLETS SODIUM MONTELUKAST 4901 TABLETS SODIUM MONTELUKAST 400 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 02-Jun-15 Full INDIAPAKISTAN 16-Aug-14 24-Feb-17INDIA Full Full PAKISTAN 21-Jun-17 02-Dec-14 Full Full PAKISTAN 21-Apr-16UNITED KINGDOM Full INDIAPAKISTAN 30-Jun-18PAKISTAN 16-Jan-15 Full Full 26-Apr-17INDIA Years Two 26-Nov-16 Full Ltd XL Laboratories XL (Pvt) Ltd Hilton Pharma (Pvt) Ltd Zafa Pharmaceuticals Laboratories (Pvt) Ltd Micro Labs Ltd INDIAGetz Pharma Pakistan (Pvt) Ltd Merck Sharp & 31-Oct-14Dohme Full Cipla LtdCipla Ltd INDIACadila pharmaceuticals INDIALtd 21-Dec-15Caraway Pharmaceuticals Full 05-Jul-18Hilton Pharma (Pvt) Ltd Full Zim Laboratories Ltd (Contd.) Ltd Healthcare lanka Ltd (Pvt) Ltd Ltd Pharmaceuticals (Pvt) Ltd Ltd (Pvt) Ltd Breathe Free Lanka (Pvt) Ltd Sunshine Healthcare lanka Ltd Health (Pvt) Ltd Healthcare lanka Ltd Pharmaceuticals (Pvt) Ltd TABLETS TABLETS SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP MYTEKA -10BREATHEZY TABLETS TABLETSMONTAZA Sunshine Axia (Pvt) Ltd TABLETS MSN Laboratories 10MONEST International Yaden TABLETS SMM Halcyon (Pvt) SINGULAIR TABLETS Baur & Co (Pvt) A CARAMONTMYTEKA TABLETS George Steuart LEUKO 5 TABLETS Sunshine VENTEK 5 TABLETS Tabrane TABLETS Morison PLC Searle-Pakistan PAKISTAN 10-Apr-15 Full ASMAACT TABLETS SMM Halcyon (Pvt) MONTIGET TABLETS Hemas MONTAIR-10 TABLETSMONTAIR-4MONTELAST-4 Breathe Free Lanka CHEWABLE CHEWABLE 10MG 10MG 10MG 10MG 10MG 5MG 5MG 5MG 5MG 10MG 10MG 10MG 4MG 4MG 4911 TABLETS SODIUM MONTELUKAST 4908 TABLETS SODIUM MONTELUKAST 4909 TABLETS SODIUM MONTELUKAST 4910 TABLETS SODIUM MONTELUKAST 4913 TABLETS SODIUM MONTELUKAST 4917 TABLETS SODIUM MONTELUKAST 4918 TABLETS SODIUM MONTELUKAST 4919 TABLETS SODIUM MONTELUKAST 4920 TABLETS SODIUM MONTELUKAST 4907 TABLETS SODIUM MONTELUKAST 4912 TABLETS SODIUM MONTELUKAST 4914 TABLETS SODIUM MONTELUKAST 4915 TABLETS SODIUM MONTELUKAST 4916 TABLETS SODIUM MONTELUKAST I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 401 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 PAKISTAN 03-Jul-14PAKISTAN Full PAKISTAN 16-Jan-15 Full PAKISTAN 10-Apr-14 Full 26-Apr-17 Years Two PAKISTANBANGLADESH 26-Aug-14 08-Nov-14 Full Full PAKISTANPAKISTAN 10-Apr-16 Full 23-Jan-14PHILIPPINES Full 22-May-16 Full INDIAINDIA 11-Sep-18INDIA Years Two 14-Sep-18INDIA Provisional 02-May-15 Full 24-Sep-16 Full (Pvt ) Ltd (Pvt ) Ltd Company Ltd Highnoon Laboratories Ltd Caraway Pharmaceuticals Hilton Pharma (Pvt) Ltd Incepta Pharmaceuticals Ltd CCL Pharmaceuticals (Pvt) Ltd Amherst Laboratories Innova Captab INDIA 24-Aug-16 Full Belco Pharma (Pvt) Ltd Belco Pharma (Pvt) Ltd Human Verve Care Laboratories Human Verve Care Laboratories (Contd.) Healthcare lanka Ltd Health (Pvt) Ltd Healthcare lanka Ltd (Pvt) Ltd Pharmaceuticals Lanka (Pvt) Ltd Health (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Agency Pvt Ltd Agency Pvt Ltd Agency Pvt Ltd Agency Pvt Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP CARAMONTLEUGEN TABLETSMYTEKA George Steuart TABLETSPULMINAIR 10 TABLETS Ceyoka (Pvt) Ltd TABLETS Genix Pharma LEUGEN Sunshine PharmAce (Pvt) Ltd Kopran Ltd TABLETS INDIA Ceyoka (Pvt) Ltd Genix Pharma 23-Jun-16 Full AEROTEL TABLETS Sunshine N/AVERMOR 10VERMOR SR 30 TABLETS TABLETS TABLETS Leader Pharma Leader Pharma Leader Pharma 5MG 5MG 5MG 10MG BP 10MG USP 5MG TABLETS TABLETS 30MG BP TABLETS 4922 TABLETS SODIUM MONTELUKAST 4923 TABLETS SODIUM MONTELUKAST 4924 TABLETS SODIUM MONTELUKAST 4925 TABLETS SODIUM MONTELUKAST 4926 TABLETS SODIUM MONTELUKAST 4927 4MGTABLETS MONTELUKAST VENTELUCAST4928 4MGTABLETS MONTELUKAST TABLETS VENTEK 44929 4MGTABLETS MONTELUKAST Citihealth Imports MONTELUK TABLETS4930 4MGTABLETS MONTELUKAST TABLETS EZ KASTAIR 4931 Morison PLC 5MGTABLETS MONTELUKAST CCL TABLETS 5 VENTOKAST The Searle TABLETS George Steuart Slim 4921 TABLETS SODIUM MONTELUKAST 4932 30MG BP MORPHINE SULPHATE N/A TABLETS Leader Pharma 4933 10MG BP MORPHINE SULPHATE 4934 10MG BP MORPHINE SULPHATE 4935 SR MORPHINE SULPHATE 402 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 02-May-18INDIA Years Two 24-Aug-18 Years Two INDIA 18-Dec-15 Full INDIA 10-Nov-17 Years Two 10-Nov-17 Years Two INDIAINDIA 20-Oct-14INDIA Full 12-Aug-14 Full PAKISTAN 03-Sep-14 25-Jul-18 Full PAKISTAN Provisional 19-Aug-16PAKISTAN Full 15-Dec-14BANGLADESH Full 14-Mar-15 Full Laboratories (Pvt) Ltd Verve Human Verve Care Laboratories Human Verve Care Laboratories Cadila pharmaceuticals Ltd Concept Pharmaceuticals Ltd Concept Pharmaceuticals Ltd Laboratories XL (Pvt) Ltd Torrent Pharmaceuticals Ltd Torrent Pharmaceuticals Ltd The Schazoo Pharmaceutucal Laboratories (Pvt) Ltd Remington pharmaceutical Industries (Pvt) Ltd Popular Pharmaceuticals Ltd (Contd.) Agency Pvt Ltd Leader Pharma Agency Pvt Ltd Healthcare lanka Ltd International (Pvt) Ltd International (Pvt) Ltd Ltd Ltd Ltd Edna Medicals (Pvt) Ltd Co Ltd Services Pvt. Ltd TABLETS OPHTHALMIC SOLUTION SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP VERMOR SR 15 PROLONED RE 2.5MOSART TABLETSMOSACON 5 Sunshine TABLETSMOSACON 5 Softcare TABLETSMOFRIDE 5 Softcare VOLMIA TABLETSMOSID-MT Kamazu (Pvt) Ltd TABLETS Micro Labs Ltd TABLETSMOSID MT INDIA SMM Halcyon (Pvt) Edna Medicals (Pvt) TABLETS 400PALZIC 13-Aug-14 Edna Medicals (Pvt) TABLETS Full MOXICIN EYE DROP PharmAce (Pvt) Ltd Wilshire OCUMOX OINTMENTMOXIBAC Delmege Forsyth & EYE DROPS ABC Pharma VERMOR 30 TABLETS Leader Pharma RELEASE BP 15MG RELEASE BP 2.5MG 5MG 5MG 5MG 5MG 5MG FILM COATED TABLETS w/w w/w 5MG/G ML BP 30MG BP 4937 PROLONGED MORPHINE TABLETS 4938 TABLETS MOSAPRIDE CITRATE 4939 TABLETS MOSAPRIDE CITRATE 4940 TABLETS MOSAPRIDE CITRATE 4941 TABLETS MOSAPRIDE CITRATE 4942 TABLETS MOSAPRIDE CITRATE 4943 TABLETS MOSAPRIDE CITRATE 4944 2.5MG MOSAPRIDE CITRATE 4945 MOXIFLOXACIN EYE DROPS 0.5% 4946 MOXIFLOXACIN EYE DROPS 0.5% 4947 MOXIFLOXACIN EYE DROPS 4948 MOXIFLOXACIN EYE DROPS 5MG/ 4936 TABLETS MORPHINE SULPHATE I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 403 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 09-Sep-15 Full BANGLADESH 13-Nov-17 Full PAKISTANPAKISTAN 26-Mar-14 Full 23-Mar-14GERMANY Full 08-Sep-17INDIA Full INDIA 27-Apr-16 Full 02-Aug-18INDIA Provisional 12-Jan-17 Full STATES INDIAINDIA 15-Apr-16PAKISTAN Full 23-May-18 03-Aug-16 Full PAKISTAN Full 25-Mar-14 Full Pharmaceuticals Industry Ltd Laboratories (Pvt) Ltd Ltd Elko Organization (Pvt) Ltd Bayer Schering G Ltd A Pharma Sun Pharmaceutical Medicare Ltd Ajantha Pharma Ltd Aristopharma Ltd BANGLADESH 02-May-14 Full Ltd Macleods Pharmaceuticals Ltd Getz Pharma Pakistan (Pvt) Ltd CCL Pharmaceuticals (Pvt) Ltd (Contd.) (Ceylon) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals Lanka (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP FLUOROMOX EYE DROPS Medinex (Pvt) Ltd The IBN SINA MEGAMOXOXCIN EYE DROPS Emerchemie NB AVELOX EYE DROPS Morison PLCAXADEX M INFUSION ATCO Hemas EYE DROPSMILFLODEX Chamee Chemist EYE DROPS Axa Parenterals APDROPS Hemas OPTIMOX EYE DROPS Baur & Co (Pvt) A EYE DROPS Hemas VIGAMOXAXA-MOXIN EYE DROPS Morison PLC INFUSION Chamee ChemistLaboratories Alcon UNITED Axa Parenterals MOXIMAC 400 TABLETS IVMOXIGET Pettah Pharmacy INJECTIONMOLOX Hemas INJECTION CCL 0.5% w/w SOLUTION EYE DROPS SOLUTION EYE DROPS 0.8% SODIUM CHLORIDE INFUSION SOLUTION 0.5% W/V+DEXAMETHASONE 0.1% EYE DROPS 0.5% W/V+DEXAMETHASONE 0.1% (1ML/ML) SODIUM POSPHATE BKCFREE STERILE EYE DROPS EYE DROPS 0.5% EYE DROPS 0.5% EYE DROPS 0.5% INFUSION 400MG/100ML TABLETS 400MG TABLETS 400MG/250ML 400MG/250ML 4949 MOXIFLOXACIN EYE DROPS USP 4950 MOXIFLOXACIN 0.5% OPHTHALMIC 4951 MOXIFLOXACIN 0.5% OPHTHALMIC 4952 MOXIFLOXACIN 400MG IN 250ML 4953 MOXIFLOXACIN HYDROCHLORIDE 4954 MOXIFLOXACIN HYDROCHLORIDE 4955 MOXIFLOXACIN HYDROCHLORIDE 4956 MOXIFLOXACIN HYDROCHLORIDE 4957 MOXIFLOXACIN HYDROCHLORIDE 4958 MOXIFLOXACIN HYDROCHLORIDE 4959 MOXIFLOXACIN HYDROCHLORIDE 4960 MOXIFLOXACIN INJECTION 4961 MOXIFLOXACIN INJECTION 404 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAPAKISTAN 01-Mar-15BANGLADESH 17-Jan-18 Full 14-Dec-16 Full Full PAKISTAN 04-Nov-17PAKISTAN Full 11-Mar-14INDIA Full INDIA 09-Mar-18 Years Two GERMANY 24-Feb-14 08-Sep-16 Full Full INDIAINDIA 24-May-18 Years Two INDIA 08-Dec-15 Full 08-Aug-16 Full Pharmaceuticals Ltd Indoco Remedies India (Pvt ) Ltd Bayer A G GERMANY 08-Sep-16 Full Getz Pharma (Pvt) Ltd CCL CCL Pharmaceuticals (Pvt) Ltd Mankind Pharma Ltd MSN Laboratories Ltd Bayer Schering G A Pharma Germany for Bayer vital Gmbh Fredun Pharmaceuticals Ltd J Duncan Healthcare (Pvt) Ltd Zim Laboratories Ltd (Contd.) Hemas Pharmaceuticals (Pvt) Ltd Ceyoka (Pvt) Ltd Genix Pharma Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals Lanka (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd George Steuart Health (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd SOLUTION SOLUTION TABLETS SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP X-GENIVENTI OPHTHALMIC EYE DROPS PharmAce (Pvt) Ltd Square MO FLOREN OPHTHALMIC SOLUTION USP 0.5% SOLUTION USP 0.5% SOLUTION USP SOLUTION USP 0.5% SOLUTION USP 4963 MOXIFLOXACIN OPTHALMIC 4964 MOXIFLOXACIN OPTHALMIC 4965 400MG MOXIFLOXACIN TABLETS AVELOX TABLETS Hemas 4962 MOXIFLOXACIN OPTHALMIC 4966 400MG MOXIFLOXACIN TABLETS MOXIGET TABLETS Hemas 4967 400MG MOXIFLOXACIN TABLETS MOLOX4968 400MGTABLETS MOXIFLOXACIN MAHAFLOX 400 TABLETS TABLETS4969 400MGTABLETS MOXIFLOXACIN 400 MOXOFT CCL 4970 Hemas 400MG MOXIFLOXACIN TABLETS TABLETS AVELOX4971 Citihealth Imports 400MGTABLETS MOXIFLOXACIN TABLETS MOXIGRAM4972 400MGTABLETS MOXIFLOXACIN MOXFRE Hemas TABLETS4973 400MGTABLETS MOXIFLOXACIN MELOCIN 400 Kamazu (Pvt) Ltd FILM COA Micro Labs Ltd4974 400MGTABLETS MOXIFLOXACIN TABLETS INDIA 400 MOXIRIL Slim TABLETS 11-Jan-15 Tabrane Full I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 405 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 26-Aug-18 Years Two BANGLADESH 02-Aug-14 Full GERMANY/ FRANCE INDIATHAILAND 29-Oct-14INDIA 22-Feb-14 Full Full INDIA 24-Feb-16INDIA Full 19-Oct-16 Full 28-Apr-16THAILAND Full 20-Sep-17 Full INDIAVIETNAM 11-Oct-14 11-Jul-18BANGLADESH Full Years Two 12-Mar-15 Full Globe Pharmaceuticals Ltd Sanbe FarmaT P INDONESIA 30-Jun-14 Full Apex Laboratories Ltd Company Ltd Laboratories Ltd Mega Lifesciences (Pvt) Ltd Laboratories XL (Pvt) Ltd Unique Pharmaceutical Labs Mega Lifesciences (Pvt) Ltd Sanbe FarmaT P INDONESIA 29-Jul-15 Full S Kant Healthcare Ltd United International Pharma Co Ltd Globe Pharmaceuticals Ltd (Contd.) (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Ltd A Baur & Co (Pvt) A Ltd Ltd Health (Pvt) Ltd Ltd Pharmaceuticals (Pvt) Ltd Co Ltd Health (Pvt) Ltd (Pvt) Ltd CAPSULES SYRUP Lifeline SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP SEAS PLUS SYRUP Healthcare Tabrane FENZAHOVITE-SL GELETIN SOFT NEWTONE CAPSULES FORTEPEDIVIT Associates Pharma CAPSULES Raptakos Brett & CAPSULES SMM Halcyon (Pvt) PREGNACARE George Steuart CAPSULESVITACAP N/ASYRUP CAPSULES Baur & Co (Pvt) A Astron (Pvt) Ltd SRI LANKA 07-Aug-15 Full OBIMINXTRUM GOLD TABLETS TABLETS George Steuart Healthcare Tabrane OIL SYRUP OIL CAPSULES CAPSULES CAPSULES CAPSULES CAPSULES FOR PREGNANCY CAPSULES TABLETS TABLETS 4977 & CALCIUM MULTIVITAMIN ELKANA TABLETS Lifeline 4976 WITH COD LIVER MULTIVITAMIN 4978 & MINERALS MULTIVITAMIN ZINCOVIT TABLETS Baur & Co (Pvt) A 4979 & MINERALS MULTIVITAMIN 4980 & MINERALS MULTIVITAMIN 4981 & MINERALS MULTIVITAMIN 4982 & MINERALS MULTIVITAMIN 4983 & MINERALS MULTIVITAMIN 4984 & MINERALS MULTIVITAMIN 4985 & MINERALS SYRUP MULTIVITAMIN SANATONE 4975 0.4MGTABLETS MOXONIDINE PHYSIOTENS TABLETS CIC Holdings PLC Mylan 4986 & MINERALS SYRUP MULTIVITAMIN ZINCORUP4987 & MINERALS SYRUP MULTIVITAMIN DELVIT SYRUP SYRUP N/A Delmege Forsyth & Astron (Pvt) Ltd SRI LANKA 15-Oct-14 Full 4988 & MINERALS MULTIVITAMIN 4989 & MINERALS MULTIVITAMIN 406 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 BANGLADESH 08-Feb-18 Full INDIABANGLADESH 24-Jul-15 11-Aug-15 Full Full INDIAPAKISTAN 11-Sep-18 Years Two 03-Jul-15 Full INDIABANGLADESH 23-Feb-16 19-Mar-15 Full Full AUSTRALIA 14-Oct-14BANGLADESH Full 20-Dec-14 Full PAKISTAN 23-Aug-14 Full Pharmaceuticals Ltd Meyer Organics (Pvt) Ltd The ACME Laboratories Ltd U S V Ltd INDIA 25-Oct-18 Full Pharme Products Ltd Industries (Pvt) Ltd/DIS. By Mackwood &Phillips Co. Pakistan Pharmaceuticals Ltd Stallion Laboratories Pvt Ltd Globe Pharmaceuticals Ltd Contract Manufacuring & Packging Services pty Ltd Abbott Laboratories Merck (Pvt) Ltd PAKISTAN 08-Jun-16 Full (Contd.) Ltd Ltd Pharmaceuticals (Pvt) Ltd Healthcare lanka Ltd (Pvt) Ltd (Pvt) Ltd Ltd Healthcare lanka Ltd (Ceylon) Ltd TABLETS PharmAce (Pvt) Ltd Square SYRUP Siba Healthcare SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP EVAGREEN EVAGREEN SILVER FEROGLOBIN LIQUID ORAL SMM Halcyon (Pvt) PLUS SUPRABIT TABLETS PLUSMULTIVIT TABLETS Alaris Lanka (Pvt) SURBEX-Z PharmAce (Pvt) Ltd Square TABLETSMULTIBIONTA-M CAPSULES Sunshine Emerchemie NB SUPPLEMENT SYRUP (IRON,FOLIC ACID ,VIT A, ACID ,VIT (IRON,FOLIC SYRUP B COMPLEX ZINC COPPER & VIT Manganees) TABLETS TABLETS TABLETS CAPSULES 4990 & MINNERAL MULTIVITAMIN 4991 & MINNERAL MULTIVITAMIN 4992AND MINERALS MULTIVITAMIN 4993 NUTRUM 50+ DROPS MULTIVITAMIN TABLETS Mega Pharma (Pvt) GROVIT DROPS ORAL Hemas 4994 SYRUP MULTIVITAMIN DELICES SYRUP Sunshine 4995 SYRUP MULTIVITAMIN KAYCIPLEX4996 SYRUP MULTIVITAMIN SYRUP4997 TABLETS MULTIVITAMIN SENATOGEN Ceyoka (Pvt) Ltd4998 WITH MINERALS Karach Chemical MULTIVITAMIN TRIBION4999 & MINERALS MULTIVITAMINS TABLETS5000 Healthcare Tabrane WITH ZINC MULTIVITAMINS 5001 MULTIVITAMINS+MINERALS I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 407 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAPHILIPPINES 01-Feb-17 08-Jan-16INDIA Full Full INDIA 16-Oct-17 Years Two INDIA 16-Oct-17 Years Two BANGLADESH 05-Aug-17 08-Apr-16 Full INDIA Full BANGLADESH 26-Sep-18 25-Jul-15 Years Two BANGLADESH Full 30-Mar-15INDIA Full INDIA 05-Aug-17 Full 13-Oct-14 Full INDIA 24-Feb-14 Full Pharmaceuticals Ltd Scott Edil Pharmacia Ltd Agio Pharmaceuticals Ltd Smithkline Beecham Limited Concept Pharmaceuticals Ltd Concept Pharmaceuticals Ltd Agio Pharmaceuticals Ltd Incepta Pharmaceuticals Ltd Fourrts (India) Laboratories Ltd Healthcare Pharmaceuticals Wallace Pharmaceuticals Ltd Micro Labs Ltd INDIA 07-Jun-14 Full Glenmark Pharmaceuticals Ltd (Contd.) Ltd (Pvt) Ltd Beecham (Pvt) Ltd International (Pvt) Ltd International (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd Sunshine Healthcare lanka Ltd (Pvt) Ltd Ltd (Pvt) Ltd Healthcare lanka Ltd OINTMEN SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP DERMOCON M CREAMDERMOCON M Softcare CREAMMUPIBAN Softcare TREGO OINMENT OINTMENT OINTMENT Citihealth Imports Citihealth Imports EFIPRES INJECTION Citihealth Imports w/w w/w w/w w/w (20MG/1G) 5011 2% USP MUPIROCIN OINTMENT N/A OINTMENT C Medical (Pvt) T P 5003 2% MUPIROCIN OINTMENT 5004 2.0% BP MUPIROCIN OINTMENT BACTOROBAN OINTMENT5005 2.0% BP MUPIROCIN OINTMENT Smithkline 5006 2.0% BP MUPIROCIN OINTMENT 5007 2.0% BP MUPIROCIN OINTMENT 5008 2% USP MUPIROCIN OINTMENT MUPIFEN5009 2% USP MUPIROCIN OINTMENT BACTROCIN TOPICAL 5010 2% USP MUPIROCIN OINTMENT OINTMENT MUPIDERM PharmAce (Pvt) Ltd Square 5012 OINTMENT 2% USP MUPIROCIN OINTMENT B-Bact Citihealth Imports 5013 2% USP MUPIROCIN OINTMENT MUPIRAX OINTMENT Emar Pharma (Pvt) OINTMENT Micro Mega Lanka 5002 MUPIROCIN CREAM 2% W/W 5014 2% USP MUPIROCIN OINTMENT SUPIROCIN OINTMENT Sunshine 408 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAITALY 28-May-16 Full INDIA 25-Nov-14 Full KOREA 01-Dec-14 Full ITALY 06-Sep-17 Years Two 15-Dec-15 Full INDIAINDIA 27-Oct-17 Years Two INDIA 27-Oct-17 Years Two INDIA 25-Apr-15 Full INDIA 05-Jan-17INDIA Full 24-Aug-17 Years Two GERMANY 05-Jan-17 06-Mar-18 Full Years Two Pharmaceuticals (India) Ltd Pharmaceuticals Co Ltd Roche SpA, for La F Hoffmann Roche Ltd Emcure Pharmaceuticals Ltd Roche SpA, for La F Hoffmann Roche Ltd Roche SpA SWITZERLAND 26-Sep-18Years Two Pharmaceuticals Ltd Pharmaceuticals Ltd (Pvt) Ltd West Coast West Pharmaceurical works Ltd J Duncan Healthcare (Pvt) Ltd J Duncan Healthcare (Pvt) Ltd Novartis Pharma Produktion GmbH (Contd.) Ltd (Ceylon) Ltd Ltd Baur & Co (Pvt) A Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Ltd TABLETS SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP MUPRITOP OINTMENT PharmAce (Pvt) Ltd Aurochem IMMUCEPT 250IMMUCEPT CAPSULESCELLCEPT PharmAce (Pvt) Ltd Kwang Dong CAPSULES 500CELLCEPT FILM COA Baur & Co (Pvt) A POCYM 500 TABLETSAssociates Pharma Bafna POCYM 500 TABLETSMYCOVEXAssociates Pharma Bafna TABLETSMUNOLOK 500 TABLETS Global Impex AV 500MYCOFET Slim TABLETSMUNOLOK 250 TABLETS PharmAce (Pvt) Ltd Globela Pharma 180MGMYFORTIC TABLETS Slim Baur & Co (Pvt) A 20MG/G CAPSULES 250MG CAPSULES 250MG 500MG TABLETS TABLETS USP 500MG USP TABLETS TABLETS USP 500MG USP TABLETS 500MG USP TABLETS 500MG USP TABLETS 500MG USP TABLETS 250MG USP TABLETS ABLETS GASTRO RESISTANT 180MG 5015 USP MUPIROCIN OINTMENT 5016 500MG MOFETIL MYCOPHENOLATE CELLCEPT5017 500MG MOFETIL TABLETS MYCOPHENOLATE MOFILET Baur & Co (Pvt) A 5018 MOFETIL MYCOPHENOLATE TABLETS5019 Emerchemie NB MOFETIL MYCOPHENOLATE 5020 MOFETIL MYCOPHENOLATE 5021 MOFETIL MYCOPHENOLATE 5022 MOFETIL MYCOPHENOLATE 5023 MOFETIL MYCOPHENOLATE 5024 MOFETIL MYCOPHENOLATE 5025 MOFETIL MYCOPHENOLATE 5026 MOFETIL MYCOPHENOLATE 5027 SODIUM MYCOPHENOLATE I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 409 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 SWITZERLAND 08-Mar-18 Provisional GERMANY 15-Dec-17INDIA Years Two INDIA 26-Mar-18 Full 28-Sep-16BANGLADESH Full 17-Jan-18 Provisional INDIAINDIA 09-Jul-18 Years Two 31-Aug-17INDIA Full BANGLADESH 03-Dec-15 25-May-15SRI LANKA Full Full 07-Dec-17INDIAYears Two INDIA 02-Jul-15INDIA 19-May-15 Full Full 10-Jul-16 Full (Ceylon) (Pvt) Ltd Novartis Pharma Produktion GmbH Novartis Pharma GmbH Germany Atoz Pharmaceuticals (Pvt) Ltd Windlas Biotech (Pvt) Ltd Micro Labs Ltd INDIAThe ACME Laboratories Ltd Mercury 25-Feb-17Laboratories Ltd Full Galen Pharmaceuticals (Pvt) Ltd Medicamen Biotech Ltd The ACME Laboratories Ltd Neon Laboratories Ltd Human Verve Care Laboratories Atoz Pharmaceuticals (Pvt) Ltd (Contd.) Ltd Baur & Co (Pvt) A Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Micro Mega Lanka (Pvt) Ltd Mega Pharma (Pvt) Ltd International Yaden (Pvt) Ltd (Pvt) Ltd Ltd Ltd (Pvt) Ltd Agency Pvt Ltd (Pvt) Ltd TABLETS TABLETS FOR ORAL SOLUTION SOLUTION SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP MYFORTIC FILM COA N/AN/A POWDER N/A TABLETSN/A Pharma Tropical NALIGRAM TABLETSN/A TABLETS TABLETS Kamazu (Pvt) Ltd Micro Labs LtdNEX 400 Mega Pharma (Pvt) Baur & Co (Pvt) A INDIAN-XONE TABLETS INJECTIONNALTOX 31-Dec-14 N/A Ravilux Company INJECTION Full Leader Pharma TABLETS M S J Industries Euro Asian Pharma MYFORTIC TABLETS Baur & Co (Pvt) A NALIGRAM ORAL TABLETS 360MG TABLETS 300MG/5ML SUSPENSION BP 250MG 500MG 500MG 500MG 500MG 400MCG/01ML INJECTION USP ML TABLETS 50MG USP TABLETS 180MG TABLETS 300MG/5ML SUSPENSION B.P 5029 SODIUM MYCOPHENOLATE 5030 500MG BP TABLETS NABUMETONE NORACET5031 500MG BP TABLETS NABUMETONE TABLETS 500 NABUTON TABLETSAsian Pharma 5032 Euro 500MG BP TABLETS NABUMETONE NABUFLAM Lifeline FILM COA 5034 NALIDIXIC ACID ORAL 5035 NALIDIXIC ACID BP TABLETS 5036 NALIDIXIC ACID BP TABLETS 5037 NALIDIXIC ACID BP TABLETS 5038 NALIDIXIC ACID BP TABLETS 5039 NALIDIXIC ACID BP TABLETS 5040 NALOXONE HYDROCHLORIDE 5041 0.4MG/ NALOXONE INJECTION BP 5042 HYDROCHLORIDE NALTREXONE 5028 SODIUM MYCOPHENOLATE 5033 NALIDIXIC ACID ORAL 410 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIA 11-Jan-18 Years Two PAKISTANPAKISTAN 07-Jun-18 Full 11-Aug-14CYPRUS Full 12-Jan-14 Full INDIA 16-Dec-14NEW ZEALAND Full 25-Jun-18Years Two BANGLADESH 11-Jul-15 Full Sunwaya Rohto Pharmaceutical Pvt Ltd Sanbe FarmaT P INDONESIA 31-Oct-14Merck (Pvt) Ltd Full PAKISTANMerck (Pvt) Ltd PAKISTAN 23-Jul-17Years Two 08-Nov-17 Full (Pvt ) Ltd Pharmaceuticals (Pvt) Ltd Delobris Pharmaceuticals 01.06.18 Ltd-AT Yaden-LO42/17 Merck (Pvt) Ltd PAKISTAN 08-Nov-17 Full Aristopharma Ltd BANGLADESH 04-Jan-15 Full Fredun Pharmaceuticals Ltd Douglas Pharmaceuticals Ltd Incepta Pharmaceuticals Ltd (Contd.) Yaden International Yaden (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Ceylon) Ltd (Ceylon) Ltd (Pvt) Ltd (Ceylon) Ltd Pharmaceuticals (Pvt) Ltd Health (Pvt) Ltd Ltd (Pvt) Ltd SOLUTION SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP NAPHASAN EYE DROPS Lifeline XINEP OPHTHALMIC NEOPROX 250 TABLETSNEOPROX Emerchemie NB GENOXEN TABLETS TABLETS Emerchemie NB Ceyoka (Pvt) Ltd Genix Pharma TORMAX TABLETS CIC Holdings PLC Platinum 0.025% AND PHENIRAMINE 0.3% STERILE MALEATE OPTHALMIC SOLUTION SUSPENSION 250MG 500MG 500MG 550MG 5044 NAPHAZOLINE HYDROCHLORIDE 5043 OPTHALMIC NAPAFENAC 5045 TABLETS NAPROXEN DISPERSIBLE 5046 USP TABLETS NAPROXEN SODIUM 5047 USP TABLETS NAPROXEN SODIUM 5048 TABLETS NAPROXEN SODIUM USP 5049 500MG BP TABLETS NAPROXEN NAPROREX 500 TABLETS5050 500MG BP TABLETS NAPROXEN Access International NEOPROX TABLETS Emerchemie NB 5051 500MG BP TABLETS NAPROXEN NAPRO 500 TABLETS Hemas 5052 500MG BP TABLETS NAPROXEN NAPROFRED 500 TABLETS5053 500MG BP TABLETS NAPROXEN MOVIBON 500 George Steuart 5054 250MG BP TABLETS NAPROXEN TABLETS NAXEN5055 250MG BP TABLETS NAPROXEN Kamazu (Pvt) Ltd TICOFLEX 250 Micro Labs Ltd TABLETS5056 INDIA TABLETS 250MG BP TABLETS NAPROXEN MOVIBON 250 Farnell Ceylon (Pvt) Citihealth Imports TABLETS 21-Sep-17Years Two Kamazu (Pvt) Ltd Micro Labs Ltd INDIA 22-Aug-15 Full I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 411 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 16-Dec-14 Full INDIA 28-Jan-17 Full 28-Jan-17INDIA Full SAUDI ARABIA 20-May-14 09-Jul-18 Years Two Full SAUDI ARABIA 20-May-14 Full INDIAINDIA 13-Jul-19 Years Two 13-Jul-17 Years Two Aristopharma Ltd BANGLADESH 26-Jan-16 Full Fredun Pharmaceuticals Ltd Zim Laboratories Ltd Zim Laboratories Ltd Sante (Pvt) Ltd PAKISTANMercury Laboratories Ltd 02-Apr-18Norgine Pharma Provisional France & Packed by Riyadh Pharma Medical & Cosmetics PRODUCTS Ltd Norgine Pharma France & Packed by Riyadh Pharma Medical & Cosmetics PRODUCTS Ltd Export LtdTorrent INDIAJ.B.Chemicals & Pharmaceuticals 12-Jan-14J.B.Chemicals & Pharmaceuticals Full Micro Labs Ltd INDIA 31-Dec-15 Full (Contd.) Pharmaceuticals (Pvt) Ltd Health (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Emerchemie NB (Ceylon) Ltd International Yaden (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Ltd Health (Pvt) Ltd Health (Pvt) Ltd (Pvt) Ltd SUSPENSION SUSPENSION SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP NAPROZIM TABLETSNAPROZIM Tabrane TABLETSNATASAN Tabrane OPHTHALMIC PLUSNORMACOL GRANULES Hemas PLUSNORMACOL GRANULES Hemas NEBICARD 2.5 TABLETS Edna Medicals (Pvt) NEBILOLNEBILONG TABLETS TABLETS George Steuart Micro Mega Lanka N/A OPHTHALMIC NEBILOL TABLETS George Steuart GASTRO RESISTANT GASTRON RESISTANT SUSPENSION 5% / 5ML PLUS GENTLE LAXATIVE PLUS GENTLE LAXATIVE 2.5MG TABLETS 5MG TABLETS 5MG TABLETS SUSPENSION USP 5% W/V SUSPENSION USP 5MG TABLETS 5057 250MG BP TABLETS NAPROXEN NAPRO 250 TABLETS Hemas 5058 250MG BP TABLETS NAPROXEN NAPROFRED 250 TABLETS5059 250MG BP TABLETS NAPROXEN George Steuart 5060 500MG BP TABLETS NAPROXEN 5061 OPTHALMIC NATAMYCIN 5063 HIGH FIBER GRANULES NATURAL 5064 HIGH FIBER GRANULES NATURAL 5065 HYDROCHLORIDE NEBIVOLOL 5067 HYDROCHLORIDE NEBIVOLOL 5068 HYDROCHLORIDE NEBIVOLOL 5062 OPTHALMIC NATAMYCIN 5066 HYDROCHLORIDE NEBIVOLOL 412 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 25-Sep-16 Full INDIA 04-Apr-18 Years Two INDIA 15-Jan-14BANGLADESH Full 08-Jun-16 05-Nov-14INDIA Full Full INDIA 09-May-17 Full BANGLADESH 30-Jul-14 08-Jun-16 Full JORDAN Full 14-Nov-15 Full INDIAINDIA 16-Mar-18 Full MACAU 15-Jun-16 Full 01-Apr-14 Full Pharmaceuticals Ltd Pharmaceuticals Ltd Pvt Ltd Chemical Industries Chemical Industries Co. LLC Pharmaceuticals (India) Ltd Cadila pharmaceuticals Ltd Atoz Pharmaceuticals (Pvt) Ltd Agio Pharmaceuticals Ltd Middle East Pharmaceuticals & Chemical Industries & Medical Appliacnces Co. Ashford Laboratories Ltd (Contd.) Healthcare lanka Ltd (Pvt) Ltd (Pvt) Ltd Adamjee & M I Sons (Pvt) Ltd (Pvt) Ltd AEROSOL AEROSOL INHALATION SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP NEVOL 5NEVOL TABLETS PharmAce (Pvt) Ltd Medley NODON 2.5NEVOL TABLETS TABLETS 5NUBETA Sunshine PharmAce (Pvt) Ltd Medley TABLETS CIC Holdings PLC Abbott Healthcare MULTISOL AEROSOL POLYBAC-N OINTMENTSPORINEX Ceyoka (Pvt) Ltd Global Pharma OINTMENTDEXOPTIC-N PharmAce (Pvt) Ltd EYE DROPS Aurochem Ceylon Teastar TABLETS 5MG TABLETS TABLETS 5MG TABLETS 2.5MG IP TABLETS 5MG IP TABLETS 150,000 IU & BASE (AS SULPHATE) BACITRACIN (as ZIC ) 40,000 IU BACITRACIN OINTMENT SULPHATE USP 5000U & BACITRACIN SULPHATE 1% USP ZINC 400 U OINTMENT DEXAMETHASONE SODIUM OPTHALMIC SOLUION PHOSPHATE 5MG/1MG USP 5069 HYDROCHLORIDE NEBIVOLOL 5070 HYDROCHLORIDE NEBIVOLOL 5071 HYDROCHLORIDE NEBIVOLOL 5072 HYDROCHLORIDE NEBIVOLOL 5073 5MGTABLETS NEBIVOLOL 5074 5MGTABLETS NEBIVOLOL BIPINOR 55075 2.5MGTABLETSLETS TABLETS NEBIVOLOL 5 NEBIVAS NEBOBETA CIC Holdings PLC5076 TABLETS 2.5MGTABLETSLETS NEBIVOLOL Advanced TABLETS BIPINOR 2.5Asian Pharma Euro 5077 Citihealth Imports NEOMYCIN 500,000IU POLYMIXIN TABLETS CIC Holdings PLC Advanced 5078 B AND POLYMIXIN NEOMYCIN 5079 B NEOMYCIN 3400 U POLYMIXIN 5080 + NEOMYCIN SULPHATE I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 413 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 04-Jul-14 Full INDIABANGLADESH 01-Jan-14 24-Apr-15 Full BANGLADESH Full 23-Dec-16 Full INDIAINDIA 17-Sep-14INDIA Full 21-Apr-14BANGLADESH Full 16-Aug-18 28-Dec-18 Full Full SRI LANKA 04-Jul-17STATES Full TURKEY 29-Mar-18PAKISTAN Years Two 13-Sep-14 Full Pharmaceuticals Ltd Pharmaceuticals Ltd PharmaceuticalS (Pvt) Ltd Pharmaceuticals Ltd (Ceylon) (Pvt) Ltd Cadila Healthcare Ltd Harson Laborstories Belco Pharma (Pvt) Ltd World Medicine World Ilac san ve Remington pharmaceutical Industries (Pvt) Ltd Aristopharma Ltd BANGLADESH 10-Oct-18Years Two (Contd.) Sunshine Healthcare lanka Ltd (Pvt) Ltd Agency Pvt Ltd Pharmaceuticals (Pvt) Ltd Delmege Forsyth & Co Ltd Hemas Pharmaceuticals (Pvt) Ltd SOLUTION SUSPENSION SUSPENSION SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP NEBANOL POWDERNEBANOL PharmAce (Pvt) Ltd Square OINTMENTTILSTIGMIN PharmAce (Pvt) Ltd Square N/A INJECTION CIC Holdings PLCN/A (India) Ltd Tablets INDIAOSTIG 2.5 INJECTION Citihealth Imports INJECTION 15-Jul-14 INJECTIONVERSIA Leader Pharma Ceyoka (Pvt) Ltd Full Ciron Drugs & INJECTION PharmAce (Pvt) Ltd Square DEXONA-E OPHTHALMIC NEPANAC OPHTHALMIC NEVAN OPHTHALMIC + BACITRACIN ZINC BP 250 IU + BACITRACIN ZINC BP POWDER B SULPHATE 3.5MG+POLYMIXIN AND BACITRACIN ZINC 5000IU USP USP 400IU OINMENT 0.5MG /ML 0.5MG /ML 2.5MG /ML 2.5MG/ML 0.5MG/ML INJECTION USP + DEXAMETHASONE 0.1% OPTHALMIC SOLUION USP SUSPENSION 0.1% SUSPENSION 0.1%W/V STERILE 5082 5MG BP NEOMYCIN SULPHATE 5083 USP NEOMYCIN SULPHATE 5084 NEOSTIGMINE INJECTION BP 5085 NEOSTIGMINE INJECTION BP 5086 NEOSTIGMINE INJECTION BP 5087 NEOSTIGMINE INJECTION BP 5088 NEOSTIGMINE METHYLSUPHATE 5089 15MG USP TABLETS NEOSTIGMINE N/A5090 EYE DROPS 0.1% NEPAFENAC NEVANAC TABLETS EYE DROPS N/A Morison PLCLaboratories Alcon UNITED M S J Industries 5081 0.35% NEOMYCIN SULPHATE 5091 EYE DROPS 0.3% NEPAFENAC 0.3 APFECTO EYE DROPS Slim 5092 OPTHALMIC NEPAFENAC 5093 OPTHALMIC NEPAFENAC 414 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 THAILAND 21-Sep-15INDIA Full INDIA 09-May-15 Full 01-Dec-16 Full INDIAINDIA 24-Jul-14INDIA Full 31-Jul-14PAKISTAN Full 18-Jul-14 30-Jan-18 Full Years Two INDIAPAKISTAN 02-Sep-18 Provisional INDIA 30-Jun-17 Full 02-Apr-17 Full Sciences (Pvt) Ltd Aristopharma Ltd BANGLADESH 11-May-17 B S Laboratory L Full Ltd United Biotech (Pvt) Ltd Cipla Ltd INDIA 25-Aug-15 Full Hetero Drugs Ltd INDIA 23-Jan-18 Full Hetero Labs Ltd INDIA 23-Jan-18 Full West Coast West Pharmaceurical works Ltd Pharmaceuticals West Coast West Pharmaceurical works Ltd OBS Pakistan (Pvt) Ltd Wings Biotech INDIA 28-Jun-18 Full Centurion Laboratories Pvt Ltd Ferozsons Laboratories Ltd Pharmafabrikon Unit (Contd.) Hemas Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pte) Ltd (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd (Ceylon) Ltd (Pvt) Ltd (Pvt) Ltd (Ceylon) Ltd (Pvt) Ltd SUSPENSION SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP N/ANETMICIN INJECTION INJECTIONAssociates Pharma R & D Intertrades Steril Gene Life NEVANBACTROCIN OPHTHALMIC INJECTION Lifeline 100MG/2ML 100MG/2ML USP SUSPENSION 0.1%W/V STERILE 100MG/2ML 5096 INJECTION NETILMICIN SULPHATE 5097 INJECTION NETILMICIN SULPHATE 5098 200MGTABLETS NEVIRAPINE NEVIMUNE TABLETS Breathe Free Lanka 5094 OPTHALMIC NEPAFENAC 5095 INJECTION NETILMICIN SULPHATE 5099 200MG USP TABLETS NEVIRAPINE NEVIVIR TABLETS Mansel (Ceylon) 5100 200MG USP TABLETS NEVIRAPINE NEVIVIR TABLETS Mansel (Ceylon) 5101 10MGTABLETS NICORANDIL NICOVEX 10 TABLETS Global Impex AV 5102 10MGTABLETS NICORANDIL 5103 5MGTABLETS NICORANDIL 10 NICODIL 5104 TABLETS NICOVEX 5 10MG BP TABLETS NICORANDIL IKODIL5105Associates 10MG BP Pharma TABLETS NICORANDIL TABLETS The Madras 10 RANDIL Global Impex AV TABLETS TABLETS Emerchemie NB International Yaden 5106 10MG BP TABLETS NICORANDIL N/A TABLETS International Yaden 5107 10MG BP TABLETS NICORANDIL NICO5108 10MG BP TABLETS NICORANDIL N/A TABLETS Emerchemie NB TABLETS Novachem Lanka I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 415 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 PAKISTANPAKISTAN 30-Jan-18 Years Two PAKISTAN 30-Jan-18 Years Two INDIA 30-Jan-18 Full INDIA 25-Nov-14 Full INDIA 07-Jan-15 Full INDIA 29-Sep-17 Years Two INDIA 16-Nov-17INDIA Full 14-Mar-17INDIA Full 26-Nov-18 Years Two INDIA 16-Feb-17 Full INDIA 17-Nov-14 Full INDIA 10-Apr-18 Provisional 18-Feb-18 Full OBS Pakistan (Pvt) Ltd OBS Pakistan (Pvt) Ltd OBS Pakistan (Pvt) Ltd Gelnova laboratories (Pvt) Ltd Unique Pharmaceutical Labs Unique Pharmaceutical Labs Sunrise International LabS Ltd J.B.Chemicals & Pharmaceuticals Mercury Laboratories Ltd Cadila Healthcare Ltd Unique Pharmaceutical Labs Fredun Pharmaceuticals Ltd E Merck (India) Ltd Merck Limited INDIA 26-Jan-18 Full (Contd.) (Pvt) Ltd (Ceylon) Ltd (Pvt) Ltd Ltd Health (Pvt) Ltd Health (Pvt) Ltd Pharmaceutical (Pvt) Ltd Health (Pvt) Ltd (Pvt) Ltd Healthcare lanka Ltd Health (Pvt) Ltd Health (Pvt) Ltd (Ceylon) Ltd (Ceylon) Ltd TABLETS George Steuart TABLETS George Steuart SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP NICARDIA XL 30 XL NICARDIA TABLETSCARDISUN SR George Steuart TABLETS NICARDIA RETARD Kent N/ADEPIN E RETARD TABLETS TABLETS NICARDIA Sunshine RETARD-10 International Yaden NEFIN 20 SR TABLETSDEPICOR SR 10 TABLETS George Steuart DEPICOR SR 20 TABLETS Emerchemie NB Emerchemie NB TABLETS 30MG TABLETS 20MG USP TABLETS 20MG USP TABLETS 20MG BP TABLETS 20MG IP TABLETS 10MG TABLETS TABLETS 20MG TABLETS 10MG IP TABLETS 20MG IP TABLETS 5111 20MG BP TABLETS NICORANDIL IKODIL TABLETS Mansel (Ceylon) 5110 20MG BP TABLETS NICORANDIL IKODIL5112 2MG NICOTINE PASTE TABLETS5113 NICOTINE LOZENGES 2MG Emerchemie NB NOBACCO 25114 NIFEDIPINE EXTENDED RELEASE NOSMOK 2MG PASTE LOZENGES5115 NIFEDIPINE EXTENDED RELEASE George Steuart Lanka (Pvt) Tabrane 5116 NIFEDIPINE EXTENDED RELEASE 5117 NIFEDIPINE PROLONGED RELEASE 5118 NIFEDIPINE PROLONGED RELEASE 5119 RELEASE NIFEDIPINE SUSTAINED 5109 10MG BP TABLETS NICORANDIL IKODIL TABLETS Mansel (Ceylon) 5120 NIFEDIPINE SLOW RELEASE 5121 RELEASE NIFEDIPINE SUSTAINED 5122 RELEASE NIFEDIPINE SUSTAINED 416 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 GERMANY 08-Sep-17INDIA Full SWITZERLAND 20-May-15 19-Sep-17 Years Two Full INDIASWITZERLAND 08-Mar-18 19-Sep-17 Years Two Full SWITZERLAND 08-Mar-18 Full INDIAINDIA 16-May-18 Years Two INDIA 13-Aug-15 Full 14-Sep-17 Full INDIAINDIA 20-Sep-18SRI LANKA Years Two 26-Jul-18 01-Jan-14 Years Two Full Bayer Pharma A A Bayer Pharma G Germany for Bayer vital Gmbh (Ceylon) (Pvt) Ltd Therdose Pharma (Pvt) Ltd Novartis Pharma Stein .AG Switzerland for novatis Pharma Shcweiz AG Switzerland Therdose Pharma (Pvt) Ltd Novartis Pharma A G Novartis Pharma A G Centurion Laboratories Pvt Ltd Coast West Pharmaceurical works Ltd Simpex Pharma (Pvt) Ltd Biocon Limited INDIAMercury Laboratories Ltd 04-Sep-18Mercury Laboratories Ltd Provisional (Contd.) eld fi Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Ltd (Pvt) Ltd Ltd Ltd (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd International Yaden (Pvt) Ltd SUSPENSION SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP TASIGNATASIGNA CAPSULES Baur & Co (Pvt) A CAPSULES Baur & Co (Pvt) A BIOMAB EGFR INJECTION Medmart Pharma N/AN/A ORAL TABLETS N/A M S J Industries N/A INJECTION International Yaden MONOHYDRATE 200MG HARD MONOHYDRATE CAPSULES GELATIN 200MG HARD MONOHYDRATE CAPSULES GELATIN ANTIBODY EGFR MONOCLONAL INJECTION 50MG/10ML SUSPENSION 25MG/5ML 100MG 50MG/10ML 5123 30MGTABLETS NIFEDIPINE LA ADALAT TABLETS Hemas 5124 NILOTINIB CAPSULES 150MG5125 NILOTINIB CAPSULES 150MG N/A TASIGNA5126 CAPSULES NILOTINIB CAPSULES 200MG CAPSULES Pharma R N Vision 5127 Baur & Co (Pvt) A NILOTINIB HYDROCHLORIDE N/A5128 NILOTINIB HYDROCHLORIDE CAPSULES5129 30MG BP TABLETS NIMODIPINE Pharma R N Vision N/A5130 30MG BP TABLETS NIMODIPINE VEXDIPINE 305131 30MG BP TABLETS NIMODIPINE TABLETS TABLETS NIMOPIN5132 Global Impex AV International Yaden ANTI NIMOTUZUMAB (HUMANIZED TABLETS Somer 5134 ORAL NITROFURANTOIN 5135 BP TABLETS NITROFURANTOIN 5133 INJECTION USP NITROGLYCERIN I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 417 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 SRI LANKA 02-Aug-15INDIA Full BANGLADESH 28-Dec-17 27-Feb-14 Years Two INDIA Full INDIA 29-Oct-18 Years Two INDIA 10-Jun-18 Full INDIA 11-May-18 Provisional INDIA 05-Nov-16INDIA Full 23-Oct-14INDIA Full 03-Oct-15INDIA Full 02-Mar-18 Years Two GERMANY 26-Nov-18 Years Two 13-Jun-15 Full BANGLADESH 15-Jun-15INDIA Full 23-Apr-18 Full (Ceylon) (Pvt) Ltd Pharmaceuticals Ltd PharmaceuticalS (Pvt) Ltd Sciences (Pvt) Ltd Pharmaceuticals Ltd SG Pharma (Pvt) Ltd Mercury Laboratories Ltd Centurion Laboratories Pvt Ltd Troikaa Pharmaceuticals Ltd Belco Pharma (Pvt) Ltd SG Pharma (Pvt) Ltd Corona Remedics (Pvt) Ltd Bayer Weiner GmbH & Co. KC Germany for AG Bayer Pharma Germany Belco Pharma (Pvt) Ltd (Contd.) Pharmacy (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Agency Pvt Ltd Pharmacy (Pvt) Ltd Healthcare lanka Ltd Pharmaceuticals (Pvt) Ltd Agency Pvt Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP N/A TABLETS N/A M S J Industries NITROSOL SPRAYANRIL INJECTION SPRAY The Esses GLYMERC PharmAce (Pvt) LtdN/A Square TABLETSMYONIT International Yaden TABLETSN/A TABLETS International Yaden NODRESOL Slim NORADERIN INJECTION INJECTION The Esses INJECTION Leader Pharma N/A Ceyoka (Pvt) LtdNOSTRA Ciron Drugs & INJECTION TABLETSAssociates Pharma Sterile Gena Life Sunshine MENORAL-5 TABLETSN/A PharmAce (Pvt) Ltd Square TABLETS Leader Pharma 50MG 5MG/1ML 400MCG SPRAY SUBLINGUAL 0.5MG USP TABLETS 0.5MG USP TABLETS 0.5MG USP TABLETS 1mg/ml -Sterile BP 1mg/ml -Sterile IP STERILE 2MG/ML IP 2MG/ML 5MG USP TABLETS 5MG 5MG 5136 BP TABLETS NITROFURANTOIN 5137 INJECTION USP NITROGLYCERIN 5138 METERED DOSE NITROGLYCERIN 5139 SUBLINGUAL NITROGLYCERIN 5140 SUBLINGUAL NITROGLYCERIN 5141 SUBLINGUAL NITROGLYCERIN 5142 NORADRENALINE CONCENTRATE 5143 NORADRENALINE CONCENTRATE 5144 NORADRENALINE CONCENTRATE 5145 NORADRENALINE INJECTION BP 5146 NORETHISTERONE ACETATE 5147 5MG NORETHISTERONE TABLETS PRIMOLUT-N TABLETS5148 BP NORETHISTERONE TABLETS Hemas 5149 BP NORETHISTERONE TABLETS 418 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 25-Feb-17 Full SWITZERLAND/ AUSTRIA INDIAPAKISTAN 06-Apr-14INDIA 17-Feb-16 Full Full INDIA 01-Feb-14 Full INDIA 21-Aug-14 Full INDIA 21-May-17 Full INDIA 21-May-17 Full INDIA 18-Jun-18INDIA Full 02-May-16 Full 04-Jun-18 Years Two Sandoz GmbH -Austria for Novartis Pharma A G Macleods Pharmaceuticals Ltd OBS Pakistan (Pvt) Ltd Cadila Healthcare Ltd Laboratories Ltd Reliance Life Sciences (Pvt) Ltd Reliance Life Sciences (Pvt) Ltd Centurion Laboratories Pvt Ltd (Pvt) Ltd Sandoz GmbH SWITZERLAND 16-Jun-18 Full Encube Ethicals (Pvt) Ltd Cipla Ltd INDIA 21-Dec-14 Full (Contd.) (Pvt) Ltd Ltd (Pvt) Ltd (Pvt) Ltd Healthcare lanka Ltd Services Pvt. Ltd Services Pvt. Ltd (Pvt) Ltd Ltd Micro Mega Lanka (Pvt) Ltd INJECTION Baur & Co (Pvt) A SOLOTION SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP SANDOSTATIN SANDOSTATIN LAR NORMAC TABLETSNEGAFLOX Pettah Pharmacy TABLETSLUSIA-F Sunshine IMMUNINE 600IU TABLETS SOLUTION I.V ABC Pharma Ceyoka (Pvt) LtdIMMUNINE 600IU SOLUTION I.V Mylan ABC Pharma N/A 30PHOTOBAN TOPICAL TABLETSOTIDE 50 International Yaden SANDOSTATIN INJECTION INJECTION Klintas (Pvt) Ltd Baur & Co (Pvt) A United Biotech NORGESTNORLUT-N TABLETS TABLETS Kamazu (Pvt) Ltd Micro Labs Ltd Breathe Free Lanka INDIA 16-Jun-14 Full LONG ACTING REPEATABLE 400MG 0.03MG & FERROUS ESTRADIOL 75MG FUMARATE 5% USE BP FOR INTRAVENOUS SOLUTION 5% USE BP FOR INTRAVENOUS SOLUTION UNITS 3%+OXYBENXONE 3% LOTION 50MCG/ML POWDER FOR SUSPENSION INJECTION 30MG 400MG 5MG 5MG 5162 OCTREOTIDE INJECTION 20MG 5153 400MGTABLETS NORFLOXACIN NOROXIN5154 USP NORFLOXACIN TABLETS TABLETS5155 0.3MG & ETHINYL NORGESTREL Mansel (Ceylon) 5156 IMMUNOGLOBULIN NORMAL 5157 IMMUNOGLOBULIN NORMAL 5158 500,000 B.P TABLETS NYSTATIN 5159 7.5%+AVOBENZONE OCTINOXATE 5160 INJECTION OCTREOTIDE ACETATE 5161 LAR OCTREOTIDE ACETATE 5152 USP TABLETS NORFLOXACIN 5150 BP NORETHISTERONE TABLETS 5151 USP NORETHISTERONE TABLETS I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 419 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIASWITZERLAND 21-Nov-14 16-Jul-14INDIA Full Full PAKISTAN 14-Aug-16 28-Feb-14 Full INDIA Full PAKISTAN 16-Mar-16 13-Jul-14PAKISTAN Full Full 13-May-14INDIA Full 08-Aug-16INDIA Full INDIA 15-Oct-14 Full PAKISTAN 26-Feb-18 Provisional 11-Sep-17INDIA Full INDIA 09-Oct-15 Full 20-Jan-18 Full Novartis Pharma A G Remington pharmaceutical Industries (Pvt) Ltd Hilton Pharma (Pvt) Ltd Elko Organization (Pvt) Ltd Piramal Enterprises (Ltd) Allergan ,India for India (Pvt) Ltd Unique Pharmaceutical Labs Nabiqasim Industries (Pvt) Ltd Macleods Pharmaceuticals Ltd Unique Pharmaceutical Labs Sun Pharmaceutical industries Amanta Healthcare Ltd Ltd Centaur Pharmaceutical (Pvt) Ltd (Contd.) Ltd Co Ltd Healthcare lanka Ltd (Ceylon) Ltd Pharmaceuticals (Pvt) Ltd Health (Pvt) Ltd Health (Pvt) Ltd (Pvt) Ltd Health (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Citihealth Imports (Pvt) Ltd Chamee Chemist Axa Parenterals George Steuart Health (Pvt) Ltd SOLUTION INFUSION DROPS SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP SANDOSTATIN INJECTIONALEMBIC OWIN D OPHTHALMIC Baur & Co (Pvt) A AXAFLOX VENOUS INTRA OPTOFLOXEXOCIN EYE OINTMENT Emerchemie NB EYE DROPSOXOP Hemas EYE & EAR OCTRIDE 50 INJECTION Hemas INJECTION 50MCG/ML DEXAMETHASONE 0.1% EYE DROPS 200MG/100ml 0.3% OINTMENT EYE 3MG/ML SOLUTION USP DROPS DROPS 0.3% W/V 50MCG/ML 5164 OCTREOTIDE SOLUTION 5165AND OFLOXACIN 0.3% 5166 OFLOXACIN EAR DROPS 0.6% PLUS KUNOXY 5167 EAR DROPS OFLOXACIN INFUSION Delmege Forsyth & 5168 OFLOXACIN INJECTION 200MG OFLOBID5169 OFLOXACIN OPHTALMIC 5170 INJECTION OFLOXACIN OPHTALMIC Sunshine 5171 OFLOXACIN STERILE EYE /EAR 5172 400MGTABLETS OFLOXACIN OFLO 4005173 200MG U S P TABLETS OFLOXACIN ALBACT TABLETS5174 200MG U S P TABLETS OFLOXACIN OFLOMAC 200 TABLETS George Steuart TABLETS5175 200MG U S P TABLETS OFLOXACIN George Steuart OFLO 200 Pettah Pharmacy TABLETS George Steuart 5163 INJECTION OCTREOTIDE ACETATE 420 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 26-Jan-15 Full INDIA 28-Sep-18 Years Two INDIA 01-Jul-15 Full INDIA 04-Jan-18 Full INDIA 01-Jun-17 Years Two INDIA 05-Aug-14 Full BANGLADESH 22-Feb-18 16-Jun-14 Years Two Full BANGLADESH 10-Apr-17 Years Two INDIA 20-Nov-17 Years Two INDIA 26-Sep-14 Full West Coast West Pharmaceurical works Ltd Windlas Biotech (Pvt) Ltd Stallion Laboratories Pvt Ltd Sun Pharmaceutical industries Sun Pharmaceutical industries Hiral Labs Ltd INDIA 13-Jun-18 Provisional Torrent Torrent Pharmaceuticals Ltd Sun Pharmaceutical industries Pharmaceuticals Ltd Pharmaceuticals Ltd Pharmaceuticals Ltd Micro Labs Ltd INDIA 19-Apr-18Years Two Torrent Torrent Pharmaceuticals Ltd (Contd.) (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd (Ceylon) Ltd (Ceylon) Ltd Ltd Pharmaceuticals (Pvt) Ltd (Ceylon) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd TABLETS Emerchemie NB SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP OLAVEX 5 MDOLAVEX TABLETS OLEANZ RAPITAB 5 Global Impex AV TOLANZ 5TOLANZ TABLETS Hemas OLAN ODT 5OLAN ODT TABLETS Micro Mega Lanka TOLANZ 10TOLANZ TABLETS Hemas TABLETS 5MG TABLETS 5MG TABLETS TABLETS 5MG TABLETS TABLETS 5MG TABLETS TABLETS 10MG TABLETS 5179 DISSOLVING OLANZAPINE RAPIDLY 5180 DISSOLVING OLANZAPINE RAPIDLY 5181 10MG OLANZAPINE TABLETS N/A5182 10MGTABLETS OLANZAPINE 10 OZIP 5183 10MGTABLETS OLANZAPINE TABLETS 10 STALANZA 5184 TABLETS 10MGTABLETS OLANZAPINE Lifeline TABLETS OLEANZ 10 PharmAce (Pvt) Ltd5185 Medley 5MGTABLETS OLANZAPINE Siba Healthcare TABLETS5186 DEPREX 5 5MGTABLETS OLANZAPINE Emerchemie NB TABLETS5187 LOPEZ-5 5MGTABLETS OLANZAPINE PharmAce (Pvt) Ltd Square 5188 OLEANZ 5 5MG BP TABLETS TABLETS OLANZAPINE HIOLANZ-5 TABLETS Harcourts (Pvt) Ltd General TABLETS Emerchemie NB MAPS Pharma (Pvt) 5178 OLANZAPINE ORODISPERSIBLE 5177 OLANZAPINE ORODISPERSIBLE 5176 OLANZAPINE ORODISPERSIBLE I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 421 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 PAKISTANINDIA 22-Feb-18 Years Two 30-Sep-16 Full PAKISTAN 16-Jul-18BANGLADESH Provisional 16-Jun-14 Full INDIAINDIA 05-Sep-17 Full INDIA 01-Nov-17 Full INDIA 15-Aug-15 Full INDIA 05-Aug-16 Full INDIA 05-Sep-14 Full INDIA 01-Nov-17 Full INDIA 15-Jun-16 Full 14-Jun-14 Full Macleods Pharmaceuticals Ltd Ferozsons Laboratories Ltd Akums Drugs & Pharmaceuticals Ltd Zim Laboratories Ltd Cadila Healthcare Ltd Stallion Laboratories Pvt Ltd Akums Drugs & Pharmaceuticals Ltd Zim Laboratories Ltd Centurion Laboratories Pvt Ltd Cadila Healthcare Ltd Micro Labs Ltd INDIA 09-Aug-14 Full Amarant Pharmaceuticals (Pvt) Ltd Pharmaceuticals Ltd (Contd.) (Pvt) Ltd (Ceylon) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP OLMESAR 20 TABLETS Pettah Pharmacy ORION TABLETS Emerchemie NB TABLETS 20MG TABLETS TABLETS 10MG TABLETS 5201 MEDOXOMIL OLMESARTAN 5200 MEDOXOMIL OLMESARTAN 5190 10MG USP TABLETS OLANZAPINE DEPREX 105191 10MG USP TABLETS OLANZAPINE TABLETS 10 OLAVEX 5192 PharmAce (Pvt) Ltd 10MG USP TABLETS OLANZAPINE Square TABLETS ZAPINE 105193 Global Impex AV 10MG USP TABLETS OLANZAPINE TABLETS OLANDUS 105194 TABLETS 5MG USP TABLETS OLANZAPINE Tabrane 5 STALANZA Hemas 5195 5MG USP TABLETS OLANZAPINE TABLETS 5 OLAVEX 5196 Siba Healthcare 5MG USP TABLETS OLANZAPINE TABLETS ZAPINE 55197 5MG USP TABLETS OLANZAPINE Global Impex AV N/A TABLETS5198 5MG USP TABLETS OLANZAPINE Tabrane OLANDUS 55199 5MG USP TABLETS OLANZAPINE TABLETS TABLETS OLAN 5 International Yaden Hemas TABLETS Micro Mega Lanka 5189 10MG USP TABLETS OLANZAPINE AMPREXA TABLETS Health Care RCA 422 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 PAKISTANBANGLADESH 21-Mar-14 28-Jan-14 Full Full PAKISTAN 24-Feb-17INDIA Full INDIA 20-Jan-15 Full INDIA 07-Nov-17 Full 04-Dec-17PAKISTAN Full 21-Oct-16INDIA Full INDIA 25-Oct-14INDIA Full 07-Oct-15PAKISTAN Full 07-Nov-17 19-Aug-14 Full BANGLADESH Full 14-Mar-15 Full Pharmaceuticals Ltd Hilton Pharma (Pvt) Ltd Sun Pharma (Pvt) Ltd Zim Laboratories Ltd Macleods Pharmaceuticals Ltd Ferozsons Laboratories Ltd Cadila Healthcare Ltd Glaxo Smithkiline Pharmaceuticlas Zim Laboratories Ltd Remington pharmaceutical Industries (Pvt) Ltd Popular Pharmaceuticals Ltd Ferozsons Laboratories Ltd (Contd.) Healthcare lanka Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd (Ceylon) Ltd Healthcare lanka Ltd (Ceylon) Ltd Pharmaceuticals (Pvt) Ltd Co Ltd Services Pvt. Ltd (Ceylon) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP OLMECAR 20 TABLETS 20OMSANA PharmAce (Pvt) Ltd Square TABLETS 20OLMEZEST TABLETS Sunshine 20OLMESART Hemas TABLETSOLMESAR H Tabrane TABLETSORION DIU Pettah Pharmacy TABLETSOLMI 40 Emerchemie NB BENITEC 40 TABLETS 40OLMESART TABLETS Sunshine TABLETS Glaxo Wellcome FORTEZOLOPAT EYE DROPS Tabrane Delmege Forsyth & PATADIN EYE DROPS ABC Pharma ORION TABLETS Emerchemie NB TABLETS 40MG TABLETS TABLETS 20MG TABLETS 20MG TABLETS 20MG TABLETS 20MG TABLETS TABLETS MEDOXOMIL 20MG+HYDROCHLOROTHIAZIDE 12.5MG TABLETS TABLETS MEDOXOMIL 20MG+HYDROCHLOROTHIAZIDE 12.5MG TABLETS 40MG TABLETS 40MG TABLETS W/V TABLETS 20MG TABLETS 5211 MEDOXOMIL OLMESARTAN 5203 MEDOXOMIL OLMESARTAN 5204 MEDOXOMIL OLMESARTAN 5205 MEDOXOMIL OLMESARTAN 5206 MEDOXOMIL OLMESARTAN 5207 OLMESARTAN 5208 OLMESARTAN 5209 MEDOXOMIL OLMESARTAN 5210 MEDOXOMIL OLMESARTAN 5212 EYE DROPS 0.2% OLOPATADINE 5213 EYE DROPS 1MG/ML OLOPATADINE 5202 MEDOXOMIL OLMESARTAN I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 423 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 13-Nov-17 Full TURKEY 23-Aug-17INDIA Years Two TURKEY 07-Sep-15 23-Aug-17 Full Years Two STATES PAKISTAN 06-Feb-14INDIA Full INDIA 01-Mar-15 Full INDIA 10-Mar-16 Full INDIA 16-Mar-16 Full BANGLADESH 23-Nov-18 25-Jul-17 Full INDIA Full INDIA 24-May-18 Years Two INDIA 13-Mar-16 Full 08-Apr-15 Full World Medicine World Ilac san ve Elko Organization (Pvt) Ltd Pharmaceuticals Ltd Amanta Healthcare Ltd World Medicine World Ilac san ve Ajantha Pharma Ltd Indoco Remedies India Indoco Remedies India Sun Pharmaceutical industries PharmaceuticalS (Pvt) Ltd Sunwaya Rohto Pharmaceutical Pvt Ltd Sun Pharmaceutical industries (Contd.) Pharmaceuticals (Pvt) Ltd (Ceylon) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Baur & Co (Pvt) A Ltd Hemas Pharmaceuticals (Pvt) Ltd Emar Pharma (Pvt) Ltd Hemas Pharmaceuticals (Pvt) Ltd Ceyoka (Pvt) Ltd Ciron Drugs & International Yaden (Pvt) Ltd Hemas Pharmaceuticals (Pvt) Ltd SUSPENSION SOLUTION SOLUTION SOLUTION SOLUTION DROPS SOLUTION SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP OLOPAT 0.1%PALLADA OPHTHALMIC EYE DROPS Slim PATANOLXEPAT EYE DROPS Morison PLCALERCHEK EYE DROPSLaboratories Alcon UNITED Emerchemie NB OPHTHALMIC ALERCHEK 0.2% OPHTHALMIC DSWINOLAP OPHTHALMIC N/AALACOT OPHTHALMIC OLOPAT EYE DROPS PharmAce (Pvt) Ltd Square WINOLAP EYE & EAR ALEMBIC NEOLAP OPHTHALMIC SOLUTION Citihealth Imports PALLADA 0.1%PALLADA EYE DROPS Slim 0.1% EYE DROPS 0.1% EYE DROPS OPHTHALMIC SOLUTION 0.1% EYE DROPS OPHTHALMIC SOLUTION 0.1% EYE DROPS OPHTHALMIC SOLUTION 0.1% EYE DROPS OPHTHALMIC SOLUTION 0.2% EYE DROPS OPHTHALMIC SOLUTION 0.2% W/V 0.1% OPHTHALMIC SOLUTION USP W/V 0.1% OPHTHALMIC SOLUTION USP W/V 0.1% OPHTHALMIC SOLUTION USP W/V 0.1% OPHTHALMIC SOLUTION USP W/V 0.2% OPHTHALMIC SOLUTION USP W/V 0.1% EYE DROPS 5215 HYDROCHLORIDE OLOPATADINE 5216 HYDROCHLORIDE OLOPATADINE 5217 HYDROCHLORIDE OLOPATADINE 5218 HYDROCHLORIDE OLOPATADINE 5219 HYDROCHLORIDE OLOPATADINE 5220 HYDROCHLORIDE OLOPATADINE 5221 HYDROCHLORIDE OLOPATADINE 5222 HYDROCHLORIDE OLOPATADINE 5223 HYDROCHLORIDE OLOPATADINE 5224 HYDROCHLORIDE OLOPATADINE 5225 HYDROCHLORIDE OLOPATADINE 5226 HYDROCHLORIDE OLOPATADINE 5214 HYDROCHLORIDE OLOPATADINE 424 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 PAKISTAN 11-Sep-15MALAYSIA Full 13-Mar-14AUSTRALIA Full 20-May-14 Full IRANAUSTRALIA 07-Jun-14 13-Feb-15 Full Full INDIA 01-Mar-18PAKISTAN Full INDIA 30-Jun-15 Full INDONESIA 14-Aug-14 03-Nov-16 Full Full BANGLADESH 23-Jan-14 Full INDIA 24-Nov-15 Full Contract Manufacuring & Packging Services pty Ltd Zahravi Pharmaceutical Company Iran Sterling Lab INDIALtd Agio Pharmaceuticals 24-Feb-14Ltd Caprifaminda PT Full Laboratories Indonesia for Farma P.T.Sanbe Laboratories XL (Pvt) Ltd Cipla Ltd INDIA 01-Jan-14 Full Elko Organization (Pvt) Ltd CCM Pharmaceuticals SDN BHD Contract Manufacuring & Packging Services pty Ltd Renown Pharmaceuticals Pvt Ltd Pharmaceuticals Ltd (Contd.) Ltd Corporation (Pvt) Ltd Co Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Ltd (Pvt) Ltd Emerchemie NB (Ceylon) Ltd Lifeline Pharmaceuticals (Pvt) Ltd Alaris Lanka (Pvt) Ltd Softcare International (Pvt) Ltd SUSPENSION GELETIN SOFT CAPSULES CAPSULES CAPSULES SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP NATURALLE FISH NATURALLE OIL BEATSOMEGA-3 CAPSULES Alaris Lanka (Pvt) AUSOMEA CAPSULES Glenford GLEATIN SOFT RENOWN PLUS GELATIN SOFT XEPAT FORTEXEPAT OPHTHALMIC 1000MG 1000MG CAPSULES 1000MG CAPSULES 1000MG CAPSULES 1000MG (Natural) SUSPENSION USP 0.2% EYE SUSPENSION USP DROPS 5234 OMEPRAZOLE CAPSULES 20MG ZOLTAR TABLETS CIC Holdings PLC PharmEvo (Pvt) 5228 CAPSULES 3 FISH OIL OMEGA 5229 CAPSULES 3 FISH OIL OMEGA 5230 SOFT-GELATIN 3 FISH OIL OMEGA 5231 SOFT-GELATIN 3 FISH OIL OMEGA 5232 3 PURE FISH OIL OMEGA 5233 20MG OMEPRAZOLE CAPSULES IP TRISEC5235 CAPSULES OMEPRAZOLE CAPSULES 20MG ZEMO 20 Darley Butler & 5236 OMEPRAZOLE CAPSULES 20MG PUMPITOR CAPSULES Citihealth Imports 5237 CAPSULES OMEPRAZOLE CAPSULES 20MG SECLO 20 Lifeline 5238 OMEPRAZOLE CAPSULES 20MG CAPSULES HYCID 205239 OMEPRAZOLE CAPSULES 20MG PharmAce (Pvt) Ltd LOMAC Square CAPSULES SMM Halcyon (Pvt) CAPSULES Breathe Free Lanka 5227 OPHTHALMIC OLOPATADINE I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 425 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIA 05-Sep-18INDIA Years Two SRI LANKA 23-May-17 Years Two 18-Jun-18INDIA Provisional INDIA 29-Oct-14 Full BANGLADESH 13-Feb-15 19-Apr-14 Full Full INDIAINDIA 03-Apr-18 Provisional BANGLADESH 21-Mar-18 25-Mar-15 Provisional Full INDIAINDIA 07-Feb-15INDIA Full 13-May-17 Years Two 03-Dec-14 Full MBL PharmaMBL PAKISTANPharmaceuticals Ltd 12-Mar-17Priivate Limited Full Pharmaceuticals Ltd Akriti pharmaceuticals Pvt Ltd Globe Pharmaceuticals Ltd Theon Pharmaceuticals Ltd Medicon Pharmaceuticals Ltd Health Care IVA (Pvt) Ltd Healthcare Ltd Medicamen Biotech Ltd Dr Reddy's Laboratories Ltd Medochemie Ltd CYPRUSLaboratories (Pvt) 05-Nov-14Ltd Full (Contd.) Ltd Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Ceylon) Ltd Celyon (Pvt) Ltd CAPSULES Associated Pharma SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP RELOC 20 CAPSULES PharmAce (Pvt) Ltd Bhydburg PEPTAZ CAPSULESOMEROC Markss HLC (Pvt) OMERAN 20 CAPSULES CAPSULES N/AAssociates Pharma Bafna Celogen Lanka 20MG THEOPRAZ 20 CAPSULES 20OMEL Slim 20IVACID CAPSULES Act Enterpriese CAPSULESN/A Slim N/A CAPSULES Kamazu (Pvt) Ltd CAPSULES Syncom Slim

GASTRO RESISTANT GASTRO RESISTANT GASTRO RESISTANT GASTRO RESISTANT GASTRO RESISTANT GASTRO RESISTANT GASTRO RESISTANT GASTRO RESISTANT GASTRO RESISTANT 5242 OMEPRAZOLE CAPSULES 20MG 5241 OMEPRAZOLE CAPSULES 20MG 5243 OMEPRAZOLE CAPSULES 20MG 5244 OMEPRAZOLE CAPSULES 20MG 5245 20MG OMEPRAZOLE CAPSULES BP ZIOM5246 20MG OMEPRAZOLE CAPSULES BP 20 OP CAPSULES5247 20MG OMEPRAZOLE CAPSULES BP MEDOPRAZOLE Alaris Lanka (Pvt) CAPSULES5248 20MG OMEPRAZOLE CAPSULES BP PROHIBIN Healthcare Tabrane 5249 20MG OMEPRAZOLE CAPSULES BP CAPSULES Ceyoka (Pvt) Ltd5250 20MG OMEPRAZOLE CAPSULES BP Leben 5251 20MG OMEPRAZOLE CAPSULES BP 5252 20MG OMEPRAZOLE CAPSULES BP 5253 20MG OMEPRAZOLE CAPSULES BP 5240 OMEPRAZOLE CAPSULES 20MG OMEZ CAPSULES Emerchemie NB 426 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 PAKISTAN 11-Mar-15 Full PAKISTAN 23-Mar-16SRI LANKA Full 28-Jul-18INDIAYears Two INDIA 03-Jan-17INDIA Full 15-Jun-15INDIA Full 05-Mar-16 Full INDIA 23-Jun-17 Full INDIA 08-Apr-16INDIA Full 23-Jun-17INDIA Full 22-Nov-17 Years Two PAKISTAN 02-Apr-16 23-Mar-16 Full PAKISTAN Full 24-Mar-16 Full CCL CCL Pharmaceuticals (Pvt) Ltd Ltd. Medico Remedies (Pvt) Ltd Ltd Centurion Laboratories Pvt Ltd Adore Pharmaceuticals (Pvt) Ltd Health Pell Tech Care (Pvt) Ltd Scences Comed Chemical Ltd Swiss Pharmaceuticals (Pvt) Ltd & Well Well Pharma (Pvt) Ltd & Well Well Pharma (Pvt) Ltd Wings Biotech INDIA 01-Aug-14 Full Well & Well & Well Well Pharma (Pvt) Ltd (Contd.) Pharmaceuticals Lanka (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Ltd Pharmaceuticals (Pvt) Ltd Ltd Ltd Laboratories (Pvt) Ltd Laboratories (Pvt) Ltd (Pvt) Ltd Laboratories (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP PROLOC CAPSULES CCL OMEPAL 20OMEPAL OMMED 20 CAPSULES N/A CAPSULESCEZOLE 20 Akbar N/A CAPSULES CIC Lifesciences Harcourts (Pvt) Ltd Coral Laboratories ZIFAM CAPSULES 20OMEPELL International Yaden CAPSULES CAPSULES Alaris Lanka (Pvt) OMISWISS 20 Slim CAPSULESN/A PharmAce (Pvt) Ltd Swiss Garnier Life SANAMIDOL CAPSULES CAPSULESOMREL Pharma (Pvt) Talex C Medical (Pvt) T P OMREL CAPSULES Associated CAPSULES Associated OMREL CAPSULES Associated CAPSULES 20MG GASTRO RESISTANT GASTRO RESISTANT GASTRO RESISTANT GASTRO RESISTANT GASTRO RESISTANT GASTRO RESISTANT GASTRO RESISTANT GASTRO RESISTANT GASTRO RESISTANT GASTRO RESISTANT GASTRO RESISTANT GASTRO RESISTANT 5267 RELEASE OMEPRAZOLE DELAYED 5255 20MG OMEPRAZOLE CAPSULES BP 5256 20MG OMEPRAZOLE CAPSULES BP 5257 20MG OMEPRAZOLE CAPSULES BP 5258 20MG OMEPRAZOLE CAPSULES BP 5259 20MG OMEPRAZOLE CAPSULES BP 5260 20MG OMEPRAZOLE CAPSULES BP 5261 20MG OMEPRAZOLE CAPSULES BP 5262 20MG OMEPRAZOLE CAPSULES BP 5263 20MG OMEPRAZOLE CAPSULES BP 5264 20MG OMEPRAZOLE CAPSULES BP 5265 40MG OMEPRAZOLE CAPSULES BP 5266 20MG OMEPRAZOLE CAPSULES I.P WINCID CAPSULES International Yaden 5254 20MG OMEPRAZOLE CAPSULES BP I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 427 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIA 26-Jan-15 Full INDIAINDIA 03-Nov-17INDIA Full 07-Aug-16 Full INDIA 30-Aug-17 Full INDIA 11-May-16 Full INDIA 21-Apr-17 Years Two INDIA 11-May-17 Years Two INDIA 07-Jun-16 Full 15-Feb-17 Full INDIA 31-Jan-14 Full Dr Reddy's Laboratories Ltd Zee Laboratories INDIA 15-Jul-17Years Two (Pvt) Ltd G D Laboratories (India) Pvt Ltd Macleods Pharmaceuticals Ltd Akums Drugs & Pharmaceuticals Ltd Global Pharma Co. LLC Cadila Healthcare Ltd Torrent Pharmaceuticals Ltd Unique Pharmaceutical Labs Micro Labs Ltd INDIA 11-Sep-17Years Two Micro Labs Ltd INDIA 11-Sep-18 Full Pharmaceuticals (Pvt) Ltd Innova Captab INDIA 05-Oct-16 Full (Contd.) (Ceylon) Ltd Services Pvt. Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Healthcare lanka Ltd Ltd Health (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP OMEZ INJECTION Emerchemie NB ZECID-20 CAPSULES ABC Pharma STROZOIEOZG CAPSULES PharmAce (Pvt) Ltd Swiss Pharma OMEPRAZ 20 CAPSULES CAPSULESOSKAR 20 Lifeline Pettah Pharmacy CAPSULESOMEPRAGLOBE CAPSULES Hemas Akbar OCIDOMIZAC CAPSULESOMLEK 20 Sunshine CAPSULES Edna Medicals (Pvt) CAPSULESOMICAP George Steuart CAPSULES Micro Mega Lanka PRAZOLID 20 CAPSULESAssociates Pharma Osaka OMICAP CAPSULES Micro Mega Lanka INNOCID 20 CAPSULES Slim (LYOPHIIZED) 40MG (LYOPHIIZED) CAPSULES USP 20MG CAPSULES USP CAPSULES USP 20MG CAPSULES USP 20MG CAPSULES USP 20MG CAPSULES USP 20MG CAPSULES USP 20MG CAPSULES USP 20MG CAPSULES USP 20MG CAPSULES USP 20MG CAPSULES USP 20MG CAPSULES USP CAPSULES 20MG 20MG CAPSULES USP CAPSULES BP 20MG CAPSULES BP 5281 OMEPRAZOLE FOR INJECTION 5280 RELEASE OMEPRAZOLE DELAYED 5271 RELEASE OMEPRAZOLE DELAYED 5272 RELEASE OMEPRAZOLE DELAYED 5273 RELEASE OMEPRAZOLE DELAYED 5274 RELEASE OMEPRAZOLE DELAYED 5275 RELEASE OMEPRAZOLE DELAYED 5276 RELEASE OMEPRAZOLE DELAYED 5277 RELEASE OMEPRAZOLE DELAYED 5278 RELEASE OMEPRAZOLE DELAYED 5279 RELEASE OMEPRAZOLE DELAYED 5268 RELEASE OMEPRAZOLE DELAYED 5270 RELEASE OMEPRAZOLE DELAYED 5269 RELEASE OMEPRAZOLE DELAYED 428 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 19-Sep-17BANGLADESH Full 13-Jun-17 18-Jun-15 Full Full INDIABANGLADESH 30-Aug-14 23-Jan-18 Full Full INDIA 25-Feb-15 Full CHINAINDIA 29-Dec-17 Years Two PAKISTAN 13-Nov-15INDIA 15-Jun-15 Full Full INDIA 03-Jul-15BANGLADESH Full 06-Jan-14 02-Mar-16 Full Full INDIA 25-Jul-18 Full Centurion Laboratories Pvt Ltd Cadila Healthcare Ltd Globe Pharmaceuticals Ltd United Biotech (Pvt) Ltd Scott Edil Pharmacia Ltd Pharmaceuticals Ltd Stallion Laboratories Pvt Ltd (Pvt ) Ltd Marksons Pharma Ltd Globe Pharmaceuticals Ltd Cadila Healthcare Ltd Cipla Ltd INDIA 14-Jul-15 Full Youcare Youcare Pharmaceutical Group Co Ltd PharmaceuticalS (Pvt) Ltd (Contd.) (Pvt) Ltd Healthcare lanka Ltd (Pvt) Ltd Health (Pvt) Ltd Ltd (Pvt) Ltd Plc (Pvt) Ltd Healthcare lanka Ltd (Pvt) Ltd Ino-Life Healthcare (Pvt) Ltd INJECTION PharmAce (Pvt) Ltd Square INJECTION SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP N/AOFRAN INJECTION TABLETSVOMIZ 8MG International Yaden INJECTIONPREMESIS Sunshine INJECTION 8MGO-SET Healthcare Tabrane INJECTION George Steuart N/A INJECTION C Medical (Pvt) T P SOMECIDAUMI INJECTION Siba Healthcare INJECTION Ceyoka (Pvt) Ltd Genix Pharma OCIDLOMAC INJECTION Sunshine INJECTION Breathe Free Lanka DERRICK POWDER FOR GASTRO RESISTANT MG/4ML USP MG/4ML 8MG/4ML 8MG/4ML INJECTION 40MG 40MG INJECTION 40MG IV Vial IV Vial 40MG 5291 10MG BP TABLETS OMEPRAZOLE 5292 ONDANSETRON INJECTION 8 5293 ONDANSETRON INJECTION 8 5294 ONDANSETRON INJECTION IP 5295 ONDANSETRON INJECTION IP 5290 OMEPRAZOLE SODIUM FOR 5283 OMEPRAZOLE FOR INJECTION 5284 OMEPRAZOLE FOR INTRAVENOUS 5285 OMEPRAZOLE INJECTION 40MG OMEMARK5286 OMEPRAZOLE INJECTION 40MG N/A INJECTION5287 OMEPRAZOLE INJECTION 40MG Browns & Company OP-405288 OMEPRAZOLE INJECTION 40MG/ INJECTION Ceyoka (Pvt) Ltd INJECTION5289 OMEPRAZOLE INJECTION 40MG/ Ciron Drugs & Healthcare Tabrane 5282 OMEPRAZOLE FOR INJECTION I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 429 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 27-Jan-18 Years Two BANGLADESH 11-Oct-16 21-May-18BANGLADESH Years Two Full 02-Nov-17 Full INDIA 11-Oct-17 Full INDIAINDIA 29-May-18 Years Two INDIA 04-Jan-14INDIA Full 25-Feb-15INDIA Full 11-Feb-14INDIA Full 12-Mar-14INDIA Full 11-Jan-18 Provisional 07-Sep-17 Full INDIA 27-Jan-18 Full Mankind Pharma Ltd Mercury Laboratories Ltd Healthcare Pharmaceuticals Cephalosporins Ltd Scences Zim Laboratories Alkem Laboratories Ltd United Biotech (Pvt) Ltd SG Pharma (Pvt) Ltd (Pvt) Ltd PharmaceuticalS (Pvt) Ltd Divine Laboratories (Pvt) Ltd Cipla Ltd INDIA 23-Nov-17 Full Cadila pharmaceuticals Ltd Ltd (Contd.) Hemas Pharmaceuticals (Pvt) Ltd International Yaden (Pvt) Ltd Citihealth Imports (Pvt) Ltd PharmAce (Pvt) Ltd Square PharmAce (Pvt) Ltd Swiss Garnier Life Tabrane Pharmaceuticals (Pvt) Ltd (Ceylon) Ltd Health (Pvt) Ltd Pharmacy (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Healthcare lanka Ltd SOLUTION SOLUTION SOLUTION SUSPENSION SUSPENSION INTEGRATING TABLETS SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP AMZIF 100EMISTAT ORAL OFRAN ORAL 4DANSET ORAL ODS 8ONDANSET DIS- ORALLY ORAL TILSETVOMIKIND 4 INJECTION ORAL CIC Holdings PLC (India) Ltd Tablets INDIA 30-Jan-15 Full ONDEM 4MGO-SET TABLETSN/A INJECTION Emerchemie NB George Steuart ONDAWIVOMISETRON INJECTION INJECTION INJECTION The Esses N/A Pharmatec (Pvt) Ltd Belco Pharma Ceyoka (Pvt) Ltd Ciron Drugs & EMESET INJECTION INJECTION Slim Breathe Free Lanka ONSETT INJECTION Sunshine USP 4MG/5ML USP 4MG/5ML USP 4MG/5ML SUSPENSION USP 4MG/5ML SUSPENSION USP 8MG TABLETS DISINTEGRATING 4MG/2ML 4MG/5ML USP TABLETS 4MG TABLETS 4MG/2ML MG/ML MG/ML MG/ML MG/ML MG/ML 2MG/ML 5306 SOLUTION ONDANSETRON ORAL 5307 SOLUTION ONDANSETRON ORAL 5308 ONDANSETRON ORAL 5309 ONDANSETRON ORAL 5310 ONDANSETRON ORALLY 5304 ONDANSETRON INJECTION USP 5305 SOLUTION ONDANSETRON ORAL 5297 ONDANSETRON HYDROCHLORIDE 5298 ONDANSETRON INJECTION IP 5299 2 ONDANSETRON INJECTION USP 5300 2 ONDANSETRON INJECTION USP 5301 2 ONDANSETRON INJECTION USP 5302 2 ONDANSETRON INJECTION USP 5303 2 ONDANSETRON INJECTION USP 5296 ONDANSETRON INJECTION USP 430 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 BANGLADESH 20-Jul-18 Years Two INDIAINDIA 02-Aug-18 Years Two INDIA 21-Oct-14 Full INDIA 30-Jan-18 Full INDIA 25-Feb-15INDIA Full 04-Jan-14INDIA Full 21-May-18 Provisional INDIA 03-May-17 Full INDIA 22-Feb-18 Years Two BANGLADESH 07-May-17 29-Sep-16INDIA Full Full 08-Aug-16 Full Incepta Pharmaceuticals Ltd Mankind Pharma Ltd Alkem Laboratories Ltd Zim Laboratories Ltd Centurion Laboratories Pvt Ltd Cadila pharmaceuticals Ltd Ankur Drugs & Pharma (Pvt) Ltd Windlas Biotech (Pvt) Ltd Healthcare Pharmaceuticals Cadila Healthcare Ltd Cipla Ltd INDIA 23-Nov-17Years Two Healthcare (Pvt) Ltd Alkem Laboratories Ltd (Contd.) (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Ceylon) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Healthcare lanka Ltd International (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Healthcare lanka Ltd (Pvt) Ltd Emerchemie NB (Ceylon) Ltd TABLETS SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP ONASERON TABLETS Citihealth Imports VOMIKIND MD4 TABLETSONDEM-MD 4 Hemas TABLETS ODS 4ONDANSET ORALLY Emerchemie NB Tabrane VOMIKIND 4 TABLETSEMISTAT Hemas VOMIZ 4 TABLETSEMESET Citihealth Imports TABLETS Sunshine TABLETS Breathe Free Lanka 8MG DISINTEGRATING TABLETS USP TABLETS DISINTEGRATING 4MG DISINTEGRATING TABLETS USP TABLETS DISINTEGRATING 4MG USP TABLETS DISINTEGRATING 4MG 4MG 4MG 4MG 4MG 5311 ONDANSETRON ORALLY 5323 USP ONDANSETRON TABLETS 5312 ONDANSETRON ORALLY 5313 ONDANSETRON ORALLY 5314 2MGTABLETS ONDANSETRON 2 OSAT 5315 8MGTABLETS ONDANSETRON ONDEM5316 4MG BP TABLETS ONDANSETRON TABLETS N/A5317 Ceyoka (Pvt) Ltd 8MG BP TABLETS ONDANSETRON FILM COATED 8 ONSETT Global Pharma 5318 TABLETS 4 MG IP TABLETS ONDANSETRON TABLETS ONDEN 4 International Yaden 5319 USP Sunshine ONDANSETRON TABLETS TABLETS5320 USP ONDANSETRON TABLETS Softcare 5321 USP ONDANSETRON TABLETS 5322 USP ONDANSETRON TABLETS I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 431 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 PAKISTAN 04-Dec-18 Years Two PAKISTAN 12-Sep-15INDIA Full INDIA 16-Jul-16INDIA Full 04-Jun-16INDIA Full 04-Apr-15 Full PAKISTAN 04-Apr-15 04-Mar-15 Full PAKISTAN Full INDIA 14-Dec-16 Full 10-Aug-16 Full INDIABANGLADESH 06-Sep-16 04-Jul-16 Full Full Bharat Parenterals Ltd Unicure Ramadies (Pvt) Ltd Cadila Healthcare Ltd Getz Pharma Pakistan (Pvt) Ltd Aurochem Laboratories (India) Ltd. Pharmaceuticals & Chemical Works Laboratories (Pvt) Ltd Sakar Healthcare India Ltd Pharmaceuticals Ltd Bio FarmaT P INDONESIA 21-Jul-14 Full Cadila Healthcare Ltd (Contd.) (Pvt) Ltd Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Healthcare lanka Ltd Ceyoka (Pvt) Ltd ISIS Morison PLC ATCO Hemas Pharmaceuticals (Pvt) Ltd Services Pvt. Ltd Healthcare lanka Ltd SOLUTION POWDER SACHET SOLUTION SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP LOW OSMOLAR O.R.S ORESMINERVA POWDER ORAL ALUPENT Pharma Tropical POWDER ORAL Emar Pharma (Pvt) 10ZYPENT ORAL TABLETS Hemas NOVOSAL ORAL OFRAN DOSEMULTI TABLETS DROPS ORAL ABC Pharma PharmAce (Pvt) Ltd Square VOMIZ 8 TABLETS Sunshine POWDER 20.5G 4.3G 10MG/5ML BP 10MG ELECTROLYTE SOLUTION ELECTROLYTE ( SODIUM CHLORIDE BP 1.3G,TRISODIUM CITRATE 1.45G,POTASSIUM DIHYDRATE CHLORIDE ANHYDROUS 6.75G 500ML) 8MG ATTENUATED (LIVE MULTI-DOSE DROPS) ORAL 8MG 5328 SALT REHYDRATION ORAL 5329 BP SALTS REHYDRATION ORAL 5330 BP SALTS REHYDRATION ORAL 5331 SOLUTION ORCIPRENALINE ORAL 5332 BP ORCIPRENALINE TABLETS 5333 CAPSULES 120MG ORLISTAT ORLIFIT5334 CAPSULES 120MG ORLISTAT 5335 CAPSULES 120MG ORLISTAT ORSLIM CAPSULES ZYTRIM Hemas CAPSULES CIC Holdings PLC CAPSULES PharmEvo (Pvt) Sunshine 5327 REHYDRATION ORAL 5325 USP ONDANSETRON TABLETS 5326 POLIO MYELITIS VACCINE ORAL 5324 USP ONDANSETRON TABLETS 432 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 MALAYSIA 10-Apr-15INDIA Full INDIA 07-Nov-17ITALY Full 24-Oct-14INDIA Full 17-Mar-15PAKISTAN Full 27-Sep-17 17-Jul-15INDIA Full Full PAKISTAN 27-Sep-17 02-Aug-18INDIA Years Two Full PAKISTAN 13-Aug-14 19-Apr-18 Full PAKISTAN Years Two INDIA 24-Mar-17 Years Two INDIA 24-Apr-16 Full BANGLADESH 13-Aug-16 13-May-14 Full Full Zim Laboratories Ltd Meyer Organics (Pvt) Ltd Roche SpA Segrate Italy for F Hoffman Meyer Organics (Pvt) Ltd Getz Pharma Pakistan (Pvt) Ltd Meyer Organics (Pvt) Ltd CCL Pharmaceuticals (Pvt) Ltd Akums Drugs & Pharmaceuticals Ltd Ferozsons Laboratories Ltd Health Pell Tech Care (Pvt) Ltd Akums Drugs & Pharmaceuticals Ltd Healthcare Pharmaceuticals Pharmaniaga Manufacturing berhand Laboratories (Pvt) Ltd (Contd.) Pharmaceuticals (Pvt) Ltd Ltd Ltd Ltd Pharmaceuticals (Pvt) Ltd Ltd Pharmaceuticals Lanka (Pvt) Ltd (Pvt) Ltd (Ceylon) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd (Ceylon) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP 5337 CAPSULES 120MG ORLISTAT ORLIZIM 1205338 CAPSULES 120MG ORLISTAT CAPSULES5339 CAPSULES 120MG ORLISTAT REESHAPE 120 Tabrane CAPSULES XENICAL5340 CAPSULES 60MG ORLISTAT SMM Halcyon (Pvt) 5341 CAPSULES 60MG ORLISTAT CAPSULES REESHAPE 60 CAPSULES Baur & Co (Pvt) A 5342 ORLIFIT CAPSULES 60MG ORLISTAT SMM Halcyon (Pvt) 5343 120MG CAPSULES USP ORLISTAT REESHAPE 60 ORLOVIT CAPSULES CAPSULES5344 Hemas 120MG CAPSULES USP ORLISTAT ORLIVEX 120 SMM Halcyon (Pvt) CAPSULES5345 CAPSULES CCL 120MG CAPSULES USP ORLISTAT 120 SLIMTAB Global Impex AV 5346 CAPSULES 120MG CAPSULES USP ORLISTAT ORLIS PharmAce (Pvt) Ltd5347 120MG CAPSULES USP Wilshire ORLISTAT 120 PELLTRIN CAPSULES5348 CAPSULES 60MG CAPSULES USP ORLISTAT ORLIVEX 60 Slim Emerchemie NB 5349 CAPSULES 120MG ORLISTAT CAPSULES LYSTA Global Impex AV CAPSULES Citihealth Imports 5336 CAPSULES 120MG ORLISTAT CUVARLIX CAPSULES Emerchemie NB I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 433 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 BANGLADESH 18-Sep-18 Provisional INDIAARGENTINA 16-Jun-18 11-Jan-18ARGENTINA Full Full 11-Jan-17INDIA Full 24-Oct-14 Full INDIAINDIA 14-Mar-18 Years Two INDIA 26-Nov-15 Full SWITZERLAND 11-May-17 23-Dec-15 Years Two SWITZERLAND Full 23-Dec-15SWITZERLAND Full 23-Dec-15SWITZERLAND Full 23-Dec-15SWITZERLAND Full 23-Dec-15 Full Laboratoire A Kemex S Nazarre Bioprofarma SA Terrada Naprod Life Scienc (Pvt) Ltd Beacon Pharmaceuticals Ltd Celon Laboratories Ltd Amol Pharmaceuticals (Pvt) Ltd Sun Pharmaceutical industries F Hoffman-La Roche Ltd F Hoffman-La Roche Ltd F Hoffman-La Roche Ltd F Hoffman-La Roche Ltd Cenexi SAS Fontenay France for F Hoffmann-La roche ltd-Swit Hetero Labs Ltd INDIA 29-Jun-18Years Two Unique Pharmaceutical Labs (Contd.) (Ceylon) Ltd (Ceylon) Ltd (Pvt) Ltd (Ceylon) Ltd Medmart Pharma (Pvt) Ltd (Pvt) Ltd (Ceylon) Ltd Ltd Ltd Ltd Ltd Ltd (Pvt) Ltd Health (Pvt) Ltd INJECTION SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP ZILDOX 100 INJECTION Ravilux Company FLUVIR CAPSULES Mansel (Ceylon) (LYOPHILISED) 75MG 5360 INJECTION 100MG OXALIPLATIN CELDACH5361 INJECTION 100MG OXALIPLATIN 100 OXALTIE POWDER FOR 5362 INJECTION 100MG OXALIPLATIN INJECTION 100 OXALTIE 5363 INJECTION 100MG OXALIPLATIN Emerchemie NB INJECTION Emerchemie NB 5359 80MGTABLETS OSIMERTINIB TAGRIX TABLETS Emerchemie NB 5351 500MGTABLETS ORNIDAZOLE ORWEL5352 500MGTABLETS ORNIDAZOLE DAZOLIC TABLETS5353 CAPSULES 30MG OSELTAMIVIR TAMIFLU5354 Pharma Avenier TABLETS CAPSULES 30MG OSELTAMIVIR TAMIFLU5355 CAPSULES 45MG OSELTAMIVIR Emerchemie NB CAPSULES TAMIFLU5356 Baur & Co (Pvt) CAPSULES 45MG A OSELTAMIVIR CAPSULES TAMIFLU5357 Baur & Co (Pvt) CAPSULES 75MG A OSELTAMIVIR CAPSULES TAMIFLU Baur & Co (Pvt) A CAPSULES5358 CAPSULES USP OSELTAMIVIR Baur & Co (Pvt) A CAPSULES Baur & Co (Pvt) A 5350 500MGTABLETS ORNIDAZOLE 500 ORNIGIL TABLETS George Steuart 434 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 15-Jun-18INDIA Full 21-Apr-17INDIA Full 11-May-18 Full INDIA 07-Nov-16 Full SWITZERLAND 11-May-14 21-Aug-18 Full Full INDIAARGENTINA 16-Feb-14 11-Jan-18 Full Full INDIA 22-Aug-14 Full INDIA 19-Aug-18 Years Two Celon Laboratories Ltd United Biotech (Pvt) Ltd Sun Pharmaceutical industries Windlas Biotech (Pvt) Ltd Sun Pharmaceutical industries Novartis Pharma S.P.A. Micro Labs Ltd INDIA 05-Dec-17Years Two Techno Drugs LtdTechno BANGLADESH 04-Jun-16 Full Laboratoire A Kemex S Nazarre Cipla LtdPharmaceutical INDIAPvt Ltd Drugs LtdTechno BANGLADESH 20-May-16 13-Aug-14 Full Full Fresenius Kabi Oncology Ltd Cipla Ltd INDIA 02-Apr-14 Full Zydus Hospira Oncology (Pvt) Ltd (Contd.) (Pvt) Ltd Health (Pvt) Ltd (Ceylon) Ltd Pharmaceuticals (Pvt) Ltd (Ceylon) Ltd Ltd (Pvt) Ltd Pharmaceticals (Ceylon) Ltd (Pvt) Ltd Pharmaceticals Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP CELDACH 50OPLATIN INJECTION INJECTION Medmart Pharma George Steuart CARBOX 300 TABLETS Micro Mega Lanka OXOL INJECTION Ceyoka (Pvt) Ltd Kavbir X-PLAT INJECTION Breathe Free Lanka X-PLAT INJECTION Breathe Free Lanka OXALIZYD 100 INJECTION Hemas 50MG/25ML 50MG/25ML 300MG 50MG/25ML & 100MG/50ML 50MG/25ML 50MG/25ML 100MG/50ML 100MG/20ML 5372 INJECTION USP OXALIPLATIN 5373 INJECTION USP OXALIPLATIN 5374 150MGTABLETS OXCARBAZEPINE OXETOL5375 150MGTABLETS OXCARBAZEPINE CARBOX 150 TABLETS5376 TABLETS 300MGTABLETS OXCARBAZEPINE Emerchemie NB OXETOL Lifeline 5377 300MGTABLETS OXCARBAZEPINE 300 TRILEPTAL TABLETS5378 TABLETS IP OXCARBAZEPINE TABLETS Emerchemie NB Baur & Co (Pvt) A 5369 INJECTION OXALIPLATIN 5371 50MG INJECTION BP OXALIPLATIN OXALOTIN 100 INJECTION S P L 5367 INJECTION 50MG OXALIPLATIN 50 OXALTIE 5368 INJECTION OXALIPLATIN INJECTION Emerchemie NB 5370 100MG INJECTION BP OXALIPLATIN OXALOTIN 100 INJECTION S P L 5366 INJECTION 2mg/ml OXALIPLATIN OXITAN INJECTION Markss HLC (Pvt) 5365 INJECTION OXALIPLATIN 5364 INJECTION OXALIPLATIN I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 435 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 02-Jul-18BANGLADESH Years Two 15-Mar-18 12-Dec-18 Provisional Years Two BANGLADESH 05-Aug-16 Full INDIAINDIA 31-Jan-14 Full BANGLADESH 02-Jan-16 15-Mar-18 Provisional Full INDONESIA 09-Dec-17 Years Two INDIA 01-Oct-17 Years Two INDIA 27-Oct-17 Years Two Treffer Treffer Pharmaceuticals Incepta Pharmaceuticals Ltd Centaur Pharmaceutical (Pvt) Ltd Megasys Biotek (Pvt) Ltd Incepta Pharmaceuticals Ltd Merck Sharp PT Dohme Pharma Tbk Merck Limited INDIA 17-Mar-15 Full Treffer Treffer Pharmaceuticals Pharmaceuticals Ltd Cipla Ltd INDIA 12-Jan-17 Full Zim Laboratories Ltd Cipla Ltd INDIA 12-Jan-17 Full Zim Laboratories Ltd (Contd.) (Pvt) Ltd (Pvt) Ltd Health (Pvt) Ltd Agency Pvt Ltd (Pvt) Ltd Ltd (Ceylon) Ltd (Pvt) Ltd PharmAce (Pvt) Ltd Square (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd SOLUTION SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP RYNEXNOCON 0.05% SPRAY NASAL Citihealth Imports NASAL SINAREST DROPS NASAL OXINA George Steuart RYNEX DROPS NASAL Leader Pharma AFRIN SPRAY NASAL Citihealth Imports NASIVION SPRAY NASAL Baur & Co (Pvt) A DROPS NASAL Emerchemie NB OXYSPAS 5OXYSPAS TABLETS Breathe Free Lanka OXIBUZIM 5 TABLETS Tabrane OXYSPAS 2.5OXYSPAS TABLETS Breathe Free Lanka OXIBUZIM 2.5 TABLETS Tabrane HYDROCHLORIDE 0.05% NASAL HYDROCHLORIDE 0.05% NASAL SOLUTION HYDROCHLORIDE 0.05% NASAL SOLUTION HYDROCHLORIDE 0.05% NASAL SOLUTION HYDROCHLORIDE 0.05% NASAL SOLUTION HYDROCHLORIDE 0.05% NASAL SOLUTION HYDROCHLORIDE 0.05% NASAL SOLUTION HYDROCHLORIDE 0.05% NASAL SOLUTION USP 5MG USP USP 5MG USP USP 2.5MG USP USP 2.5MG USP 5384 5MG BP TABLETS OXYBUTYNIN N/A5385 OXYMETAZOLINE 5386 OXYMETAZOLINE TABLETS5387 OXYMETAZOLINE International Yaden 5388 OXYMETAZOLINE 5389 OXYMETAZOLINE 5390 OXYMETAZOLINE 5391 OXYMETAZOLINE 5383 2.5MG BP TABLETS OXYBUTYNIN N/A TABLETS International Yaden 5382 TABLETS OXYBUTYNIN CHLORIDE 5381 TABLETS OXYBUTYNIN CHLORIDE 5380 TABLETS OXYBUTYNIN CHLORIDE 5379 TABLETS OXYBUTYNIN CHLORIDE 436 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 BANGLADESH 08-Oct-15 Full BANGLADESH 13-May-18 Full BANGLADESH 05-Aug-17 Full INDIAINDIA 27-Mar-14 Full INDIA 12-Aug-17 Years Two 02-Jan-16 Full INDIAINDIA 12-Jul-14 Full BANGLADESH 10-Feb-15 04-Nov-14 Full Full Incepta Pharmaceuticals Ltd Centaur Pharmaceutical (Pvt) Ltd (Pvt) Ltd Beximco Pharmaceuticals Ltd Pharmaceuticals Ltd Pharmaceuticals (Pvt) Ltd Merck Limited INDIA 13-Sep-15 Full Cadila Healthcare Ltd Incepta Pharmaceuticals Ltd Merck (Pvt) Ltd INDIA 09-Sep-14 Full Pharmaceuticals (Pvt) Ltd (Contd.) (Pvt) Ltd Health (Pvt) Ltd (Ceylon) Ltd PharmAce (Pvt) Ltd Square Healthcey (Pvt) Ltd Biodeal Emerchemie NB (Ceylon) Ltd N/A Astron (Pvt) Ltd SRI LANKA 03-Apr-14 Full Healthcare lanka Ltd (Pvt) Ltd (Ceylon) Ltd Healthcey (Pvt) Ltd Biodeal SOLUTION SOLUTION SOLUTION OINTMEN SOLUTION SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP RYNEXNOCON 0.025% DROPS NASAL NASAL Citihealth Imports PDSINAREST DROPS NASAL George Steuart N/AOXINA-P NASAL NASIVION DROPS NASAL Pharmatec (Pvt) Ltd Megasys Biotek TETRACORT NASAL TOPICAL NAZOLIN DROPS NASAL Emerchemie NB ZYCKSRYNEX SPRAY NASAL Sunshine NASIVION MINI DROPS NASAL DROPS NASAL Citihealth Imports Emerchemie NB N/A NASAL HYDROCHLORIDE USP 0.025% HYDROCHLORIDE USP DROP NASAL 0.025% HYDROCHLORIDE USP SOLUTION NASAL 0.025% HYDROCHLORIDE USP SOLUTION NASAL 0.025% HYDROCHLORIDE USP SOLUTION NASAL 0.025% HYDROCHLORIDE USP SOLUTION NASAL 0.025% SOLUTION USP 1% 3%+HYDROCORTISONE USP OINTMENT HYDROCHLORIDE NASAL SPRAY SPRAY HYDROCHLORIDE NASAL ACTUATION 25MCG 0.05% (EACH DELIVERS OXYMETAZOLINE 25MCG) HYDROCHLORIDE USP HYDROCHLORIDE 0.05% USP HYDROCHLORIDE 0.05% USP SOLUTION NASAL 0.05% HYDROCHLORIDE BP HYDROCHLORIDE NASAL 0.01% SOLUTION USP HYDROCHLORIDE 0.05% USP HYDROCHLORIDE 0.05% USP SOLUTION NASAL 5397 OXYMETAZOLINE 5398 OXYMETAZOLINE 5399 OXYMETAZOLINE 5400 OXYMETAZOLINE 5401 OXYMETAZOLINE 5402 NASAL OXYMETAZOLINE 5403 OXYTETRACYCLINE 5396 OXYMETAZOLINE 5393 OXYMETAZOLINE 5394 OXYMETAZOLINE 5395 OXYMETAZOLINE 5392 OXYMETAZOLINE I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 437 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 11-Jan-14INDIA Full 15-Jun-16INDIA Full 15-Jul-15INDIA Full 11-Jan-17 Years Two INDIA 04-Sep-15INDIA Full 25-Feb-14INDIA Full 04-Sep-15INDIA Full 22-Jun-17INDIA Full 22-Jun-17BANGLADESH 24-Oct-17 Full 30-Jul-15 Years Two INDIA Full INDIA 02-Jan-19 Years Two INDIA 01-Nov-18 Years Two 02-Jun-17 Full Gland Pharma (Pvt) Ltd Neon Laboratories Ltd Laboratories Ltd ADMAC Lifesciences Fresenius Kabi Oncology Ltd ADMAC Lifesciences Getwell Pharmaceuticals Getwell Pharmaceuticals United Biotech (Pvt) Ltd Beacon Pharmaceuticals Ltd Sun Pharmaceutical industries Pharma (Pvt) Ltd Neon Laboratories Ltd Getwell Pharmaceuticals (Contd.) Services Pvt. Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Ltd Pharmaceuticals (Pvt) Ltd Pharmacy (Pvt) Ltd Pharmacy (Pvt) Ltd Health (Pvt) Ltd (Ceylon) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd The Esses Pharmacy (Pvt) Ltd SUSPENSION SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP CELTAX 260CELTAX 260PACLIBENZ INJECTION INJECTIONAssociates Pharma Celon INTAXEL Slim 100PACLIBENZ INJECTION INJECTION 260 Markss HLC (Pvt) PACLIWEL Slim INJECTIONPACLIWEL The Esses 30PACLITEC INJECTION INJECTION 30XELPAC The Esses George Steuart INJECTION 100NANOPAC Emerchemie NB POWDER FOR BEVETEX 100 INJECTION 30CANTAXEL Hemas INJECTIONAssociates Pharma Chandra Bhagat POLYMYCIN OINTMENT N/A Astron (Pvt) Ltd SRI LANKA 09-Apr-17Years Two 100MG/16.67ML 260MG/43.4ML 260MG/43.4ML /1ML 260MG/43.47ML 30MG/5ML. 30MG/5ML. 6MG IN 1ML (PROTEIN BOUND PARTICLES) 100MG/50ML FOR NANO CONCENTRATE DISPESION 100MG/VIAL 30MG/5ML POLYMYXIN B SULPHATE 10,000 B SULPHATE POLYMYXIN U/G OINTMENT 5411 FOR INJECTION USP PACLITAXEL 5406 5IU/ML INJECTION BP OXYTOCIN N/A5407 5IU/ML INJECTION BP OXYTOCIN EVATOCIN5408 INJECTION PACLITAXEL INJECTION INJECTION5409 INJECTION USP PACLITAXEL Ravilux Company ABC Pharma 5410 FOR INJECTION 6MG PACLITAXEL 5412 FOR INJECTION USP PACLITAXEL 5413 FOR INJECTION USP PACLITAXEL 5414 FOR INJECTION USP PACLITAXEL 5415 FOR INJECTION USP PACLITAXEL 5416 FOR SUSPENSION PACLITAXEL 5417 INJECTION PACLITAXEL 5418 INJECTION USP PACLITAXEL 5404 OXYTETRACYCLINE 30mg & 5405 2IU/ML INJECTION B.P OXYTOCIN EVATOCIN INJECTION Ravilux Company 438 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIABANGLADESH 15-Feb-17 28-Oct-14 Full Full INDIAINDIA 25-Aug-14 Full ARGENTINA 08-Nov-15 03-Nov-15BELGIUM Full Full 21-Jun-18BANGLADESH 19-Oct-18 Full Years Two INDIAINDIA 26-Dec-15 Full 28-Jan-18 Years Two INDIAINDIA 05-Apr-14 Full 07-Jun-14 Full Pharmaceuticals Ltd Zim Laboratories Ltd Panacea Biotec (Pvt) Ltd Bioprofarma SA Terrada Beacon Pharmaceuticals Ltd SG Pharma (Pvt) Ltd Pharmafabrikon Unit Micro Labs Ltd INDIA 08-Jul-14 Full Fresenius Kabi Oncology Ltd Janssen Cilag Pharmaceutica Lda NV Belgium Parenteral Drugs Ltd INDIA Belco Pharma (Pvt) Ltd Sanbe FarmaT P INDONESIA 16-Jul-15 Full Adley Formulation INDIA 07-Feb-14 Full (Contd.) Pharmaceuticals (Pvt) Ltd Ltd (Ceylon) Ltd (Ceylon) Ltd Pharmacy (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd Ltd Emerchemie NB (Ceylon) Ltd (Pvt) Ltd Agency Pvt Ltd Pharmaceuticals (Pvt) Ltd Healthcare lanka Ltd SUSPENSION FOR INJECTION SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP TRUPAN TABLETS PharmAce (Pvt) Ltd Square PACLIALLPANATAXEL INJECTION Markss HLC (Pvt) INJECTIONINVEGA SUSTENNA Emerchemie NB NANOXEL INJECTION Markss HLC (Pvt) PACLIPAR 30PACLIPAR INJECTIONN/A Omacx Healthcare SANTOTAXEL INJECTION INJECTION Lifeline Leader Pharma ADPAXIL INJECTION Sunshine RELEASE TABLET 20MG RELEASE TABLET PARTICLES FOR INJECTABLE FOR INJECTABLE PARTICLES SUSPENSION 100MG INJECTION 30MG/5ML. RELEASE SUSPENSION FOR INJECTION 100MG/ML INJECTION 20MG/ML WITH INJECTION 20MG/ML OF EXCIPIENTS CONCENTRATE 30MG/5ML IN 1ML IN 1ML 30MG/5ML 5432 DELAYED PANTOPRAZOLE 5431 CAPSULE 20MG PANTOPRAZOLE 20 PANTOZIM CAPSULES Tabrane 5424 PROTEIN BOUND PACLITAXEL 5425 SOLUTION FOR PACLITAXEL 5426 PROLONGED PALIPERIDONE 5427 0.5MGTABLETS PALONOSETRON PALOXI5428 CAPSULES 10000 IU PANCREATIN N/A TABLETS5429 40MGTABLETS PANTOPRAZOLE 40 BRIKOPACID Emerchemie NB 5430 40MG TABLETSTABLETS PANTOPRAZOLE 40 PANTOCAR CAPSULES Novachem Lanka TABLETS The Esses Micro Mega Lanka 5423 NANOPARTICLE PACLITAXEL 5420 INJECTION USP PACLITAXEL 5421 6MG INJECTION USP PACLITAXEL 5422 6MG INJECTION USP PACLITAXEL 5419 INJECTION USP PACLITAXEL I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 439 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 18-Aug-16INDIA Full 29-Mar-17 Years Two INDIA 21-Apr-18INDIA Full 24-Sep-17 Years Two INDIA 25-Nov-15 Full BANGLADESH 20-Jun-17 30-May-18 Full Full INDIA 03-Oct-15 Full INDIAINDIA 31-Oct-18 Years Two BANGLADESH 11-Nov-14 19-Sep-17 Years Two Full c Stridden fi Gu Biopharma Pvt ltd Alkem Laboratories Ltd Unique Pharmaceutical Labs Stallion Laboratories Pvt Ltd Cadila Healthcare Ltd Marksons Pharma Ltd (Pvt) Ltd Pharmaceuticals Ltd Sydler Remedies (Pvt) Ltd Akums Drugs & Pharmaceuticals Ltd Incepta Pharmaceuticals Ltd Aristopharma Ltd BANGLADESH 11-May-17Years Two IPCA LaboratoriesIPCA INDIA 02-Oct-14 Full (Contd.) Pharmaceuticals (Pvt) Ltd (Ceylon) Ltd Health (Pvt) Ltd (Pvt) Ltd Healthcare lanka Ltd Plc Klintas (Pvt) Ltd United Biotech Ltd (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Hemas Pharmaceuticals (Pvt) Ltd INJECTION RELEASE TABLETS SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP STRIPOLE INJECTION IVPAN Slim PANUMIV INJECTIONPENSTAL INJECTION Emerchemie NB George Steuart PANTODAC INJECTION Siba Healthcare INJECTION Sunshine PANTAZOL 40PANTAZOL POWDER FOR GENOCID 40 TABLETSVEXPRAZOLE 20 TABLETS Alaris Lanka (Pvt) 20PANTONIX Global Impex AV TABLETSPROMPIN 40 Citihealth Imports TABLETS Hemas PANTONEX DR 20PANTONEX DELAYED 40MG/10ML INJECTION 40MG INJECTION 40MG INJECTION 40MG INJECTION 40MG 40MG RELEASE TABLET 40MG RELEASE TABLET 20MG USP TABLET RELEASE 20MG USP TABLET RELEASE 40MG USP TABLET RELEASE RELEASE TABLET 20MG RELEASE TABLET 5439 FOR INJECTION PANTOPRAZOLE 5440 FOR IV PANTOPRAZOLE 5441 FOR IV PANTOPRAZOLE 5442 FOR IV PANTOPRAZOLE 5443 FOR IV PANTOPRAZOLE 5444 INJECTION 40MG PANTOPRAZOLE 40 TRUPAN 5445 INJECTION INJECTION 40MG PANTOPRAZOLE 40 PANLOC PharmAce (Pvt) Ltd Square INJECTION Browns & Company 5438 FOR INJECTION PANTOPRAZOLE 5434 DELAYED PANTOPRAZOLE 5435 DELAYED PANTOPRAZOLE 5436 DELAYED PANTOPRAZOLE 5437 DELAYED PANTOPRAZOLE 5433 DELAYED PANTOPRAZOLE 440 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 BANGLADESH 23-Dec-14 Full INDIAINDIA 14-Mar-15 Full INDIA 28-Mar-16 Full INDIA 01-Apr-15BANGLADESH Full 14-Mar-16 11-Jul-17 Years Two Full INDIAINDIA 31-Oct-18 Years Two INDIA 14-Sep-18 Provisional INDIA 26-Oct-17 Full INDIA 01-Aug-18INDIA Full 30-Jan-15INDIA Full 26-Oct-17 Full 07-Nov-17 Full

Laboratories (Pvt) Ltd Wallace Pharmaceuticals Ltd Laboratories (Pvt) Ltd Pharmaceuticals Ltd Sydler Remedies (Pvt) Ltd Fredun Pharmaceuticals Ltd Alkem Laboratories Ltd Cadila Healthcare Ltd Globe Pharmaceuticals Ltd Ltd Cadila Healthcare Ltd Sun Pharmaceutical industries Cadila Healthcare Ltd (Contd.) Ltd Ltd Health (Pvt) Ltd (Ceylon) Ltd Healthcare lanka Ltd (Pvt) Ltd Sunshine Healthcare lanka Ltd Hemas Pharmaceuticals (Pvt) Ltd Sunshine Healthcare lanka Ltd COATED COATED TABLETS COA.) COATED TABLETS SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP ULTOP 20ULTOP TABLETSZANPAN Ceyoka (Pvt) Ltd 40ULTOP TABLETS Leben Emar Pharma (Pvt) TABLETS 20PROTON TRUPAN TABLETS Ceyoka (Pvt) Ltd Leben Galanica (Pvt) LtdGENOCID 20 TABLETS Prism Life Science TABLETS 20PANFRED PharmAce (Pvt) Ltd Square TABLETS Alaris Lanka (Pvt) PANTODAC George Steuart SUGAR PANTOCID (EN. TABLETS 20PAN PANTODAC TABLETS SUGAR PANTODAC Emerchemie NB TABLETS Sunshine EUROPAN INJECTION Healthcare Tabrane TABLETS TABLETS TABLETS 20MG RELEASE TABLET 40MG RELEASE TABLET 20MG USP TABLET RELEASE 20MG USP TABLET RELEASE 20MG USP TABLET RELEASE 20MG USP TABLET RELEASE 20MG USP TABLET RELEASE 20MG USP TABLET RELEASE 40MG USP TABLET RELEASE 40MG 5447 SODIUM 20MG PANTOPRAZOLE 5448 SODIUM 40MG PANTOPRAZOLE 5449 SODIUM 40MG PANTOPRAZOLE 5450 SODIUM DELAYED PANTOPRAZOLE 5451 SODIUM DELAYED PANTOPRAZOLE 5452 SODIUM DELAYED PANTOPRAZOLE 5453 SODIUM DELAYED PANTOPRAZOLE 5454 SODIUM DELAYED PANTOPRAZOLE 5455 SODIUM DELAYED PANTOPRAZOLE 5456 SODIUM DELAYED PANTOPRAZOLE 5457 SODIUM DELAYED PANTOPRAZOLE 5458 SODIUM DELAYED PANTOPRAZOLE 5446 INJECTION BP PANTOPRAZOLE I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 441 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIABANGLADESH 22-Feb-17 08-Dec-17 Full INDIA Full INDIA 04-Apr-14 Full INDIA 29-Jan-14 Full INDIA 21-Aug-14 Full BANGLADESH 16-Oct-15 19-Sep-17 Years Two Full INDIAINDIA 08-Nov-17 Years Two INDIA 07-Nov-17 Full 11-Jul-17 Full BANGLADESH 20-Feb-14 Full BANGLADESH 17-Dec-14 Full Navana Pharmaceuticals Ltd Aurochem Pharmaceuticals (India) Ltd Agio Pharmaceuticals Ltd Akums Drugs & Pharmaceuticals Ltd Sunrise International LabS Ltd Incepta Pharmaceuticals Ltd Sun Pharmaceutical industries Cadila Healthcare Ltd J.B.Chemicals & Pharmaceuticals Alkem Laboratories Ltd Globe Pharmaceuticals Ltd Healthcare Pharmaceuticals (Contd.) (Pvt) Ltd (Pvt) Ltd Co Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd Pharmaceutical (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Healthcare lanka Ltd Health (Pvt) Ltd Emerchemie NB (Ceylon) Ltd RELEASE TABLETS SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP EUROPAN TABLETS 20PREGEL Healthcare Tabrane TABLETS Citihealth Imports PANTAC 40PANTAKIND TABLETS TABLETS Darley Butler & 40PANZAC Hemas TABLETSVEXPRAZOLE 40 TABLETS Citihealth Imports 40MGPROTAC Global Impex AV TABLETS 40PANTONIX Kent TABLETSPANTOCID Citihealth Imports TABLETSPANTODAC Hemas TABLETS 40PAN Sunshine DELAYED PANUM TABLETS George Steuart 40MG 20MG RELEASE TABLET USP 40MG USP TABLET RELEASE 40MG USP TABLET RELEASE 40MG USP TABLET RELEASE 40MG USP TABLET RELEASE 40MG USP TABLET RELEASE 40MG USP TABLET RELEASE 40MG USP TABLET RELEASE 40MG USP TABLET RELEASE 40MG USP TABLET RELEASE RELEASE TABLET USP 40MG USP TABLET RELEASE 5460 SODIUM DELAYED PANTOPRAZOLE 5461 SODIUM DELAYED PANTOPRAZOLE 5462 SODIUM DELAYED PANTOPRAZOLE 5463 SODIUM DELAYED PANTOPRAZOLE 5464 SODIUM DELAYED PANTOPRAZOLE 5465 SODIUM DELAYED PANTOPRAZOLE 5466 SODIUM DELAYED PANTOPRAZOLE 5467 SODIUM DELAYED PANTOPRAZOLE 5468 SODIUM DELAYED PANTOPRAZOLE 5459 SODIUM DELAYED PANTOPRAZOLE 5472 BP TABLETS PANTOPRAZOLE 5473 USP TABLETS PANTOPRAZOLE 442 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 ARGENTINA 05-Aug-16INDIA Full INDIA 24-Mar-14INDIA Full 16-May-14 Full 28-May-16INDIA Full INDIA 11-Apr-18 Provisional INDIA 09-Apr-15INDIA Full 01-Oct-15INDIA Full 29-Oct-18 Years Two INDIA 10-Jun-16 Full INDIA 16-Jan-18 Years Two INDIA 17-May-14AUSTRALIA Full 03-Jun-18 Years Two 15-Dec-16 Full Quimica Montpellier SA (Pvt) Ltd Zim Laboratories Ltd Zee Laboratories INDIAKwality Pharmaceuticals Pvt Ltd 05-Jan-17SG Pharma (Pvt) Ltd Full SG Pharma (Pvt) Ltd Mercury Laboratories Ltd Medicamen Biotech Ltd Laboratories (Pvt) Ltd (Pvt) Ltd Laboratories (Pvt) Ltd Glaxo Smithkiline Australia (Pvt) Ltd Pharmaceuticals Ltd (Contd.) (Ceylon) Ltd Klintas (Pvt) Ltd United Biotech Pharmaceuticals (Pvt) Ltd Services Pvt. Ltd (Pvt) Ltd Pharmacy (Pvt) Ltd Pharmacy (Pvt) Ltd (Pvt) Ltd Slim Pharmaceuticals (Pvt) Ltd Ceyoka (Pvt) Ltd Leben Chamee Chemist Alvita Pharma Ceyoka (Pvt) Ltd Leben Beecham (Pvt) Ltd COA.) SOLUTION SUSPENSION SOLUTION SOLUTION SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP PEPTAZOL 20PEPTAZOL TABLETS Emerchemie NB N/A INJECTION International Yaden N/AN/AN/A INJECTIONN/A The Esses INJECTION The Esses INJECTIONKALDOL International Yaden ORAL N/A ORAL KELVIN ORAL PANADEINE ORAL RAPIDENE TABLETS Smithkline TABLETS N/A Astron (Pvt) Ltd SRI LANKA 14-Sep-15 Full 20MG 20MG/ML INJECTION USP ML ML ML 120MG/5ML SOLUTION B.P 120MG/5ML SOLUTION B.P 120MG/5ML SOLUTION B.P 120MG/5ML-Elixir SUSPENSION B.P 8MG TABLETS 8MG PHOSPHATE 5479 HYDROCHLORIDE PAPAVERINE 5474 USP TABLETS PANTOPRAZOLE 5475 40MGTABLETS PANTOPRAZOLE 40 PANZOL 5476 40MGTABLETS PANTOPRAZOLE TABLETS 40 PANTAZOL 5477 40MGTABLETS PANTOPRAZOLE (EN. TABLETS PharmAce (Pvt) Ltd 40 PANTOZIM Flamingo 5478 40MG CAPSULESTABLETS PANTOPRAZOLE PANZEL Tabrane TABLETS5480 20MG/ INJECTION BP PAPAVERINE 5481 ABC Pharma 30MG/ INJECTION BP PAPAVERINE 5482 60MG/ INJECTION BP PAPAVERINE 5483 ORAL (PAEDIATRIC) PARACETAMOL 5484 ORAL (PAEDIATRIC) PARACETAMOL 5485 ORAL (PAEDIATRIC) PARACETAMOL 5486 ORAL (PAEDIATRIC) PARACETAMOL 5487 500MG+CODEINE PARACETAMOL 5488 500MG+CODEINE PARACETAMOL I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 443 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 SRI LANKA 24-Aug-18INDIA Provisional INDIA 02-Jul-14BANGLADESH 15-Apr-16 Full 02-Jul-14 Full INDONESIA Full 19-May-15GERMANY Full 10-Feb-14 Full BANGLADESH 31-Oct-14 Full GERMANY 05-Feb-15BANGLADESH 04-Nov-14 Full Full BANGLADESH 30-Mar-16 Full BANGLADESH 30-Mar-16 Full (Ceylon) Ltd Shefa Healthcare (Pvt) ltd Shefa Healthcare (Pvt) ltd Incepta Pharmaceuticals Ltd Actavis T P Indonesia RublePharma Arzeneimittel Gmbh Medochemie Ltd CYPRUSBeximco Pharmaceuticals 12-Feb-14Ltd Medochemie Ltd Full CYPRUSRublePharma Arzeneimittel 12-Feb-14Gmbh Beximco Full Pharmaceuticals Ltd Medochemie Ltd CYPRUSPharmaceuticals 12-Feb-14Ltd Full Pharmaceuticals Ltd (Contd.) Health (Pvt) Ltd Health (Pvt) Ltd Citihealth Imports (Pvt) Ltd (Ceylon) Ltd Pharmaceuticals (Pvt) Ltd Celyon (Pvt) Ltd (Ceylon) Ltd Celyon (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Ceylon) Ltd Celyon (Pvt) Ltd SOLUTION SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP PANADOL DROPS N/A Glaxo Wellcome 125NAPA SUPPOSITORY Emerchemie NB DENK 250PARA SUPPOSITORY Akbar ACE 500 SUPPOSITORY PharmAce (Pvt) Ltd Square MAXMOLMAXMOL DROPS ORAL George Steuart ACETAMIN DROPS ORAL George Steuart ORAL DUMIN DENK 125PARA SUPPOSITORY TUBE RECTAL Akbar Emerchemie NB ARFEN 125 SUPPOSITORY Associated Pharma ARFEN 250 SUPPOSITORY Associated Pharma 250NAPA SUPPOSITORYARFEN 500 Emerchemie NB SUPPOSITORY Associated Pharma ACE 125 SUPPOSITORY PharmAce (Pvt) Ltd Square 80MG/0.8ML 125MG 250MG 500MG INFANTS 80MG/0.8ML INFANTS 80MG/0.8ML INFANTS 120MG/5ML BP 125MG/2.5ML 125MG 125MG 250MG 250MG 500MG 125MG 5496 SUPPOSITORY PARACETAMOL 5498 SUPPOSITORY PARACETAMOL 5501 BP SUPPOSITORY PARACETAMOL 5489 DROPS PARACETAMOL 5490 DROPS FOR ORAL PARACETAMOL 5491 DROPS FOR ORAL PARACETAMOL 5492 SOLUTION ORAL PARACETAMOL 5493 SOLUTION RECTAL PARACETAMOL 5494 SUPPOSITORY PARACETAMOL 5495 SUPPOSITORY PARACETAMOL 5497 SUPPOSITORY PARACETAMOL 5499 SUPPOSITORY PARACETAMOL 5500 SUPPOSITORY PARACETAMOL 5502 BP SUPPOSITORY PARACETAMOL 444 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 BANGLADESH 30-Mar-16 Full INDIAINDIA 25-Jun-18 Provisional INDIA 02-Feb-17INDIA Full 20-Jan-17INDIA Full 22-Mar-18 Provisional INDIA 13-Feb-14INDIA Full 02-May-16INDIA Full 04-Apr-14INDIA Full 14-Sep-16SRI LANKA Full 03-Dec-14 30-Nov-17 Full Years Two PAKISTAN 23-Jun-15SRI LANKA Full 28-Feb-18INDIAYears Two 23-Feb-15 Full Pharmaceuticals Ltd Fourrts (India) Laboratories Ltd Theon Pharmaceuticals Ltd Astra Lifecare (India) (Pvt) Ltd Medico Remedies (Pvt) Ltd Medicamen Biotech Ltd Semos Pharmaceuticals (Pvt) Ltd Indoco Remedies India Pvt Ltd (Pvt) Ltd Healthcare Ltd (Pvt) Ltd Pharmaceuticals Manufacturer Corporation (Ceylon) (Pvt) Ltd (Contd.) Healthcare lanka Ltd Pharmaceuticals (Pvt) Ltd Health (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP ACE 250 SUPPOSITORY PharmAce (Pvt) Ltd Square 250MG 5511 500MG BP TABLETS PARACETAMOL PARARIGHT TABLETS Chamee Chemist Alvita Pharma 5503 BP SUPPOSITORY PARACETAMOL 5504500MG BP TABLETS PARACETAMOL 500 MCMOL 5505 500MG BP TABLETS PARACETAMOL PARACIL TABLETS5506 Pharmatec (Pvt) Ltd500MG BP TABLETS PARACETAMOL McCopy Pharma PAMACARE TABLETS5507 500MG BP TABLETS PARACETAMOL THEOPAR TABLETS Sunshine 5508 PharmAce (Pvt) Ltd 500MG BP TABLETS TABLETS PARACETAMOL N/A Swiss Pharma 5509 500MG BP TABLETS PARACETAMOL ASMOL Slim 5510 500MG BP TABLETS PARACETAMOL N/A TABLETS TABLETS Kamazu (Pvt) Ltd George Steuart Syncom 5512 500MG TABLETS BP TABLETS PARACETAMOL N/A Akbar 5513 500MG BP TABLETS PARACETAMOL PACIDOL TABLETS TABLETS5514 500MG BP TABLETS PARACETAMOL PYROL Slim N/A5515500MG BP TABLETS PARACETAMOL PARACETOL TABLETS5516 500MG BP TABLETS TABLETS PARACETAMOL FEBREX Pharma Tech Bio State N/A TABLETS Hemas M S J Industries I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 445 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 04-Jun-14 Full 04-Jun-14 Full INDIAINDIA 24-Feb-16IRELAND Full 12-Oct-16INDIA 30-Sep-14 Full SWEDEN Full 14-Feb-14 21-Jan-14 Full INDIA Full 01-Sep-17 Full BANGLADESH 03-Apr-14 Full INDIAINDIA 10-Aug-17 Full UNITED KINGDOM 22-Jul-17 Years Two UNITED KINGDOM Ltd Cadila Healthcare Ltd Glaxo Smithkiline Dungarvan Ltd Magna Labortories (Guiarat) (Pvt) Ltd Fresenius Kabi A.B Atoz Pharmaceuticals (Pvt) Ltd LaboratoriesIPCA INDIAMedochemie Ltd CYPRUS 23-Jan-14Pharmaceuticals 21-Oct-17Ltd Full LaboratoriesIPCA Full INDIAAtoz Pharmaceuticals (Pvt) Ltd 29-Dec-14Cadila Healthcare Full Ltd Glaxo Operations UK Ltd Glaxo Operations UK Ltd (Contd.) Celyon (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Beecham (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Ltd Ltd Pharmaceuticals (Pvt) Ltd Ltd Ltd TABLETS Smithkline INJECTION Hemas SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP ACTIFAST KABIVEN PERIPHERAL EMULSION FOR INJECTION (GLUCOSE 11%+VITAMIN 1%+IINTRALIPID 20%) 5524 20MG BP TABLETS PAROXETINE AFENTRAL5525 20MG BP TABLETS PAROXETINE OXAT TABLETS Associated Pharma 5527 10MG USP TABLETS PAROXETINE TABLETS OXEDEP PharmAce (Pvt) Ltd Square TABLETSAsian Pharma Euro 5517500MG BP TABLETS PARACETAMOL METAMOL TABLETS Kamazu (Pvt) Ltd B D H Industries 5518 500MG BP TABLETS PARACETAMOL PARAGON5519 500MG BP TABLETS TABLETS PARACETAMOL PANADOL 5520 5ML INJECTION BP PARALDEHYDE Hemas MAGFIT5521 NUTRITION PARENTERAL INJECTION5522 20MGTABLETS International PAROXETINE Yaden OXEDEP5523 10MG BP TABLETS PAROXETINE 10 PARI TABLETS TABLETSAsian Pharma Euro 5526 Emar Pharma (Pvt) 20MG BP TABLETS PAROXETINE PARI-205528 TABLETS 20MG USP TABLETS PAROXETINE 20 XET Emar Pharma (Pvt) 5529 200MGTABLETS PAZOPANIB TABLETS5530 400MGTABLETS PAZOPANIB VOTRIENT Hemas VOTRIENT TABLETS TABLETS Baur & Co (Pvt) A Baur & Co (Pvt) A 446 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 08-Feb-14 Full SWITZERLAND 01-Nov-15INDIA Full UNITED 18-Sep-17STATES Years Two INDIA 25-Jul-18 Years Two INDIA 24-Jun-16INDIA Full 16-Oct-17 Years Two INDIA 27-Oct-17 Years Two Intas INDIAYears 16-Aug-18 F Hoffman-La Two Roche Ltd Sun Pharmaceutical industries Eli Lilly & Company USA & Lilly Pharma Fertigung Und Distribution Dr Reddy's Laboratories Ltd Shilpa Medicar Ltd INDIANatco Pharma Ltd INDIA 23-Nov-18 Provisional United Biotech (Pvt) Ltd 16-Feb-18 Provisional Shilpa Medicar Ltd INDIASun Pharmaceutical 23-Nov-18industries Provisional Shilpa Medicar Ltd INDIAMylan Laboratories Ltd 23-Nov-18 Provisional (Contd.) Pharmaceutical Ltd Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Emerchemie NB (Ceylon) Ltd Slim Pharmaceuticals (Pvt) Ltd Healthcare lanka Ltd Health (Pvt) Ltd Slim Pharmaceuticals (Pvt) Ltd Hemas Pharmaceuticals (Pvt) Ltd Slim Pharmaceuticals (Pvt) Ltd Markss HLC (Pvt) Ltd POWDER FOR INJECTION POWDER FOR INJECTION LYOPHILIZED LYOPHILIZED POW INJECTION INJECTION INFUSION INJECTION SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP NEUPEG INJECTIONPEGASYS Novex INJECTION Baur & Co (Pvt) A LISNOXIPEMEX IV INJECTION Sunshine INJECTION 500PEXITAZ George Steuart LYOPHILIZED MYTREX LYOPHILIZED PEXITAZ 100PEXITAZ INJECTIONALIMTA Hemas INFUSIONPODOXRED 100MG Hemas PEMSHIL POWDER FOR PEMSHIL POWDER FOR PEMSHIL POWDER FOR RECOMBINANT HUMAN RECOMBINANT GRANULOCYTE COLONY INJECTION FACTOR STIMULATING 6MG /ML INJECTION 180mcg/0.5ml 100MG 100MG 500MG 500MG 100MG 500MG 100MG 100MG 500MG 500MG 5532 2a PEGINTERFERON ALFA 5537 PEMETREXED FOR INJECTION 5538 PEMETREXED FOR INJECTION 5540 PEMETREXED FOR INJECTION 5542 PEMETREXED FOR INJECTION 5531 PEGFILGRASTIM (PEGYLATED 5533 PEMETREXED FOR INFUSION 5534 PEMETREXED FOR INFUSION 5535 PEMETREXED FOR INJECTION 5536 PEMETREXED FOR INJECTION 5539 PEMETREXED FOR INJECTION 5541 PEMETREXED FOR INJECTION I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 447 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 27-Oct-17 Years Two INDIA 25-Apr-18 Years Two INDIA 18-May-18FRANCE Years Two 17-May-18 Years Two 04-Mar-16ARGENTINA Full 26-Dec-18 Years Two INDIAINDIA 12-Jul-17BANGLADESH Full 08-Apr-16 24-Feb-16 Full Full FRANCE 08-Feb-18IRELAND Full 01-Oct-17 Years Two FRANCE 08-Feb-18INDIA Full 06-Apr-17 Years Two Mylan Laboratories Ltd Dr Reddy's Laboratories Ltd Getwell Pharmaceuticals Getwell Pharmaceuticals Eli Lilly & Company Indanapolis, Indiana USA Bioprofarma SA Terrada Health Pell Tech Care (Pvt) Ltd Les Laboratories Servier Servier (Iteland) Industries Ltd Iireland for Les Laboratories Sevier France Les Laboratories Servier (Pvt) Ltd Pharmaceuticals Ltd Ltd (Contd.) Markss HLC (Pvt) Ltd Emerchemie NB (Ceylon) Ltd Pharmacy (Pvt) Ltd Pharmacy (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Emerchemie NB (Ceylon) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd POWDER FOR INJECTION LYOPHILIZED LYOPHILIZED POWDER FOR INJECTION POWDER FOR INJECTION SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP MYTREX LYOPHILIZED PODOXRED 500MG 100PEMETRA INJECTION 500PEMETRA The Esses INJECTIONALIMTA The Esses SOLUTIONBAGOXED Hemas LYOPHILIZED N/A 40PELLPENTA CAPSULES CAPSULES CROXIFLY Slim Chamee Chemist TABLETS Alvita Pharma 10COVERSYL TABLETS PharmAce (Pvt) Ltd Square PRETERAX Hemas TABLETS 5COVERSYL Hemas TABLETS PD-2DIANEAL Hemas SOLUTION CIC Holdings PLC Baxter (India)(Pvt) 500MG 500MG POWDER FOR INJECTION 100MG POWDER FOR INJECTION 500MG FOR SOLUTION CONCENTRATE FOR INFUSION 100MG INJECTION 500MG 250MG CAPSULE 40MG COATED 400MG USP TABLETS RELEASE 10MG 2.5MG 10MG+INDAPAMIDE TABLETS 5MG WITH 1.5% W/W DEXTROSE IP 5543 PEMETREXED FOR INJECTION 5544 PEMETREXED FOR INJECTION 5545 PEMETREXED LYOPHILIZED 5546 PEMETREXED LYOPHILIZED 5547 PEMETREXED POWDER FOR 5548 PEMETREXED POWDER FOR 5549 PENICILLAMINE CAPSULES BP 5550 SODIUM ENTERIC PENTAZOCINE 5551 EXTENDED PENTOXIFYLLINE 5552 ARGININE PERINDOPRIL TABLETS 5553 ARGININE PERINDOPRIL 5554 ARGININE PERINDOPRIL TABLETS 5555 SOLUTION DIALYSIS PERITONEAL 448 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 PHILIPPINES 28-Dec-17INDIA Years Two INDIA 23-May-17 Years Two PHILIPPINES 29-May-14 29-Jun-18 Years Two INDIA Full PHILIPPINES 15-Dec-17 26-Apr-14PAKISTAN Years Two Full INDIA 06-Jan-18 Provisional PAKISTAN 12-May-17 Years Two 05-Jul-14INDIA Full INDIA 07-Apr-16 Full INDIA 28-Mar-14 Full PAKISTAN 02-May-15 05-Jul-14 Full BANGLADESH 31-Mar-17 Full Full Phils Inc Mithra Industries (P) Ltd Mithra Industries (P) Ltd Laboratories Philippines Ltd Ltd Phils Inc Ltd Mithra Industries (P) Ltd Pharma Tabros (Pvt) Ltd Encube Ethicals (Pvt) Ltd Unijules Life Sciences Ltd Wallace Pharmaceuticals Ltd Pharma Tabros (Pvt) Ltd Pharmaceuticals Ltd (Contd.) Lucenxia Lanka (Pvt) Ltd Lucenxia Lanka (Pvt) Ltd Indoscan (Pvt) Ltd Euromed CIC Holdings PLC Baxter (India)(Pvt) CIC Holdings PLC Baxter Healthcare CIC Holdings PLC Baxter (India)(Pvt) Lucenxia Lanka (Pvt) Ltd Laboratories (Pvt) Ltd Healthcare lanka Ltd Pharmaceuticals (Pvt) Ltd Ltd Laboratories (Pvt) Ltd SOLUTION SOLUTION DIALYSIS SOLUTION SOLUTION SOLUTION SOLUTION SOLUTION SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP DIANEAL PDDIANEAL SOLUTION CIC Holdings PLC Baxter Healthcare N/AN/A DIALYSIS EUROPERSOL WITH 1.5% DEXTROSE DIALYSIS PDDIANEAL DIALYSIS PD-2DIANEAL DIALYSIS PD-2DIANEAL DIALYSIS N/A DIALYSIS IP WITH 1.5% W/W DEXTROSE IP WITH 4.25% DEXTROSE POTASSIUM WITH 1.5% WITH 1.5% DEXTROSE WITH 2,5% DEXTROSE WITH 2.5% DEXTROSE WITH 2.5% DEXTROSE WITH 2.5% DEXTROSE SOLUTION 5556 SOLUTION DIALYSIS PERITONEAL 5557 SOLUTION DIALYSIS PERITONEAL 5558 SOLUTION DIALYSIS PERITONEAL 5559 SOLUTION DIALYSIS PERITONEAL 5560 SOLUTION DIALYSIS PERITONEAL 5561 SOLUTION DIALYSIS PERITONEAL 5562 SOLUTION DIALYSIS PERITONEAL 5563 SOLUTION DIALYSIS PERITONEAL 5564 PERMETHRIN 0.5% v/V SOLUTION SCABRID LOTION LOTION5565 PERMETHRIN CREAM 1% Associated 5566 PERMETHRIN CREAM 5% PERLICE5567 PERMETHRIN CREAM 5% METHRIN CREAM CREAM CREAM5568 PERMETHRIN CREAM 5% SKAB CREAM Sunshine Lifeline CREAM5569 PERMETHRIN CREAM 5% SCABRID CREAM CREAM Emar Pharma (Pvt) SCABEX Associated CREAM PharmAce (Pvt) Ltd Square I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 449 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIA 07-Apr-17INDIA Full INDIA 12-Jan-14INDIA Full 13-Feb-14INDIA Full 29-Apr-14INDIA Full 26-Apr-18INDIA Full 27-Jan-18 Provisional INDIA 22-Mar-18SRI LANKA Full 23-Nov-18 11-Dec-14INDIA Years Two Full SRI LANKA 29-Oct-18 10-Oct-14 Years Two INDIA Full INDIA 23-Mar-18 Provisional INDIA 09-Jun-18 Years Two 07-Nov-14 Full Encube Ethicals (Pvt) Ltd Natco Pharma Ltd INDIABelco Pharma (Pvt) Ltd 11-Jul-17Neon Laboratories Ltd Full Human Verve Care Laboratories Kwality Pharmaceuticals Pvt Ltd Human Verve Care Laboratories Mercury Laboratories Ltd Mercury Laboratories Ltd Kwality Pharmaceuticals Pvt Ltd Human Verve Care Laboratories SG Pharma (Pvt) Ltd Sciences (Pvt) Ltd (Ceylon) (Pvt) Ltd Pharmaceuticals Manufacturing COP (Contd.) Lanka (Pvt) ltd Healthcare lanka Ltd Agency Pvt Ltd (Pvt) Ltd Agency Pvt Ltd (Pvt) Ltd Agency Pvt Ltd (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd Agency Pvt Ltd Pharmacy (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP N/A INJECTION Leader Pharma PEMNAT INJECTION I.V Sunshine N/AN/AVERBITAL INJECTIONN/A Ravilux Company INJECTION INJECTIONAssociates Pharma Leader Pharma 60 Steril Gene Life VERBITAL INJECTION TABLETSN/A International Yaden N/A Leader Pharma N/A TABLETSN/A TABLETS International Yaden TABLETS N/AN/A TABLETS International Yaden PHENVER N/A M S J Industries INJECTIONNEFRISOL INJECTION International Yaden Leader Pharma INJECTION SPMC/State The Esses 1.5ML 500MG 1.5ML 200MG/ML 200MG/ML 200MG/ML INJECTION USP 60MG BP TABLETS 30MG 30MG 60MG TABLETS 250MG B.P HYDROCHLORIDE INJECTION USP 10MG/ML 10MG/ML 10MG/ML 5572 75MG/ PETHIDINE INJECTION B.P 5570 PERMETHRIN CREAM 5% PERMITE CREAMInternational Curatio 5571 PERMETREXED FOR INJECTION 5573 75MG/ PETHIDINE INJECTION B.P 5574 INJECTION BP PHENOBARBITAL 5575 INJECTION BP PHENOBARBITAL 5576 SODIUM PHENOBARBITAL 5577 SODIUM PHENOBARBITAL 5578 BP TABLETS PHENOBARBITAL 5579 BP TABLETS PHENOBARBITAL 5580 BP TABLETS PHENOBARBITAL 5581 PENICILLIN PHENOXYMETHYL 5582 PHENYLEPHRINE 5583 PHENYLEPHRINE INJECTION BP 5584 PHENYLEPHRINE INJECTION BP 450 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 18-Jun-18INDIA Years Two 14-Aug-18INDIA Years Two 13-Jun-18INDIA Provisional 05-Dec-18INDIA Full 19-Jun-16INDIA Full 25-Feb-15INDIA Full 23-Mar-17 Full INDIA 18-Jun-17 Years Two FRANCE 14-Sep-17 Full 17-Feb-16SWITZERLAND 17-Feb-16 Full Full INDIAINDIA 17-Aug-18INDIA Years Two 27-Apr-16INDIA Full 27-Mar-18 Years Two 28-Mar-15 Full (Pvt) Ltd Mercury Laboratories Ltd Human Verve Care Laboratories Healthcare Vital (Pvt) Ltd SG Pharma (Pvt) Ltd Acme Formulation (Pvt) Ltd Centurion Laboratories Pvt Ltd Centurion Laboratories Pvt Ltd Cenexi SAS Fontenay France for F Hoffmann-La roche ltd-Swit Cenexi SAS Fontenay Sous Bois Mercury Laboratories Ltd Mackur Laboratories Ltd Healthcare Vital (Pvt) Ltd SG Pharma (Pvt) Ltd Sciences (Pvt) Ltd (Contd.) (Pvt) Ltd Agency Pvt Ltd (Pvt) Ltd Pharmacy (Pvt) Ltd Healthcare lanka Ltd (Pvt) Ltd (Pvt) Ltd Ltd Ltd (Pvt) Ltd Pharmaceticals (Pvt) Ltd Pharmacy (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP PHRINTEC INJECTION Klintas (Pvt) Ltd United Biotech N/AN/AVERTOIN INJECTIONN/A International Yaden INJECTION INJECTIONEPINOTIN Pharma Associates Leader Pharma Samarth Life INJECTION INJECTION International Yaden The Esses KONAKION MM INJECTION Baur & Co (Pvt) A KONAKION MM INJECTIONK-WIN Baur & Co (Pvt) A 20INNOTEL INJECTION -LPHYTOVIA INJECTION International Yaden INJECTION S P L PHYTOKON International Yaden INJECTION The Esses 10MG/ML BP 250MG/5ML BP 250MG/5ML BP 50MG/ML BP 50MG/ML BP 250MG/5ML USP 10MG/ML (PAEDIATRIC) 2MG/0.2ML 1 MG/0.5ML 1.0MG /0.5ML 10MG/1ML 10MG/1ML 5585 PHENYLEPHRINE INJECTION IP 5586 SODIUM INJECTION PHENYTOIN 5587 SODIUM INJECTION PHENYTOIN 5588 SODIUM INJECTION PHENYTOIN 5589 SODIUM INJECTION PHENYTOIN 5590 SODIUM INJECTION PHENYTOIN 5591 100MG I.P TABLETS PHENYTOIN EPTOIN5592 100MG B.P TABLETS PHENYTOIN N/A TABLETS5593 50MG BP TABLETS PHENYTOIN Sunshine N/A5594 TABLETS INJECTION PHYTOMENADIONE International Yaden 5595 TABLETS INJECTION PHYTOMENADIONE International Yaden 5596 INJECTION B.P PHYTOMENADIONE 5597 INJECTION BP PHYTOMENADIONE 5598 INJECTION BP PHYTOMENADIONE 5599 INJECTION BP PHYTOMENADIONE I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 451 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIATHAILAND 15-May-14 19-Oct-14 Full INDIA Full INDIA 28-Mar-14INDIA Full 18-Sep-18 Full FRANCE 30-May-18 Provisional 22-Mar-18GERMANY Full 22-Mar-18INDIA Full 22-Jan-18 Years Two INDIAINDIA 28-Dec-17 Years Two INDIA 05-Feb-18 Years Two INDIA 25-May-18 Provisional 27-Apr-15 Full PharmaceuticalS (Pvt) Ltd Atlantic Laboratories Corporation Ltd SG Pharma (Pvt) Ltd Sunwaya Rohto Pharmaceutical Pvt Ltd MEDA Manufacturing Avenue MEDA Manufacturing U S V Ltd INDIACadila Healthcare Ltd 09-Apr-18Years Two Pharmaceuticals PharmaceuticalS (Pvt) Ltd Pharmaceuticals Ltd Laboratories (Pvt) Ltd Pharmaceutical Pvt Ltd (Contd.) (Pvt) Ltd Pharmacy (Pvt) Ltd (Pvt) Ltd Ltd Ltd Pharmaceuticals (Pvt) Ltd Healthcare lanka Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP N/A INJECTION Ceyoka (Pvt) Ltd Ciron Drugs & GLIZONE-15 TABLETS Sunshine 30PIOTONE TABLETSAssociates Pharma The Madras VITAMIN K1VITAMIN INJECTIONPHYTOKON International Yaden N/A INJECTION The Esses CARPINOL INFUSION EYE DROPS Ceyoka (Pvt) Ltd International Yaden Ciron Drugs & 15GLITO PIOZ TABLETS PharmAce (Pvt) Ltd Medley TABLETS 30GLITO Hemas TABLETSPISA PharmAce (Pvt) Ltd Medley INJECTION Ceyoka (Pvt) Ltd Kavbir 10MG/1ML 15 MG TABLETS 30MG 10MG/1ML 1MG/0.5ML 2MG/1ML 4% DROPS BP 15 MG TABLETS 15 MG TABLETS 30MG TABLETS INJECTION 2.25G 5611 USP TABLETS PIOGLITAZONE 5609 HYDROCHLORIDE PIOGLITAZONE 5600 INJECTION BP PHYTOMENADIONE 5601 INJECTION BP PHYTOMENADIONE 5602 INJECTION BP PHYTOMENADIONE 5603 INJECTION BP PHYTOMENADIONE 5604 EYE PILOCARPINE NITRATE 5605 PIMECROLIMUS CREAM 1%5606 ELIDEL PIMECROLIMUS CREAM 1%5607 HYDROCHLORIDE PIOGLITAZONE ELIDEL CREAM5608 HYDROCHLORIDE PIOGLITAZONE TABLETS Baur & Co (Pvt) A Baur & Co (Pvt) A 5610 HYDROCHLORIDE PIOGLITAZONE 5612 FOR TAZOBACTAM PIPERACILLIN & 452 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 18-Aug-15SAUDI ARABIA 18-Jul-18 Full 23-Apr-15 Years Two INDIA Full INDIA 18-Dec-15INDIA Full 28-Feb-18 Years Two INDIA 14-Oct-15INDIA Full 10-Jun-14INDIA Full 01-Aug-15 Full INDIA 08-Jul-14 Full PAKISTAN 22-May-14 11-Jul-17 Full Years Two INDONESIA 18-Jun-17 Years Two INDONESIA 23-Jun-16 Full VHB Medi Sciences Ltd United Biotech (Pvt) Ltd Navesta Pharmaceuticals (Pvt) Ltd Aristo Pharmaceuticals Ltd Ltd Zeiss Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Astral Steritech (Pvt) Ltd GMH Organics india for Vexxa Life ciences (Pvt) Ltd India Swiss Paranterals (Pvt) Ltd The Schazoo Pharmaceutucal Laboratories (Pvt) Ltd T Dankos P Farma T Dankos P Farma (Contd.) Lanka Ltd Nitin Lifesciences fi (Pvt) Ltd Health (Pvt) Ltd Navesta Pharmaceuticals (Pvt) Ltd Darley Butler & Co Ltd Sano Medimex Pharma (Pvt) Ltd AssociatesPharma AMN Life Science Baur & Co (Pvt) A Ltd Global Impex AV (Pvt) Ltd C Medical (Pvt) T P Ltd Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd INJECTION INJECTION INJECTION INJECTION INJECTION INJECTION INJECTION INJECTION SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP PIPTAZ 4.5GPIPTAZ INJECTION Medmart Pharma TAZIN 4.5GTAZIN N/A INJECTION George Steuart DURATAZ POWDER FOR POWDER FOR BRODACTAM POWDER FOR 4.5TAZORIGHT POWDER FOR AMPITOPTBACTUM POWDER FOR POWDER FOR VEXZO-TP POWDER FOR 4.5GMTAZOBAK POWDER FOR INJECTION USP 4.5G INJECTION USP INJECTION USP 4.5G INJECTION USP 4.5G INJECTION USP 4.5G PER VIAL INJECTION USP 4.5G FOR INJECTION USP 4.5G FOR INJECTION USP FOR INJECTION (4.5g) FOR INJECTION USP 4000MG/500MG PER VIAL FOR INJECTION USP 4000MG/500MG PER VIAL FOR INJECTION USP 4000MG/500MG PER VIAL 5613 FOR TAZOBACTAM PIPERACILLIN & 5614 FOR TAZOBACTAM PIPERACILLIN & 5615 FOR TAZOBACTAM PIPERACILLIN & 5616 FOR PIPERACILLIN +TAZOBACTAM 5617 PIPERACILLIN 4G+TAZOBACTAM 5618 PIPERACILLIN 4G+TAZOBACTAM 5619 PIPERACILLIN 4G+TAZOBACTAM 5620 PIPERACILLIN 4G+TAZOBACTAM 5621 PIPERACILLIN 4G+TAZOBACTAM 5622 PIPERACILLIN 4G+TAZOBACTAM 5623 INJECTION 1G/5ML PIRACETAM CEREMIN5624 INJECTION 200MG/ML PIRACETAM KALCETAM INJECTION5625 Baur & Co (Pvt) A 800MG TABLETS PIRACETAM INJECTION Hemas KALCETAM TABLETS Hemas I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 453 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 14-Sep-17 Full 06-Aug-18PAKISTAN Years Two 21-Jul-17PAKISTAN Full 08-Jun-17ITALY Full PAKISTAN 10-Apr-15INDIA 11-Nov-16 Full Full INDIA 07-Feb-14INDIA Full 20-Jan-16SWEDEN Full 17-Jan-18 12-Jun-15 Full Full BANGLADESH 05-Oct-17 Years Two SWITZERLAND 21-Mar-14 Full Simpex Pharma (Pvt) Ltd Mercury Laboratories Ltd Cipla LtdMartin Daw Marker Ltd INDIAGetz Pharma 08-Apr-17Pakistan (Pvt) Ltd Years Two Laboratories XL (Pvt) Ltd Kemwell Biopharma (Pvt) Ltd Meyer Organics (Pvt) Ltd Recipharm Strangeas AB ,Sweden for Leo Pharmaceutical Products Novartis Pharma A G Pharmaceuticals (Pvt ) Ltd Pharmaceuticals Ltd (Contd.) eld fi Pharmaceuticals (Pvt) Ltd (Ceylon) Ltd (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Ltd Pharmaceuticals (Pvt) Ltd Ltd Pharmaceuticals (Pvt) Ltd Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP NYSABREXIN TABLETSPIROXIM-NEO TABLETS Hemas TABLETS Burhani Enterprises Ceyoka (Pvt) Ltd Chiesi Genix Pharma UGESICSELEXID TABLETS TABLETS SMM Halcyon (Pvt) 200EMCIL Hemas TABLETS PharmAce (Pvt) Ltd Square TABLET 20MG TABLET 20MG TABLET 20MG TABLETS 20MG TABLETS 200MG 200MG TABLETS 5629 PIROXICAM 0.5% GEL PCAM GEL Emerchemie NB 5626 800MG TABLETS PIRACETAM MANACETAM TABLETS Somer 5627 200MGTABLETS PIRFENIDONE N/A5628 200MGTABLETS PIRFENIDONE PIRFENEX5630 TABLETS TABLETS PIROXICAM 0.5% GEL5631 PIROXICAM B CYCLODEXTRIN International Yaden Breathe Free Lanka 5632 PIROGEL PIROXICAM B CYCLODEXTRIN 5633 CYCLODEXTRIN PIROXICAM BETA GEL5634 20MG PIROXICAM CAPSULES USP KAPIROX 205635 0.5% w/w BP PIROXICAM GEL N/A CAPSULES DOLONEX5636 SMM Halcyon (Pvt) PIROXICAM ORODISPERSIBLE 5637 GEL Astron (Pvt) Ltd PIVMECILLINAM HYDROCHLORIDE SRI LANKA 14-Jul-14 Hemas 5638 PIVMECILLINAM HYDROCHLORIDE Full 5639 0.5MGTABLETS PIZOTIFEN SANDOMIGRAN TABLETS Baur & Co (Pvt) A 454 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 14-Feb-17 Full BANGLADESH 30-Dec-17 Full BANGLADESH 22-Mar-15 Full KINGDOM BELGIUM 06-Jul-18NETHERLANDS 07-Nov-15 Provisional Full NETHERLANDS 15-Apr-16 Full NETHERLANDS 27-Jul-18 Full PAKISTAN 01-Jul-15 Full INDIA 15-Oct-18 Years Two INDIA 06-Feb-18 Full Navana Pharmaceuticals Ltd Navana Pharmaceuticals Ltd Actavis UK Ltd UNITED Glaxo Smithkiline A Biologicals S Merck & Co Inc for Merck USA Sharp & Dohme Bilthoven Biological B V Bilthoven Biological B V (Pvt ) Ltd Pvt Ltd Win Medicare Ltd INDIA 17-Jul-18 Provisional Scences (Contd.) Co Ltd Co Ltd (Ceylon) Ltd Pharmaceuticlas (Pvt) Ltd Ltd (Pvt) Ltd (Pvt) Ltd Ceyoka (Pvt) Ltd Genix Pharma CIC Holdings PLC Heathcare TILL Robert Hall & Co Ltd PharmAce (Pvt) Ltd Swiss Garnier Life FOR ORAL FOR ORAL SOLUTION SOLUTION SOLUTION FOR ORAL SOLUTION SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP SWISSPEG POWDER SYNFLORIX INJECTIONPNEUMOVAX-23 INJECTION GlaxoSmithkiline Baur & Co (Pvt) A N/AN/A INJECTION Citihealth Imports MOVCOL INJECTION Citihealth Imports ORAL PEGLECMVICOL ORAL POWDER POWDER FOR ORAL SOLUTION POWDER FOR ORAL VALENT VACCINE VALENT VACCINE POLYSACCHARIDE PLOYVALENT -TRIVALENT ,INACTIVATED SUSPENSION FOR INJECTION DOSE) (MULTY -TRIVALENT ,INACTIVATED SUSPENSION FOR INJECTION(SINGLE DOSE) 13.125G,SODIUM CHLORIDE 0.3507G,SODIUM BICARBONATE CHLORIDE 0.17G.POTASSIUM 0.0466G FOR ORAL & ELECTROLYTES SOLUTION 13.125G+SODIUM CHLORIDE BP BP +SODIUM BICARBONATE BP CHLORIDE 178.6MG+POTASSIOUM 46.6MG POWDER ORAL BP SOLUTION 5650 3350 GLYCOL POLYETHYLENE 5640 1.5MGTABLETS PIZOTIFEN PIZOFEN-TS TABLETS Darley Butler & 5641 0.5MG B.P TABLETS PIZOTIFEN PIZOFEN 0.55642 0.5MG B.P TABLETS PIZOTIFEN TABLETS N/A5643 10 CONJUGATE PNEUMOCOCCAL Darley Butler & 5644 PNEUMOCOCCAL TABLETS5645 POLIOMYELITIS VACCINE Emerchemie NB 5646 POLIOMYELITIS VACCINE 5647 GLYCOL POLYETHYLENE 5648 3350 GLYCOL POLYETHYLENE 5649 3350 GLYCOL POLYETHYLENE I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 455 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 21-Feb-18 Full STATES PAKISTAN 16-Dec-17 Full PAKISTANFRANCE 10-Aug-18 Full INDIA 29-Apr-14 Full PAKISTAN 25-Feb-14 07-Jun-17 Full INDIA Full 24-Nov-14MALAYSIA Full 11-Sep-17PHILIPPINES Years Two 15-Jul-15INDIA Full GERMANY 01-Mar-15 27-Aug-15 Full INDIA Full 02-Jul-18 Years Two Pasteur fi Alcon Laboratories UNITED Aristopharma Ltd BANGLADESH 06-Feb-18S J & G Fazul Full Ellahie (Pvt) Ltd S J & G Fazul Ellahie (Pvt) Ltd Bharat Biotech International Ltd The Schazoo Pharmaceutucal Laboratories (Pvt) Ltd SG Pharma (Pvt) Ltd B Braun Medical Industries Amherst Laboratories Amanta Healthcare Ltd Hameln Pharma Plus GmbH Treffer Pharmaceuticals S A (Contd.) Lanka Ltd Sano fi Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd (Ceylon) Ltd Edna Medicals (Pvt) Ltd Pharmacy (Pvt) Ltd (Pvt) Ltd Health (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd International Yaden (Pvt) Ltd SOLUTION TABLETS SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP SYSTANE ULTRASYSTANE EYE DROPS Baur & Co (Pvt) A FERRICURE CAPSULES V H Distributors A SYSTEAR EYE DROPS Hemas FERRICURE SYRUP V H Distributors A TYPHIM VITYPBAR INJECTION Sano I-FRESH INJECTION I.V Emerchemie NB OPHTHALMIC N/AN/A INJECTIONTASCIT The Esses N/A INJECTION TABLETS B Braun Lanka N/A George Steuart INJECTIONN/A Akbar INJECTION Akbar EXT.REL.

CAPSULES 150MG + PROPYLENE GLYCOL 0.3% EYE + PROPYLENE GLYCOL DROPS + PROPYLENE GLYCOL 0.3% EYE + PROPYLENE GLYCOL DROPS SYRUP 217.4mg in 5ml SYRUP VACCINE 0.25MG in .5ML VACCINE (VI 25MCG / 0.5ML VACCINE CAPSULAR)SALMONELLA 0.6%, STERILE POVIDONE USP OPHTHALMIC SOLUTION +MAGNESIUM CHLORIDE 162.65MG PROCALNE 13.64MG STERILE CARDIOPLEGIA PER ML 20ML CONCENTRATE 14.9% I.V INJE. CONCENTRATE 1080MG RELEASE TABLETS 15% BP 15 % CONCENTRATE 1080MG USP TABLETS RELEASE 5653 IRON COMPLEX POLYSACCHARIDE 5651 400 0.4% GLYCOL POLYETHYLENE 5652 400 0.4% GLYCOL POLYETHYLENE 5654 IRON COMPLEX POLYSACCHARIDE 5655 TYPHOID POLYSACCHARIDE 5656 TYPHOID POLYSACCHARIDE 5657 1.4%, USP ALCOHOL POLYVINYL 5658 CHLORIDE 59.65MG POTASSIUM 5659 CHLORIDE POTASSIUM 5660 CHLORIDE EXTENDED POTASSIUM 5661 CHLORIDE INJECTION POTASSIUM 5662 CHLORIDE STERILE POTASSIUM 5663 EXTENDED CITRATE POTASSIUM 456 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAPAKISTAN 01-Sep-15 01-Aug-18 Full PAKISTAN Provisional 01-Aug-18INDIA Provisional 06-Aug-17INDIA Years Two INDIA 03-Apr-15INDIA Full 26-Aug-17 Years Two PAKISTAN 12-Feb-15 16-Dec-16 Full BANGLADESH 15-Dec-14 Full Full INDIAPAKISTAN 23-Aug-15 09-Jan-16 Full Full BANGLADESH 27-Mar-16 Full Pondchy Pharmaceuticals Genome Pharmceuticals (Pvt) Ltd Genome Pharmceuticals (Pvt) Ltd G S Pharmabutor (Pvt) Ltd Win Medicare ltd INDIALaboratories (Pvt) Ltd 24-Sep-15G S Pharmabutor (Pvt) Ltd Full G S Pharmabutor (Pvy) Ltd for Win Medical (Pvt) Ltd Brookes Pharma (Pvt) Ltd Brookes Pharma (Pvt) Ltd Sterling LabGlobe INDIAPharmaceuticals Ltd 03-Nov-15 Full Pharmaceuticals Ltd Chemicals Pvt Ltd (Contd.) Pharmaceuticals (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd Ltd Robert Hall & Co Ltd Ltd Ltd Pharmaceuticals (Pvt) Ltd Hemas Pharmaceuticals (Pvt) Ltd Co Ltd (Pvt) Ltd GARGLE Robert Hall & Co PESSARIES MOUTH SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP POTCIT XRPOTCIT TABLETS Neon ZYLO-P OINTMENT Ceyoka (Pvt) Ltd Leben APODINE OINTMENT Healthcare Tabrane URO-K 10 MEQ TABLETSURO-K 10 MEQ Lanka Tabrane TABLETS BETADINE Lanka GARGLE Tabrane BETADINE VAGINAL BETADINEBETADINE CREAM GARGLE Robert Hall & Co Robert Hall & Co VIODINSANIDINE MOUTH WASH PharmAce (Pvt) Ltd Square PYODINE MOUTH WASH Ceyoka (Pvt) Ltd Sirmaxo STERIDINE GARGLE & OINTMENT Darley Butler & RELEASE USP 1080MG RELEASE USP OINTMENT 5% USP 10 MEQ USP 10 MEQ USP GERMICIDE GARGLE (MINT) PESSARIES CREAM 5% W/V 1% BP 1% BP 1% BP 10%W/W 5669 POVIDONE IODINE 5% W/W 5677 USP POVIDONE IODINE OINTMENT 5664 EXTENDED CITRATE POTASSIUM 5665 TABLETS CITRATE POTASSIUM 5666 TABLETS CITRATE POTASSIUM 5667 POVIDONE IODINE 2% 5668 POVIDONE IODINE 200MG VAGINAL 5670 POVIDONE IODINE BETADINE 5671 POVIDONE IODINE GARGLE 1% 5672 0.5% w/w POVIDONE IODINE GEL PYODINE GEL5673 GEL POVIDONE IODINE MOUTH WASH 5674 POVIDONE IODINE MOUTH WASH Hemas 5675 POVIDONE IODINE MOUTH WASH 5676 POVIDONE IODINE OINTMENT I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 457 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 07-Oct-17 Years Two INDIA 28-Mar-14INDIA Full 03-May-16INDIA Full 11-Aug-16 Full INDIA 20-Oct-16INDIA Full 30-Oct-17SRI LANKA Full 24-Mar-14 01-Mar-18 Full Full PAKISTAN 01-Apr-18INDIA Full INDIA 20-Apr-15 Full INDIA 06-Oct-15 Full 25-Feb-14 Full Unijules Life Sciences Ltd Nem Laboretories (P) Ltd Healthcare Vital (Pvt) Ltd Cian Healthcare (Pvt) Ltd G S Pharmabutor (Pvt) Ltd Navketan Research & Labo. (Pvt) Ltd (Pvt) Ltd Sterling LabBrookes Pharma INDIA(Pvt) Ltd 09-Mar-18 Provisional Alembic Pharmaceuticals Ltd Sun Pharmaceutical industries Pharmaceuticals (India) Ltd Pharmaceuticals Ltd (Contd.) Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Ltd Services Pvt. Ltd N/ACo Ltd Suraksa Pharma Pharmaceuticals (Pvt) Ltd (Pvt) Ltd (Ceylon) Ltd OINTMENT Lifeline SOLUTION SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP POVIDINE OINTMENT PYODINE SOLUTION Hemas NEODINEVITA-DONE OINTMENT Lifeline IODIN PLUS OINTMENT International Yaden OINTMENTPOVINATE Slim OINTMENTBETADINE PharmAce (Pvt) Ltd Aurochem NOVASEPT OINTMENT OINTMENT Robert Hall & Co SETADINE ABC Pharma STERDINE 10 TOPICAL SOLUTION Darley Butler & NEOPAM 0.18XOLEPRAL INJECTION TABLETS Pharmacare LtdPRAMIPREX 0.25 Citihealth Imports Troikaa TABLETS Emerchemie NB 5% 10% W/V SOLUTION USP 5% 5% 5% 5% 5% 10% 10% 10% 1G/ SINGLE VIAL INJECTION USP 0.18MG TABLETS 0.25MG TABLETS 5687 TOPICAL POVIDONE IODINE 5678 USP POVIDONE IODINE OINTMENT 5679 USP POVIDONE IODINE OINTMENT 5680 USP POVIDONE IODINE OINTMENT 5681 USP POVIDONE IODINE OINTMENT 5682 USP POVIDONE IODINE OINTMENT 5683 USP POVIDONE IODINE OINTMENT 5684 USP POVIDONE IODINE OINTMENT 5685 POVIDONE IODINE SOLUTION BP 5686 POVIDONE IODINE SOLUTION BP 5688 PRALIDOXIME CHLORIDE FOR 5689 PRAMIPEXOLE DIHYDROCHLORIDE 5690 PRAMIPEXOLE DIHYDROCHLORIDE 458 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 28-Jul-17 Years Two INDIA 01-Oct-15 Full PAKISTAN 25-Feb-14 20-May-18 Full Years PAKISTAN Two 04-Jan-14INDIA Full PAKISTAN 15-Nov-17PAKISTAN 27-Oct-17 Full Years Two 04-Jan-14INDIA Full FRANCE 15-Nov-14 Full 25-Feb-16FRANCE Full 25-Feb-16SRI LANKA Full 27-Feb-18 Provisional Sun Pharmaceutical industries Alembic Pharmaceuticals Ltd Sun Pharmaceutical industries Abbott Laboratories CCL Pharmaceuticals (Pvt) Ltd CCL Pharmaceuticals (Pvt) Ltd Bafna Pharmaceuticals Ltd Fareva Amboise Zone Industrielle Fareva Amboise Zone Industrielle Renata Limited BANGLADESH 09-Dec-15 Full Pharmaceuticals Ltd (Pvt) Ltd Manufacturing (Pvt) Ltd (Contd.) (Ceylon) Ltd (Pvt) Ltd (Ceylon) Ltd Healthcare lanka Ltd Pharmaceuticals Lanka (Pvt) Ltd Pharmaceuticals Lanka (Pvt) Ltd Celyon (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Ceylon) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP PRAMIPEX 0.5 TABLETS Emerchemie NB XOLEPRAL 0.7XOLEPRAL TABLETSPRAMIPREX 1 Citihealth Imports TABLETS Emerchemie NB MINIPRESS XL TABLETSMINIPRESS XL Hemas TABLETSPRAZOLIN Hemas TABLETSALPHAPRESS TABLETS N/A Emerchemie NB Lina TABLETS 0.5MG TABLETS TABLETS 0.7MG TABLETS 1MG TABLETS 2.5MG TABLETS TABLETS 1MG TABLETS 1MG TABLETS 5691 PRAMIPEXOLE DIHYDROCHLORIDE 5692 PRAMIPEXOLE DIHYDROCHLORIDE 5693 PRAMIPEXOLE DIHYDROCHLORIDE 5694 CREAM 1% PRAMOXINE HCL TRONOLANE5695TABLETS 10MG PRASUGREL CREAM EFICLOT5696TABLETS 10MG PRASUGREL Sunshine 10 RECLAP 5697 TABLETS 10MGTABLETS PRASUGREL 5698 TABLETS 5MG CCL TABLETS PRASUGREL PRASURELAssociates Pharma 5699 TABLETS Bafna EFICLOT 5MGTABLETS PRASUGREL Ceyoka (Pvt) Ltd5700 5 RECLAP PRAZOSIN HYDROCHLORIDE TABLETS Lowitt Pharma TABLETS5701 CCL PRAZOSIN HYDROCHLORIDE 5MG Associated Pharma 5702 PRAZOSIN HYDROCHLORIDE 5703 PRAZOSIN HYDROCHLORIDE I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 459 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 30-Sep-14 Full 30-Sep-14 Full INDIAINDIA 23-Sep-15INDIA Full 11-Jan-18 Provisional INDIA 12-Jul-17INDIA Full 03-Mar-18INDIA Full 04-May-16INDIA Full 25-Sep-14INDIA Full 05-Jun-14 Full INDIA 24-Jun-18 Years Two PAKISTAN 05-Jul-18 15-Oct-14 Full Full STATES STATES BANGLADESH 26-Feb-14 Full Ltd Centurion Laboratories Pvt Ltd Indi Pharma (Pvt) Ltd Opthalmincs Sunwaya Rohto Pharmaceutical Pvt Ltd Piramal Enterprises Ltd Remington pharmaceutical Industries (Pvt) Ltd Alcon Laboratories UNITED Scottish Pharma INDIAGlobe Pharmaceuticals Ltd 10-Sep-18Years Two Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Ltd (Contd.) (Pvt) Ltd Emar Pharma (Pvt) Ltd Chamee Chemist Indiana (Pvt) Ltd Hemas Pharmaceuticals (Pvt) Ltd Delmege Forsyth & Co Ltd Ltd Ltd Healthcare Tabrane (Pvt) Ltd SOLUTION CREAM SUSPENSION SUSPENSION SOLUTION EYE DROPS Baur & Co (Pvt) A EYE DROPS Morison PLCLaboratories Alcon UNITED SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP PREDNIN-A EYE DROPS International Yaden P-CORT ORAL PERSOL FORTEPERSOL TOPICAL 10 PRED-S OPHTHALMIC N/AFORTIPRAD OPHTHALMIC OPHTHALMIC ECONOPRED PLUS ECONOPRED PLUS SYRUP 5MG/5ML SYRUP OPHTHALMIC SUSPE. USP 1% OPHTHALMIC SUSPE. USP W/W +BENZOYL PEROXIDE 10% CREAM +BENZOYL 1% OPHTHALMIC SUSPE. USP W/W OPHTHALMIC SUSPE.10MG/ML USP OPHTHALMIC SUSPE.10MG/ML USP OPHTHALMIC SUSPENSION 1% OPHTHALMIC SUSPENSION 1% 5711 PREDNISOLONE ACETATE 5717 SOLUTION PREDNISOLONE ORAL 5704 1MG BP TABLLETS PRAZOSIN N/A TABLETS Chamee Chemist Bajaj Healthcare 5705 1MG BP TABLLETS PRAZOSIN N/A5706 1MG BP TABLLETS PRAZOSIN 5707 PRAZORIGHT 1MG BP TABLLETS PRAZOSIN TABLETS TABLETS N/A5708 SULPHUR 5% PRECIPITATED Chamee Chemist Healthcey (Pvt) Ltd5709 Biodeal Alvita Pharma PREDNISOLONE 25MG BP5710 TABLETS PREDNISOLONE ACETATE N/A International Yaden 5712 TABLETS PREDNISOLONE ACETATE Chamee Chemist5713 PREDNISOLONE ACETATE Bajaj Healthcare 5714 PREDNISOLONE ACETATE 5715 PREDNISOLONE ACETATE 5716 5MG PREDNISOLONE BP 5 PREDNOL TABLETS Alaris Lanka (Pvt) 460 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAPHILIPPINES 12-Mar-15 21-Jun-14INDIA Full Full INDIA 07-Nov-14INDIA Full 30-Aug-18 Provisional INDIA 03-Jun-18SRI LANKA Full 31-Dec-17 28-Dec-14 Years Two INDIA Full INDIA 08-Apr-14INDIA Full 14-Sep-18 Provisional INDIA 05-Nov-16INDIA Full 04-Jul-14INDIA Full 02-May-16INDIA Full 12-Mar-15 Full 09-Feb-14 Full Pharmaceuticals LLOYD Laboratories Inc Laborate Pharmaceuticals Axon Drugs (Pvt) Ltd Meyer Organics (Pvt) Ltd Unicure (India) (Pvt) Ltd B D H Industries Ltd Astra Lifecare (India) (Pvt) Ltd Medopharm (PVT Ltd Pharmaceuticals Ltd Pharmaceuticals Manufacturer Corporation Pharmaceuticals Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Contd.) Pharma Associates Madras Akmed Pharma (Pvt) Ltd Services Pvt. Ltd Healthcare lanka Ltd Ltd Ltd Services Pvt. Ltd Health (Pvt) Ltd Pharmaceuticals (Pvt) Ltd SOLUTION SOLUTION SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP N/A ORAL REDNISOL TABLETS Emar Pharma (Pvt) PHOSPHATE ORAL SOLUTION ORAL PHOSPHATE 5MG/5ML 5MG 5718 PREDNISOLONE SODIUM 5719 20MG/5ML PREDNISOLONE SYRUP MEDSONE5720 5MGTABLETS PREDNISOLONE ORAL N/A5721 5MG BP TABLETS PREDNISOLONE PREDILAB 55722 5MG BP TABLETS PREDNISOLONE N/A TABLETS TABLETS5723 ABC Pharma 5MG BP TABLETS PREDNISOLONE PREDNITABAssociates Pharma Bafna 5724 5MG BP TABLETS PREDNISOLONE TABLETS N/A TABLETS Sunshine SMM Halcyon (Pvt) 5725 USP. TABLETS PREDNISOLONE TABLETS5726 1MG BP TABLETS PREDNISOLONE N/A N/A5727 5MG BP TABLETS PREDNISOLONE METAPRED5728 5MG BP TABLETS PREDNISOLONE TABLETS N/A TABLETS State 5729 5MG BP TABLETS PREDNISOLONE Associates Pharma ASTOLON ABC Pharma Bafna 5730 5MG BP TABLETS PREDNISOLONE OPRED TABLETS TABLETS5731 5MG BP TABLETS PREDNISOLONE Chamee Chemist EMSOLONE George Steuart TABLETS Alvita Pharma TABLETSAssociates Pharma Osaka Akbar I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 461 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 05-Nov-16INDIA Full 14-Sep-18 Provisional SRI LANKA 24-May-18 24-Sep-14 Provisional SRI LANKA Full 10-Aug-16INDIA Full BANGLADESH 18-Nov-14 08-Sep-17 Years Two Full PAKISTAN 25-Mar-15BANGLADESH 08-Sep-17 Full Years Two PAKISTAN 05-Aug-16INDIA Full PAKISTAN 12-May-17 17-May-18 Full Years INDIA Two INDIA 13-Jun-17 Full 25-Jul-18 Full B D H Industries Ltd Treffer Pharmaceuticals Getz Pharma (Pvt) Ltd Hilton Pharma (Pvt) Ltd Zim Laboratories Ltd CCL Pharmaceuticals (Pvt) Ltd Akums Drugs & Pharmaceuticals Ltd Unichem Laboratories Pharmaceuticals Ltd (Ceylon) (Pvt) Ltd Ltd Pharmaceuticals Ltd Pharmaceuticals Industry Ltd Pharmaceuticals Industry Ltd (Contd.) (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Healthcare lanka Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals Lanka (Pvt) Ltd Plc Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP N/AN/A TABLETS Pharma Associates TABLETS Bafna International Yaden 20MG 20MG 5732 5MG BP TABLETS PREDNISOLONE METAPRED TABLETS Ravilux Company 5733 BP PREDNISOLONE TABLETS 5734 BP PREDNISOLONE TABLETS 5735 5MG BP TABLETS PREDNISOLONE N/A5736 5MG BP TABLETS PREDNISOLONE N/A5737 5MG BP TABLETS PREDNISOLONE NISOL TABLETS5738 PREGABALIN CAPSULES 100MG TABLETS N/A 50 NEUREGA TABLETS5739 N/A PREGABALIN CAPSULES 100MG CAPSULESAssociates Pharma GABICA Bafna Ceyoka (Pvt) Ltd5740 M S J Industries PREGABALIN CAPSULES 100MG The IBN SINA 50 NEUREGA Inter Pharm (Pvt) CAPSULES5741 PREGABALIN CAPSULES 100MG CAPSULES Hemas ZEEGAP Ceyoka (Pvt) Ltd5742 PREGABALIN CAPSULES 100MG The IBN SINA PREGAZIM 100 CAPSULES5743 TABLETS PREGABALIN CAPSULES 150MG Sunshine GABLIN Tabrane 5744 PREGABALIN CAPSULES 150MG AKUGABALIN CAPSULES5745 PREGABALIN CAPSULES 150MG CAPSULES CCL 150 PREGBA Browns & Company CAPSULES Baur & Co (Pvt) A 462 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 01-Mar-18PAKISTAN Full 03-Mar-15 03-Aug-14 Full INDIA Full INDIA 18-Feb-15PAKISTAN Full 26-Jul-14 04-Apr-14 Full INDIA Full INDIA 01-Jan-14BANGLADESH Full 21-Feb-17 13-Mar-14 Full Full INDIA 03-Feb-18 Full INDIAINDIA 15-Dec-17 Full 23-Nov-16 Full Ltd Windlas Biotech (Pvt) Ltd Getz Pharma (Pvt) Ltd Coast West Pharmaceurical works Ltd Shaigan Pharmaceuticals (Pvt) Ltd Sun Pharmaceutical industries Aristo Pharmaceuticals Ltd MSN Laboratories Alembic Pvt Ltd for Pharmaceuticals - India Kopran Ltd Torrent INDIAPharmaceuticals Ltd Sai Mirra Innopharm (Pvt) 28-Jan-14Ltd Full Pharmaceuticals Laboratories (Contd.) Pharmaceuticals (Pvt) Ltd Healthcare lanka Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Ceylon) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Ltd Healthcare lanka Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP 5757 PREGABALIN CAPSULES 150MG 150 TORGABALIN CAPSULES Hemas 5746 PREGABALIN CAPSULES 150MG PREGASAFE 150 CAPSULES Axia (Pvt) Ltd MSN Laboratories 5747 PREGABALIN CAPSULES 150MG GABIN 1505748 PREGABALIN CAPSULES 150MG CAPSULES 150MG GABICA 5749 CAPSULES Sunshine PREGABALIN CAPSULES 150MG PREGAB 150 Hemas 5750 PREGABALIN CAPSULES 150MG CAPSULES VEXER 1505751 PREGABALIN CAPSULES 150MGAssociates Pharma The Madras CAPSULES PEGALIN5752 Global Impex AV PREGABALIN CAPSULES 150MG 150 LYRIGAB CAPSULES5753 PREGABALIN CAPSULES 150MG CAPSULES Akbar MAXGALIN 150MG CAPSULES5754Associates Ashland PREGABALIN CAPSULES 150MG Baader Schulz Emerchemie NB 150 NEUROVAN CAPSULES5755 PREGABALIN CAPSULES 150MG Hemas AXOGURD 150 CAPSULES5756 PREGABALIN CAPSULES 150MG Citihealth Imports NEUROLIN 150MG CAPSULES Alaris Lanka (Pvt) 5758 PREGABALIN CAPSULES 150MG NEUROBALIN 150 CAPSULES Sunshine I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 463 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIA 17-Jun-17 Full INDIAPAKISTAN 13-Jun-17 27-Apr-14 Full INDIA Full 03-Feb-16PAKISTAN Full 03-Aug-15PAKISTAN Full 27-Apr-14INDIA Full PAKISTAN 24-Jun-17 18-Jun-15 Full INDIA Full 06-Aug-14 Full BANGLADESH 15-Jun-16 Full Zim Laboratories Ltd Innova Captab INDIAAkums Drugs & Pharmaceuticals Ltd 24-Aug-16 Full MSN Laboratories Alembic Pvt Ltd for Pharmaceuticals - India Getz Pharma Pakistan (Pvt) Ltd Sun Pharmaceutical industries CCL Pharmaceuticals (Pvt) Ltd Coast West Pharmaceurical works Ltd Aristopharma Ltd BANGLADESH 15-Mar-14 Full Pharmaceuticals Ltd Laboratories (Pvt) Ltd Laboratories (Pvt) Ltd (Contd.) Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Ceylon) Ltd Pharmaceuticals Lanka (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP 5761 PREGABALIN CAPSULES 150MG AKUGABALIN CAPSULES Lotus 5770 PREGABALIN CAPSULES 50MG NEUROLIN 50 CAPSULES PharmAce (Pvt) Ltd Square 5759 PREGABALIN CAPSULES 150MG PREGAZIM 150 CAPSULES Tabrane 5760 PREGABALIN CAPSULES 150MG 150 NOVAPREG CAPSULES Slim 5762 PREGABALIN CAPSULES 200MG SYNGAB5763 PREGABALIN CAPSULES 300MG AXOGURD CAPSULES5764 Morison PLC PREGABALIN CAPSULES 50MG TABLETS GABICA ATCO 5765 Citihealth Imports PREGABALIN CAPSULES 50MG SYNGAB CAPSULES5766 PREGABALIN CAPSULES 50MG Hemas MAXGALIN 50 CAPSULES5767 PREGABALIN CAPSULES 50MG CAPSULES Morison PLC GABLIN Emerchemie NB 5768 PREGABALIN CAPSULES 50MG ATCO VEXER 50 CAPSULES5769 PREGABALIN CAPSULES 50MG CCL CAPSULES 50 NEUROVAN CAPSULES Global Impex AV Hemas 464 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 PAKISTAN 25-Mar-18INDIA Full INDIA 06-Aug-18INDIA Full 31-Aug-18 Years Two INDIA 03-Mar-15INDIA Full 18-Feb-15 Full 13-May-16 Full INDIA 03-Feb-16 Full PAKISTAN 04-Apr-16INDIA Full 21-Feb-16 Full Getz Pharma Pakistan (Pvt) Ltd Coast West Pharmaceurical works Ltd Windlas Biotech (Pvt) Ltd Atoz Pharmaceuticals (Pvt) Ltd Aristopharma Ltd BANGLADESH 13-Mar-14MSN Laboratories Full Alembic Pvt Ltd for Pharmaceuticals - India Delta Pharma Ltd BANGLADESH 04-Apr-14Shaigan Full Pharmaceuticals (Pvt) Ltd Sun Pharmaceutical industries Kopran LtdCipla Ltd INDIA INDIA 28-Jan-14 Full 11-Sep-14 Full Ltd Pharmaceuticals (Contd.) Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd Healthcare lanka Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Ceylon) Ltd Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP 5778 PREGABALIN CAPSULES 75MG AXOGURD 75 CAPSULES Citihealth Imports 5780 PREGABALIN CAPSULES 75MG PEGALIN CAPSULES Akbar 5783 PREGABALIN CAPSULES 75MG 75 NOVA CAPSULES Breathe Free Lanka 5771 PREGABALIN CAPSULES 75MG GABICA CAPSULES Hemas 5772 PREGABALIN CAPSULES 75MG VEXER 755773 PREGABALIN CAPSULES 75MG CAPSULES PREGASAFE 755774 PREGABALIN CAPSULES 75MG CAPSULES Global Impex AV GABIN 755775 Axia (Pvt) Ltd PREGABALIN CAPSULES 75MG PREGAB 755776 CAPSULES MSN Laboratories PREGABALIN CAPSULES 75MG Sunshine REGALIN 75 CAPSULES5777 PREGABALIN CAPSULES 75MGAssociates Pharma CAPSULES The Madras NEUROCAN 75Asian Pharma Euro CAPSULES Hemas 5779 PREGABALIN CAPSULES 75MG 75 PREGADEL CAPSULES Hyena 5781 PREGABALIN CAPSULES 75MG MAXGALIN 755782 PREGABALIN CAPSULES 75MG CAPSULES NEUROLIN 75MG Emerchemie NB CAPSULES Alaris Lanka (Pvt) I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 465 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAPAKISTAN 01-Jan-14 14-Mar-14 Full Full BANGLADESH 15-Jun-16 Full BANGLADESH 06-Oct-17 Years Two INDIAINDIA 17-Jun-17 Full INDIA 22-Oct-14 Full 23-Nov-16 Full GERMANY 12-May-15GERMANY Full 12-May-16INDIA Full 27-Nov-15 Full zer zer fi fi Laboratories CCL Pharmaceuticals (Pvt) Ltd Orion pharma Ltd BANGLADESH 19-May-14Pharmaceuticals Full Ltd Zim Laboratories Ltd Jenburkt Pharmaceuticals Ltd Sai Mirra Innopharm (Pvt) Ltd Innova Captab INDIAP Manufacturing Deutschland 24-Aug-16GmbH P Full Manufacturing Deutschland GmbH Theon Pharmaceuticals Ltd Pharmaceuticals Industry Ltd (Contd.) Pharmaceuticals Lanka (Pvt) Ltd Co Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Healthcare lanka Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP LYRICA CAPSULES Hemas LYRICA CAPSULESSEREMAX 150 SR CAPSULES Hemas Ceyline 150MG 75MG RELEASE CAPSULES 150MG 5787 PREGABALIN CAPSULES 75MG NEUROLIN 75MG CAPSULES PharmAce (Pvt) Ltd Square 5793 PREGABALIN HARD CAPSULES 5784 PREGABALIN CAPSULES 75MG 75 LYRIGAB CAPSULESAssociates Ashland Baader Schulz 5785 PREGABALIN CAPSULES 75MG GABLIN5786 PREGABALIN CAPSULES 75MG XIL CAPSULES CCL 5788 PREGABALIN CAPSULES 75MG CAPSULES 75 NEUREGA 5789 PREGABALIN CAPSULES 75MG Darley Butler & CAPSULES PREGAZIM 755790 Ceyoka (Pvt) Ltd PREGABALIN CAPSULES 75MG CAPSULES The IBN SINA 75 NERVEGE Tabrane 5791 PREGABALIN CAPSULES 75MG CAPSULES NEUROBALIN 755792 Hemas CAPSULES PREGABALIN CAPSULES 75MG Sunshine 75 NOVAPREG CAPSULES Slim 5794 PREGABALIN HARD CAPSULES 5795 PREGABALIN SUSTAINED 466 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 15-Oct-14 Full INDIAINDIA 26-Nov-15 Full INDIA 06-Feb-18 Years Two INDIA 08-Dec-18 Years Two INDIA 29-Sep-15BANGLADESH 08-Feb-18 Full 14-Nov-14PAKISTAN Full Full PAKISTAN 17-Oct-17 Years Two 17-Oct-17KINGDOM Years Two INDIA 08-Sep-17 Full INDIAINDIA 26-Oct-14 Full 08-Sep-16 Full

fi Theon Pharmaceuticals Ltd Inventia Healthcare (Pvt) Ltd Inventia Healthcare (Pvt) Ltd Cooper Pharma Ltd SG Pharma (Pvt) Ltd OBS Pakistan (Pvt) Ltd OBS Pakistan (Pvt) Ltd Actavis UK Ltd UNITED Olive Healthcare INDIACadila Healthcare Ltd 12-Sep-16Olive Healthcare Full INDIASun Pharmaceutical industries 12-Sep-16Cadila Healthcare Full Ltd Bangaladesh Ltd (Contd.) Lanka Ltd Sano fi Pharmaceuticals (Pvt) Ltd (Ceylon) Ltd (Ceylon) Ltd Ltd Pharmacy (Pvt) Ltd (Ceylon) Ltd (Pvt) Ltd (Ceylon) Ltd Slim Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Slim Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Hemas Pharmaceuticals (Pvt) Ltd CAPSULES CAPSULES CAPSULES SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP SEREMAX 75 SR CAPSULES Slim VAGESTON CAPSULES Hemas SUSTEN 200 EMULSION Hemas SEGABIN SR 150 TABLETSSEGABIN SR 300 Emerchemie NB TABLETS Emerchemie NB N/ASTEMETILU-PROGEST CAPSULES TABLETS CAPSULESU-PROGEST The Esses Sano Emerchemie NB CAPSULESCYCLOGEST Mansel (Ceylon) PESSARIESPROSTIUM 100 GELETIN SOFT Emerchemie NB PROSTIUM 200 GELETIN SOFT VAGESTON GELATIN SOFT RELEASE CAPSULES 75MG CAPSULES 100MG CAPSULES 200MG RELEASE TABLETS 150MG RELEASE TABLETS 300MG RELEASE TABLETS CAPSULES 50MG USP 5MG BP TABLETS 200MG 200MG 400MG CAPSULES 100MG CAPSULES 200MG CAPSULES 200MG 5806 GELATIN PROGESTERONE SOFT 5808 GELATIN PROGESTERONE SOFT 5796 PREGABALIN SUSTAINED 5797 PREGABALIN SUSTAINED 5798 PREGABALIN SUSTAINED 5799 75MGTABLETS PREGABALIN 5800 PROCARBAZINE HYDROCHLORIDE PREGLEX 755801 TABLETS PROCHLORPERAZINE MALEATE 5802 PROGESTERONE CAPSULES Arrow Pharma (Pvt) 5803 PROGESTERONE CAPSULES 5804 PROGESTERONE PESSARIES 5805 GELATIN PROGESTERONE SOFT 5807 GELATIN PROGESTERONE SOFT 5809 GELATIN PROGESTERONE SOFT I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 467 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 11-Oct-17 Full BANGLADESH 08-Feb-14 Full INDIAINDIA 13-Feb-17 Full 09-Apr-14 Full INDIA 26-Feb-15 Full UNITED KINGDOM SRI LANKA 08-Feb-16SRI LANKA Full 01-Jan-15INDIA Full INDIA 22-Dec-15INDIA Full 15-Mar-14INDIA Full 12-Sep-14INDIA Full 04-Jul-15INDIA Full 12-Nov-18INDIA Years Two 27-Jul-14 Full 26-Apr-15 Full

fi Bangaladesh Ltd Pharmaceutical Unijules Life Sciences Ltd Sun Pharmaceutical industries Olive Healthcare INDIAFleet Laboratories UK 12-Sep-16(Ceylon) (Pvt) Ltd Full Mercury Laboratories Ltd Healthcare Vital (Pvt) Ltd (Ceylon) (Pvt) Ltd Laboratories (Pvt) Ltd (Pvt) Ltd Pharmaceutica (Pvt) Ltd (Pvt) Ltd Sciences (Pvt) Ltd (Contd.) Lanka Ltd Sano fi Pharma AssociatesPharma Central drugs and Pharmaceuticals (Pvt) Ltd Ltd Hemas Pharmaceuticals (Pvt) Ltd Slim Pharmaceuticals (Pvt) Ltd N/A M S J Industries (Pvt) Ltd (Pvt) Ltd SOLUTION CAPSULES CAPSULES TABLETS SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP PROZAVOMINE ORAL TABLETS Sano METHAZINE INJECTION Lifeline SUSTEN 400 GELETIN SOFT PROSTIUM 400 GELETIN SOFT N/AN/AN/A FILM COA TABLETSPROMERIGHT INJECTION TABLETS N/AN/A Chamee Chemist Ceyoka (Pvt) Ltd Alvita Pharma N/A Leben INJECTION M S J Industries N/A Chamee ChemistN/A TABLETS Samrudh PROVITA INJECTION Chamee Chemist Alvita Pharma International Yaden INJECTION INJECTIONAssociates Pharma International Yaden Steril Gene Life SYRUP 5MG/5ML SYRUP 25MG TABLETS 25MG./ML CAPSULES 400MG CAPSULES 400MG BP 10MG BP 25MG BP 25MG BP 25MG/1ML 25MG INJECTION BP 10MG USP 25MG./ML 25MG./ML 25MG./ML 5811 GELATIN PROGESTERONE SOFT 5812 8% GEL PROGESTERONE VAGINAL CRINONE 8% GEL Baur & Co (Pvt) A 5810 GELATIN PROGESTERONE SOFT 5813 PROMETHAZINE HYDROCHLORIDE 5814 PROMETHAZINE HYDROCHLORIDE 5815 PROMETHAZINE HYDROCHLORIDE 5816 PROMETHAZINE HYDROCHLORIDE 5817 PROMETHAZINE HYDROCHLORIDE 5818 PROMETHAZINE HYDROCHLORIDE 5819 PROMETHAZINE INJECTION BP 5820 PROMETHAZINE INJECTION BP 5821 PROMETHAZINE INJECTION BP 5823 SOLUTION PROMETHAZINE ORAL 5824 BP PROMETHAZINE THEOCLATE 5822 PROMETHAZINE INJECTION BP 468 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIA 30-Jun-16SRI LANKA Full 07-Jan-17 Full AUSTRIA 27-Aug-17 Years Two AUSTRIA 11-Oct-17 Years Two GERMANY 18-Aug-14INDIA Full INDIA 05-Apr-14 Full INDIA 20-Jul-14 Full INDIA 14-Aug-17 Years Two INDIA 26-Dec-17INDIA Years Two 15-Aug-14 Full 26-Jun-14 Full Chemicals (Pvt) Ltd (Ceylon) (Pvt) Ltd AurolabFresenius Kabi INDIAAustria Gmbh Austria Fresenius kabi Ab Sweden Fresenius Kabi 28-Dec-16Austria Gmbh Austria Fresenius Full kabi Ab Sweden Sanbe FarmaT P INDONESIA 08-Aug-16B Braun Melsungen A G Full Aculife Healthcare (Pvt) Ltd Aculife Healthcare (Pvt) Ltd Troikaa Pharmaceuticals Ltd Healthcare Vital (Pvt) Ltd Neon Laboratories Ltd SG Pharma (Pvt) Ltd (Contd.) Lenstech Innovations Pvt Ltd Pharmaceuticals (Pvt) Ltd Hemas Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Healthcare lanka Ltd Healthcare lanka Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd Pharmacy (Pvt) Ltd SOLUTION INFUSION INJECTION B Braun Lanka SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP SANISCRUB M HAND RUB Ceyoka (Pvt) Ltd Srimaxo AUROCAINE OPHTHALMIC FRESOFOL INJECTIONFRESOFOL Hemas VENOUS INTRA PROANES 1% INJECTION Lifeline LIPURO 1% RELAXOL-10 INJECTIONN/A International Yaden PRANOSOL INJECTION INJECTION The Esses Ravilux Company OPTHALMIC SOULUTION USP 5MG/ OPTHALMIC SOULUTION USP ML INJECTION OR INFUSION 1% 10mg/ml INJECTION OR ONFUSION 1% (10MG/ML) EMUSION FOR EMULSION USP INJECTION OR INFUSION ML 200mg/20ml 1MG/ML INJECTION IP 30G+MECETRONIUM HAND 0.2G DRY ETHYLSULFATE RUB 5826 15MG BP PROPANTHELINE 5827 HYDROCHLORIDE PROPARACAINE N/A5828 EMULSION FOR PROPOFOL TABLETS5829 EMULSION FOR PROPOFOL N/A5830 INJECTABLE PROPOFOL 5831 M S J Industries INJECTION 10MG/ML PROPOFOL PROPOFOL 5832 1% W/V INJECTION BP PROPOFOL 1% NIRFOL 5833 1% W/V INJECTION BP PROPOFOL INJECTION 1% NIRFOL Sunshine 5834 1% W/V INJECTION BP PROPOFOL INJECTION TROYPOFOL Sunshine 5835 INJECTION 10MG/ INJECTION BP PROPOFOL Slim 5836 INJECTION BP PROPOFOL 5837 HYDROCHLORIDE PROPRANOLOL 5825 45G+PROPANOL-1 PROPANOL-2 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 469 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 02-Jul-18 Years Two SRI LANKA 04-Sep-18 Years Two 03-Mar-14INDIA Full INDIA 07-Jul-15 Full FRANCE 22-Aug-17 Full 18-May-18INDIA Full INDIA 11-Feb-15INDIA Full 12-May-15 Full INDIA 18-Sep-16 Full INDIA 24-Feb-14SWITZERLAND Full 28-Nov-17 01-Oct-18 Years Two Full Treffer Treffer Pharmaceuticals Laboratories (Pvt) Ltd (Ceylon) (Pvt) Ltd Laboratories (Pvt) Ltd Macleods Pharmaceuticals Ltd Cenexi France For AB Astra Zeneca Swden SG Pharma (Pvt) Ltd Laboratories (Pvt) Ltd Zim Laboratories Ltd Macleods Pharmaceuticals Ltd Mercury Laboratories Ltd ICN Polfa Rzesow SA,Poland for Valeant Pharmaceuticals Switzerland (Contd.) (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmacy (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd Ltd INJECTION Hemas SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP N/A TABLETS International Yaden PTU PROTAMINE LEO SULPHATE TABLETSPROTIDE Pettah Pharmacy PYRALEB INJECTION The Esses TABLETSPYRASIM 125 TABLETS Ceyoka (Pvt) LtdMACROZIDE Leben Tabrane TABLETSN/A Pettah Pharmacy MESTINON TABLETS TABLETS Baur & Co (Pvt) A International Yaden 50MG IU /ML) SOLUTION FOR HEPARIN AND INFUSION 10MG/ INJECTION ML 50MG/5ML I.P TABLETS TABLETS TABLETS 500MG 60MG TABLETS SUSTAINTED RELEASE TABLETS TABLETS RELEASE SUSTAINTED 80MG BP 5839 10MG BP TABLETS PROPRANOLOL 10 ARTEFLO 5840 TABLETS 40MG BP TABLETS PROPRANOLOL N/A5841 Ceyoka (Pvt) Ltd 40MG BP TABLETS PROPRANOLOL 40 ARTEFLO Leben 5842 TABLETS BP TABLETS PROPYLTHIOURACIL TABLETS Ceyoka (Pvt) Ltd5843 N/AANTI (1400 SULPHATE PROTAMINE Leben 5844 INJECTION SULPHATE PROTAMINE M S J Industries 5845 125MG PAMOATE PYRANTEL 5846 125MG PAMOATE PYRANTEL 5847 PYRAZINAMIDE 500MG BP 5848 BP PYRAZINAMIDE TABLETS 5849 PYRIDOSTIGMINE BROMIDE 5838 HYDROCHLORIDE PROPRANOLOL 470 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 26-Mar-16 Full INDIAINDIA 16-Jun-18INDIA Full 25-Jul-18 Years Two INDIA 11-Oct-18 Provisional INDIA 28-Mar-15 Full 23-Jun-17STATES Full INDIAINDIA 19-Nov-17 Years Two PAKISTAN 16-Sep-15 10-Jun-15 Full PAKISTAN Full 01-Jan-15 Full INDIAINDIA 29-Dec-17INDIA Full 20-Apr-17 Full 09-Jan-17 Full Centurion Laboratories Pvt Ltd Mercury Laboratories Ltd Centurion Laboratories Pvt Ltd SG Pharma (Pvt) Ltd Centurion Laboratories Pvt Ltd Merck & Co Inc UNITED Akums Drugs & Pharmaceuticals Ltd Sun Pharmaceutical industries Hilton Pharma (Pvt) Ltd Hilton Pharma (Pvt) Ltd Cipla LtdIndia Ltd INDIAAtoz Pharmaceuticals (Pvt) Ltd 29-Mar-14India Ltd Full (Contd.) (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd Pharmacy (Pvt) Ltd (Pvt) Ltd Ltd (Pvt) Ltd (Ceylon) Ltd Healthcare lanka Ltd Healthcare lanka Ltd (Pvt) Ltd (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP N/A TABLETS International Yaden PRANOSOLN/A TABLETS The Esses GARDASIL TABLETS INJECTION International Yaden Baur & Co (Pvt) A QVEX 200 TABLETS Global Impex AV XR 150QUSEL TABLETS XR 200QUSEL Sunshine TABLETSSEROQUIN 100 Sunshine TABLETS 100QUETAPIL TABLETS Breathe Free Lanka QUTI 100 PharmAce (Pvt) Ltd Psychotropics 25QUETAPIL TABLETS TABLETSAsian Pharma Euro PharmAce (Pvt) Ltd Psychotropics 25MG 25MG RECOBINANT PAPILLOMAVIRUS VACCINE 60MG TABLETS 200MG TABLETS TABLETS EXTENDED RELEASE 150MG TABLETS EXTENDED RELEASE 200MG 100MG 100MG 100MG 25MG 5851 10MG BP TABLETS PYRIDOXINE N/A5852 25MG BP TABLETS PYRIDOXINE N/A5853 BP PYRIMETHAMINE TABLETS TABLETS5854 USP PYRIMETHAMINE TABLETS TABLETS International Yaden 5855 HUMAN QUADRIVALENT International Yaden 5850 BP PYRIDOSTIGMINE TABLETS 5856 QUETIAPINE EXTENDED RELEASE 5857 25MG QUETIAPINE FUMARATE QUTIPIN 255858 QUETIAPINE FUMARATE TABLETS5859 QUETIAPINE FUMARATE Emerchemie NB 5860 TABLETS QUETIAPINE FUMARATE 5861 TABLETS QUETIAPINE FUMARATE 5862 TABLETS QUETIAPINE FUMARATE 5863 TABLETS QUETIAPINE FUMARATE I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 471 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 09-Feb-17 Full INDIA 19-Nov-14 Full 27-Aug-18 Years Two PAKISTAN 07-Oct-17PAKISTAN Full 13-Sep-16BANGLADESH Full 08-Jun-17 Full PAKISTAN 31-Jul-16INDIA Full PAKISTAN 09-Oct-18 Years Two 13-Sep-14BANGLADESH Full 08-Jun-17 Full INDIA 12-Sep-17 Years Two Sun Pharmaceutical industries Akums Drugs & Pharmaceuticals Ltd Mercury Laboratories Ltd LaboratoriesIPCA INDIA LaboratoriesIPCA INDIA 04-Apr-14Hilton Pharma Full (Pvt) Ltd 04-Apr-14Medizan Full Laboratories (Pvt) Ltd Chemical Industries Hilton Pharma (Pvt) Ltd Coast West Pharmaceurical works Ltd Medizan Laboratories (Pvt) Ltd Chemical Industries Concept Pharmaceuticals Ltd (Contd.) (Ceylon) Ltd (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Healthcare lanka Ltd Pharmaceuticals (Pvt) Ltd Healthcare lanka Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd International (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP QUTIPIN 300 TABLETSOVEX 100 Emerchemie NB TABLETSN/A SR 200QUEL Global Impex AV TABLETS TABLETS SR 300QUEL Hemas TABLETS International Yaden Hemas TABLETS 100MG TABLETS 200MG TABLETS 200MG TABLETS 300MG TABLETS 300MG 5865 RELEASE QUETIAPINE SUSTAINED 5866 RELEASE QUETIAPINE SUSTAINED 5867 RELEASE QUETIAPINE SUSTAINED 5868 RELEASE QUETIAPINE SUSTAINED 5869 100MG QUETIAPINE TABLETS QUSEL5870 100MGTABLETS QUETIAPINE 100 PEQUIT 5871 TABLETS 100MGTABLETS QUETIAPINE TABLETS QMAX 1005872 Sunshine 200MG QUETIAPINE TABLETS Ceyline TABLETS QUSEL5873 25MGTABLETS QUETIAPINE CIC Holdings PLC Advanced 5874 QVEX 25 TABLETS 25MGTABLETS QUETIAPINE 5875 25 PEQUIT Sunshine TABLETS 25MGTABLETS QUETIAPINE TABLETS Global Impex AV 5876 25 Q-DEP 50MG USP TABLETS QUETIAPINE 50 QUETIACEPT TABLETS Ceyline TABLETS Softcare CIC Holdings PLC Advanced 5864 TABLETS QUETIAPINE FUMARATE 472 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAPAKISTAN 02-Aug-18 22-Mar-18 Years Two PAKISTAN Years Two 22-Mar-18INDIA Years Two INDIA 16-May-18INDIA Full 12-Sep-17 Years Two INDIA 12-Nov-18 Years Two INDIA 12-Sep-17 Years Two INDIA 26-Dec-15 Full PAKISTAN 07-Nov-17 22-Jan-14 Full Full INDIAINDIA 22-Mar-18 Provisional 29-Sep-14 Full Pvt Ltd Laboratories (Pvt) Ltd Laboratories (Pvt) Ltd Sun Pharma Laboratories Ltd Concept Pharmaceuticals Ltd Centurion Laboratories Pvt Ltd Concept Pharmaceuticals Ltd SG Pharma (Pvt) Ltd Zim Laboratories Ltd Genome Pharmceuticals (Pvt) Ltd Zee Laboratories INDIAEisai Pharmaceticals India Pvt Ltd 17-Sep-16Cadila pharmaceuticals Full Ltd (Contd.) (Ceylon) Ltd International (Pvt) Ltd (Pvt) Ltd International (Pvt) Ltd Pharmacy (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Services Pvt. Ltd Ltd Sunshine Healthcare lanka Ltd COA.) SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP N/A INJECTION The Esses RABEZAP 20PARIT TABLETSRABELOC 20 TABLETS ABC Pharma (EN. TABLETS Baur & Co (Pvt) A STERILE CONCETRATE BP 300MG/ BP STERILE CONCETRATE ML 20MG 20MG 20MG 5878 200MG USP TABLETS QUETIAPINE QUZIQ 2005879 200MG USP TABLETS QUETIAPINE TABLETS QUIZQ-2005880 PharmAce (Pvt) Ltd 200MG USP TABLETS QUETIAPINE TABLETS Wilshire QUTIPIN 2005881 25MG USP TABLETS QUETIAPINE TABLETSLtd(Pvt) Pharmatec Wilshire 25 QUETIACEPT TABLETS5882 Emerchemie NB 25MG USP TABLETS QUETIAPINE N/A Softcare 5883 25MG USP TABLETS QUETIAPINE 25 QUETIACEPT TABLETS5884 TABLETS QUININE DIHYDROCHLORIDE Softcare International Yaden 5885 RABEPRAZOLE CAPSULES 10MG RABIZIM 105886 RABEPRAZOLE CAPSULES 20MG CAPSULES RENOM 20 5887 Tabrane TABLETS RABEPRAZOLE SODIUM CAPSULES5888 TABLETS RABEPRAZOLE SODIUM Lanka Tabrane 5889 TABLETS RABEPRAZOLE SODIUM 5877 200MG USP TABLETS QUETIAPINE 200 PSYQUIT TABLETS PharmAce (Pvt) Ltd Consern Pharma I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 473 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 02-May-17 Full 26-Aug-17 Years Two INDIAINDIA 15-Feb-18 Provisional 03-Feb-17INDIA Full PAKISTAN 10-Jan-14 20-May-14 Full INDIA Full INDIA 31-Aug-17 Years Two INDIA 06-Jul-17 Years Two INDIA 01-Jan-15INDIA Full 13-Jul-17INDIA Years Two 15-Oct-18 Provisional 29-Sep-14 Full Co. LLC Inventia Healthcare (Pvt) Ltd Aristopharma Ltd BANGLADESH 13-Mar-14 Full Specialities (Pvt) Ltd Akriti pharmaceuticals Pvt Ltd Cipla LtdCadila Healthcare Ltd INDIAHighnoon Laboratories Ltd 17-May-15Bharat Parenterals Full Ltd Torrent Pharmaceuticals Ltd Stallion Laboratories Pvt Ltd (Pvt) Ltd Dr Reddy's Laboratories Ltd Cadila pharmaceuticals Ltd (Contd.) (Ceylon) Ltd Pharmaceuticals (Pvt) Ltd Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Healthcare lanka Ltd (Pvt) Ltd Hemas Pharmaceuticals (Pvt) Ltd (Pvt) Ltd (Ceylon) Ltd Healthcare lanka Ltd COA.) SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP RABZOLE 20 TABLETSRABOTIDE FAST TABLETS Ceyoka (Pvt) LtdRABE 20 Emerchemie NB Global Pharma 20PEPTARD TABLETS TABLETS Hemas 20RISOL Associates Pharma Indchemie Health 10RABECIP TABLETSHAPPI TABLETS Alaris Lanka (Pvt) Breathe Free Lanka RABECID 20 TABLETS CAPSULESRABIRON 20MG Hemas CAPSULES Sunshine VELOZ 20 Pharma Tropical (EN. 20 TABLETS RABESTA TABLETSUNIRAB 20MG INJECTION Siba Healthcare RAZO 20 Klintas (Pvt) LtdRABELOC 10 United Biotech TABLETS TABLETS Emerchemie NB Sunshine 20MG 20MG 20MG 20MG BP TABLETS COA 20MG RELEASE TABLETS CAPSULES 20MG CAPSULES 20MG CAPSULES 20MG 20MG TABLETS INJECTION 20MG 20MG TABLETS RESISTANT 10MG 20MG 5891 TABLETS RABEPRAZOLE SODIUM 5892 TABLETS RABEPRAZOLE SODIUM 5893 TABLETS RABEPRAZOLE SODIUM 5894 TABLETS RABEPRAZOLE SODIUM 5895 RABEPRAZOLE SODIUM 10MG ENT. 5896 RABEPRAZOLE SODIUM DELAYED 5897 RABEPRAZOLE SODIUM ENT.COA 5898 RABEPRAZOLE SODIUM ENT.COA 5899 RABEPRAZOLE SODIUM ENT.COA 5900 RABEPRAZOLE SODIUM ENT.COA 5901 RABEPRAZOLE SODIUM FOR 5902 RABEPRAZOLE SODIUM GASTRO 5903 TABLETS RABEPRAZOLE SODIUM 5890 TABLETS RABEPRAZOLE SODIUM 474 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 27-Mar-16INDIA Full 15-Jun-15INDIA Full 05-Nov-14 Full INDIA 02-Mar-16 Full INDIA 18-Nov-17 Full INDIA 23-Nov-17 Full GERMANY 20-Mar-14 04-Aug-15INDIA Full Full INDIA 01-Jan-15 Full 15-May-18 Provisional FRANCE 17-Dec-17 Full INDIA 18-Jul-14 Full Pasteur India Ltd INDIA 11-Apr-17 Full India Ltd INDIA 23-Apr-14 Full fi fi fi Macleods Pharmaceuticals Ltd Co. LLC Akums Drugs & Pharmaceuticals Ltd Laboratories (Pvt) Ltd Laboratories (Pvt) Ltd Bioproducts Vins (Pvt) Ltd Chiron Behring Ltd Vaccines Human biologicals Institite Macleods Pharmaceuticals Ltd Behring CSL GmbH S A Sano West Coast West Pharmaceurical works Ltd (Contd.) Lanka Ltd Sano Aventis Aventis Lanka Ltd Sano fi fi fi (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Beecham (Pvt) Ltd Ltd Pettah Pharmacy (Pvt) Ltd Services Pvt. Ltd Lanka Ltd (Pvt) Ltd COA.) SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP RABEMAC 10 TABLETS Pettah Pharmacy VINRAB 1000IU INJECTION Hemas RABIPUR INJECTION Smithkline BERIRAB-P INJECTION ABC Pharma CARDACE-H TABLETS Sano CARDACE H5 TABLETS Sano VEXAPRIL TH VEXAPRIL TABLETS Global Impex AV IMMUNOGLOBULIN FRAGMENTS THAN 1000IU INJECTION LESS NOT 2.5IU 10MG 150IU/ML 2.5MG+HYDROCHLOROTHIAZIDE 12.5MG TABLETS 5MG+HYDROCHLOROTHIAZIDE 12.5MG TABLETS 2.5MG+HYDROCHLOROTHIAZIDE 12.5MG TABLETS 5911 RABIES HUMAN IMMUNOGLOBULIN 5905 10MGTABLETS RABEPRAZOLE RABZOLE 105906 20MGTABLETS RABEPRAZOLE TABLETS VEXRAB5907 20MGTABLETS RABEPRAZOLE Ceyoka (Pvt) Ltd RABEMAC 20 TABLETS Global Pharma 5908 20MG IP TABLETS RABEPRAZOLE (EN. TABLETS RBEN 20 Global Impex AV 5909 20MG IP TABLETS RABEPRAZOLE RBEN 20 TABLETS5910ANTI RABIES RABIES (EQUINE Ceyoka (Pvt) Ltd TABLETS Leben Ceyoka (Pvt) Ltd5912 Leben BP VACCINE RABIES INACTIVATED 5913 BP RABIES VACCINE 5914 INACTIVATED RABIES VACCINE VERORAB ABHAYRAD INJECTION INJECTION Sano Arumed (Pvt) New 5904 TABLETS RABEPRAZOLE SODIUM 5915 RAMIPRIL 5917 RAMIPRIL 5916 RAMIPRIL I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 475 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 01-Mar-15INDIA Full 01-Mar-15INDIA Full 26-Nov-15 Full INDIA 16-Jul-14BANGLADESH Full 31-Oct-14 18-Mar-14PAKISTAN Full Full BANGLADESH 26-Jan-14 10-Sep-14 Full INDIA Full PAKISTAN 16-Jul-15INDIA 26-Jan-14 Full Full INDIA 18-Mar-14 Full 16-Jul-15 Full India Ltd INDIA 05-Mar-14 Full India Ltd INDIA 19-Mar-14 Full India Ltd INDIA 16-Oct-16 Full fi fi fi Bal Pharma Ltd INDIAPharmaceuticals 28-Nov-14Pharmaceuticals Centaur Full Pharmaceutical (Pvt) Ltd Coast West Pharmaceurical works Ltd Unichem Laboratories Healthcare Pharmaceuticals Ltd Healthcare Pharmaceuticals Coast West Pharmaceurical works Ltd Ltd Unichem Laboratories Coast West Pharmaceurical works Ltd (Contd.) Lanka Ltd Sano Lanka Ltd Sano Lanka Ltd Sano fi fi fi (Pvt) Ltd Health (Pvt) Ltd (Pvt) Ltd Ltd (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd Ltd (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP 5919 2.5MG CAPSULES BP RAMIPRIL CARDIKA5920 5MG CAPSULES BP RAMIPRIL 5921 CARDIKA 2.5MG BP TABLETS RAMIPRIL CAPSULES PREFACEAssociates Pharma 5922 The Madras 2.5MG BP TABLETS CAPSULES RAMIPRIL TABLETSAssociates 2.5 VEXAPRIL Pharma The Madras 5923 2.5MG BP TABLETS RAMIPRIL TABLETS George Steuart 5924 RAMIZ 2.5MG 2.5MG BP TABLETS RAMIPRIL Global Impex AV TABLETS5925 ACECARD 10MGTABLETS RAMIPRIL 5926 Baur & Co (Pvt) A 1.25MG BP TABLETS RAMIPRIL TABLETS RAMIPACE5927 ACECARD 1.25MG BP TABLETS RAMIPRIL Citihealth Imports TABLETS 1.25 VEXAPRIL TABLETS5928 1.25MG BP TABLETS RAMIPRIL TABLETS CIC Holdings PLC5929 1.25 RAMIPACE PharmEvo (Pvt) Citihealth Imports 5MG BP TABLETS RAMIPRIL Global Impex AV TABLETS5930 5MG BP TABLETS RAMIPRIL RAMIZ 5MG CIC Holdings PLC PharmEvo (Pvt) 5931 5 VEXAPRIL TABLETS 1.25MG IP TABLETS RAMIPRIL TABLETS CARDACE Baur & Co (Pvt) A Global Impex AV TABLETS Sano 5918 2.5MG CAPSULES BP RAMIPRIL 2.5 SERVACE CAPSULES International Yaden 5932 10MG IP TABLETS RAMIPRIL CARDACE TABLETS Sano 5933 2.5MG IP TABLETS RAMIPRIL CARDACE 2.5 TABLETS Sano 476 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 SWITZERLAND 21-Jul-14GERMANY Full INDIA 29-Apr-15 Full INDIA 02-Mar-18 Full PAKISTAN 15-Jun-16 31-Aug-17 Full Full INDIAINDIA 27-Apr-16INDIA Full 02-May-15INDIA Full 02-Apr-16INDIA Full 16-Apr-16INDIA Full 27-Apr-17 Years Two INDIA 03-Mar-14INDIA Full 16-Mar-14 Full 06-Sep-16 Full India Ltd INDIA 30-Jun-14 Full fi Novartis Pharma A G Novartis Pharma GmbH Germany Cadila pharmaceuticals Ltd Unique Pharmaceutical Labs Nabiqasim Industries (Pvt) Ltd Mackur Laboratories Ltd Pharmafabrikon Unit Human Verve Care Laboratories Nitin Lifesciences Ltd (Pvt) Ltd Cadila pharmaceuticals Ltd Gland Pharma (Pvt) Ltd Unique Pharmaceutical Labs (Contd.) Lanka Ltd Sano fi Ltd Ltd Healthcare lanka Ltd Health (Pvt) Ltd Health (Pvt) Ltd Pharmaceticals (Pvt) Ltd Agency Pvt Ltd Pharmaceuticals (Pvt) Ltd Healthcare lanka Ltd Services Pvt. Ltd Health (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP LOCENTIS PFS INJECTION Baur & Co (Pvt) A RANTAC-150 TABLETSPEPTIURE George Steuart TABLETSXANTID 150RANCURE George Steuart TABLETSN/A CIC Holdings PLC INJECTION C I Ltd A RANIVER S P L BANGLADESHRANIMIT INJECTION 07-Mar-17 INJECTIONYears Two Novachem Lanka Leader Pharma RANIDONE INJECTIONACILOC 2ML Slim INJECTION INJECTION Pharmatec (Pvt) Ltd Belco Pharma N/A Sunshine RANTAC INJECTION INJECTION ABC Pharma George Steuart INJECTION 10MG/ML 150MG 150MG 150MG 25MG/2ML ML ML ML ML ML ML 50MG/2ML 5934 5MG IP TABLETS RAMIPRIL CARDACE TABLETS Sano 5935 RANIBIZUMAB INJECTION 10MG/ML LUCENTIS5936 RANIBIZUMAB SOLUTION FOR INJECTION5937TABLETS RANITIDINE 300MG USP Baur & Co (Pvt) A ACILOC5938 USP TABLETS RANITIDINE HCL TABLETS5939 USP TABLETS RANITIDINE HCL Sunshine 5940 USP TABLETS RANITIDINE HCL 5941 RANITIDINE INJECTION BP 5942 25MG/ RANITIDINE INJECTION BP 5943 25MG/ RANITIDINE INJECTION BP 5944 25MG/ RANITIDINE INJECTION BP 5945 25MG/ RANITIDINE INJECTION USP 5946 25MG/ RANITIDINE INJECTION USP 5947 25MG/ RANITIDINE INJECTION USP 5948 RANITIDINE INJECTION USP I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 477 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 CHINAINDIA 20-Oct-15 Full INDIA 01-Mar-18 Full 15-Nov-17INDIA Full INDIA 20-Jan-17INDIA Full 14-Dec-14INDIA Full 19-Sep-18 Years Two INDIA 19-Aug-14INDIA Full 14-Dec-14INDIA Full 09-Jun-18 Full CHINA 14-Aug-17 Years Two 22-Feb-17INDIA Full 09-May-18 Full Glaxo Smithkiline Co Ltd (Tiangin) Cadila pharmaceuticals Ltd Torrent Pharmaceuticals Ltd Biolab Co Ltd THAILANDUnique Pharmaceutical Labs 27-May-15 Full Ltd Concept Pharmaceuticals Ltd Pharmaceuticals Ltd Zim Laboratories Ltd Reliance Life Sciences (Pvt) Ltd Sunshine Pharmaceuticals Co Ltd Ltd Vaccine (Contd.) Pharmaceuticlas (Pvt) Ltd Healthcare lanka Ltd (Pvt) Ltd Health (Pvt) Ltd Health (Pvt) Ltd International (Pvt) Ltd Pharmaceuticals (Pvt) Ltd ABC Pharma Services Pvt. Ltd SOLUTION FOR INJECTION SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP RANCV 1000 TABLETSRANLO ER 500 TABLETS Axia (Pvt) LtdRANOSIN Softcare MSN Laboratories RANASAFE 500 TABLETS TABLETSRABIZIM 20 Pharma Associates Axia (Pvt) Ltd Madras TABLETSRELIPOIETIN MSN Laboratories 4000IU Tabrane EPIAOFOLIGRAF INJECTION Ceyoka (Pvt) Ltd INJECTION Shenyang Ceyoka (Pvt) Ltd Bharat Serums & TABLTES 1000MG TABLTES 500MG TABLTES 500MG TABLTES 500MG TABLTES 20MG ALPHA ERYTHROPOIETIN INJECTION 4000IU/0.4ML INJECTION ERYTHROPOIETIN 10000 IU/ML HORMONE POWER STIMULATING FOR INJECTION 150IU 5950 150MG USP TABLETS RANITIDINE ACILOC5951 150MG USP TABLETS RANITIDINE RANITIN TABLETS5952 150MG USP TABLETS RANITIDINE RANIDINE Sunshine TABLETS5953 300MG USP TABLETS RANITIDINE RANTAC TABLETS Edna Medicals 5954 RANOLAZINE EXTENDED RELEASE George Steuart TABLETS5955 RANOLAZINE EXTENDED RELEASE George Steuart 5956 RANOLAZINE EXTENDED RELEASE 5957 RANOLAZINE EXTENDED RELEASE 5958 TABLETS REBEPRAZOLE SODIUM 5959 HUMAN RECOMBINANT 5960 HUMAN RECOMBINANT 5961 HUMAN FOLLICLE RECOMBINANT 5949 150MG RANITIDINE TABLETS ZANTAC TABLETS GlaxoSmithkiline 478 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 02-Sep-15 Full KOREA 16-Aug-17 Full ARGENTINA 07-Dec-17ARGENTINA Full 16-Dec-17 Years Two BANGLADESH 18-Sep-18 Provisional CHINA 22-Jan-18CHINA Years Two 22-Jan-18INDIA Years Two UNITED 06-Mar-14KINGDOM Full INDIAINDIA 25-May-15 Full 11-Feb-17 Full L G Life Sciences L Ltd LtdWockhardt INDIA Biosidus S.A.Av de Los Biosidus S.A.Av 02-Aug-18de Los Years Two Beacon Pharmaceuticals Ltd Lilly France SAS FRANCE Yichang Humanvell 19-Jul-14Pharmaceuticals Co Ltd Full Yichang Humanvell Pharmaceuticals Co Ltd Laborarories (Pvt) Ltd Glaxo Operations UK Ltd Macleods Pharmaceuticals Ltd Macleods Pharmaceuticals Ltd (Contd.) Services Pvt. Ltd (Ceylon) Ltd Pharmaceuticals (Pvt) Ltd Slim Pharmaceuticals (Pvt) Ltd (Ceylon) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticlas (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd INJECTION SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP NEWMON-R INJECTIONGLARITUS ABC Pharma HEMAX INJECTION Emerchemie NB HEMAX INJECTION Slim POWDER / HUMULIN-R INJECTIONN/A Hemas N/A INJECTION Slim INJECTION Slim INJECTION 100IU/ML INJECTION ERYTHROPOIETIN 20000 IU/ML INJECTION ERYTHROPOIETIN 40000 IU/ML INSULIN 100IU/ML NEUTRAL FOR INJECTION 1MG FOR INJECTION 1MG FOLLITROPIN POWDER FOR INJECTION 75 IU VIAL 5963 INSULIN GLARGINE RECOMBINANT 5964 rhu -HUMAN RECOMBINANT 5965 rhu -HUMAN RECOMBINANT 5966 40MGTABLETS REGORAFENIB REGONIX5967 REGULAR HUMAN INSULIN/ TABLETS5968 HYDROCHLORIDE REMIFENTANIL Emerchemie NB 5969 HYDROCHLORIDE REMIFENTANIL 5970 1MG USP TABLETS REPAGLINIDE 1 PAGLIMID 5971 1% W/W OINTMENT RETAPAMULIN TABLETS ALTARGO5972LtdBiogenics Swiss 150MG CAPSULES BP RIFAMPICIN Cassel Research OINTMENT MACOX5973 GlaxoSmithkiline 300MG CAPSULES BP RIFAMPICIN MACOX CAPSULES Pettah Pharmacy CAPSULES Pettah Pharmacy 5962 HUMAN RECOMBINANT I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 479 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 PAKISTANPAKISTAN 20-Mar-18 Years Two INDIA 20-Mar-18 Years Two PAKISTAN 06-Apr-16 11-Mar-14INDIA Full Full ARGENTINA 15-Dec-17 Years Two 24-Jul-18 Provisional BANGLADESH 03-Apr-17 Years Two PAKISTAN 25-Jun-15 Full INDIAINDIA 05-Jul-18 Full 08-Jun-18 Provisional Ferozsons Laboratories Ltd Ferozsons Laboratories Ltd Alkem Laboratories Ltd CCL Pharmaceuticals (Pvt) Ltd Cadila Healthcare Ltd Quimica Montpellier SA Micro Labs Ltd INDIAMicro Labs Ltd INDIA 20-Jan-14Pharmaceuticals Ltd Full Cipla Ltd 16-Apr-14 Full Medizan Laboratories (Pvt) INDIALtd Cipla Ltd 09-Feb-18Cadila Healthcare Ltd INDIA Full Centurion Laboratories Pvt Ltd 09-Feb-18 Full (Contd.) (Ceylon) Ltd (Ceylon) Ltd (Ceylon) Ltd Pharmaceuticals Lanka (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Ceylon) Ltd (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP GEMFOS 35OSTEORISE TABLETS TABLETS Emerchemie NB STOPLOS CCL TABLETSBAGRIED Hemas TABLETS Emerchemie NB 35MG 35MG 150MG USP 150MG USP 5975 550MGTABLETS RIFAXIMIN 5976 TABLETS SODIUM RISEDRONATE 550 RIFAXA 5977 TABLETS SODIUM RISEDRONATE TABLETS5978 TABLETS SODIUM RISEDRONATE Emerchemie NB 5979 TABLETS SODIUM RISEDRONATE 5980TABLETS RISPERIDONE 1MG 5981 2MGTABLETS RISPERIDONE RISPOND5982 2MG BP TABLETS RISPERIDONE RISPOND TABLETS RISCORD5983 1MG USP TABLETS RISPERIDONE TABLETS Micro Mega Lanka RISNIA-1 TABLETS5984 1MG USP TABLETS RISPERIDONE Micro Mega Lanka 1 DONRESP Harcourts (Pvt) Ltd TABLETS General 5985 1MG USP TABLETS RISPERIDONE TABLETS 1 RISINA Breathe Free Lanka 5986 2MG USP TABLETS RISPERIDONE Ceyline RISPONZ 2 TABLETS5987 2MG USP TABLETS RISPERIDONE TABLETS N/A Breathe Free Lanka Hemas TABLETS International Yaden 5974 200MGTABLETS RIFAXIMIN 200 RIFAXA TABLETS Emerchemie NB 480 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 PAKISTAN 16-Oct-17INDIA Years Two INDIA 16-Oct-17 Years Two INDIA 29-Jun-17 Years Two INDIA 22-Feb-18INDIA Full 14-Oct-14 Full 29-Apr-14INDIA Full 05-Feb-14 Full RUSSIA 09-Mar-18 Years Two INDIAINDIA 09-Mar-18 Provisional 09-Mar-18 Provisional Pharmaceuticals Pvt Ltd Zim Laboratories Ltd Windlas Biotech (Pvt) Ltd India Ltd Laboratories XL (Pvt) Ltd Sun Pharmaceutical industries Cipla LtdCadila Healthcare Ltd INDIAHetero Labs Ltd INDIA 05-Jun-14AryoGen Pharmed IRAN Full 21-Jun-18joint Stock 09-Mar-18 Full Company Provisional Hetero Drugs Ltd INDIAHetero Biopharma Limited 09-Mar-18 Provisional Reliance Life Sciences (Pvt) Ltd (Contd.) Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Ltd (Ceylon) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd George Steuart Health (Pvt) Ltd Ltd ABC Pharma Services Pvt. Ltd INFUSION INJECTION SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP RITOCOM TABLETSACELLBLA Mansel (Ceylon) INFUSIONRILAST PharmAce (Pvt) Ltd BIOCAD Closed RILAST SOLUTION INJECTION Pharma DIVASA 50MG/200MG FOR SOLUTION INJECTION 10mg/10ml FOR SOLUTION INJECTION 10mg/10ml SOLUTION INJECTION 10MG/1ML 5989 2MG USP TABLETS RISPERIDONE RESPIZIM 25990 2MG USP TABLETS RISPERIDONE TABLETS N/A5991 Tabrane 2MG USP TABLETS RISPERIDONE ZEPID 25992 2MG USP TABLETS RISPERIDONE TABLETS RESPIXL5993 TABLETS 2MG USP TABLETS RISPERIDONE SIZODON Lifeline TABLETS PharmAce (Pvt) Ltd5994 Psychotropics 2MG USP TABLETS RISPERIDONE RISNIA-2 TABLETS SMM Halcyon (Pvt) 5995 4MG USP TABLETS RISPERIDONE RISPONZ 4 Emerchemie NB TABLETS5996 TABLETS & LOPINAVIR RITONAVIR TABLETS Breathe Free Lanka 5997 RITUXIMAB 500MG/50ml Hemas 5998 RITUXIMAB CONCENTRATE ZYTUX 5005999 RITUXIMAB CONCENTRATE INJECTION6000 Slim FOR RITUXIMAB CONCENTRATE 6001 RITUXIMAB INJECTION 100MG 100 RITUXIREL SOLUTION FOR 5988 2MG USP TABLETS RISPERIDONE RISPERIN TABLETS Klintas (Pvt) Ltd Hansel I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 481 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIASWITZERLAND 24-Jan-17 09-Mar-18 Provisional Full INDIA 27-Sep-17 Full SWITZERLAND 08-Aug-17 Full SPAIN 08-Aug-17 Full SPAIN 08-Aug-17GERMANY Full 15-Mar-17GERMANY Full 26-Feb-17INDIA Full 02-Jul-18 Years Two Novartis Farmaceutica SA Spain for Novartis pharma AG Torrent Pharmaceuticals Ltd Export LtdTorrent INDIANovartis pharmaceuticals 27-Sep-17Ltd Full Novartis Pharma Stein .AG Switzerland for novatis Pharma Shcweiz AG Switzerland Novartis Farmaceutica SA Spain for Novartis pharma AG Lohmann LTS Theraple Systeme AG Mercury Laboratories Ltd AryoGen Pharmed IRANGenentech Inc 09-Mar-18 SWITZERLAND Provisional Reliance Life 05-Jun-15Sciences (Pvt) Ltd Full Lohmann LTS Theraple Systeme AG (Contd.) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Ltd Ltd Ltd Baur & Co (Pvt) A Ltd (Pvt) Ltd Slim Pharmaceuticals (Pvt) Ltd Ltd ABC Pharma Services Pvt. Ltd Baur & Co (Pvt) A Ltd PATCH SOLUTION INJECTION PATCH SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP EXELONEXELON CAPSULES Baur & Co (Pvt) A CAPSULES Baur & Co (Pvt) EXELON A CAPSULES Baur & Co (Pvt) A 5EXELON PATCH TRANSDERMAL N/A INJECTION International Yaden EXELON PATCH TRANSDERMAL 3MG CAPSULES 4.6MG CAPSULES 6MG 4.6MG 24 HOURS PATCH INJECTION 10MG/1ML PATCH 13.5MG 24 HOURS PATCH 6011 TRANSDERMAL RIVASTIGMINE 6005 1.5MG CAPSULES RIVASTIGMINE EXELON6006 CAPSULES 1.5MG RIVASTIGMINE CAPSULES 1.5 RIVADEM 6007 Baur & Co (Pvt) A CAPSULES 3MG CAPSULES RIVASTIGMINE 3 RIVADEM Hemas 6008 HARD CAPSULES RIVASTIGMINE CAPSULES6009 HARD GELATIN RIVASTIGMINE Hemas 6010 HARD GELATIN RIVASTIGMINE 6012 TRANSDERMAL RIVASTIGMINE 6013 ROCURCNIUM BROMODE 6002 RITUXIMAB INJECTION 100MG ZYTUX 100 INJECTABLE 6003 RITUXIMAB INJECTION 10mg/1ml MABTHERA6004 RITUXIMAB INJECTION 500MG INJECTION 500 RITUXIREL SOLUTION FOR Baur & Co (Pvt) A 482 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 GERMANY 11-May-17 Full BANGLADESH 19-Mar-17 Full PAKISTAN 19-Oct-16INDIA Full INDIA 21-Nov-17 Full INDIA 08-Sep-17 Years Two INDIA 07-May-16 Full INDIA 20-Apr-17 Years Two BANGLADESH 18-May-15 02-Mar-16 Full Full INDIA 08-Dec-17INDIA Years Two 31-Oct-18 Years Two Hameln Pharmaceuticals GmbH Germany Mayne Pharma (Pvt) Ltd Pharmaceuticals Ltd Hilton Pharma (Pvt) Ltd Sun Pharmaceutical industries Atoz Pharmaceuticals (Pvt) Ltd Sun Pharmaceutical industries Atoz Pharmaceuticals (Pvt) Ltd Sun Pharmaceutical industries Pharmaceuticals Ltd Pharmaceuticals PharmaMBL PAKISTANSydler Remedies (Pvt) Ltd 17-Feb-18Years Two (Contd.) Pharmaceuticals (Pvt) Ltd Healthcare lanka Ltd (Ceylon) Ltd (Pvt) Ltd (Ceylon) Ltd (Pvt) Ltd (Ceylon) Ltd Ltd Ltd INJECTION Akbar SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP ROCUROMIUM- HAMELN 0.25PERKIROL TABLETSRONIROL PharmAce (Pvt) Ltd Square ROPARK TABLETS Sunshine ROPIN 0.5 TABLETS Emerchemie NB TABLETSROPARKAsian Pharma Euro ROPIM-1 TABLETS Emerchemie NB ROPARK TABLETS Euro Asian Pharma TABLETS Emerchemie NB VAPTOR 10RUSAT TABLETSROSTIN 10 TABLETS Morison PLC 10ROZALIP TABLETSAssociates Pharma The Madras Searle-Pakistan TABLETS PAKISTAN Markss HLC (Pvt) Alaris Lanka (Pvt) 05-Apr-18 Full 0.25MG TABLETS 0.25MG TABLETS 0.25MG TABLETS 0.5MG 0.5MG 1MG 1MG 10MG 10MG 10MG 10MG SOLUTION FOR INJECTION 10MG/ ML 6015 ROPINIROLE HYDROCHLORIDE 6016 ROPINIROLE HYDROCHLORIDE 6017 ROPINIROLE HYDROCHLORIDE 6018 ROPINIROLE HYDROCHLORIDE 6019 ROPINIROLE HYDROCHLORIDE 6020 ROPINIROLE HYDROCHLORIDE 6021 ROPINIROLE HYDROCHLORIDE 6022 2MGTABLETS ROPINIROLE 6023 2 PERKIROL TABLETS CALCIUM ROSUVASTATIN 6024 TABLETS TABLETS CALCIUM ROSUVASTATIN 6025 TABLETS CALCIUM ROSUVASTATIN PharmAce (Pvt) Ltd Square 6026 TABLETS CALCIUM ROSUVASTATIN 6014 ROCURCNIUM BROMODE I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 483 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 11-Dec-16PAKISTAN Full 02-Jun-15 23-Apr-16 Full Full INDIA 01-Jun-17INDIA Full PAKISTAN 25-Aug-16INDIA 12-Mar-18 Full Years Two PAKISTAN 16-Sep-17 03-Jan-18 Years Two INDIA Full INDIA 05-Sep-16 Full INDIA 24-Mar-14 Full INDIA 27-Jan-15 Full INDIA 10-Aug-17 Years Two 27-Jan-15 Full Scences (Pvt ) Ltd Fredun Pharmaceuticals Ltd Atoz Pharmaceuticals (Pvt) Ltd Micro Labs Ltd INDIAMedibios Laboratories (Pvt) Ltd 18-Jan-16Ltd Full Ltd CCL Pharmaceuticals (Pvt) Ltd Akums Drugs & Pharmaceuticals Ltd Troikaa Pharmaceuticals Ltd Health Care IVA (Pvt) Ltd Torrent Pharmaceuticals Ltd MSN Laboratories Alembic Pvt Ltd for Pharmaceuticals - India (Contd.) Health (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd (Ceylon) Ltd Pharmaceuticals Lanka (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP ROSWISS 10 TABLETSROSCA PharmAce (Pvt) Ltd Swiss Garnier Life TABLETS Ceyoka (Pvt) Ltd Genix Pharma ROSU 10 TABLETS George Steuart ROSTAT-10 TABLETS 10TURBOVAS TABLETS Euro Asian Pharma ROVASTAT Micro Mega Lanka TABLETSX-PLENDED Emerchemie NB 10LDNIL TABLETSCRESTAT CIC Holdings PLC TABLETS PharmEvo (Pvt) TABLETSROVEX Axia (Pvt) Ltd CCL MSN Laboratories 10ROSUKAA TABLETS TABLETS 10IVROVAS Global Impex AV Slim TABLETSROSUCOR Slim TABLETS 10ROSAVAE TABLETS Hemas Citihealth Imports 10MG 10MG 10MG 10MG 10MG 10MG 10MG 10MG 10MG 10MG 10MG 10MG 10MG 10MG 6028 TABLETS CALCIUM ROSUVASTATIN 6029 TABLETS CALCIUM ROSUVASTATIN 6030 TABLETS CALCIUM ROSUVASTATIN 6031 TABLETS CALCIUM ROSUVASTATIN 6032 TABLETS CALCIUM ROSUVASTATIN 6033 TABLETS CALCIUM ROSUVASTATIN 6034 TABLETS CALCIUM ROSUVASTATIN 6035 TABLETS CALCIUM ROSUVASTATIN 6036 TABLETS CALCIUM ROSUVASTATIN 6037 TABLETS CALCIUM ROSUVASTATIN 6027 TABLETS CALCIUM ROSUVASTATIN 6039 TABLETS CALCIUM ROSUVASTATIN 6040 TABLETS CALCIUM ROSUVASTATIN 6038 TABLETS CALCIUM ROSUVASTATIN 484 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 01-Jun-17 Full INDIA 21-Apr-17PAKISTAN Full 21-Jun-18 16-Nov-17INDIA Full Full INDIA 12-Oct-14 Full PAKISTAN 13-Aug-14 06-Aug-14 Full INDIA Full 03-Feb-15INDIA Full INDIA 10-Aug-17 Years Two INDIA 20-Jan-16 Full PAKISTAN 21-Apr-17 06-Nov-15 Full Full Sun Pharmaceutical industries Ltd Getz Pharma Pakistan (Pvt) Ltd Atoz Pharmaceuticals (Pvt) Ltd Akums Drugs & Pharmaceuticals Ltd Pharma Tabros (Pvt) Ltd MSN Laboratories Alembic Pvt Ltd for Pharmaceuticals - India Torrent Pharmaceuticals Ltd Sun Pharmaceutical industries Sun Pharmaceutical industries Novins International (Pvt) Ltd Atoz Pharmaceuticals (Pvt) Ltd (Contd.) (Ceylon) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd Laboratories (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Ceylon) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP ROSUVAS 10ROSUVAS TABLETS 20LDNIL Emerchemie NB ROVISTA TABLETSROSTAT-20 TABLETS Axia (Pvt) Ltd TABLETS Hemas MSN Laboratories ROVEX 20 Euro Asian Pharma TABLETSRAST Global Impex AV 20ROSAVE TABLETS TABLETSROSUCOR Associated Citihealth Imports TABLETS 20ROZAVEL TABLETS Hemas 20ROSUVAS Hemas TABLETS 5ROSATIN Emerchemie NB TABLETS Biolife ROSTAT-10 TABLETS Euro Asian Pharma 10MG 20MG 20MG 20MG 20MG 20MG 20MG 20MG 20MG 20MG 5MG 10MG 6042 TABLETS CALCIUM ROSUVASTATIN 6043 TABLETS CALCIUM ROSUVASTATIN 6044 TABLETS CALCIUM ROSUVASTATIN 6045 TABLETS CALCIUM ROSUVASTATIN 6046 TABLETS CALCIUM ROSUVASTATIN 6047 TABLETS CALCIUM ROSUVASTATIN 6048 TABLETS CALCIUM ROSUVASTATIN 6049 TABLETS CALCIUM ROSUVASTATIN 6050 TABLETS CALCIUM ROSUVASTATIN 6051 TABLETS CALCIUM ROSUVASTATIN 6052 TABLETS CALCIUM ROSUVASTATIN 6041 TABLETS CALCIUM ROSUVASTATIN I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 485 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 19-Nov-15 Full INDIA 07-Feb-15 Full 31-Jan-18 Provisional INDIAINDIA 26-Dec-15INDIA Full 21-Apr-17INDIA Full 02-Jul-17 Full INDIA 09-Apr-15 Full INDIA 02-Oct-15INDIA Full 02-Jun-14PAKISTAN Full 24-Apr-18 Years Two INDIA 29-Apr-18 Years Two 07-Jul-17 Full IVA Health Care IVA (Pvt) Ltd Ltd U S V Ltd INDIAFredun Pharmaceuticals Ltd Ranbaxy 02-Apr-17laboratories Ltd G D Laboratories Full (India) Pvt Ltd G D Laboratories (India) Pvt Ltd Fredun Pharmaceuticals Ltd Scences Pharmaceuticals (India) Ltd (Pvt) Ltd Akums Drugs & Pharmaceuticals Ltd Akums Drugs & Pharmaceuticals Ltd (Contd.) Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Health (Pvt) Ltd (Ceylon) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Health (Pvt) Ltd PharmAce (Pvt) Ltd Swiss Garnier Life Plc (Pvt) Ltd TABLETS SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP IVCOVAS 5IVCOVAS TABLETS 5LENIL Slim 5ROSEDAY TABLETS TABLETSROSU 5 Axia (Pvt) Ltd Hemas 5ROSUVAS MSN Laboratories TABLETS 10RVS TABLETS George Steuart Emerchemie NB 5RVS TABLETSROSU 20 Lifeline TABLETSROSWISS 20 TABLETS Lifeline FILM COA George Steuart ROVEX TABLETS Global Impex AV 5MG 5MG 5MG 5MG 5MG 10MG IP 5MG IP 20MG USP 20MG TABLETS 5MG 6054 TABLETS CALCIUM ROSUVASTATIN 6055 TABLETS CALCIUM ROSUVASTATIN 6056 TABLETS CALCIUM ROSUVASTATIN 6057 TABLETS CALCIUM ROSUVASTATIN 6058 TABLETS CALCIUM ROSUVASTATIN 6059 TABLETS CALCIUM ROSUVASTATIN 6060 TABLETS CALCIUM ROSUVASTATIN 6061 TABLETS CALCIUM ROSUVASTATIN 6062 FILM COATED ROSUVASTATIN 6063 10MGTABLETS ROSUVASTATIN 10 ROZA 6064 10MGTABLETS ROSUVASTATIN ROSUCAL6065 TABLETS 10MGTABLETS ROSUVASTATIN 10 UNOSAT PharmAce (Pvt) Ltd TABLETS Aurochem TABLETS Ceyoka (Pvt) Ltd Lowitt Pharma Browns & Company 6053 TABLETS CALCIUM ROSUVASTATIN 486 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 PAKISTAN 22-Nov-17PAKISTAN Full 19-Jan-18INDIA Full PAKISTAN 09-Jul-15 06-Aug-14 Full INDIA Full PAKISTAN 30-Jun-15INDIA 17-Jul-14 Full Full PAKISTAN 09-Oct-14 02-Jan-18INDIA Full Full INDIA 19-Dec-14INDIA Full 09-Nov-16 Full INDIA 08-Nov-17 Full INDIA 07-Jul-17 Full 22-Dec-16 Full Getz Pharma (Pvt) Ltd Hilton Pharma (Pvt) Ltd Zim Laboratories Ltd Pharma Tabros (Pvt) Ltd Mepro Pharmaceuticals (Pvt) Ltd Ferozsons Laboratories Ltd MSN Laboratories Ltd CCL Pharmaceuticals (Pvt) Ltd Ltd Windlas Biotech (Pvt) Ltd Agio Pharmaceuticals Ltd Akums Drugs & Pharmaceuticals Ltd Ltd (Contd.) Pharmaceuticals (Pvt) Ltd Healthcare lanka Ltd Pharmaceuticals (Pvt) Ltd Laboratories (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Ceylon) Ltd Ltd Pharmaceuticals Lanka (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP 6067 10MG TABLETS ROSUVASTATIN ROLIP6068 10MGTABLETS ROSUVASTATIN 10 ROVATIN 6069 TABLETS 10MG TABLETS ROSUVASTATIN TABLETS RAST Sunshine 6070 10MGTABLETS ROSUVASTATIN Tabrane 10 STATINOX 6071 TABLETS 10MGTABLETS ROSUVASTATIN TABLETS AURORA6072 10MGTABLETS ROSUVASTATIN Associated Akbar AURITZ6073 10MG TABLETS ROSUVASTATIN TABLETS CRESTAT6074 Emerchemie NB 10MG TABLETSTABLETS ROSUVASTATIN 10 TABLETS ROVAZ 6075 10MGTABLETS ROSUVASTATIN Baur & Co (Pvt) A 10MG RISTOR CCL TABLETS6076 10MGTABLETS ROSUVASTATIN TABLETS ROZUSTOR Burhani Enterprises Saga laboratories 6077 Lifeline 10MGTABLETS ROSUVASTATIN TABLETS 10 UNOSAT 6078 10MGTABLETS ROSUVASTATIN Citihealth Imports TABLETS ROSADAM 10 TABLETS Lotus Harcourts (Pvt) Ltd Coral Laboratories 6066 10MG TABLETS ROSUVASTATIN ROVISTA TABLETS Hemas I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 487 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 06-Oct-15 Full PAKISTAN 22-Feb-18 Years Two INDIAINDIA 07-Jul-18 Years Two INDIA 02-Mar-15 Full INDIA 09-Nov-16 Full 06-Jan-18PAKISTAN Full 03-Jan-16 Full INDIA 11-May-16 Full INDIAUNITED 11-May-16KINGDOM Full Ferozsons Laboratories Ltd Cian Healthcare (Pvt) Ltd Pharmaceuticals (India) Ltd Windlas Biotech (Pvt) Ltd Zim Laboratories Ltd PharmaMBL PAKISTAN CCL Pharmaceuticals (Pvt) Ltd 17-Feb-18Years Two Innova Captab INDIA Laboratories Titan (Pvt) Ltd 20-Nov-16 Full Innova Captab INDIA Laboratories Titan (Pvt) Ltd 20-Nov-16 R I P Pharmaceutical Full Inc (Contd.) (Ceylon) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Ltd Pharmaceuticals Lanka (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Lifescience (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Lifescience (Pvt) Ltd Pharmaceuticals (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP 6082 20MGTABLETS ROSUVASTATIN AURORA6083 20MGTABLETS ROSUVASTATIN 6084 VAPIOR 20MGTABLETS ROSUVASTATIN TABLETS 20 RAPIVAST 6085 20MGTABLETS ROSUVASTATIN TABLETS Emerchemie NB TABLETS 20 ROZA 6086 Morison PLC 20MGTABLETS Slim ROSUVASTATIN 20MG RISTOR TABLETS Searle-Pakistan6087 20MGTABLETS ROSUVASTATIN TABLETS PAKISTAN PharmAce (Pvt) Ltd 20 ROVATIN Aurochem 10-Apr-186088 Lifeline 20MGTABLETS ROSUVASTATIN TABLETS Full ROSTIN 206089 20MG TABLETS ROSUVASTATIN Tabrane CRESTAT TABLETS6090 20MGTABLETS ROSUVASTATIN 20 Markss HLC (Pvt) TABLETS ROSUNOVA 6091 TABLETS 20MGTABLETS ROSUVASTATIN CCL 20 R-VASTIN Slim TABLETS Negolec 6080 10MGTABLETS ROSUVASTATIN 10 R-VASTIN 6081 10MG TABLETS ROSUVASTATIN TABLETS CRESTOR Negolec TABLETS Hemas 6079 10MGTABLETS ROSUVASTATIN 10 ROSUNOVA TABLETS Slim 488 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 20-Jan-16 Full PAKISTAN 04-Sep-15PAKISTAN 04-Jun-16 Full Full 19-Jun-16INDIA Full INDIA 10-Sep-16 Full PAKISTAN 11-May-16 29-Jun-18 Full Years Two INDIAINDIA 28-Jan-18INDIA Full 31-Oct-18 Years Two INDIA 09-Jul-15 Full PAKISTAN 27-Feb-14 16-Nov-17 Full Full Umedica Laboratories (Pvt) Ltd Pharmaceuticals Ltd Ltd Nabiqasim Industries (Pvt) Ltd SRS Pharmaceuticals (Pvt) Ltd Laboratories Titan (Pvt) Ltd Hilton Pharma (Pvt) Ltd Theon Pharmaceuticals Ltd Sydler Remedies (Pvt) Ltd Zim Laboratories Ltd Atoz Pharmaceuticals (Pvt) Ltd Getz Pharma Pakistan (Pvt) Ltd (Contd.) Pharmaceuticals Pvt Ltd Health (Pvt) Ltd (Pvt) Ltd Lifescience (Pvt) Ltd Healthcare lanka Ltd Pharmaceuticals (Pvt) Ltd Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP 6093 20MGTABLETS ROSUVASTATIN 20 ROSUFAST 6094 20MGTABLETS TABLETS ROSUVASTATIN X-PLENDED 206095 20MGTABLETS ROSUVASTATIN Associates Pharma TABLETS Bafna ROVIROS 206096 20MGTABLETS ROSUVASTATIN CIC Holdings PLC TABLETS PharmEvo (Pvt) ROSU-K 206097 40MGTABLETS ROSUVASTATIN George Steuart TABLETS 40 R-VASTIN 6098 5MG TABLETS ROSUVASTATIN TABLETSAssociates Axero ROLIP6099 5MGTABLETS ROSUVASTATIN Negolec 6100 5MG TABLETS VAPTOR ROSUVASTATIN TABLETS THEOROS-56101 5MGTABLETS ROSUVASTATIN TABLETS Sunshine TABLETS6102 5 ROZALIP 5MGTABLETS ROSUVASTATIN Morison PLC Slim 5 ROVATIN TABLETS6103 5MGTABLETS Searle-Pakistan ROSUVASTATIN PAKISTAN TABLETS ROSTAT-5 Alaris Lanka (Pvt) 6104 5MG TABLETS ROSUVASTATIN 05-Apr-18 Tabrane Years Two TABLETS ROVISTAAsian Pharma Euro TABLETS Hemas 6092 20MGTABLETS ROSUVASTATIN UMEBEX 20 TABLETS Gamma I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 489 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIA 19-Mar-16 Full INDIA 11-Aug-17 Years Two INDIA 05-May-14 Full INDIA 19-Mar-16 Full UNITED STATES 11-Nov-16 Full PAKISTANINDIA 17-Jul-14 Full 23-Sep-14PAKISTAN Full INDIA 17-Jul-15 Full 10-Jun-14 Full Hetero Labs Ltd INDIAPharma Fabrikon INDIAOasis 05-Dec-14Laboratories (Pvt) Ltd Full 12-Mar-18 Provisional Pharmaceuticals (Pvt) ltd Medispray Laboatories (Pvt) Ltd Oasis Laboratories (Pvt) Ltd MBL PharmaMBL PAKISTANInnova Captab INDIA 17-Feb-18Years Two R I P Pharmaceutical Inc, Purerto Rice 20-Nov-16AstraZeneca UK Ltd Full Ltd Ltd Micro Labs Ltd INDIAFerozsons Laboratories Ltd Scences 18-Jan-15 Full (Contd.) (Ceylon) Ltd (Pvt) Ltd Imports (Pvt ) Ltd (Pvt) Ltd ltd Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd (Ceylon) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP 6111 5MGTABLETS ROSUVASTATIN 5 ROSUNOVA TABLETS Slim 6116 10MG IP TABLETS ROSUVASTATIN ROSUTEC 106117 10MG IP TABLETS ROSUVASTATIN TABLETS ROSVOR 106118 10MG IP TABLETS ROSUVASTATIN 10 SUVAST Glaxo Wellcome TABLETS TABLETS Novachem Lanka Union Lanka 6115 10MG IP TABLETS ROSUVASTATIN 10 ROSATIN TABLETS Algarash (Pvt) Ltd Surien 6114 10MG IP TABLETS ROSUVASTATIN ROSULIP TABLETS Breathe Free Lanka 6113 10MG IP TABLETS ROSUVASTATIN 10 SUVAST TABLETS RS Biogenics (Pvt) 6110 5MGTABLETS ROSUVASTATIN ROSTIN 56112 TABLETS 5MG TABLETS ROSUVASTATIN CRESTOR Markss HLC (Pvt) TABLETS Hemas 6106 5MGTABLETS ROSUVASTATIN 6107 5 ZYROVA 5MGTABLETS ROSUVASTATIN 6108 5 TURBOVAS 5MGTABLETS ROSUVASTATIN TABLETS TABLETS6109 AURORA 5MGTABLETS ROSUVASTATIN LtdBiogenics Swiss Cadila Healthcare Micro Mega Lanka ROSWISS 5 TABLETS TABLETS Emerchemie NB PharmAce (Pvt) Ltd Swiss Garnier Life 6105 5MGTABLETS ROSUVASTATIN X-PLENDED TABLETS CIC Holdings PLC PharmEvo (Pvt) 490 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIA 07-Jul-18 Years Two SRI LANKAINDIA 04-Jul-17Years Two 03-Apr-14INDIA Full 14-Feb-14INDIA Full INDIA 20-Mar-16 Full 13-Sep-14 Full INDIAINDIA 20-Mar-16 Full INDIA 09-Nov-16 Full 10-Sep-15 Full Cian Healthcare (Pvt) Ltd U S V Ltd INDIA(Ceylon) (Pvt) Ltd Medispray Laboatories (Pvt) 02-Apr-18Ltd Years Two Hetero Labs Ltd INDIAPharmafabrikon Unit U S V Ltd 09-Dec-14 Full INDIAOasis Laboratories (Pvt) Ltd Medispray 02-Apr-18Laboatories (Pvt) Years Two Ltd Pharma Fabrikon INDIAHetero Drugs Ltd INDIAOasis 30-Apr-14Laboratories (Pvt) Ltd Full 05-Dec-14Windlas Biotech (Pvt) Ltd Full SRS Pharmaceuticals (Pvt) Ltd (Contd.) Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd (Ceylon) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd ltd (Pvt) Ltd (Pvt) Ltd (Ceylon) Ltd Imports (Pvt ) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP ROSU-K 10 TABLETSAssociates Axero 10MG 6119 10MG IP TABLETS ROSUVASTATIN 10 RAPIVAST TABLETS Slim 6120 10MG IP TABLETS ROSUVASTATIN 10 ROSEDAY 6121 TABLETS 10MG IP TABLETS ROSUVASTATIN ROS 106122 20MG IP TABLETS Hemas ROSUVASTATIN ROSULIP TABLETS6123 20MG IP TABLETS ROSUVASTATIN ROSUTEC 20 TABLETS N/A6124 20MG IP TABLETS ROSUVASTATIN TABLETS ROSVOR 20 Breathe Free Lanka 6125 20MG IP TABLETS ROSUVASTATIN 20 ROSEDAY Glaxo Wellcome TABLETS M S J Industries 6126 TABLETS 5MG IP TABLETS ROSUVASTATIN Novachem Lanka 5 SUVAST Hemas 6127 5MG IP TABLETS ROSUVASTATIN TABLETS ROSULIP6128 5MG IP TABLETS ROSUVASTATIN RS Biogenics (Pvt) ROSVOR 5 TABLETS6129 5MG IP TABLETS ROSUVASTATIN ROSUTEC 5 TABLETS Breathe Free Lanka 6130 5MG IP TABLETS ROSUVASTATIN 5 SUVAST TABLETS Novachem Lanka 6131 5MG IP TABLETS ROSUVASTATIN Glaxo Wellcome TABLETS 5 RISTOR 6132 USP TABLETS ROSUVASTATIN Union Lanka TABLETS Lifeline I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 491 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIABELGIUM 10-Sep-16 Full 21-Aug-18BELGIUM Provisional 26-May-18UNITED STATES 02-Mar-16 Full Full SWITZERLAND 08-Apr-18SWITZERLAND Full 08-Apr-18 Years Two SWITZERLAND 08-Apr-17 Full BANGLADESH 02-Aug-18 Provisional BANGLADESH 23-Nov-14 Full BANGLADESH 30-Jun-18 Full INDIA 30-Jun-16 Full SRS Pharmaceuticals (Pvt) Ltd Glaxo Smithkiline Pakistan Ltd Glaxo Smithkiline A Biologicals S Merck Sharp & Dohme Sterling LabNovartis Pharma INDIAStein .AG Novartis Pharma Stein .AG 06-Jun-16Novartis Pharma Stein .AG Full Switzerland for novatis Pharma Shcweiz AG Switzerland Healthcare Pharmaceuticals Cipla LtdBeximco INDIAPharmaceuticals Ltd Healthcare Pharmaceuticals 30-Apr-14 Full Stallion Laboratories Pvt Ltd (Contd.) (Pvt) Ltd Pharmaceuticlas (Pvt) Ltd Pharmaceuticlas (Pvt) Ltd Baur & Co (Pvt) A Ltd Co Ltd Ltd Ltd Ltd Citihealth Imports (Pvt) Ltd (Pvt) Ltd Emerchemie NB (Ceylon) Ltd (Pvt) Ltd (Pvt) Ltd SOLUTION INHALTION INHALATION Breathe Free Lanka AEROSOL INHALATION SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP ROTARIXROTARIX LIQUID ORAL GlaxoSmithkiline ROTATEO VACCINE ORAL GlaxoSmithkiline ORAL DUOLIN MDI PRESSURIZED SEROFLO 125 HFA BEXITROL-F 25/50 HFA 25/250FLUMETOL INHALER Citihealth Imports ATTENUATED 50/ML 10 CDID ORAL 10 CDID ORAL 50/ML ATTENUATED VACCINE 10 CDID ORAL 50/ML ATTENUATED VACCINE SOLUTION ORAL PENTAVALENT BROMIDE 20MCG IPRATROPIUM PRESSURIZED INHALER FLUTICASONE PROPIONATE INHALER 125MCG/ACTUATION FLUTICASONE PROPIONATE 250MCG INHALER CFC FREE FLUTICASONE PROPIONATE 250MCG INHALER CFC FREE 6134 LIVE VACCINE ROTAVIRUS 6135 LIVE VACCINE ROTAVIRUS 6136 LIVE VACCINE ROTAVIRUS 6137 150MGTABLETS ROXITHROMYCIN ROXTER6138 15MGTABLETS RUXOLITINIB TABLETS6139 20MGTABLETS RUXOLITINIB 15 JAKAVI 6140 Darley Butler & 5MGTABLETS RUXOLITINIB 20 JAKAVI TABLETS 5 JAKAVI TABLETS Baur & Co (Pvt) A 6141AND 100MCG SALBUTAMOL Baur & Co (Pvt) A TABLETS6142 25MCG & SALBUTAMOL Baur & Co (Pvt) A 6143 25MCG & SALBUTAMOL 6144 25MCG & SALBUTAMOL 6145 BPTABLETS 2MG SALBUTAMOL SALTAL-2 TABLETS Siba Healthcare 6133 5MG USP TABLETS ROSUVASTATIN ROSU K 5 TABLETSAssociates Axero 492 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 SRI LANKA 23-Apr-16 Full INDIAINDIA 16-Sep-14INDIA Full 21-Mar-14 Full PHILIPPINES 10-Oct-17 Years Two 11-Apr-14INDIA Full CHINA 08-Jun-18 Years Two INDIA 09-Nov-16 Full INDIA 25-Oct-18INDIA Years Two 14-Aug-18INDIA Full 04-Jul-18INDIA Provisional 06-Jun-18BANGLADESH Years Two 27-Sep-18 11-Jun-18 Provisional Years Two (Ceylon) (Pvt) Ltd F D C Limited INDIAS Kant Healthcare Ltd S Kant Healthcare 26-Mar-14Ltd Full Concept Pharmaceuticals Ltd LLOYD Laboratories Inc Concept Pharmaceuticals Ltd Shandong Jewim Pharmaceutical Co. Ltd (Pvt) Ltd Mercury Laboratories Ltd Human Verve Care Laboratories (Pvt) Ltd (Pvt) Ltd Beximco Pharmaceuticals Ltd (Contd.) Healthcare lanka Ltd Co Ltd Mediccon Pharmaceuticals Ltd Softcare International (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Softcare International (Pvt) Ltd Emerchemie NB (Ceylon) Ltd (Pvt) Ltd Agency Pvt Ltd Chamee Chemist Alvita Pharma (Ceylon) Ltd SYRUP POWDER DRY FOR INHALATION INHALATION CAPSULES SOLUTION SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP SALMODIL EXPSALMODIL SYRUPDELCORIL Sunshine DAWAKOF SYRUP EXPECTORANT DPI SEROLET Delmege Forsyth & 50/250 SALBUFLO CAPSULESASTHALIN Slim POWDER FOR 400SALMATE POWDER DRY SALBUTASN/A INJECTIONCERSUBATA Klintas (Pvt) Ltd United Biotech INJECTION 200SALRIGHT INJECTION NEBULIZING Leader Pharma N/A International Yaden AZMAZOL TABLETS SYRUP Chamee Chemist Emerchemie NB Alvita Pharma 4MG/5ML SYRUP 4MG/5ML 4MG+GUAIFENASIN 100MG HCL. 4MG+GUAIPHENESIN 1MG IN 10ML 100MG+MENTHOL FLUTICASONE PROPIONATE POWDER 250MCG DRY CAPSULES INHALATION CAPSULE 200MCG INHALATION CAPSULE 400MCG INHALATION CAPSULES 400MCG ML ML ML 5MG/ML SOLUTION BP 5MG/ML SOLUTION BP 2MG/5ML 6147 2MG+BROMHEXINE SALBUTAMOL 6148 2MG+BROMHEXINE SALBUTAMOL 6149 2MG+BROMHEXINE SALBUTAMOL 6150 50MCG+ SALBUTAMOL 6151 POWDER DRY SALBUTAMOL 6152 POWDER DRY SALBUTAMOL 6153 INHALATION SALBUTAMOL 6154 5MG/ IP INHALATION SALBUTAMOL 6155 1MG/ INJECTION BP SALBUTAMOL 6156 1MG/ INJECTION BP SALBUTAMOL 6157 NEBULIZER SALBUTAMOL 6158 NEBULIZER SALBUTAMOL 6159 SOLUTION ORAL SALBUTAMOL 6146 BPTABLETS 2MG SALBUTAMOL N/A TABLETS N/A M S J Industries I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 493 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 SRI LANKA 02-Mar-16 Full SRI LANKA 24-Feb-18INDIA Full INDIA 18-Oct-18BANGLADESH Full 08-Jun-14 19-Mar-14 Full Full SRI LANKA 01-Jan-18INDIA Provisional CHINA 22-Jun-18 Years Two TURKEY 01-Jul-18 Provisional 15-Dec-17TURKEY Years Two 15-Dec-17 Years Two Hovid SDN Bhd MALAYSIA 14-Oct-14Pharmaceuticals Pvt Ltd Full PharmaceuticalS (Pvt) Ltd Pharmaceutical Medicon Pharmaceuticals Ltd Cipla LtdBiolab Co Ltd INDIA THAILAND(Ceylon) (Pvt) Ltd 07-Jan-14Concept 18-Jan-15Pharmaceuticals Full Ltd Full Jewim Pharmaceutical (Shandong) Co ltd Medicine World Ilac san ve Medicine World Ilac san ve Pharmaceuticals Pvt Ltd Cipla Ltd INDIA 22-Oct-14 Full (Contd.) Pharmaceuticals (Pvt) Ltd N/ACeyoka (Pvt) Ltd Ciron Drugs & Gamma AssociatesPharma Central drugs and Act Enterpriese (Pvt) Ltd (Pvt) Ltd Health (Pvt) Ltd International (Pvt) Ltd (Ceylon) Ltd Slim Pharmaceuticals (Pvt) Ltd Slim Pharmaceuticals (Pvt) Ltd Breathe Free Lanka (Pvt) Ltd N/A Gamma SOLUTION SOLUTION SOLUTION SOLUTION CAPSULES Softcare CAPSULES Emerchemie NB INHALATION INHALATION DOSE INHALER SOLUTION SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP VENTAMOL SYRUPBRONCODIL ORAL Thorn N/ASALS ORAL AZMET ORAL ASTHALIN ORAL SALMOL SYRUPN/A SYRUP Breathe Free Lanka DPI ASTHALET 200 George Steuart SYRUP SALMATE 200MCG FLOWCAPS N/AVENTACORT AEROSOL VENTACORT M S J Industries AEROSOL ASTHALIN HFA METERED N/A ORAL 2MG/5ML 2MG/5ML 2MG/5ML 2MG/5ML 2MG/5ML 2MG/5ML 2MG/5ML 2MG/5ML 200MCG BP INHALATION CAPSULE 200MCG INHALATION 100MCG/200 BP INHALATION METERED INHALATION 100MCG/200 BP INHALATION METERED INHALATION 100MCG B.P INHALATION 2MG/5ML 6161 SOLUTION ORAL SALBUTAMOL 6162 SOLUTION BP ORAL SALBUTAMOL 6163 SOLUTION BP ORAL SALBUTAMOL 6164 SOLUTION BP ORAL SALBUTAMOL 6165 SOLUTION BP ORAL SALBUTAMOL 6166 SOLUTION BP ORAL SALBUTAMOL 6167 SOLUTION BP ORAL SALBUTAMOL 6168 SOLUTION BP ORAL SALBUTAMOL 6169 POWDER FOR SALBUTAMOL 6170 POWDER SALBUTAMOL 6171 PRESSURIED SALBUTAMOL 6172 PRESSURIED SALBUTAMOL 6173 PRESSURISED SALBUTAMOL 6160 SOLUTION ORAL SALBUTAMOL 494 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 28-Aug-14 Full INDIACHINA 10-Mar-18 Full BANGLADESH 26-Mar-15 02-Jun-15 Full Full INDIABANGLADESH 24-Oct-14 30-Jun-16 Full Full PHILIPPINES 20-Jul-16 Full BANGLADESH 24-Apr-18 Full SPAIN/ AUSTRALIA SRI LANKA 27-Jan-18Years Two Shandong Jewim Pharmaceutical Co. Ltd Beximco Pharmaceuticals Ltd Midascare Pharmaceuticals (Pvt) Ltd Healthcare Pharmaceuticals Cipla LtdLaboratories INDIACipla LtdGlaxo Smithkiline 06-Feb-14Pakistan Ltd INDIA Full Glaxo Wellcome S A 12-Feb-14Cipla Ltd Full Cipla Ltd INDIA INDIASciences (Pvt) Ltd 15-Sep-14 Full 11-Jul-18 Full Cadila Healthcare Ltd (Contd.) (Ceylon) Ltd (Ceylon) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd Breathe Free Lanka (Pvt) Ltd Pharmaceuticlas (Pvt) Ltd GlaxoSmithkiline Pharmaceuticlas (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd Sunshine Healthcare lanka Ltd INHALATION AEROSOL INHALATION DOSE INHALER SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP SALBUTIS INHALATION HFAAZMASOL Emerchemie NB INHALATION Emerchemie NB MAXIFLOPULMOCEF INHALATION Lifeline ASTHALIN INHALATION Citihealth Imports HIVENT SOLUTIONASTHALIN DP Breathe Free Lanka SOLUTION POWDER FOR Indoscan (Pvt) Ltd Euro-Med VENTOLIN EVOHALER ASTHALIN DP CAPSULESASTHALIN DP Breathe Free Lanka CAPSULESSALHALE 200 Breathe Free Lanka INHALATION N/A Emergen Life DERIHALER METERED INHALATION B.P 100MCG B.P INHALATION 100MCG B.P INHALATION 100MCG B.P INHALATION 100MCG B.P INHALATION SOLUTION 5MG/ML 2.5MG/ML NEBULIZATION POWDER FOR INSUFFLATION INHALAER 100MC AEROSOLVE GCFC FREE POWDER for INHALATION CAPSULES 400MCG CAPSULES POWDER INHALATION 200MCG CAPSULES POWDER INHALATION 200MCG BP INHALATION B.P 100MCG B.P INHALATION 6175 PRESSURISED SALBUTAMOL 6176 PRESSURISED SALBUTAMOL 6177 PRESSURISED SALBUTAMOL 6178 PRESSURISED SALBUTAMOL 6179 RESPIRATORY SALBUTAMOL 6180 SOLUTION FOR SALBUTAMOL 6181 200MCG SULPHATE SALBUTAMOL 6182 2MG SULPHATE SALBUTAMOL VENTOLIN6183 SULPHATE SALBUTAMOL TABLETS6184 DRY SULPHATE SALBUTAMOL GlaxoSmithkiline 6185 DRY SULPHATE SALBUTAMOL 6186 DRY SULPHATE SALBUTAMOL 6174 PRESSURISED SALBUTAMOL I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 495 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 06-Oct-15 Full SRI LANKA 20-Feb-18INDIA Full INDIA 19-Mar-18 Years Two INDIA 16-Jul-16 Full INDIA 08-Jan-17 Full SRI LANKA 19-Aug-15 14-Aug-17INDIA Full Full MALAYSIA 13-Feb-17 23-Jan-16INDIA Full Full INDIA 11-Jul-18 Full 29-Aug-15FRANCE Full 06-Oct-15FRANCE/ NETHERLANDS Full Medico Remedies (Pvt) Ltd Fourrts (India) Laboratories Ltd Laboratories (Pvt) Ltd (Ceylon) (Pvt) Ltd Healthcare Ltd Pharmaceuticals SDN BHD Centaur Pharmaceutical (Pvt) Ltd Glenmark Pharmaceuticals Ltd Glaxo Wellcome Production Glaxo Wellcome Production, Zone Industrielle Sciences (Pvt) Ltd Laboratories (Pvt) Ltd (Contd.) Pharmaceuticals (Pvt) Ltd Healthcare lanka Ltd Indoscan (Pvt) Ltd Hoe George Steuart Health (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Glaxo Wellcome (Ceylon) Ltd Pharmaceuticlas (Pvt) Ltd N/ACeyoka (Pvt) Ltd Leben Emergen Life SOLUTION SOLUTION INHALATION Hemas METERED DOSE AE INHALER GlaxoSmithkiline FOR INHALATION SOLUTION SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP TREATEMENT TOPICAL SINAREST-S NASAL SF COMBIWAVE 250 SERETIDE EVOHALER SERETIDE EVOHALER SALHALE 400 POWDER DRY CORNS &WARTS) W/V +FLUTICASONE PROPIONATE 250MCG ACTUATION PRESSURISED INHALTION +FLUTICASONE PROPIONATE 250MCG ACTUATION PRESSURISED INHALTION +FLUTICASONE PROPIONATE 50MCG POWDER INHALATION CAPSULES POWDER INHALATION 400MCG BP 6188 2MG/5ML BP SYRUP SALBUTAMOL LEBASMA6189 2MG B.P TABLET SALBUTAMOL ORAL ASTHAMED6190 2MG B.P TABLET SALBUTAMOL TABLETS SALFIL-26191 4MG B.P TABLET SALBUTAMOL Akbar LEBASMA TABLETS6192 4MG B.P TABLET SALBUTAMOL Sunshine TABLETS N/A6193 2MG B.PTABLETS SALBUTAMOL N/A6194 Ceyoka (Pvt) Ltd ACID 17% W/W (ELLGY SALICYLIC Leben TABLETS6195 SOLUTION 0.74% SALINE NASAL TABLETS N/A6196 25MCG SALMETEROL Kamazu (Pvt) Ltd Syncom 6197 M S J Industries 25MCG SALMETEROL 6198 25MCG SALMETEROL 6187 DRY SULPHATE SALBUTAMOL 496 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIABANGLADESH 15-Jun-16 05-Jul-16 Full SRI LANKA Full 13-Nov-15 Full SRI LANKA 17-Aug-16BANGLADESH Full 05-Jul-16 Full INDIABANGLADESH 10-Oct-17 Years Two 05-Jul-16 Full SRI LANKA 17-Sep-16SRI LANKA Full 09-Jul-16FRANCE Full 17-Jun-16 Full Incepta Pharmaceuticals Ltd Sciences (Pvt) Ltd Cipla Ltd INDIAManufacturing (Pvt) Ltd Incepta 12-Sep-14Pharmaceuticals Ltd Full Concept Pharmaceuticals Ltd Incepta Pharmaceuticals Ltd Manufacturing (Pvt) Ltd Sciences (Pvt) Ltd Glaxo Wellcom Production Zone Industrille Glenmark Pharmaceuticals Ltd (Contd.) Citihealth Imports (Pvt) Ltd N/ABreathe Free Lanka (Pvt) Ltd Emergen Life (Pvt) Ltd International (Pvt) Ltd (Pvt) Ltd N/AN/A Lina GlaxoSmithkiline Pharmaceuticlas (Pvt) Ltd Emergen Life Pharmaceuticals (Pvt) Ltd FOR INHALATION FOR INHALATION POWDER CAPUSES POWDERDRY Softcare FOR INHALATION FOR INHALATION DOSE INHALER INHALATION Hemas SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP FLUTISAL 100FLUTISAL POWDER DRY 100FLUTIMATE POWDER DRY 100SEROFT INHALATION 250FLUTIVENT CAPSULES N/A 250FLUTISAL POWDER DRY Citihealth Imports DPI SEROLET Lina 50/500 500FLUTISAL POWDER DRY Citihealth Imports 500FLUTIVENT POWDER DRY FLUTIHALE 500 POWDER DRY N/A METERED COMBIWAVE SF COMBIWAVE 50 FLUTICASONE PROPRONATE FLUTICASONE PROPRONATE POWDER 100MCG DRY FLUTICASONE PROPRONATE POWDER 100MCG DRY FLUTICASONE PROPRONATE POWDER 100MCG DRY FLUTICASONE PROPRONATE POWDER FOR 250MCG DRY I CAPSULES INHALATION FLUTICASONE PROPRONATE POWDER FOR 250MCG DRY I CAPSULES INHALATION +FLUTICASONE PROPRONATE POWDER INHALTION 500MCG DRY CAPSULES +FLUTICASONE PROPRONATE POWDER INHALTION 500MCG DRY CAPSULES +FLUTICASONE PROPRONATE POWDER INHALTION 500MCG DRY CAPSULES FLUTICASONE PROPRONATE 500MCG CAP FLUTICASONE PROPRONATE 500MCG CAP +FLUTICASONE PROPRONATE +FLUTICASONE PROPRONATE AEROSOL 50MCG / ACTIVATION INHALATION 6200 50MCG & SALMETEROL 6201 50MCG & SALMETEROL 6202 50MCG & SALMETEROL 6203 50MCG & SALMETEROL 6204 50MCG & SALMETEROL 6205 50MCG SALMETEROL 6206 50MCG SALMETEROL 6207 50MCG SALMETEROL 6208 50MCG SALMETEROL 6209 50MCG SALMETEROL 6199 25MCG SALMETEROL I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 497 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 BANGLADESH 17-Jan-16 Full CHINA 04-Jan-18 Provisional FRANCE 17-Jun-16INDIA Full INDIA 29-Jan-16 Full 10-Mar-18 Full BANGLADESH 18-Nov-16 Full BANGLADESH 23-Nov-17 Years Two INDIA 24-Mar-18 Full Shandong Jewim Pharmaceutical Co. Ltd Cipla Ltd Glaxo Wellcom INDIAProduction Zone Industrille Glenmark Pharmaceuticals 20-May-14Ltd Full Cadila Healthcare Ltd Cipla LtdHealthcare INDIAPharmaceuticals Beximco Pharmaceuticals 06-Mar-14Ltd Full Cipla LtdCadila Healthcare INDIALtd 30-Apr-14 Full Cipla LtdThe ACME INDIALaboratories Ltd 14-Jun-14 Full (Contd.) (Ceylon) Ltd (Pvt) Ltd GlaxoSmithkiline Pharmaceuticlas (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Healthcare lanka Ltd Breathe Free Lanka (Pvt) Ltd (Pvt) Ltd Emerchemie NB (Ceylon) Ltd (Pvt) Ltd Sunshine Healthcare lanka Ltd (Pvt) Ltd Ltd DOSE INHALER INHALATION Hemas DOSE INHALER AEROSOL INHALATION DOSE INHALER CAPSULES Mega Pharma (Pvt) SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP FLUTIMATE 250FLUTIMATE CAPSULESSEROFLO Emerchemie NB CAPSULESN/A Breathe Free Lanka SF COMBIWAVE 125 METERED FORAIRSEROFLO INHALATION Sunshine METERED FLUMETOL INHALATIONBEXITROL-F 25/125 Citihealth Imports SEROFLO 50 HFA INHALATION Breathe Free Lanka FORAIR 250 METERED SEROFLO CAPSULESSALFLU 250 ROTACAP Breathe Free Lanka FLUTICASONE 250MCG POWDER INHALATION FLUTICASONE 250MCG POWDER INHALATION FLUTICASONE PROPIONATE 250MCG POWDER INHALATION PRESAURIAED PROPRONATE 125MCG ACTUATION 25MCG+FLUTICASONE 125MCG PROPIONATE 25MCG+FLUTICASONE 125MCG PROPIONATE 25MCG+FLUTICASONE 125MCG PROPIONATE 25MCG+FLUTICASONE 125MCG/ACTUATION PROPIONATE 25MCG+FLUTICASONE 50MCG/ACTUATION PROPIONATE 25MCG+FLUTICASONE PROPIONATE250MCG/Inhalation FLUTICASONE PROPINATE FLUTICASONE PROPINATE 500MCG CAP FLUTICASONE 250MCG POWDER INHALATION 6211 50MCG, SALMETEROL 6212 50MCG, SALMETEROL 6213 50MCG, SALMETEROL 6214 50MCG, SALMETEROL 6215 & FLUTICASONE SALMETEROL 6216 SALMETEROL 6217 SALMETEROL 6218 SALMETEROL 6219 SALMETEROL 6220 SALMETEROL 6221 SALMETEROL 6210 50MCG SALMETEROL 498 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 BANGLADESH 01-Dec-17 Full PAKISTAN 09-Mar-18FRANCE Full 21-Jun-16CHINA Full SRI LANKA 04-Jan-18 Years Two 15-May-16 Full SRI LANKA 15-May-16 Full SRI LANKA 09-Jul-15INDIA Full INDIA 15-Sep-17 Full 15-Sep-17 Full Cipla Ltd INDIA 30-Apr-14 Full Beximco Pharmaceuticals Ltd Cipla LtdGetz Pharma (Pvt) INDIALtd Glaxo Wellcom Production Zone 06-Mar-14Industrille Full Shandong Jewim Pharmaceutical Co. Ltd Manufacturing Akbar (Pvt) Ltd for Pharmaceuticals (Pvt) Ltd Manufacturing (Pvt) Ltd Sciences (Pvt) Ltd Midascare Pharmaceuticals (Pvt) Ltd Midascare Pharmaceuticals (Pvt) Ltd (Contd.) (Pvt) Ltd Emerchemie NB (Ceylon) Ltd Breathe Free Lanka (Pvt) Ltd Hemas Pharmaceuticals (Pvt) Ltd GlaxoSmithkiline Pharmaceuticlas (Pvt) Ltd (Ceylon) Ltd N/AN/A Lina Pharmaceuticals (Pvt) Ltd Emergen Life Lifeline Pharmaceuticals (Pvt) Ltd INHALATION Breathe Free Lanka INHALATION METERED DOSE INHALER INHALER DOSE INHALER FOR INHALATION POWDER CAPUSES INHALATION SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP SEROFLO 250 HFA BEXITROL-F AEROSOL SEROFLO 250 AUTHALER SALTROLN/A METERED 500FLUTIMATE CAPSULES METERED 500FLUTIDEL Emerchemie NB CAPSULES N/AFLUTIDEL POWDER DRY FLUTIHALE 250 Lina INHALATION 125HFAFLUSAL INHALATION Lifeline 250HFAFLUSAL AEROSOL 25MCG+FLUTICASONE PROPIONATE250MCG/Inhalation 25MCG+FLUTICASONE PROPIONATE250MCG/Inhalation 25MCG+FLUTICASONE PROPIONATE250MCG/Inhalation 25MCG+FLUTICASONE PROPIONATE250MCG/Inhalation FLUTICASONE 100MCG CAPSULES POWDER INHALER FOR DRY ,FLUTICASONE 500MCG DRY POWDER CAPSULES ,FLUTICASONE PROPIONATE POWDER 500MCG DRY CAPSULES INHALATION FLUTICASONE PROPIONATE POWDER 250MCG DRY CAPSULES INHALATION BP FLUTICASONE PROPIONATE 250MCG INHALATION FLUTICASONE PROPIONATE 125MCG AEROSOL FLUTICASONE PROPIONATE 250MCG 6222 SALMETEROL 6223 SALMETEROL 6224 SALMETEROL 6225 SALMETEROL 6226 50MCG & SALMETEROL 6227 50MCG SALMETEROL 6228 50MCG SALMETEROL 6229AND 50MCG SALMETEROL 6230AND 50MCG SALMETEROL 6231 25MCG, XINAFOATE SALMETEROL 6232 25MCG, XINAFOATE SALMETEROL I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 499 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 PHILIPPINES 11-Apr-14 Full PHILIPPINES 11-Apr-14 Full INDIAINDIA 26-Feb-15PAKISTAN Full 17-Dec-14 24-Feb-17 Full SWITZERLAND 27-Sep-18 Full Years Two INDIAINDIA 15-May-15 Full 17-Aug-14INDIA Full 27-Mar-15INDIA Full 21-Mar-14 Full LLOYD Laboratories Inc Unicure Ramadies (Pvt) Ltd Fredun Pharmaceuticals Ltd Nabiqasim Industries (Pvt) Ltd Novartis Pharma A G Biolab Co Ltd THAILAND(india) (Pvt) Ltd 13-Mar-15Sun Pharmaceutical Full industries Cipla LtdSun Pharmaceutical INDIAindustries Cipla Ltd 29-Mar-14India Ltd INDIA Full 06-Feb-14 Full LLOYD Laboratories Inc (Contd.) Slim Pharmaceuticals (Pvt) Ltd Health (Pvt) Ltd Health (Pvt) Ltd Health (Pvt) Ltd Baur & Co (Pvt) A Ltd Health (Pvt) Ltd (Ceylon) Ltd (Pvt) Ltd (Ceylon) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd SUSPENSION INJECTION SHAMPOO Ceyoka (Pvt) Ltd Galentic Pharma SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP SALMEFLO POWDER DRY SEOLEFRAMBI TABLETS TABLETS George Steuart COSENTYX George Steuart JULAB SOLUTION FOR SELDRUF Shampoo TABLETS 100ZOSERT George Steuart TABLETS 100SERDEP Emerchemie NB TABLETS 50ZOSERT Breathe Free Lanka TABLETS 50SERDEP Emerchemie NB ZERLIN 100 TABLETS TABLETS Breathe Free Lanka PharmAce (Pvt) Ltd Psychotropics SALMEFLO POWDER DRY Slim AND FLUTICASONE PROPIONATE AND FLUTICASONE PROPIONATE POWDER FOR 500MCG DRY INHALATION 1000MG 1000MG ML 5MG 2.5% w/v SUSPENSION USP 100MG 100MG 50MG TABLETS 50MG TABLETS 100MG USP TABLETS 40MCG+FLUTICASONE 250MCG DRY PROPIONATE IN POWDER FOR INHALATION CAPSULES 6234 50MCG SALMETEROL(XINAFOATE) 6235 (1G) SECNIDAZOLE TABLETS 6236 (1G) SECNIDAZOLE TABLETS 6237 1000MGTABLETS SECNIDAZOLE DYSEN FORTE6238 TABLETS SECUKINUMAB INJECTION 150MG/ 6239 George Steuart SELEGELINE HYDROCHLORIDE 6240 TOPICAL SELENIUM SULPHIDE 6241 HYDROCHLORIDE SERTRALINE 6242 HYDROCHLORIDE SERTRALINE 6243 HYDROCHLORIDE SERTRALINE 6244 HYDROCHLORIDE SERTRALINE 6245 HYDROCHLORIDE SERTRALINE 6233 XINAFOATE SALMETEROL 500 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 PAKISTAN 23-Jun-16PAKISTAN Full 23-Jun-16INDIA Full 05-Aug-14INDIA Full 17-Aug-14 Full BANGLADESH 31-Jan-14INDIA Full 13-Nov-18 Years Two INDIA 13-Aug-16UNITED STATES Full 16-Nov-18 Years Two INDIA 18-Jul-14 Full Genome Pharmceuticals (Pvt) Ltd Cadila Healthcare Ltd LaboratoriesIPCA INDIASun Pharmaceutical industries 01-Oct-17Years Two LaboratoriesIPCA INDIA LaboratoriesIPCA INDIA 01-Oct-17Years Two 01-Oct-17Sun Years Two Pharmaceutical industries Micro Labs Ltd INDIAPiramal Healthcare Ltd S RAbbvie S R L ITALY 23-Jul-14 Full Baxter Healthcare Corporation 16-May-18Oasis Full Laboratories (Pvt) Ltd Genome Pharmceuticals (Pvt) Ltd Healthcare Pharmaceuticals (Contd.) (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Ltd (Ceylon) Ltd Ltd Ltd (Ceylon) Ltd (Pvt) Ltd (Pvt) Ltd Healthcare lanka Ltd Pharmaceuticals (Pvt) Ltd ltd (Pvt) Ltd Citihealth Imports (Pvt) Ltd TABLETS SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP ERTALIN 50ERTALIN TABLETSSERLIN 50 Lanka Tabrane TABLETS Hemas N/ASEVORANE SOLUTION INHALATIONN/A Euro Asian Pharma Sunshine LIQUID Slim ERTALIN 100ERTALIN TABLETS Lanka Tabrane TABLETS USP 50MG USP TABLETS 50MG USP TABLETS ANAESTHETIC LIQUID ANAESTHETIC SOLUTION INHALATION TABLETS USP 100MG USP TABLETS 6247 HYDROCHLORIDE SERTRALINE 6248 HYDROCHLORIDE SERTRALINE 6249 100MGTABLETS SERTRALINE 6250 100 INOSERT 25MGTABLETS SERTRALINE TABLETS 25 ZOSERT 6251 50MGTABLETS SERTRALINE Emar Pharma (Pvt) 6252 TABLETS 50MGTABLETS SERTRALINE 50 INOSERT 6253 50MG Emerchemie NB TABLETS SERTRALINE TABLETS 50 INOSERT 6254 50MG BP TABLETS SERTRALINE TABLETS ANDEP Emar Pharma (Pvt) 50 ZOSERT 6255 Emar Pharma (Pvt) 50MG BP TABLETS SERTRALINE TABLETS FILM COA 50 ZOTRAL 6256 SEVOFLURANE INHALATION Emerchemie NB TABLETS6257 SEVOFLURANE INHALATION Micro Mega Lanka 6258 SEVOFLURANE LIQUID FOR 6259 100MGTABLETS SILDENAFIL 100 OSIGRA TABLETS RS Biogenics (Pvt) 6246 HYDROCHLORIDE SERTRALINE I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 501 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIA 02-Jul-18 Provisional INDIAINDIA 18-Jul-14 Full INDIA 07-Mar-18 Full INDIA 21-Mar-18 Provisional INDIA 26-Jul-18 Full INDIA 27-Jun-17 Full INDIA 21-Jan-14INDIA Full 06-Feb-14INDIA Full 24-Jan-17 Full INDIA 27-Jan-15 Full INDIA 28-Apr-14 Full 02-Mar-14 Full Centurion Laboratories Pvt Ltd Zee Laboratories INDIAOasis Laboratories (Pvt) Ltd 14-Jul-17Zim Laboratories Years Two Ltd Theon Pharmaceuticals Ltd Zim Laboratories Ltd Akums Drugs & Pharmaceuticals Ltd Pharmaceuticals (India) Ltd Unicure Ramadies (Pvt) Ltd Synmedic Laboratories (Pvt) Ltd Health Care IVA (Pvt) Ltd Laboratories (Pvt) Ltd Cadila pharmaceuticals Ltd (Contd.) (Pvt) Ltd Services Pvt. Ltd Imports (Pvt ) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Healthcare lanka Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP ENOGRA ODS 50ENOGRA ORALLY 100THEOGRA Tabrane TABLETS 100ENOGRA Slim TABLETS 100WELGRA Tabrane TABLETS 100EROGRA Brown & Burk TABLETSSANAGRA PharmAce (Pvt) Ltd Aurochem MAJEGRA TABLETS TABLETS 100IVAGRA Emar Pharma (Pvt) TABLETS Lifeline SILDEN 100 Slim TABLETSCUPID 100 Swiss Biogenics Ltd Cassal Research TABLETS Sunshine DISINTEGRATING STRIPS 50MG DISINTEGRATING 100MG 100MG 100MG 100MG 100MG 100MG 100MG 100MG 100MG 6261 100MGTABLETS SILDENAFIL 6262 100MGTABLETS ZEAGRA SILDENAFIL 100 OSIGRA 6263 ORALLY CITRATE SILDENAFIL TABLETS TABLETS6264 ABC Pharma TABLETS CITRATE SILDENAFIL Union Lanka 6265 TABLETS CITRATE SILDENAFIL 6266 TABLETS CITRATE SILDENAFIL 6267 TABLETS CITRATE SILDENAFIL 6268 TABLETS CITRATE SILDENAFIL 6269 TABLETS CITRATE SILDENAFIL 6270 TABLETS CITRATE SILDENAFIL 6271 TABLETS CITRATE SILDENAFIL 6272 TABLETS CITRATE SILDENAFIL 6260 100MGTABLETS SILDENAFIL N/A TABLETS International Yaden 502 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 12-Jun-14INDIA Full 23-Oct-14 Full 17-Jul-17INDIA Full INDIA 03-Feb-14INDIA Full 17-Dec-14 Full 21-Mar-18 Provisional INDIAINDIA 26-Jul-18 Full 04-Jul-17INDIA Full INDIA 15-Feb-14BANGLADESH Full 30-Jan-14 12-Sep-18 Full Full G D Laboratories (India) Pvt Ltd Akums Drugs & Pharmaceuticals Ltd Cipla LtdAjantha Pharma Ltd INDIAUmedica Laboratories (Pvt) Ltd 14-Dec-16Theon Pharmaceuticals Full Ltd Zee Laboratories INDIAZim Laboratories Ltd 24-Oct-17Akums Drugs & Years Two Pharmaceuticals Ltd Unicure Ramadies (Pvt) Ltd Agio Pharmaceuticals Ltd Pharmaceuticals Ltd Co. LLC (Contd.) Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Ltd Pharmaceuticals Pvt Ltd Pharmaceuticals (Pvt) Ltd Services Pvt. Ltd Pharmaceuticals (Pvt) Ltd Plc Ltd (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP GIAGRA 50WELGRA TABLETS TABLETS 100SILAGRA Lifeline Lotus TABLETSKAMAGRAPOWERGRA Breathe Free Lanka TABLETS TABLETS 50THEOGRA Baur & Co (Pvt) A Gamma TABLETSZEAGRA Slim 50ENOGRA TABLETS TABLETS 50WELGRA ABC Pharma Tabrane TABLETSSILDEN Browns & Company SANAGRA TABLETSAGIGRA TABLETS N/AVIGOREX 50 Emar Pharma (Pvt) TABLETS TABLETS Citihealth Imports Astron (Pvt) Ltd PharmAce (Pvt) Ltd Square SRI LANKA 12-Jan-16 Full VASIGRA TABLETS Ceyoka (Pvt) Ltd Global Pharma 50MG 100MG 100MG 100MG 100MG 100MG 50MG 50MG 50MG 50MG 50MG 50MG 50MG 100MG 6284 TABLETS CITRATE SILDENAFIL 6274 TABLETS CITRATE SILDENAFIL 6275 TABLETS CITRATE SILDENAFIL 6276 TABLETS CITRATE SILDENAFIL 6277 TABLETS CITRATE SILDENAFIL 6278 TABLETS CITRATE SILDENAFIL 6279 TABLETS CITRATE SILDENAFIL 6280 TABLETS CITRATE SILDENAFIL 6281 TABLETS CITRATE SILDENAFIL 6282 TABLETS CITRATE SILDENAFIL 6283 TABLETS CITRATE SILDENAFIL 6285 TABLETS CITRATE SILDENAFIL 6286 TABLETS CITRATE SILDENAFIL 6273 TABLETS CITRATE SILDENAFIL I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 503 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 27-Jan-16INDIA Full 26-Aug-15FRANCE Full 04-Jul-17 30-Sep-16 Full INDIA Full 16-Dec-14INDIA Full INDIA 05-Aug-14 Full 30-Nov-14INDIA Full 02-Aug-16INDIA Full INDIA 06-Apr-17 Full INDIA 27-Apr-18 Years Two 06-Jun-18 Years Two XL Laboratories XL (Pvt) Ltd Akums Drugs & Pharmaceuticals Ltd Fareva Amboise Zone Industrielle Astra Lifecare (India) (Pvt) Ltd Micro Labs Ltd INDIACadila Healthcare Ltd Umedica 18-Apr-15Laboratories (Pvt) Ltd Full Cipla LtdUnique Pharmaceutical INDIALabs 25-Feb-14Cadila pharmaceuticals Full Ltd G D Laboratories (India) Pvt Ltd Inventia Healthcare (Pvt) Ltd IVA Health Care IVA (Pvt) Ltd (Contd.) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Health (Pvt) Ltd Ltd Healthcare lanka Ltd Pharmaceuticals Pvt Ltd (Pvt) Ltd Health (Pvt) Ltd Healthcare lanka Ltd Pharmaceuticals (Pvt) Ltd (Ceylon) Ltd Pharmaceuticals (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP VILDEN 50 50WELGRA TABLETS TABLETSVIAGRA SMM Halcyon (Pvt) Lotus 50ASTAGRA TABLETS TABLETS 50NOVAGRA Hemas TABLETSPENEGRA-50 George Steuart TABLETS SMM Halcyon (Pvt) POWERGRA Sunshine TABLETS 50SILAGRA Gamma PENIMAX 50 TABLETS TABLETS Breathe Free Lanka NYTE 50 George Steuart CUPID 50 TABLETSGIAGRA TABLETS PharmAce (Pvt) Ltd Kopran Ltd Sunshine REGO TABLETS INDIA Lifeline TABLETS 10-Oct-16 Full Emerchemie NB IVAGRA 50IVAGRA TABLETS Slim 50MG 50MG 50MG 50MG 50MG 50MG 50MG 50MG 50MG 50MG 50MG 25MG 50MG TABLET 50MG 6298 TABLETS CITRATE SILDENAFIL 6288 TABLETS CITRATE SILDENAFIL 6289 TABLETS CITRATE SILDENAFIL 6290 TABLETS CITRATE SILDENAFIL 6291 TABLETS CITRATE SILDENAFIL 6292 TABLETS CITRATE SILDENAFIL 6293 TABLETS CITRATE SILDENAFIL 6294 TABLETS CITRATE SILDENAFIL 6295 TABLETS CITRATE SILDENAFIL 6296 TABLETS CITRATE SILDENAFIL 6297 TABLETS CITRATE SILDENAFIL 6299 IP TABLETS CITRATE SILDENAFIL 6300 ORODISPERSIBLE SILDENAFIL 6287 TABLETS CITRATE SILDENAFIL 504 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 18-Mar-18BANGLADESH Full 02-Aug-18 09-Dec-15 Full Full INDIAINDIA 18-Jul-16 Full INDIA 18-Jul-16BANGLADESH Full 08-Feb-18 10-Feb-14 Years Two INDIA Full INDIA 13-Sep-17 Years Two INDIA 19-Sep-17 Years Two 19-Sep-17 Years Two INDIAINDIA 13-Sep-17 Years Two 28-Mar-18 Years Two Company Ltd Pharmaceuticals Ltd Laboratories (Pvt) Ltd Oasis Laboratories (Pvt) Ltd Oasis Laboratories (Pvt) Ltd S Kant Healthcare Ltd Healthcare Pharmaceuticals Zim Laboratories Ltd Pharmaceuticals Ltd Pharmaceuticals Ltd Health Biotech Ltd BANGLADESH 14-Feb-18Years Zim Laboratories Two Ltd Unijules Life Sciences Ltd (Contd.) ltd Imports (Pvt ) Ltd Co Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP SILVERINEBURNA CREAMAssociates Pharma CREAM Raptakos Brett & PharmAce (Pvt) Ltd Square SILVINSILVELEB CREAM CREAM Kamazu (Pvt) Ltd Micro Labs Ltd Ceyoka (Pvt) Ltd Leben INDIA 28-Jun-18 Provisional SILZINE CREAM Lifeline CREAM USP % USP CREAM USP CREAM USP CREAM USP 6311 1 % W/W SULFADIAZINE SILVER 6313 1 % W/W SULFADIAZINE SILVER 6314 CREAM 1 SULFADIAZINE SILVER 6312 1 % W/W SULFADIAZINE SILVER 6302 50MGTABLETS SILDENAFIL 6303 50 OSIGRA 100MG BP TABLETS SILDENAFIL 100 DELGRA 6304 SILODOSIN CAPSULES 4MG TABLETS TABLETS6305 SILODOSIN CAPSULES 4MG Union Lanka FLOWRAP Delmege Forsyth & 6306 SILOSURE 4 SILODOSIN CAPSULES 8MG CAPSULES CAPSULES Citihealth Imports 6307 SILOCIN 8 SILODOSIN CAPSULES 8MG Tabrane 6308 CAPSULES SILOCIN 8 SILODOSIN CAPSULES 8MGAssociates Pharma 6309 Bafna SILODOSIN CAPSULES 8MG CAPSULES FLOWRAPAssociates Pharma 6310 SILOSURE 8 Bafna 1 % W/W SULFADIAZINE SILVER CAPSULES CAPSULES Citihealth Imports Tabrane 6301 50MGTABLETS SILDENAFIL 50 OSIGRA TABLETS RS Biogenics (Pvt) I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 505 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIATHAILAND 26-Jun-16 28-Feb-16THAILAND Full Full BANGLADESH 23-Nov-17 20-Nov-14 Full INDIA Full INDIA 07-Jul-16PAKISTAN Full 11-Aug-17GERMANY 22-Sep-14 Years Two Full 29-Jan-16PAKISTAN Full INDIA 03-Sep-14 Full INDIA 07-Nov-17 Years Two 23-Aug-17 Years Two INDIA 26-Jul-16 Full Mega Lifesciences Public Company (Pvt) Ltd R X Manufacturing Co. Ltd Laboratories Ltd Ltd Comed Chemical Ltd OBS Pakistan (Pvt) Ltd Denk Pharma GmbH & Co. OBS Pakistan (Pvt) Ltd Fourrts (India) Laboratories Ltd Comed Chemical Ltd Micro Labs Ltd INDIACipla LtdU S V Ltd 11-Aug-17At Medibios INDIAYears Two Laboratories (Pvt) Ltd LaboratoriesIPCA INDIA 21-Jul-15 Full 23-Feb-17 Full & Co Ltd (Contd.) Ltd Emerchemie NB (Ceylon) Ltd Harcourts (Pvt) Ltd Coral Laboratories Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Healthcare lanka Ltd Ltd (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd TABLETS SUSPENSION SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP ATR-XAEROPAC CHEWABLE COLIZA DROPS ORAL Prolifecare (Pvt) Ltd Amico ORAL GV ZINE CREAM CREAM Chamee Chemist Gopaldas Visram TABLETS 80MG TABLETS 20MG/0.3ML 40MG/ML USP USP 2% USP 6316 SIMETHICONE CAPSULES 200MG GAZGO6317 SIMETHICONE CHEWABLE CAPSULES6318 DROPS SIMETHICONE ORAL Baur & Co (Pvt) A 6319 SUSPENSION SIMETHICONE ORAL 6320 20MG USP TABLETS SIMVASTATIN 20 SIMVAX 6321 10MGTABLETS SIMVASTATIN TABLETS6322 20MG TABLETS ZOCOR 10 SIMVASTATIN C Medical (Pvt) T P SIMVO-DENK6323 TABLETS 40MGTABLETS SIMVASTATIN TABLETS6324 10MG USP TABLETS ZOCOR SIMVASTATIN Mansel (Ceylon) SIMTIN 10 Akbar 6325 10MG USP TABLETS SIMVASTATIN TABLETS TABLETS 10 SIMVAX 6326 10MG USP TABLETS SIMVASTATIN 10 SIMVAS Sunshine Mansel (Ceylon) TABLETS6327 10MG USP TABLETS SIMVASTATIN SIMCARD-10 TABLETS C Medical (Pvt) T P 6328 10MG USP TABLETS SIMVASTATIN TABLETS 10 ZOSTA Micro Mega Lanka Breathe Free Lanka 6329 TABLETS 10MG USP TABLETS SIMVASTATIN SIMLO 10 Hemas TABLETS Hemas 6315 SULPHADIAZINE CREAM SILVER 506 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 26-Jul-18 Provisional INDIA 06-Jul-18 Full PAKISTAN 12-Jul-18 Years Two INDIA 14-Mar-18 Full BANGLADESH 26-Feb-18 17-Apr-18 Provisional Years Two SRI LANKA 04-Aug-17Years Two BANGLADESH 30-Jun-16INDIA Full INDIA 23-Nov-17 Years Two PAKISTAN 08-Feb-18 14-Mar-18 Full Full Micro Labs Ltd INDIAMicro Labs Ltd INDIACipla Ltd 11-Aug-17Years Two U S V Ltd 11-Aug-16At Medibios INDIALaboratories (Pvt) Ltd Full Pharmaceuticals 21-Jul-15Ltd Full Concept Pharmaceuticals Ltd (Pvt ) Ltd Hilton Pharma (Pvt) Ltd The Acme Laboratories Ltd Manufacturing (Pvt) Ltd Healthcare Pharmaceuticals Sai Mirra Innopharm (Pvt) Ltd G D Laboratories (India) Pvt Ltd (Pvt ) Ltd (Contd.) (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd International (Pvt) Ltd Healthcare lanka Ltd Ltd (Pvt) Ltd Healthcare lanka Ltd Pharmaceuticals (Pvt) Ltd Ceyoka (Pvt) Ltd Genix Pharma TABLETS SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP SITRG 100 TABLETS 100CONSITA TABLETSAssociates Pharma Bafna GVIA Softcare SITAGLU TABLETS 100SITAGLIP TABLETS Ceyoka (Pvt) Ltd TABLETS 100SITAGLIN Sunshine Genix Pharma TABLETS Mega Pharma (Pvt) SILINOR 100MG TABLETS N/AJANTIN Citihealth Imports STIPTIN 100 TABLETS Lina TABLETSGVIA Sunshine Lifeline FILM COA 100MG 100MG 100MG 100MG 100MG 100MG 100MG 100MG 100MG 100MG 6331 20MG USP TABLETS SIMVASTATIN 20 SIMVAS 6332 20MG USP TABLETS SIMVASTATIN SIMCARD 20 TABLETS6333 5MG USP TABLETS SIMVASTATIN TABLETS 5 ZOSTA Micro Mega Lanka Breathe Free Lanka 6334 TABLETS PHOSPHATE SITAGLIPTIN TABLETS6335 TABLETS PHOSPHATE SITAGLIPTIN Hemas 6336 TABLETS PHOSPHATE SITAGLIPTIN 6337 TABLETS PHOSPHATE SITAGLIPTIN 6338 TABLETS PHOSPHATE SITAGLIPTIN 6339 TABLETS PHOSPHATE SITAGLIPTIN 6340 TABLETS PHOSPHATE SITAGLIPTIN 6341 TABLETS PHOSPHATE SITAGLIPTIN 6342 TABLETS PHOSPHATE SITAGLIPTIN 6343 TABLETS PHOSPHATE SITAGLIPTIN 6330 10MG USP TABLETS SIMVASTATIN 10 SIMVAS TABLETS Micro Mega Lanka I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 507 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 23-Jun-17PAKISTAN Full 08-Feb-18PAKISTAN 14-Mar-18 Full Full 05-Dec-18PAKISTAN Full BANGLADESH 20-Jun-17 04-Jun-16 Full Full PAKISTAN 02-Nov-17PAKISTAN Full 08-Sep-17INDIA Years Two PAKISTAN 14-Jun-15PAKISTAN 23-Jan-17 Full Full 03-Jan-14PAKISTAN Full 01-Mar-18PAKISTAN Years Two 24-May-18PAKISTAN Full 20-Jun-17 Full G D Laboratories (India) Pvt Ltd (Pvt ) Ltd The Schazoo Pharmaceutucal Laboratories (Pvt) Ltd (Pvt) Ltd Pharmaceuticals Ltd Scotmann Pharmaceuticals Shaigan Pharmaceuticals (Pvt) Ltd Zim Laboratories Ltd Ltd CCL Pharmaceuticals (Pvt) Ltd Getz Pharma (Pvt) Ltd Company Ltd (Pvt) Ltd Scences (Contd.) Pharmaceuticals (Pvt) Ltd Ceyoka (Pvt) Ltd Genix Pharma (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals Lanka (Pvt) Ltd Pharmaceuticals (Pvt) Ltd TABLETS SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP STIPTIN 50 TABLETSGVIA Lifeline FILM COA SWIZGLIPT 100SWIZGLIPT TABLETS PharmAce (Pvt) Ltd Swiss Garnier Life 100MG 50MG 100MG 6345 TABLETS PHOSPHATE SITAGLIPTIN 6346 TABLETS PHOSPHATE SITAGLIPTIN 6347 100MG TABLETS SITAGLIPTIN SITA-K6348 100MGTABLETS SITAGLIPTIN 6349 100MG LOWIPTINTABLETS SITAGLIPTIN TABLETS 100 SIGLITA 6350Associates Axero TABLETS 100MG TABLETS SITAGLIPTIN TABLETS TRAPEZE Ceyoka (Pvt) Ltd6351 100MGTABLETS SITAGLIPTIN Lowitt Pharma PharmAce (Pvt) Ltd Square 100 ADMIT TABLETS6352 100MGTABLETS SITAGLIPTIN Slim TABLETS 100 SITALIP 6353 100MGTABLETS SITAGLIPTIN Akbar TABLETS6354 100 100MG INOSITA TABLETS SITAGLIPTIN Tabrane TABLETS SITA6355 100MG TABLETS SITAGLIPTIN CIC Holdings PLC TREVIA PharmEvo (Pvt) 6356 100MGTABLETS SITAGLIPTIN TABLETS6357 100MG NSITTABLETS SITAGLIPTIN TABLETS CCL LOWIPTIN Hemas TABLETS TABLETS Morison PLC Ceyoka (Pvt) Ltd Lowitt Pharma The Searle 6344 TABLETS PHOSPHATE SITAGLIPTIN 508 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 03-Dec-14 Full INDIAPAKISTAN 23-Sep-17BANGLADESH 30-Jan-17 Full 29-Nov-17 Full Full INDIABANGLADESH 06-Feb-18 04-Jun-16 Full Full BANGLADESH 13-Feb-17 Full UNITED KINGDOM PAKISTAN 17-May-18INDIA Years Two PAKISTAN 26-Jul-18 Years Two 08-Sep-17PAKISTAN Years Two 31-Dec-14PAKISTAN Full PAKISTAN 14-Sep-17 Years Two 05-Dec-18 Full Theon Pharmaceuticals Ltd International Globe Pharmaceuticals Ltd Ankur Drugs & Pharma (Pvt) Ltd Pharmaceuticals Ltd Incepta Pharmaceuticals Ltd Merck Sharp & Dohme Ltd Concept Pharmaceuticals Ltd Shaigan Pharmaceuticals (Pvt) Ltd Getz Pharma Pakistan (Pvt) Ltd (Pvt) Ltd The Schazoo Pharmaceutucal Laboratories (Pvt) Ltd (Contd.) Pharmaceuticals (Pvt) Ltd (Pvt) Ltd International (Pvt) Ltd (Pvt) Ltd Ltd International (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP 6359 100MGTABLETS SITAGLIPTIN 6360 100MG SILO 100MGTABLETS SITAGLIPTIN TABLETS 100 SUCOSIT 6361 100MGTABLETS SITAGLIPTIN TABLETS Harcourts (Pvt) Ltd 100 SITALET Macter 6362 100MGTABLETS SITAGLIPTIN Healthcare Tabrane TABLETS 100 SIGLITA 6363 100MGTABLETS SITAGLIPTIN Softcare TABLETS 100 SITAGIL 6364 100MGTABLETS SITAGLIPTIN PharmAce (Pvt) Ltd Square TABLETS6365 100MG 25MG JANUVIA TABLETS SITAGLIPTIN TABLETS6366 Citihealth Imports 25MGTABLETS SITAGLIPTIN 25 INOSITA Baur & Co (Pvt) A 256367 CONSITA TABLETS 25MGTABLETS SITAGLIPTIN TABLETS CIC Holdings PLC6368 25 ADMIT 25MG TABLETS SITAGLIPTIN PharmEvo (Pvt) Softcare 6369 TREVIA TABLETS 50MGTABLETS SITAGLIPTIN 6370 Akbar 50MG TABLETS SITAGLIPTIN LOWIPTIN TABLETS SITA-K TABLETS Hemas Ceyoka (Pvt) Ltd TABLETS Lowitt Pharma Associates Axero 6358 100MGTABLETS SITAGLIPTIN 100 THEOGLIP TABLETS Slim I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 509 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 PAKISTANINDIA 22-Jun-18 Years Two INDIA 23-Aug-18 Years Two BANGLADESH 09-Jul-18 17-Apr-16 Years Two PAKISTAN Full 03-Jan-14PAKISTAN Full 01-Mar-18PAKISTAN Years Two 26-Feb-18PAKISTAN Full 08-Sep-17INDIA Years Two PAKISTAN 04-Jun-15BANGLADESH 23-Jan-15 Full 04-Jun-16 Full Full INDIAPAKISTAN 23-Jun-17 06-Sep-17PAKISTAN Full Full 30-Jan-17 Full Company Ltd Theon Pharmaceuticals Ltd Pharmaceuticals Ltd The ACME Laboratories Ltd CCL Pharmaceuticals (Pvt) Ltd Getz Pharma (Pvt) Ltd Hilton Pharma (Pvt) Ltd Shaigan Pharmaceuticals (Pvt) Ltd Zim Laboratories Ltd Ltd Incepta Pharmaceuticals Ltd Scences Scotmann Pharmaceuticals International (Contd.) Pharmaceuticals (Pvt) Ltd Ltd Pharmaceuticals Lanka (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Healthcare lanka Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP 6372 50MGTABLETS SITAGLIPTIN 6373 50 THEOGLIP 50MGTABLETS SITAGLIPTIN TABLETS6374 CONSITA 50MGTABLETS SITAGLIPTIN Slim 6375 50MG TABLETS SITAGLIPTIN 50 SITAGLIP TABLETS TABLETS6376 SITA 50MG Softcaps (Pvt) Ltd TABLETS SITAGLIPTIN Concept Mega Pharma (Pvt) 6377 TREVIA 50MG TABLETS SITAGLIPTIN TABLETS6378 SITAGLU 50MGTABLETS SITAGLIPTIN TABLETS CCL 6379 50 ADMIT Hemas TABLETS 50MGTABLETS SITAGLIPTIN Sunshine 506380 SITALIP TABLETS 50MGTABLETS SITAGLIPTIN 6381 50MG Akbar TABLETS TABLETS SITAGLIPTIN 50 INOSITA 50 6382 SITAGIL Tabrane TABLETS 50MGTABLETS SITAGLIPTIN 6383 TABLETS 50MG TABLETS SITAGLIPTIN CIC Holdings PLC 50 SWIZGLIPT PharmEvo (Pvt) TABLETS Citihealth Imports 6384 TRAPEZE 50MGTABLETS SITAGLIPTIN PharmAce (Pvt) Ltd Swiss Garnier Life SILO 50 TABLETS Slim TABLETS Harcourts (Pvt) Ltd Macter 6371 50MGTABLETS SITAGLIPTIN NSIT TABLETS Morison PLC The Searle 510 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIABANGLADESH 04-Jun-16 29-Jul-17 Full BANGLADESH Full 29-Nov-17 Full INDIAINDIA 06-Feb-18INDIA Full 17-May-15INDIA Full 04-Jul-18 Years Two INDIA 03-Sep-18 Years Two GERMANY 21-Mar-18 Provisional 07-Feb-17FRANCE Full INDIA 19-Oct-16 Full INDIA 21-Aug-18 Full THAILAND 14-May-15 30-Apr-17 Full INDIA Full 08-Sep-15 Full (Pvt) Ltd Pharmaceuticals Ltd Globe Pharmaceuticals Ltd Ankur Drugs & Pharma (Pvt) Ltd Health ICPA Products Ltd Bioproducts Vins (Pvt) Ltd Ltd Vaccine Kwality Pharmaceuticals Pvt Ltd B Braun Melsungen A G Care Pondchy Pharmaceuticals Centurion Laboratories Pvt Ltd Unison Laboratories Co Ltd Amanta Healthcare Ltd (Contd.) (Pvt) Ltd International (Pvt) Ltd George Steuart Health (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Healthcare lanka Ltd (Pvt) Ltd DENTAL SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP FLUORITOP SRFLUORITOP TOPICAL LYOPHILISED INJECTIONN/A Ceyoka (Pvt) Ltd Bharat Serums & N/A INJECTIONBI-BAG International Yaden RENADIUM INJECTION POWDER B Braun Lanka TABLETSN/A Ceyoka (Pvt) Ltd Neon Fresenius Medical ENEMAUNIMA ENEMA TABLETSN/A Sunshine International Yaden INJECTION Lanka Tabrane FLUORIDE VARNISH LYOPHILIZED 4.2%w/V USP INFUSION 8.4% INTRAVENOUS 650G/PACK FOR HAEMODIALYSIS 600MG USP 600MG USP 7GM 19GM+SODIUM PHOSPHATE 0.9% W/V 6386 50MGTABLETS SITAGLIPTIN 506387 SIGLITA 50MGTABLETS SITAGLIPTIN TABLETS6388 50 SUCOSIT 50MGTABLETS SITAGLIPTIN PharmAce (Pvt) Ltd TABLETS Square 506389 SITALET DENTAL TOPICAL SLOW RELEASE Healthcare Tabrane 6390 TABLETSANTISERUM I.P SNAKE VENOM N/A Softcare 6391 ANTISERUM IP SNAKE VENOME 6392 INJECTION SODIUM BICARBONATE INJECTION6393 SODIUM BICARBONATE Hemas 6394 POWDER SODIUM BICARBONATE 6395 TABLETS SODIUM BICARBONATE 6396 TABLETS SODIUM BICARBONATE 6397 SODIUM BIPHOSPHATE 6398 SODIUM CHLORIDE INJECTION BP 6385 50MGTABLETS SITAGLIPTIN ASITA TABLETSAssociates Pharma AMN Life Science I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 511 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 MALAYSIA 06-Dec-17 Full INDIAPHILIPPINES 23-Jun-17 31-Oct-18INDIA Years Two Full MALAYSIA 18-Mar-16 01-Jan-18INDIA Full Full MALAYSIA 03-Feb-16 06-Sep-17INDIA Full Years Two PAKISTAN 18-Mar-16 19-Jul-14 Full Full PHILIPPINES 09-May-16INDIA Full INDIA 01-Jun-18 Provisional MALAYSIA 07-Feb-18 Provisional 04-Jun-15 Full B Braun Medical Industries Phils Inc Ltd B Braun Medical Industries Fresenius Kabi India Pvt Ltd B Braun Medical Industries Ltd Company Ltd Laboratories Philippines Ltd Fresenius Kabi A.B Otsuka Pharmaceuticals (Pvt) Ltd Ain Medicare Sdn Bhd Aculife Healthcare (Pvt) Ltd (Contd.) (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Chamee Chemist Axa Parenterals Morison PLC The Searle Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Syndicate Medical Ltd Healthcare lanka Ltd INFUSION SOLUTION SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP N/A IV INJECTION B Braun Lanka N/AN/AN/A INJECTION CIC Holdings PLC I.V INFUSIONN/A Baxter Healthcare Chamee Chemist IV INFUSION Axa Parenterals N/A B Braun Lanka INFUSIONDNS Hemas LIQUIDPEDITRAL INFUSION ORAL VENOUS INTRA B Braun Lanka N/AN/A INFUSIONN/A Indoscan (Pvt) Ltd INJECTION Euromed NSINFUSOL Hemas INFUSION INJECTION Commercial Akbar N/A INJECTION Sunshine 3% BP USP 0.9 % USP INFUSION 4% GLUCOSE INTRAVENOUS INFUSION 5% GLUCOSE INTRAVENOUS INFUSION 5 % GLUCOSE INJECTION BP GLUCOSE 5% INFUSION CHLORIDE 1.75G,POTASSIUM 0.75MG,TRISODIUM CITRATE 1.45G,GLUCOSE DIHYDRATE ANHYDRAOUS 10.G (ORANGE FLAVOURED) INFUSION BOTTLES 0.9% USP 0.9% (500ML) 0.9% (500ML) 0.9% (500ML) 0.9% W/V 6411 SODIUM CHLORIDE INTRAVENOUS 6400 SODIUM CHLORIDE INJECTION 6401 SODIUM CHLORIDE (0.9%) IV 6402AND SODIUM CHLORIDE 0.18% 6403AND SODIUM CHLORIDE 0.45 6404 SODIUM CHLORIDE 0.45% 6405 SODIUM CHLORIDE 0.9% + 6406 SODIUM CHLORIDE 6407 SODIUM CHLORIDE INJECTION 6408 SODIUM CHLORIDE INTRAVENOUS 6409 SODIUM CHLORIDE INTRAVENOUS 6410 SODIUM CHLORIDE INTRAVENOUS 6399 SODIUM CHLORIDE INJECTION BP 512 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIACHINA 16-Sep-18 Full CHINA 27-Jul-18 Full MALAYSIA 27-Jul-17 18-Nov-17BANGLADESH Full 22-Oct-15 Full Full CHINAMALAYSIA 18-Mar-18 Provisional 18-Nov-17INDIA Full 11-Mar-14CHINA Full MACAU 01-Apr-14 Full 05-Jun-14PAKISTAN Full 10-Feb-14BANGLADESH Full 13-Jan-17 Full Pharmaceutical Co. ltd Pharmaceutical Co. Ltd B Braun Medical Industries Beximco Pharmaceuticals Ltd Hebei Tiancheng Pharmaceuticals Co Ltd B Braun Medical Industries Ltd Merck Limited INDIAAshford Laboratories Ltd Ashford 26-Aug-14Laboratories Ltd PharmaMBL Full PAKISTANLaboratories (Pvt) Ltd 01-Feb-16 Full Pharmaceuticals Ltd Aculife Healthcare (Pvt) Ltd (Contd.) B Braun Lanka (Pvt) Ltd (Ceylon) Ltd Slim Pharmaceuticals (Pvt) Ltd B Braun Lanka (Pvt) Ltd Emerchemie NB (Ceylon) Ltd (Pvt) Ltd (Pvt) Ltd Ltd Healthcare lanka Ltd INFUSION INFUSION INFUSION SOLUTION SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP N/AN/A INFUSIONN/A Pharma Associates Siehuan Kelun INJECTIONSALORIDE Pharma Associates Sichuan Kelun INTRA INJECTIONN/A Emerchemie NB N/A INTRA N/ANASI-SALINE INTRA NASAL N/A INJECTIONSALACYN CIC Holdings PLC Baxter (India)(Pvt) NASWASH EYE DROPS EYE DROPS Ceylon Teastar MICRONEMA Ceylon Teastar DROPS NASAL Markss HLC (Pvt) ENEMANACROMIN Morison PLC EYE DROPS PharmAce (Pvt) Ltd ATCO Square N/A INFUSION Sunshine INFUSION BP 0.9 % w/v INFUSION BP 0.9% W/V INFUSION BP 0.9% W/V INFUSION BP 0.9% W/V INFUSION BP 0.9% W/V INFUSION BP 0.9% W/V INFUSION BP INJECTION 0.9 % W/V SOLUTION 0.65% 0.9% SOLOTION USP 50mg/ml SOLUTION USP 0.9% AND 75MG SULPHATE LAURYL GLYCER 2% DROPS BP INFUSION BP 0.9 % w/v INFUSION BP 6413 SODIUM CHLORIDE INTRAVENOUS 6414 SODIUM CHLORIDE INTRAVENOUS 6415 SODIUM CHLORIDE INTRAVENOUS 6416 SODIUM CHLORIDE INTRAVENOUS 6417 SODIUM CHLORIDE INTRAVENOUS 6418 SODIUM CHLORIDE INTRAVENOUS 6419 FOR SODIUM CHLORIDE IP 6420 SODIUM CHLORIDE NASAL 6421 SODIUM CHLORIDE OPTHALAMIC 6422 SODIUM CHLORIDE OPTHALMIC 6423 SODIUM CHLORIDE SOLUTION BP 6424 450MG, SODIUM SODIUM CITRATE 6425 EYE SODIUM CROMOGLYCATE 6412 SODIUM CHLORIDE INTRAVENOUS I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 513 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 SPAIN 06-Feb-18 Years Two MALAYSIA 02-Dec-15BANGLADESH Full 12-Aug-14 Full INDIA 24-Mar-15 Full INDIAMALAYSIA 04-Jan-18BANGLADESH 02-Mar-15 Full 27-Mar-15 Full Full IRELAND 12-Jun-16 Full JAPANINDIA 02-Aug-18 Years Two 14-Aug-18 Years Two Pharmaceuticals SDN BHD Medicon Pharmaceuticals Ltd Apex Laboratories Ltd SA LEO Pharma DENMARK 12-Jun-15 Full S L Autovia De S L Logrono Indi Pharma (Pvt) Ltd , for Wallace Pharmaceuticala Kotra pharma (M) Ltd Eskayef Bangaladesh Ltd Leo Laboratories Ltd Laboratories LEO FRANCE G Chem LtdL 12-Jun-16 KOREASanten Full Pharmaceuticals Co. Ltd 15-Dec-14Sunway Rohto Pharmaceutical Full Pvt Ltd (Contd.) (Pvt) Ltd Ltd Hemas Pharmaceuticals (Pvt) Ltd Ceyoka (Pvt) Ltd Casen Recordat Ltd Co Ltd Healthcare lanka Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Services Pvt. Ltd Ltd International Yaden (Pvt) Ltd SOLUTION DRESSING INERT SOLUTION SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP FUSIWAL FUSIDICAXCEL CREAM OINTMENTFACIDO-O Delmege Forsyth & Emar Pharma (Pvt) OINTMENTFUCIDIN Sunshine FUCIDIN OINTMENT Hemas 200HYAL TABLETS 0.1%HYALEIN Hemas INJECTION EYE DROPS ABC Pharma HYVET-ES Baur & Co (Pvt) A OPHTHALMIC FUCIDIN INTERTULIE PHOSPHO SODA ORAL 2% 2% 2% 20MG/1G PH.EUR 250MG 1% (10mg/ml) DROPS 0.1%W/V SOLUTION 1.8% WITH SODIUM FUSIDATE WITH SODIUM FUSIDATE 2%(30MG/1.5G) OINTMENT PHOSPHATE DIHYDRATE DIHYDRATE PHOSPHATE & DISODIUM PHOSPHATE 24.4G.10.8G DODECAHYDRATE SOLUTION ORAL 6432 BP OINTMENT SODIUM FUSIDATE 6433 BP OINTMENT SODIUM FUSIDATE 6434 BP OINTMENT SODIUM FUSIDATE 6435 BP OINTMENT SODIUM FUSIDATE 6436 TABLETS SODIUM FUSIDATE 6437 INJECTION SODIUM HYALURONATE 6438 EYE SODIUM HYALURONATE 6439 OPHALMIC SODIUM HYALURONATE 6427 2% & 5G SODIUM FUSIDATE 6428 FOBAN 2% BP SODIUM FUSIDATE 6429 CREAM SODIUM FUSIDATE FUSIMED OINTMENT6430 IMPREGNATED SODIUM FUSIDATE Indoscan (Pvt) Ltd SOFINOX Hoe OINTMENT Act Enterpriese CREAM Baur & Co (Pvt) A 6426 SODIUM DIHYDROGEN 514 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 GERMANYHUNGARY 04-Jan-14 Full PAKISTAN 26-Nov-17 Years Two 24-Aug-16 Full INDIAINDIA 25-Jan-18GERMANY Full 11-Oct-18INDIA 02-Aug-18 Years Two Years Two INDIA 15-Feb-14INDIA Full 16-Aug-18 Years Two INDIA 03-May-17 Full INDIA 03-May-17 Full INDIA 03-May-17 Full 07-Sep-14 Full B Braun Avitum Avitum B Braun AG Institute of Isotopes Co Ltd Nabiqasim Industries (Pvt) Ltd for Surge Laboratories Healthcare Vital (Pvt) Ltd Mercury Laboratories Ltd Plus GmbH SG Pharma (Pvt) Ltd Scences Akums Drugs & Pharmaceuticals Ltd Akums Drugs & Pharmaceuticals Ltd Akums Drugs & Pharmaceuticals Ltd Sun Pharmaceutical industries (Contd.) (Pvt) Ltd (Pvt) Ltd George Steuart Health (Pvt) Ltd Ceyoka (Pvt) Ltd C B Fleet Co Ltd UNITED STATES 31-Jul-15(Pvt) Ltd Full (Pvt) Ltd Pharmacy (Pvt) Ltd Plc Pharmaceuticals (Pvt) Ltd Plc (Ceylon) Ltd SOLUTION ORAL SOLUTION TABLETS Browns & Company TABLETS Lotus TABLETS Browns & Company TABLETS Emerchemie NB SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP THYROTOPKLEEN ENEMA CAPSULES RECTAL Mitter International ENEMAFLEET ENEMA PHOSPHO FLEET DODA Ceyoka (Pvt) LtdSTIBOVITA C B Fleet Co Ltd UNITED STATES 31-Jul-18N/A INJECTION Full FIBROVEIN International Yaden 3%SOTRACIL INJECTION INJECTION INJECTION 200VALSURE Ceyoka (Pvt) Ltd International Yaden Hameln Pharma The Esses TABLETSBRAIPORIN 300MG PharmAce (Pvt) Ltd Swiss Garnier Life BRAIPORIN 300MG BRAIPORIN 500MG ENCORATE CHRONO 500 SOLCART BSOLCART CARTRIDGE B Braun Lanka USP 7.2g ,2.7g/15ml USP CAPSULES SOLUTION USP & (ADULT SOLUTION USP CHILDREN) 330MG/ML INJECTION BP 350MG INJECTION BP 3% INJECTION 3% 30MG/ML INJECTION BP 200MG CONTROLLED ACID BP RELEASE TABLETS 300MG CONTROLLED ACID BP RELEASE TABLETS 300MG CONTROLLED ACID BP RELEASE TABLETS 500MG CONTROLLED ACID BP RELEASE TABLETS TABLETS ACID 300MG CR CARTRIDGE FOR HAEMODIALYSIS CARTRIDGE 6444 SOLUTION SODIUM PHOSPHATE 6441 SODIUM IODIDE HARD 131 6442 RECTAL SODIUM PHOSPHATE 6443 RECTAL SODIUM PHOSPHATE 6445 SODIUM STIBOGLUCONATE 6446 SODIUM STIBOGLUCONATE 6447 SULPHATE SODIUM TETRADECYL 6448 SULPHATE SODIUM TETRADECYL 6449 & VALPROIC SODIUM VALPROATE 6450 & VALPROIC SODIUM VALPROATE 6451 & VALPROIC SODIUM VALPROATE 6452 & VALPROIC SODIUM VALPROATE 6453 & VALPROIC SODIUM VALPROATE 6440 SODIUM HYDROGEN CARBONATE I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 515 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 20-Apr-18 Years Two INDIAINDIA 28-Oct-17 Years Two INDIA 19-Jun-17 Full INDIA 28-Mar-18 Full 01-Jan-14 Full INDIAINDIA 09-May-15INDIA Full 15-Feb-18 Full 07-Aug-18 Years Two BANGLADESH 21-Dec-17 Years Two INDIABANGLADESH 16-Dec-14 06-Oct-14 Full Full BANGLADESH 21-Dec-17 Years Two BANGLADESH 02-Nov-17 Years Two KINGDOM INDIA 15-Feb-18 Full

Aventis UNITED fi fi fi Torrent Torrent Pharmaceuticals Ltd Pharmaceuticals Ltd Sun Pharmaceutical industries Sun Pharmaceutical industries (Pvt) Ltd Pharmafabrikon Unit Mercury Laboratories Ltd Torrent Torrent Pharmaceuticals Ltd Pharmaceuticals Ltd Bangaladesh Ltd Pharmaceuticals Ltd Bangaladesh Ltd Pharmafabrikon Unit (Contd.) Lanka Ltd Sano Lanka Ltd Sano Lanka Ltd Sano fi fi fi Edna Medicals (Pvt) Ltd (Ceylon) Ltd (Ceylon) Ltd (Pvt) Ltd International Yaden (Pvt) Ltd (Pvt) Ltd PharmAce (Pvt) Ltd Square (Pvt) Ltd TABLETS CIC Holdings PLCTABLETS Akums Drugs & Emerchemie NB TABLETS Emerchemie NB TABLETS Sano CONTROLLED RELEASE TABLETS SOLUTION TABLETS Edna Medicals TABLETS PharmAce (Pvt) Ltd Square TABLETS Sano CONTROLLED RELEASE TABLETS SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP EPILEX CHRONO 500 ENCORATE CHRONO 500 ENCORATE CHRONO 500 EPILIM CHRONO 500 VALPARIN VALPARIN CHRONO 300 S-VALPRON/A TABLETSN/AAssociates Pharma AMN Life Science TABLETS ORAL Novachem Lanka VALPARIN VALPARIN CHRONO 500 CR VALOATE 200MG EPILIM CHRONO 300 VALOATE CR VALOATE 300MG N/A TABLETS Sano N/A TABLETS Novachem Lanka ACID CONTROLLED RELEASE 500MG TABLETS RELEASE ACID SUSTAINED 500MG TABLETS ACID 58MG & VALPROIC TABLETS CONTROLLED RELEASE (SODIUM VALP.200MG) ACID 145MG VALPROIC TABLETS ACID 300MG CR TABLETS ACID 300MG CR RESISTANT TABLETS B.P 200MG B.P TABLETS RESISTANT 200MG/5ML SOLUTION BP VALPROIC ACID 145MG VALPROIC TABLETS CONTROLLED ACID BP VALPROIC 200MG RELEASE TABLETS 87.00MG ACID BP & VALPROIC TABLETS RELEASE TABLETS 300MG RELEASE TABLETS 200MG TABLETS RESISTANT RESISTANT TABLETS B.P 200MG B.P TABLETS RESISTANT 200MG B.P TABLETS RESISTANT 6455 & VALPROIC SODIUM VALPROATE 6456 & VALPROIC SODIUM VALPROATE 6457 133.5MG SODIUM VALPROATE 6458 333MG & SODIUM VALPROATE 6454 & VALPROIC SODIUM VALPROATE 6466 GASTRO SODIUM VALPROATE 6467 ORAL SODIUM VALPROATE 6459 333MG & SODIUM VALPROATE 6460 & BP SODIUM VALPROATE 6461 199.800MG BP SODIUM VALPROATE 6462 CONTROLLED SODIUM VALPROATE 6463 GASTRO SODIUM VALPROATE 6464 GASTRO SODIUM VALPROATE 6465 GASTRO SODIUM VALPROATE 516 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 BANGLADESH 26-Dec-14 Full INDIA 31-Dec-14INDIA Full INDIA 05-Nov-18 Years Two INDIA 26-Dec-18 Years Two INDIA 25-Oct-17INDIA Full 15-Dec-18INDIA Full 06-Jul-14INDIA Full 02-Aug-18 Years Two INDIA 16-Oct-17 Years Two 16-Oct-17INDIA Years Two INDIA 02-Jul-18 Provisional 12-May-17 Full Pharmaceuticals Ltd Elysium Pharmacuticals Torrent Ltd. For Pharmaceuticals Ltd Mercury Laboratories Ltd Sun Pharmaceutical industries Torrent Pharmaceuticals Ltd Pharmafabrikon Unit (Pvt) Ltd Cadila Healthcare Ltd Scences Scences Hetero Labs Ltd INDIACenturion Laboratories Pvt Ltd 14-Jan-18Zim Laboratories Provisional Ltd (Contd.) PharmAce (Pvt) Ltd Square (Pvt) Ltd (Pvt) Ltd (Ceylon) Ltd (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Health (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd TABLETS Edna Medicals SOLUTION SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP VALPARIN 200VALPARIN SYRUPN/A Edna Medicals ENCORATE TABLETS TABLETS VALPARIN-200 ALKALETS Emerchemie NB International Yaden N/AS-VALAPRO TABLETS TABLETSAssociates Pharma Novachem Lanka AMN Life Science N/ASOLFICARE 5 TABLETS TABLETS Tabrane International Yaden VALOATE SYRUPVALOATE ORAL SOLUTION BP 200MG/5ML SOLUTION BP 500MG B.P TABLET RELEASE TABLETS 200MG ENTERIC COATED TABLETS 200MG ENTERIC COATED 100MG GASTRO RESISTANT 100MG GASTRO RESISTANT 5MG TABLETS 5MG TABLETS SOLUTION BP 200MG/5ML SOLUTION BP 6469 ORAL SODIUM VALPROATE 6470 PROLONGED SODIUM VALPROATE 6471 B.P TABLETS SODIUM VALPROATE 6472 B.P TABLETS SODIUM VALPROATE 6473 BP TABLETS SODIUM VALPROATE 6474 BP TABLETS SODIUM VALPROATE 6475 400MGTABLETS SOFOSBUVIR 400MG SOVIHEP 6476 TABLETS 400MGTABLETS SOFOSBUVIR 6477 BUVIR-C 400MG Hemas TABLETS SOFOSBUVIR 6478 BUVIR-C 400MGTABLETS SOFOSBUVIR TABLETS6479 SOFGEN SOLIFENACIN SUCCINATE TABLETS PharmAce (Pvt) Ltd Swiss Garnier Life 6480 TABLETS SOLIFENACIN SUCCINATE PharmAce (Pvt) Ltd Swiss Garnier Life George Steuart 6468 ORAL SODIUM VALPROATE I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 517 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 ITALY 19-Mar-17 Full INDIAINDIA 11-Apr-18BANGLADESH Years Two 19-Sep-18 11-Apr-18 Provisional Years Two INDIA 22-May-15INDIA Full INDIA 24-Jul-14INDIA Full 30-Sep-15PAKISTAN Full 16-Oct-18 26-Oct-17 Full Full Novo Nordisk DENMARKMerck Serono S P A 08-Aug-17 Full Co. ltd ST Dong.A KOREANovo Nordisk 20-Jul-18 DENMARKYears Two Novo Nordisk 02-Aug-17 DENMARK Full Therdose Pharma (Pvt) Ltd 08-Aug-17Therdose Pharma Full (Pvt) Ltd Beacon Pharmaceuticals Ltd SG Pharma (Pvt) Ltd Cipla LtdSG Pharma (Pvt) Ltd INDIASamarth Life Sciences (Pvt) Ltd Simpex Pharma 16-Aug-18(Pvt) Ltd Full Company Ltd (Contd.) eld fi Healthcare lanka Ltd Ltd (Ceylon) Ltd Healthcare lanka Ltd Sunshine Healthcare lanka Ltd (Pvt) Ltd (Pvt) Ltd (Ceylon) Ltd Pharmacy (Pvt) Ltd (Pvt) Ltd Pharmacy (Pvt) Ltd Pharna (Pvt) Ltd Pharmaceuticals (Pvt) Ltd INJECTION Sunshine SOLUTION FOR INJECTION INJECTION Sunshine SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP SAIZEN 8mg INJECTIONGROWTROPIN II CARTRIDGE Baur & Co (Pvt) A NORDITROPIN Emerchemie NB NORDILET NORDITROPIN NORDILET SORANIXN/A TABLETS 40SOTALAR Emerchemie NB TABLETSN/A TABLETS Breathe Free Lanka The Esses TABLETS The Esses ALDACTONE TABLETS Morison PLC The Searle NORDITROPIN NORDILET RECOMBINANT 8MG (HUMAN RECOMBINANT GROWTH HORMONE 30IU CARTRIDGE RECOMBINANT 10MG/1.5ML /1.5ML 200MG TABLETS 160MG USP TABLETS 40MG USP TABLETS 80MG USP TABLETS TABLETS INJECTION 6482 FOR INJECTION SOMATROPIN 6483 HUMAN SOMATROPIN 6484 INJECTION SOMATROPIN 6485 INJECTION 5MG SOMATROPIN 6486 200MGTABLETS SORAFENIB 6487 200MGTABLETS SORAFENIB N/A6488 INN SORAFENIB TOSYLATE N/A6489 TABLETS HYDROCHLORIDE SOTALOL 6490 TABLETS HYDROCHLORIDE SOTALOL Pharma R N Vision 6491 HYDROCHLORIDE SOTALOL Pharma R N Vision 6492 40MG BP TABLETS SOTALOL 6493 3 M.I.U.TABLETS SPIRAMYCIN SOLET SPIRACIN6494 100MG BP SPIRONOLACTONE TABLETS TABLETS Ceylon Sergo Somer 6481 15MG /1.5ML SOMATROPIN 518 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 17-Nov-14 Full INDIA 17-May-16 Full 03-May-18 Provisional SRI LANKA 27-Jun-15INDIA Full INDIA 11-May-15 Full 16-Jul-15INDIA Full INDIA 16-Jun-16INDIA Full 22-Aug-18INDIA Full 13-Jun-15INDIA Full 02-Apr-15 Full INDIA 01-Dec-16 Full 27-Oct-17 Full Windlas Biotech (Pvt) Ltd Centaur Pharmaceutical (Pvt) Ltd State Pharmaceuticals Manufacturing Till Corporation at Heathcare Pvt Ltd Pharmaceuticals Manufacturer Corporation Unicure Ramadies (Pvt) Ltd Coast West Pharmaceurical works Ltd Sterling LabCadila INDIApharmaceuticals Ltd Ltd Vaccine 16-Feb-15 Healthcare Vital Full (Pvt) Ltd Nitin Lifesciences Ltd Fourrts (India) Laboratories Ltd Fourrts (India) Laboratories Ltd (Contd.) Pharmaceuticals (Pvt) Ltd Health (Pvt) Ltd Pharmaceuticals Manufacturer Corporation Ltd (Pvt) Ltd Co Ltd Sunshine Healthcare lanka Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Sunshine Healthcare lanka Ltd Sunshine Healthcare lanka Ltd INJECTION SUSPENSION SUSPENSION SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP SPILLAR 25 TABLETSN/A George Steuart N/A TABLETS State LACTONE TABLETSSPIROVEX 25 TABLETS N/A TABLETSLAXINORM Emar Pharma (Pvt) Global Impex AV STPASE GRANULES State Darley Butler & THROMBOFLUX POWDER / INJECTION 1000STREPIOVIT INJECTION Ceyoka (Pvt) Ltd Bharat Serums & N-SEPT International Yaden SUCRAFIL-O GEL ORAL INJECTION Slim SUCRAFIL ORAL 25MG 25MG 25MG 25MG 25MG 8% GRANULES 15,00,000 IU BP 1,500,000IU/VIAL 1000MG (1G) 1G INJECTION BP 20MG /10ML 6496 BP TABLETS SPIRONOLACTONE 6497 USP TABLETS SPIRONOLACTONE 6498 USP TABLETS SPIRONOLACTONE 6499 USP TABLETS SPIRONOLACTONE 6500 USP TABLETS SPIRONOLACTONE 6501 BP 62%+FRANGULA BP STERCULIA 6502 FOR INJECTION STREPTOKINASE 6503 for INJECTION BP. STREPTOKINASE 6504 INJECTION BP STREPTOMYCIN 6505 FOR SULPHATE STREPTOMYCIN 6506 1G & OXETACAINE SUCRALFATE 6507 SUSPENSION 1G SUCRALFATE 6495 25MG BP SPIRONOLACTONE SPILAC TABLETS Lifeline I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 519 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 30-Apr-14INDIA Full 26-Mar-14 Full INDIA 26-Mar-14INDIA Full 16-May-14INDIA Full 23-Jun-18 Years Two INDIA 01-Mar-15SRI LANKA Full 07-Feb-14 01-Jan-15INDIA Full Full INDIA 21-May-17INDIA Full 15-May-18INDIA Full 21-May-17 Full INDIA 26-Nov-15 Full INDIA 12-Nov-18 Years Two 26-Nov-15 Full zer fi SG Pharma (Pvt) Ltd Astral Pharmaceuical Industries India Astral Steritech (Pvt) Ltd for P Alkem Laboratories Ltd Centurion Laboratories Pvt Ltd SG Pharma (Pvt) Ltd PharmaceuticalS (Pvt) Ltd (Ceylon) (Pvt) Ltd Wallace Pharmaceuticals Ltd Pharmaceuticals Wallace Pharmaceuticals Ltd Pharmaceuticals Ltd Pharmaceuticals Ltd Pharmaceuticals Ltd Ltd (Contd.) Pharmacy (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Ceylon) Ltd (Pvt) Ltd Pharmacy (Pvt) Ltd Ltd Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP MAGNEXMAGNEX INJECTION Hemas INJECTION Hemas N/ASULZINE TABLETSN/A TABLETS International Yaden N/A The Esses TABLETSSAZO-EN 500 TABLETS Ceyoka (Pvt) Ltd TABLETSLAZO Ciron Drugs & Emar Pharma (Pvt) N/ASAZO-EN 500 TABLETS TABLETSN/A Emar Pharma (Pvt) Pharma Associates M S J Industries The Madras SALADOC TABLETS TABLETSN/A Pharma Associates Bafna Pharmatec (Pvt) Ltd Rhydburg TABLETS Pharma Associates Bafna MAGTAM 2GMAGTAM INJECTION Emerchemie NB 0.5G+CEFOPERAZONE 0.5G INJECTION 1G INJECTION 500MG 500MG 500MG 500MG 500MG USP TABLETS RELEASE 500MG USP TABLETS RELEASE 500MG USP TABLETS RELEASE 500MG BP TABLETS RESISTANT 500MG BP TABLETS RESISTANT 500MG BP TABLETS RESISTANT 1G INJECTION 6511 1G+CEFOPERAZONE SULBACTAM 6509 SULBACTAM 6510 1G+CEFOPERAZONE SULBACTAM 6512 USP TABLETS SULFADIAZINE 6513 USP TABLETS SULFADIAZINE 6514 USP TABLETS SULFASALAZINE 6515 USP TABLETS SULFASALAZINE 6516 DELAYED SULFASALAZINE 6517 DELAYED SULFASALAZINE 6518 DELAYED SULFASALAZINE 6519 GASTRO- SULFASALAZINE 6520 GASTRO- SULFASALAZINE 6521 GASTRO- SULFASALAZINE 6508 1G USP TABLETS SUCRALFATE N/A TABLETS The Esses 520 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 BANGLADESH 11-Apr-16 Full BANGLADESH 11-Apr-16 Full INDIAINDIA 11-Jul-16HUNGARY Full 24-Sep-14 23-Sep-14HUNGARY Full Full 23-Oct-14INDIA Full INDIA 23-Jun-17 Years Two INDIA 11-Jan-19 Years Two INDIA 11-Jan-19 Years Two 10-Jan-19 Years Two BANGLADESH 25-May-18 Years Two zer Italia SRL ITALYzer Italia SRL ITALY 23-Jun-15 Full 23-Jun-15 Full fi fi Popular Pharmaceuticals Ltd Popular Pharmaceuticals Ltd Zim Laboratories Ltd Ltd Teva Pharmaceuticals Industries Works Teva Pharmaceuticals Industries Ltd Centurion Laboratories Pvt Ltd Jodas Expoim Pvt Ltd Jodas Expoim Pvt Ltd Jodas Expoim Pvt Ltd P P Beacon Pharmaceuticals Ltd (Contd.) Services Pvt. Ltd Services Pvt. Ltd Pharmaceuticals (Pvt) Ltd (Ceylon) Ltd (Ceylon) Ltd (Pvt) Ltd International (Pvt) Ltd International (Pvt) Ltd International (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Ceylon) Ltd CAPSULES Hemas CAPSULES Hemas SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP N/A TABLETS Chamee Chemist Bajaj Healthcare SUTENT CAPSULES SUTENT CAPSULES SUNITIX CAPSULES Emerchemie NB 500MG 12.5mg 25MG 50MG 6523 100MG BP TABLETS SULINDAC ARTHODAC6524 200MG BP TABLETS SULINDAC TABLETS SULIDAC 2006525 USP SULPHASALAZINE TABLETS ABC Pharma TABLETS6526 100MGTABLETS SUMATRIPTAN Tabrane N/A6527 50MGTABLETS SUMATRIPTAN N/A6528 50MG BP TABLETS SUMATRIPTAN TABLETS 50 SUMITOP 6529 Emerchemie NB TABLETS SUNITINIB CAPSULES 12.5MG TABLETS JOSUNI 12.5 International Yaden 6530 SUNITINIB CAPSULES 25MG Emerchemie NB CAPSULES6531 JOSUNI 25 SUNITINIB CAPSULES 50MG Softcare CAPSULES6532 JOSUNI 50 CAPSULES SUNITINIB MALEATE Softcare CAPSULES6533 CAPSULES SUNITINIB MALEATE Softcare 6534 CAPSULES SUNITINIB MALEATE 6522 100MG BP TABLETS SULINDAC ARTHODAC TABLETS ABC Pharma I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 521 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 16-Nov-16 Full INDIASRI LANKA 13-Sep-17 04-Apr-16UNITED Years Two KINGDOM Full INDIAPAKISTAN 26-Sep-18 Years Two 09-Jan-14 Full INDIAINDIA 06-Jun-18 Years Two PAKISTAN 06-Jun-14 09-Jan-14 Full INDIA Full INDIA 10-Mar-18INDIA Full 25-Jul-18INDIA Years Two 18-Aug-16 Full 07-Jun-18 Years Two zer Italia SRL ITALY 23-Jun-15 Full fi P Therdose Pharma (Pvt) Ltd Pharmaceuticals Martindale Pharmaceuticals Swiss Paranterals (Pvt) Ltd CCL Pharmaceuticals (Pvt) Ltd Micro Labs Ltd INDIAAkriti pharmaceuticals Pvt Ltd Emcure 27-Apr-15Pharmaceuticals Ltd Full CCL Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Scences United Biotech (Pvt) Ltd Akriti pharmaceuticals Pvt Ltd (Contd.) Pharmaceuticals (Pvt) Ltd (Pvt) Ltd N/ALtd Eastern C Medical (Pvt) T P Ltd Pharmaceuticals Lanka (Pvt) Ltd Ltd Pharmaceuticals (Pvt) Ltd (Ceylon) Ltd Pharmaceuticals Lanka (Pvt) Ltd (Pte) Ltd Pharmaceuticals (Pvt) Ltd INJECTION CAPSULES Hemas SOLUTION SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP N/AN/A CAPSULES Pharma R N Vision N/A SOLUTION Niix Holdings (Pvt) SOLUTION FOR SUTENT SUTENT CAPSULES 50MG SOLUTION FOR 50MG/ML INJECTION (100MG IN 2ML) 100MG/2ML INJECTION BP 50MG 6536 CAPSULES SUNITINIB MALEATE 6537 B.P SPIRIT SURGICAL 6538 SUXAMETHONIUM CHLORIDE N/A6539 SUXAMETHONIUM CHLORIDE 6540 CAPSULES 0.5MG TACROLIMUS TACGRAF ANTISEPTIC 6541 CAPSULES 0.5MG TACROLIMUS CAPSULES SEEGRAF 0.56542 CAPSULES 0.5MG TACROLIMUS CAPSULES CCL AKROLIM 0.56543 CAPSULES 1MG SMM Halcyon (Pvt) TACROLIMUS CAPSULES VINGRAF 1 Slim 6544 CAPSULES 1MG TACROLIMUS CAPSULES TACGRAF6545 1MG CAPSULES USP TACROLIMUS TCOGLOB 1 Emerchemie NB 6546 CAPSULES 1MG CAPSULES USP TACROLIMUS CROMUS CAPSULES CCL 6547 1MG CAPSULES USP TACROLIMUS PharmAce (Pvt) Ltd 1 TACROTEC Globela Pharma CAPSULES6548 1MG CAPSULES USP TACROLIMUS CAPSULES AKROLIM 1 PharmAce (Pvt) Ltd Swiss Garnier Life R & D Intertrades CAPSULES Slim 6535 CAPSULES SUNITINIB MALEATE 522 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 10-Mar-18BANGLADESH Full 19-Jul-15 13-Aug-14 Full Full INDIAINDIA 29-Jun-15INDIA Full 17-May-14INDIA Full 16-Jul-14 Full IRELAND 05-Nov-17 Years Two IRELAND 25-Apr-18 Years Two IRELAND 26-Apr-18 Years Two BANGLADESH 26-Apr-18 26-Jul-18 Provisional Years Two INDIAINDIA 17-Apr-18 Full INDIA 25-Jan-19 Full 21-Jan-14 Full (Pvt) Ltd Coast West Pharmaceurical works Ltd Pharmaceuticals Ltd Glenmark Pharmaceuticals Ltd The Madras Pharmaceuticals Coast West Pharmaceurical works Ltd Glenmark Pharmaceuticals Ltd Astellas Ireland Co.Ltd Astellas Ireland Co.Ltd Astellas Ireland Co.Ltd The Acme Laboratories Ltd Macleods Pharmaceuticals Ltd Healthcare (Pvt) Ltd Pharmaceuticals (India) Ltd (Contd.) (Pvt) Ltd Healthcare lanka Ltd Ltd (Pvt) Ltd Healthcare lanka Ltd Ltd Ltd Ltd Ltd (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP ADVAGRAF 0.5ADVAGRAF CAPSULES 1ADVAGRAF Baur & Co (Pvt) A CAPSULES 3ADVAGRAF Baur & Co (Pvt) A CAPSULES Baur & Co (Pvt) A RELEASE HARD CAPSULES 0.5MG RELEASE HARD CAPSULES 1MG RELEASE HARD CAPSULES 3MG 6550 0.03% OINTMENT TACROLIMUS VEXLIMUS 0.36551 0.03% OINTMENT TACROLIMUS OINTMENT REMUS Global Impex AV 6552 0.1% W/W OINTMENT TACROLIMUS TACROZ OINTMENT6553 0.1% W/W OINTMENT TACROLIMUS ROCIMUS 0.1% OINTMENT PharmAce (Pvt) Ltd OINTMENT6554 Square 0.1% W/W OINTMENT TACROLIMUS VEXLIMUS 1.0MG Sunshine OINTMENT Baur & Co (Pvt) A 6555 0.3% OINTMENT Global Impex TACROLIMUS AV TACROZ6556 PROLONGED TACROLIMUS 6557 PROLONGED TACROLIMUS OINTMENT6558 Sunshine PROLONGED TACROLIMUS 6559 10MGTABLETS TADALAFIL 6560 10MGTABLETS TADALAFIL MEGAFIL6561 10MGTABLETS TADALAFIL DURON 10 TABLETS6562 TABLETS 10MGTABLETS 10 TADALAFIL GLOFIL Mega Pharma (Pvt) Pettah Pharmacy TABLETS 10 T-FIL Ceyoka (Pvt) Ltd TABLETS Global Pharma PharmAce (Pvt) Ltd Aurochem 6549 5MG CAPSULES USP TACROLIMUS TOOGLOB CAPSULES PharmAce (Pvt) Ltd Globela Pharma I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 523 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 COSTA RICACOSTA 24-Aug-17Years Two INDIAINDIA 25-Jan-14 Full BANGLADESH 21-Oct-17 06-Sep-18 Years Two Years Two INDIAINDIA 02-Oct-17 Years Two INDIA 21-Dec-17 Full INDIA 05-Jun-18 Full INDIA 25-Oct-18 Full INDIA 02-Apr-16 Full INDIA 10-May-18 Full INDIA 25-Oct-18 Full 17-Apr-18 Provisional Lilly France S.A.S France Healthcare (Pvt) Ltd Concept Pharmaceuticals Ltd The Acme Laboratories Ltd Cipla LtdConcept Pharmaceuticals INDIALtd Healthcare (Pvt) Ltd 27-Mar-14Zim Laboratories Full Ltd Fourrts (India) Laboratories Ltd Health Pell Tech Care (Pvt) Ltd Zim Laboratories Ltd Fourrts (India) Laboratories Ltd Macleods Pharmaceuticals Ltd (Contd.) Pharmaceuticals (Pvt) Ltd International (Pvt) Ltd Ltd (Pvt) Ltd International (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Sunshine Healthcare lanka Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Sunshine Healthcare lanka Ltd (Pvt) Ltd TABLETS TABLETS SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP 6564 10MGTABLETS TADALAFIL 6565 10MG TABLETS 10 TADALAFIL GLOFIL 6566 TABLETS 20MGTABLETS TADALAFIL TADACEPT6567 20MGTABLETS TADALAFIL Ceyoka (Pvt) Ltd TABLETS MEGAFIL Global Pharma 6568 20MGTABLETS TADALAFIL Softcare TADACIP TABLETS6569 20MGTABLETS 20 TADALAFIL TADACEPT TABLETS Mega Pharma (Pvt) TABLETS6570 10MG USP TABLETS 20 TADALAFIL GLOFIL Breathe Free Lanka Softcare 10 ZIMFIL 6571 TABLETS 10MG USP TABLETS TADALAFIL 10 EDSAVE TABLETS Ceyoka (Pvt) Ltd6572 10MG USP TABLETS TADALAFIL Global Pharma FILM COA Tabrane 10 TAFIL 6573 20MG USP TABLETS TADALAFIL 20 ZIMFIL TABLETS6574 20MG USP TABLETS TADALAFIL Slim 20 EDSAVE TABLETS6575 20MG USP TABLETS TADALAFIL FILM COA Tabrane DURON TABLETS Pettah Pharmacy 6563 10MG TABLETS TADALAFIL CIALIS TABLETS Hemas 524 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 09-Nov-15 Full INDIAINDIA 08-Apr-16 Full INDIA 17-Jun-17 Full JAPAN 25-Oct-18 Full INDIA 26-Dec-18 Years Two INDIA 28-Jul-18INDIA Years Two 09-Feb-18INDIA Full 01-Aug-18UNITED Years Two KINGDOM 01-Aug-17 Years Two INDIAPAKISTAN 02-Feb-15 22-May-14 Full INDIA Full INDIA 19-Nov-14 Full 20-May-18 Years Two Pell Tech Health Pell Tech Care (Pvt) Ltd Cadila pharmaceuticals Ltd Fourrts (India) Laboratories Ltd Santen Pharmaceuticals Co. Ltd Celon Laboratories Ltd Laboratories Ltd Co. LLC Co. LLC Astra Zeneca UK Ltd Zim Laboratories Ltd CCL Pharmaceuticals (Pvt) Ltd Akums Drugs & Pharmaceuticals Ltd Medibios Laboratories (Pvt) Ltd (Contd.) Pharmaceuticals (Pvt) Ltd Healthcare lanka Ltd Sunshine Healthcare lanka Ltd Baur & Co (Pvt) A Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals Lanka (Pvt) Ltd (Pvt) Ltd (Ceylon) Ltd SOLUTION TABLETS SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP TAFLOTAN OPHTHALMIC 0.4TAMSIN CAPSULES Tabrane 0.4TAMVEX CAPSULESBESTFLO Global Impex AV CAPSULES Emerchemie NB SOLUTION 0.0015% 0.4MG 0.4MG CAPSULES 0.4MG 6577 20MG USP TABLETS TADALAFIL 20Y JOVAN 6578 5MG USP TABLETS TADALAFIL TABLETS 5 EDSAVE 6579 OPHTHALMIC TAFLUPROST Sunshine FILM COA 6580 10MG USP CITRATE TAMOXIFEN 10 TAMOXILON 6581 10MG BP TABLETS TAMOXIFEN TABLETS MAMOFEN6582 20MG BP TABLETS TAMOXIFEN Medmart Pharma 20 TAMOLOB 6583 TABLETS 20MG BP TABLETS TAMOXIFEN TABLETS 20 TAMOLOB 6584 20MG BP TABLETS TAMOXIFEN Ceyoka (Pvt) Ltd TABLETS Khandelwal D PharmAce (Pvt) Ltd NOLVADEX Global Pharma 6585 EC CAPSULES TAMSULOSIN TABLETS PharmAce (Pvt) Ltd Global Pharma 6586 CAPSULES 0.4MG Hemas TAMSULOSIN MAXFLOW6587 CAPSULES USP TAMSULOSIN CAPSULES6588 HYDROCHLORIDE TAMSULOSIN CCL 6576 20MG USP TABLETS TADALAFIL 20 TAFIL TABLETS Slim I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 525 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 BANGLADESH 28-May-15 Full BANGLADESH 31-Oct-15PAKISTAN Full SRI LANKA 27-Aug-15 Full 27-Nov-18INDIA Provisional BANGLADESH 12-Jul-17 24-Jul-18 Full INDIA Full INDIA 26-May-16 Full INDIA 13-Jun-17 Full 13-Jun-17 Full BANGLADESH 30-Dec-17INDIA Full INDIA 17-Oct-14 Full 21-Dec-14 Full Pharmaceuticals Ltd Drug International Ltd Ferozsons Laboratories Ltd Sciences (Pvt) Ltd Macleods Pharmaceuticals Ltd Globe Pharmaceuticals Ltd Laboratories Titan (Pvt) Ltd Akums Drugs & Pharmaceuticals Ltd Akums Drugs & Pharmaceuticals Ltd Cipla LtdHealthcare INDIAPharmaceuticals S Kant Healthcare Ltd 24-Jan-14Cadila Healthcare Full Ltd (Contd.) (Pvt) Ltd (Ceylon) Ltd (Pvt) Ltd (Pvt) Ltd Lifescience (Pvt) Ltd Plc Pharmaceuticals (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd Delmege Forsyth & Co Ltd Pharmaceuticals (Pvt) Ltd RELEASE TABLETS SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP PROSTAMFLOSURE CAPSULESURIFLO Pharma Tropical CAPSULESTAMSUMAC Emerchemie NB CAPSULES CAPSULESTAMURIN N/A Pettah Pharmacy T-LOSIN CAPSULES Healthcare Tabrane Emergen Life XLWELTAM CAPSULES CAPSULES Negolec XLWELTAM Browns & Company CAPSULESURIMAX Lotus MRTAMISOL CAPSULES CAPSULESDELTAM Breathe Free Lanka Citihealth Imports N/A MODIFIED CAPSULES Hemas MAXRIN CAPSULES PharmAce (Pvt) Ltd Square CAPSULES 0.4MG CAPSULES 0.4MG 0.4M CAPSULES USP 0.4M CAPSULES USP 0.4M CAPSULES USP 0.4M CAPSULES USP 0.4MG CAPSULES USP 0.4MG CAPSULES USP MODIFILED MODIFLED RELEASE 200MCG CAP 400MCG MODIFILED RELEASE CAP MODIFILED RELEASE CAPSULES 0.4MG MODIFILED RELEASE CAPSULES 400MCG USP CAPSULES 0.4MG 6590 HYDROCHLORIDE TAMSULOSIN 6591 HYDROCHLORIDE TAMSULOSIN 6592 HYDROCHLORIDE TAMSULOSIN 6593 HYDROCHLORIDE TAMSULOSIN 6594 HYDROCHLORIDE TAMSULOSIN 6595 HYDROCHLORIDE TAMSULOSIN 6596 HYDROCHLORIDE TAMSULOSIN 6597 HYDROCHLORIDE TAMSULOSIN 6598 HYDROCHLORIDE TAMSULOSIN 6599 HYDROCHLORIDE TAMSULOSIN 6600 HYDROCHLORIDE TAMSULOSIN 6601 HYDROCHLORIDE TAMSULOSIN 6589 HYDROCHLORIDE TAMSULOSIN 526 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 09-Jul-18 Provisional INDIA 16-Mar-18 Years Two INDIA 02-Apr-15 Full 02-Apr-15 Full UNITED STATES 19-Sep-16 Full INDIAINDIA 03-May-14 Full 07-Jan-17 Full SWITZERLAND 21-Jul-14 Full INDIAPAKISTAN 18-Nov-17 13-Sep-15 Full INDIA Full 24-Nov-17 Full S P A S P ITALY 01-Mar-18 Full S P A S P ITALY 21-Jan-18 Full fi fi c Stridden c Stridden fi fi Centurion Laboratories Pvt Ltd (Pvt) Ltd GU Biopharma Pvt ltd GU Biopharma Pvt ltd (Pvt) Ltd Gland Pharma (Pvt) Ltd United Biotech (Pvt) Ltd Sano Novartis Pharma Stein .AG Switzerland for novatis Pharma Shcweiz AG Switzerland Torrent Pharmaceuticals Ltd (Pvt ) Ltd Atoz Pharmaceuticals (Pvt) Ltd (Contd.) Lanka Ltd Sano Aventis Aventis fi fi (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Slim Pharmaceuticals (Pvt) Ltd ABC Pharma Services Pvt. Ltd Ltd Lanka Ltd Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd INJECTION INJECTION SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP AMSO 200TICPLAT CAPSULES INJECTION 400AssociatesTICPLAT Pharma AMN Life Science Slim POWDER N/A CAPSULES International Yaden TELDAY-H TABLETSTELMIS-H Hemas H TABLETSTELSART- TABLETS Ceyoka (Pvt) Ltd Genix Pharma Asian Pharma Euro PROLONGED RELEASE CAPSULES 0.4MG BP 200MG 400MG PROLONGED RELEASE CAPSULES 0.2MG BP HYDROCHLOROTHIAZIDE 12.5MG TABLETS HYDROCHLOROTHIAZIDE 12.5MG TABLETS HYDROCHLOROTHIAZIDE 12.5MG TABLETS 6611 600MGTABLETS TELBIVUDINE SEBIVO 600MG TABLETS Baur & Co (Pvt) A 6603 HYDROCHLORIDE TAMSULOSIN 6604 TEICOPLANIN FOR INJECTION 6605 TEICOPLANIN FOR INJECTION 6606 TEICOPLANIN INJECTION 200MG TARGOCID INJECTION Sano 6602 HYDROCHLORIDE TAMSULOSIN 6608 TEICOPLANIN INJECTION 400MG ANTIC6609 TEICOPLANIN INJECTION 400MG TICOBACT6610 TEICOPLANIN INJECTION 400MG INJECTION TARGOCID POWDER FOR Associates Pharma AMN Life Science INJECTION Sano 6607 TEICOPLANIN INJECTION 400MG TECOPLAN INJECTIONArumed (Pvt) New 6612 40MG & TELMISARTAN 6613 40MG & TELMISARTAN 6614 40MG & TELMISARTAN I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 527 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIA 24-Mar-14 Full INDIAINDIA 25-Nov-14 Full INDIA 12-Feb-14 Full INDIA 20-Jun-17 Years Two INDIA 29-Apr-18 Full PAKISTAN 24-Feb-14 Full 08-Jun-17INDIA Years Two INDIA 30-Jul-15 Full INDIA 06-Dec-17 Full INDIA 06-Mar-14 Full 26-Nov-16 Full Troikaa Troikaa Pharmaceuticals Ltd Micro Labs Ltd INDIAAristo Pharmaceuticals Ltd 04-Apr-16Zim Laboratories Ltd Full Unichem Laboratories Cadila pharmaceuticals Ltd MSN Laboratories Alembic Pvt Ltd for Pharmaceuticals - India Ltd Coast West Pharmaceurical works Ltd Zim Laboratories Ltd Cadila Healthcare Ltd Zim Laboratories Ltd (Contd.) Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Co Ltd (Pvt) Ltd Ltd Healthcare lanka Ltd (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Healthcare lanka Ltd Pharmaceuticals (Pvt) Ltd TABLETS Global Impex AV SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP ARBITEL HARBITEL TABLETS HTELVAS Micro Mega Lanka TABLETSTELCARD H Darley Butler & TABLETSTELMISAR H Lanka Tabrane TABLETSTELI H Baur & Co (Pvt) A TELLZY-H TABLETS TABLETS Sunshine EVOSART-D Citihealth Imports TABLETSVEXTIS TH 40/12.5 CIC Holdings PLC PharmEvo (Pvt) TELCARD 80H TABLETS Tabrane TELMIKAA HTELMIKAA TABLETS Slim HYDROCHLOROTHIAZIDE 12.5MG TABLETS HYDROCHLOROTHIAZIDE 12.5MG TABLETS HYDROCHLOROTHIAZIDE 12.5MG TABLETS HYDROCHLOROTHIAZIDE 12.5MG TABLETS HYDROCHLOROTHIAZIDE 12.5MG TABLETS HYDROCHLOROTHIAZIDE USP 12.5MG TABLETS HYDROCHLOROTHIAZIDE USP 12.5MG TABLETS HYDROCHLOROTHIAZIDE USP 12.5MG TABLETS HYDROCHLOROTHIAZIDE 12.5MG TABLETS HYDROCHLOROTHIAZIDE 12.5MG TABLETS 6616 40MG & TELMISARTAN 6617 40MG & TELMISARTAN 6618 40MG & TELMISARTAN 6619 40MG & TELMISARTAN 6620 40MG & TELMISARTAN 6621 40MG & TELMISARTAN 6622 40MG & TELMISARTAN 6623 40MG & TELMISARTAN 6624 80MG & TELMISARTAN 6625 20MGTABLETS TELMISARTAN OD 20 TEL 6626 20MGTABLETS TELMISARTAN TABLETS TELCARD 20 TABLETS Sunshine Tabrane 6615 40MG & TELMISARTAN 528 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAPAKISTAN 13-Oct-17 22-Sep-17 Years Two Full INDIAINDIA 24-Mar-14 Full INDIA 06-Mar-14 Full INDIA 22-Jan-14 Full INDIA 01-Apr-14 Full INDIA 30-Apr-16 Full INDIA 08-Jun-15 Full INDIA 24-Mar-14 Full PAKISTAN 01-Jan-17 04-Jan-14 Full INDIA Full 27-Sep-14 Full Unichem Laboratories Getz Pharma (Pvt) Ltd U S V Ltd INDIA Troikaa Pharmaceuticals Ltd Cadila Healthcare 29-Jun-17Ltd Years Two Pharmaceuticals Ltd Cadila Healthcare Ltd Atoz Pharmaceuticals (Pvt) Ltd Torrent Pharmaceuticals Ltd Troikaa Pharmaceuticals Ltd Zim Laboratories Ltd CCL Pharmaceuticals (Pvt) Ltd Pharmaceuticals Ltd (Contd.) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Healthcare lanka Ltd Healthcare lanka Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals Lanka (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP 6628 20MG TABLETS TELMISARTAN TASMI6629 20MGTABLETS TELMISARTAN 20 TAZLOC 6630 20MGTABLETS TABLETS TELMISARTAN TABLETS 20 TELMIKAA Hemas 6631 20MGTABLETS TELMISARTAN TABLETS Hemas OD 20 TEL 6632 20MGTABLETS TELMISARTAN Slim TABLETS TELMED 206633 40MGTABLETS TELMISARTAN Sunshine TABLETS OD 40 TEL 6634 40MGTABLETS TELMISARTAN PharmAce (Pvt) Ltd Medley TABLETS 40 TELSART 6635 40MG TABLETS TELMISARTAN TABLETS Sunshine TELDAY6636 40MGTABLETS TELMISARTAN Asian Pharma Euro 40 TELMIKAA TABLETS6637 40MGTABLETS TELMISARTAN TABLETS Hemas TELCARD 406638 40MG TABLETS TELMISARTAN Slim TABLETS T-SAR6639 40MGTABLETS TELMISARTAN Tabrane TELMED 40 TABLETS TABLETS CCL PharmAce (Pvt) Ltd Medley 6627 20MGTABLETS TELMISARTAN TELMISAR 20 TABLETS Baur & Co (Pvt) A I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 529 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIA 01-Apr-14 Full INDIAINDIA 06-Jun-17 Years Two INDIA 15-Jun-15 Full 24-Mar-14 Full PAKISTAN 04-Jan-14INDIA Full INDIA 03-Feb-17 Full INDIA 11-Jan-14INDIA Full 08-Aug-14 Full 14-Jun-14 Full INDIA 28-Dec-17 Years Two Cadila Healthcare Ltd U S V Ltd INDIACadila Healthcare Ltd Marksons Pharma 08-Mar-18Ltd Years Two Troikaa Pharmaceuticals Ltd U S V Ltd INDIA CCL Pharmaceuticals (Pvt) Ltd Torrent 08-Mar-18Pharmaceuticals Years Two Ltd Aristo Pharmaceuticals Ltd MSN Laboratories Ltd BV Bal Pharma Ltd INDIA 29-Jan-16 Full Laboratories Bal Pharma Ltd INDIA 29-Jan-16 Full (Contd.) Lanka Ltd Unichem fi Healthcare lanka Ltd Pharmaceuticals (Pvt) Ltd Healthcare lanka Ltd Plc Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals Lanka (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Co Ltd Ltd (Pvt) Ltd (Pvt) Ltd TABLETS Darley Butler & SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP 80 6641 80MGTABLETS TELMISARTAN 80 TAZLOC 6642 80MGTABLETS TELMISARTAN TABLETS TEL-OD 806643 80MGTABLETS TELMISARTAN Hemas TABLETS6644 TELMIMARK 80 80MGTABLETS TELMISARTAN TABLETS 80 Sunshine TELMIKAA 6645 80MGTABLETS TELMISARTAN Browns & Company TABLETS 80 TAZLOC 6646 80MG TABLETS TELMISARTAN Slim TABLETS T-SAR6647 80MG TABLETS TELMISARTAN Hemas TELDAY6648 80MG TABLETS TABLETS TELMISARTAN TELVAS ARISTO TABLETS6649 CCL 80MGTABLETS TELMISARTAN 6650 Hemas CILZEC 80 20MG IP TABLETS TELMISARTAN TELPRES 806651 20MG IP TABLETS TELMISARTAN TABLETS TABLETS TELONG 206652 40MG IP TABLETS TELMISARTAN Baur & Co (Pvt) A TELSITE 40 TABLETS CIC Holdings PLC Abbott Biological TABLETS International Yaden Sano 6640 40MGTABLETS TELMISARTAN OD 40 TEL TABLETS Sunshine 6653 40MG IP TABLETS TELMISARTAN TELONG 40 TABLETS International Yaden 530 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAPAKISTAN 03-Feb-18INDIA 04-Jan-18 Full Full INDIA 27-Nov-17 Years Two INDIA 30-Mar-17 Full INDIA 22-Apr-16 Full PAKISTAN 27-Nov-17 Years Two INDIA 04-Jan-18 Full INDIA 10-Sep-16 Full 08-Apr-16INDIA Full INDIA 24-Apr-15INDIA Full 20-Jun-17INDIA Full 13-Nov-15 Full 27-Feb-18 Years Two Torrent Torrent Pharmaceuticals Ltd Ltd Cian Healthcare (Pvt) Ltd Aristo Pharmaceuticals Ltd Atoz Pharmaceuticals (Pvt) Ltd Cian Healthcare (Pvt) Ltd Ltd SRS Pharmaceuticals (Pvt) Ltd Theon Pharmaceuticals Ltd Kopran Ltd INDIALtd Scences 31-Aug-17 Health Care IVA Years Two (Pvt) Ltd Zota Healthcare Ltd (Contd.) Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Co Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Ltd Pharmaceuticals (Pvt) Ltd Ltd TABLETS Darley Butler & SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP 20 6655 20MG USP TABLETS TELMISARTAN EVOSART6656 20MG USP TABLETS TELMISARTAN 20 TANSAR TABLETS6657 TABLETS 20MG USP TABLETS TELMISARTAN TELVAS ARISTO CIC Holdings PLC PharmEvo (Pvt) Slim 6658 20MG USP TABLETS TELMISARTAN 20 TELSART TABLETS6659 20MG USP TABLETS TELMISARTAN 20 TANSAR Asian Pharma Euro 6660 TABLETS 20MG USP TABLETS TELMISARTAN EVOSART6661 20MG USP TABLETS Slim TELMISARTAN TELMI-K 20 TABLETS6662 TABLETS 20MG USP TABLETS TELMISARTAN TELSAR 20 CIC Holdings PLC PharmEvo (Pvt) Associates Axero 6663 TABLETS 20MG USP TABLETS TELMISARTAN 20 TELSTART 6664 TABLETS 20MG USP TABLETS TELMISARTAN Slim TELMICO 806665 20MG USP TABLETS TELMISARTAN Alaris Lanka (Pvt) TABLETS TELSURE 206666 20MG USP TABLETS TELMISARTAN TABLETS 20 IVATEL Harcourts (Pvt) Ltd Coral Laboratories 6667 PharmAce (Pvt) Ltd 20MG USP TABLETS TELMISARTAN Swiss Garnier Life TABLETS 20 CDTEL Slim TABLETS Alaris Lanka (Pvt) 6654 20MG USP TABLETS TELMISARTAN TELDAY TABLETS Hemas I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 531 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIA 15-Apr-16 Full INDIAINDIA 20-Mar-16 Full INDIA 11-Aug-17 Full PAKISTAN 30-Mar-15 22-Sep-17 Full Years INDIA Two INDIA 24-Feb-15INDIA Full 16-Jul-14INDIA Full 27-Mar-18 Years Two INDIA 20-Mar-16PAKISTAN Full 30-Oct-14 18-Dec-17 Full Full Innova Captab INDIA Laboratories Titan (Pvt) Ltd 24-Aug-16U S V Ltd Full INDIAOasis Laboratories (Pvt) Ltd Umedica 29-Jun-18Laboratories (Pvt) Ltd Full Aristo Pharmaceuticals Ltd Getz Pharma (Pvt) Ltd Laboratories XL (Pvt) Ltd Coast West Pharmaceurical works Ltd Zota Healthcare Ltd Oasis Laboratories (Pvt) Ltd Alkem Laboratories Ltd Ltd (Contd.) Pharmaceuticals (Pvt) Ltd Lifescience (Pvt) Ltd Pharmaceuticals (Pvt) Ltd ltd Pharmaceuticals (Pvt) Ltd Co Ltd Pharmaceuticals (Pvt) Ltd Ltd (Pvt) Ltd Ltd Imports (Pvt ) Ltd (Ceylon) Ltd TABLETS Darley Butler & SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP 40 6669 20MG USP TABLETS TELMISARTAN 20 T-TAN 6670 40MG USP TABLETS TELMISARTAN 40 TABLETS TAZLOC 6671 40MG USP Negolec TABLETS TABLETS TELMISARTAN M OSITEL Hemas 6672 40MG USP TABLETS TELMISARTAN 40 TABLETS UMESARTAN TABLETS6673 40MG USP RS Biogenics (Pvt) TABLETS TELMISARTAN TELVAS ARISTO Gamma 6674 40MG USP TABLETS TELMISARTAN TASMI6675 40MG USP TABLETS TELMISARTAN TISARTAN TABLETS6676 40MG USP TABLETS TELMISARTAN VEXTIS 40 TABLETS Hemas 6677 40MG USP TABLETS TELMISARTAN TABLETS 40TEL CD SMM Halcyon (Pvt) 6678 40MG USP TABLETS TELMISARTAN M OSITEL Global Impex AV TABLETS6679 40MG USP TABLETS TELMISARTAN TABLETS 40 TSART Alaris Lanka (Pvt) 6680 40MG USP TABLETS TELMISARTAN 40 EVOSART Union Lanka TABLETS TABLETS Emerchemie NB CIC Holdings PLC PharmEvo (Pvt) 6668 20MG USP TABLETS TELMISARTAN 20 INNOTEL TABLETS Slim 532 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 27-Jan-15 Full INDIA 24-Aug-16INDIA Full 20-Jun-17INDIA Full 13-Nov-15 Full 27-Jun-17 Full INDIAINDIA 12-Sep-15 Full INDIA 15-Apr-16 Full INDIA 10-Sep-16 Full INDIA 08-Apr-16INDIA Full 29-Sep-15PAKISTAN Full 23-Aug-17 22-Sep-17 Full Years Two MSN Laboratories Alembic Pvt Ltd for Pharmaceuticals - India Fredun Pharmaceuticals Ltd Scences Health Care IVA (Pvt) Ltd Akums Drugs & Pharmaceuticals Ltd Innova Captab INDIACadila pharmaceuticals Ltd 24-Aug-16 Laboratories Titan (Pvt) Ltd Full SRS Pharmaceuticals (Pvt) Ltd Theon Pharmaceuticals Ltd Cooper Pharma Ltd Akums Drugs & Pharmaceuticals Ltd Getz Pharma (Pvt) Ltd (Contd.) (Pvt) Ltd Health (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Healthcare lanka Ltd Lifescience (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Ltd Lotus Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd INJECTION SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP 6682 40MG USP TABLETS TELMISARTAN TELZI 406683 40MG USP TABLETS TELMISARTAN TELSURE 40 TABLETS6684 40MG USP TABLETS TELMISARTAN TABLETS 40 IVATEL George Steuart 6685 PharmAce (Pvt) Ltd 40MG USP TABLETS TELMISARTAN Swiss Garnier Life TABLETS TELCOR 406686 Slim TABLETS 40MG USP TABLETS TELMISARTAN 40 INNOTEL Lotus 6687 TABLETS 40MG USP TABLETS TELMISARTAN TELI 40 Slim 6688 40MG USP TABLETS TELMISARTAN 40 T-TAN TABLETS6689 40MG USP TABLETS TELMISARTAN TELMI-K 40 TABLETS Sunshine 6690 40MG USP TABLETS TABLETS TELMISARTAN Negolec TELSAN 40Associates Axero 6691 40MG USP TABLETS TABLETS TELMISARTAN RENISAR 406692 80MG USP TABLETS TELMISARTAN Slim TABLETS TELCOR 806693 POWDER / 80MG USP Arrow Pharma (Pvt) TABLETS TELMISARTAN TASMI TABLETS Hemas 6681 40MG USP TABLETS TELMISARTAN 40 TELZY TABLETS Citihealth Imports I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 533 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 18-Aug-17 Years Two INDIA 16-Jul-14 Full INDIA 03-Feb-15 Full INDIA 28-Feb-18 Years Two INDIA 25-Aug-16 Full INDIA 13-Nov-15 Full INDIA 15-Apr-16INDIA Full 29-Sep-15INDIA Full 23-Aug-17 Full INDIA 12-Sep-16INDIA Full 09-Nov-17INDIA Years Two 01-May-18 Provisional 21-Feb-18 Years Two Atoz Pharmaceuticals (Pvt) Ltd Coast West Pharmaceurical works Ltd MSN Laboratories Alembic Pvt Ltd for Pharmaceuticals - India Zim Laboratories Ltd Fredun Pharmaceuticals Ltd Health Care IVA (Pvt) Ltd Laboratories Titan (Pvt) Ltd Cooper Pharma Ltd Akums Drugs & Pharmaceuticals Ltd Cadila pharmaceuticals Ltd United Biotech (Pvt) Ltd Reliance Life Sciences (Pvt) Ltd United Biotech (Pvt) Ltd (Contd.) (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Health (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Lifescience (Pvt) Ltd Ltd Lotus Pharmaceuticals (Pvt) Ltd Healthcare lanka Ltd Health (Pvt) Ltd Services Pvt. Ltd Health (Pvt) Ltd INJECTION SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP TEMOTEC 100 CAPSULES 100TEMOREL George Steuart CAPSULESTEMOTEC 250 ABC Pharma CAPSULES George Steuart 100MG 100MG 250MG 6695 80MG USP TABLETS TELMISARTAN VEXTIS 806696 80MG USP TABLETS TELMISARTAN TABLETS 80 TELLZY Global Impex AV TABLETS6697 80MG USP TABLETS TELMISARTAN TELCARD 80 Citihealth Imports TABLETS6698 80MG USP TABLETS TELMISARTAN TELZI 80 Tabrane 6699 80MG USP TABLETS TELMISARTAN 80 IVATEL TABLETS6700 80MG USP TABLETS TELMISARTAN George Steuart TABLETS 80 T-TAN 6701 Slim 80MG USP TABLETS TELMISARTAN RENISAR 80 TABLETS6702 80MG USP TABLETS TELMISARTAN TABLETS TELCOR 80 Negolec 6703 POWDER / 80MG USP Arrow Pharma (Pvt) TABLETS TELMISARTAN TELI 806704 TEMOZOLOMIDE CAPSULES TABLETS6705 TEMOZOLOMIDE CAPSULES Sunshine 6706 TEMOZOLOMIDE CAPSULES 6694 80MG USP TABLETS TELMISARTAN 80 TELSART TABLETSAsian Pharma Euro 534 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIA 05-Dec-17 Years Two PAKISTAN 23-Jan-18INDIA Full PAKISTAN 11-Jul-16 23-Jan-18 Full PAKISTAN Full 09-Dec-14INDIA Full INDIA 02-Jul-18 Provisional INDIA 02-Jul-18 Provisional 02-Jul-18 Provisional INDIAGERMANY 27-Apr-18 19-Oct-15 Provisional INDIA Full 05-Dec-17 Years Two Mcneil & Argus Mcneil & Pharmaceuticals ltd Cipla LtdLaboratories (Pvt) INDIALtd Zim Laboratories Ltd 15-Oct-15 Full Laboratories (Pvt) Ltd Abbott Laboratories Centurion Laboratories Pvt Ltd Centurion Laboratories Pvt Ltd Centurion Laboratories Pvt Ltd Cipla Ltd INDIA 15-Dec-16 Full Reliance Life Sciences (Pvt) Ltd Boehringer Ingelheim Pharma gmBH & Co.Kg Argus Mcneil & Pharmaceuticals ltd (Contd.) Services Pvt. Ltd Hemas Pharmaceuticals (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Healthcare lanka Ltd (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd INJECTION SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP TENVIR TABLETS Breathe Free Lanka TERBIFIN CREAM Breathe Free Lanka TENMAC-EM TABLETS International Yaden METALYSE POWDER FOR TENMAC-EM TABLETS International Yaden TEMOREL 250TEMOREL CAPSULES ABC Pharma 40MG /VIAL 300MG & FUMARATE TABLETS 200MG EMTRICITABINE 250MG FUMARATE TABLETS 300MG TABLETS FUMARATE CREAM FUMARATE 300MG & FUMARATE TABLETS 200MG EMTRICITABINE 6711 TENOFOVIR DISOPROXIL 6708 TENECTEPLASE FOR INJECTION 6709 TENOFOVIR DISOPROXIL 6707 TEMOZOLOMIDE CAPSULES 6712 TENOFOVIR DISOPROXIL 6713 20MG BP TABLETS TENOXICAM 20 TOBITILL 6714 20MG BP TABLETS TENOXICAM TABLETS TENOXIM6715 20MG BP TABLETS TENOXICAM PharmAce (Pvt) Ltd Wilshire 20 TOBITILL TABLETS6716 TERAZOSIN HYDROCHLORIDE 2MG HYTRIN TABLETS Tabrane 6717 1MG USP TABLETS TERAZOSIN PharmAce (Pvt) Ltd Wilshire TABLETS N/A6718 2MG USP TABLETS TERAZOSIN Sunshine N/A6719 5MG USP TABLETS TERAZOSIN TABLETS N/A6720 International CREAM 1% TERBINAFINE HCL Yaden TABLETS International Yaden TABLETS International Yaden I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 535 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 PAKISTAN 06-Feb-14INDIA Full 04-Apr-14INDIA Full INDIA 11-Feb-16INDIA Full 28-Mar-14PAKISTAN Full 12-Oct-17 12-Jan-18 Full Full BANGLADESH 21-Jul-16 Full PAKISTAN 23-Mar-17 Full PAKISTAN 25-Aug-15PAKISTAN Full 27-Apr-18 Years Two Elko Organization (Pvt) Ltd Aurochem Pharmaceuticals (India) Ltd Micro Labs Ltd INDIAAgio Pharmaceuticals Ltd 09-Oct-15Indi Pharma (Pvt) Ltd Full Unique Pharmaceutical Labs Laboratories (Pvt) Ltd Micro Labs Ltd INDIAPharmaceuticals Ltd Pharma 09-Oct-15Tabros (Pvt) Ltd Full Medochemie Ltd CYPRUS Pharma Tabros 01-Sep-17(Pvt) Ltd Full Laboratories (Pvt) Ltd (Contd.) (Ceylon) Ltd Pharmaceuticals (Pvt) Ltd Ltd (Pvt) Ltd Ltd Health (Pvt) Ltd Ltd Laboratories (Pvt) Ltd Laboratories (Pvt) Ltd Laboratories (Pvt) Ltd CREAM George Steuart TABLETS Associated SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP TERBISANTERBINAFORCE CREAM CREAMFINTRIX Emerchemie NB Hemas TERBIZED CREAM CREAMCREAM TERBINYL CREAM SMM Halcyon (Pvt) TERBINOX Citihealth Imports CREAM 1.0% Emar Pharma (Pvt) TERBIDERM CREAMFINTRIX Morison PLCXFIN CREAM 1% CREAM CREAM ATCO CUTIS CREAM PharmAce (Pvt) Ltd SMM Halcyon (Pvt) Square CREAMMEDOFLORAN 250 Associated CREAM CREAM 1% CREAM 1% CREAM 1% CREAM 1% CREAM 1% CREAM 1% CREAM 1% CREAM CREAM 10MG/G 1% 250MG TABLETS 6721 CREAM 1% TERBINAFINE HCL 6722 CREAM 1% TERBINAFINE HCL 6723 TERBINAFINE HYDROCHLORIDE 6724 TERBINAFINE HYDROCHLORIDE 6725 TERBINAFINE HYDROCHLORIDE 6726 TERBINAFINE HYDROCHLORIDE 6727 TERBINAFINE HYDROCHLORIDE 6728 TERBINAFINE HYDROCHLORIDE 6729 TERBINAFINE HYDROCHLORIDE 6730 TERBINAFINE HYDROCHLORIDE 6731 TERBINAFINE HYDROCHLORIDE 6732 125MG TERBINAFINE TABLETS CUTIS6733 250MGTABLETS TERBINAFINE TERBIDERM TABLETS TABLETS Associated Morison PLC ATCO 536 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAPAKISTAN 21-Jan-14 04-Apr-18 Full Provisional INDIA 28-Aug-15INDIA Full 24-Mar-14INDIA Full 02-Jul-14 Full INDIA 11-Mar-18 Provisional INDIAPAKISTAN 11-Jan-18 Provisional 25-Jul-16 Full Agio Pharmaceuticals Ltd Laboratories (Pvt) Ltd Concept Pharmaceuticals Ltd Parmax Labo. Ltd Fourrts (India) Laboratories Ltd Merck Limited INDIAPharmaceuticals Ltd 29-May-14Medochemie Ltd Full CYPRUS 31-Jul-14Medochemie Ltd Full CYPRUS 05-Jan-15Pharmaceuticals Ltd Full Platinum Pharmaceuticals (Pvt) Ltd (Contd.) International (Pvt) Ltd Ltd Healthcare lanka Ltd Emerchemie NB (Ceylon) Ltd Laboratories (Pvt) Ltd Laboratories (Pvt) Ltd Health (Pvt) Ltd (Pvt) Ltd ORAL LIQUIDORAL Softcare LIQUIDORAL Markss HLC (Pvt) SOLUTION SYRUP Pharma Associates Bafna SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP SYNABRAON PLUS NAXCORIL SYRUP COFORILCOSOME A SYRUP ORAL TERASH Sunshine 1.5mg/5ml ATALINETURBUTE SYRUP 2.5ATALINE TABLETS Associated TABLETSTERASH 2.5 N/A Associated TABLETSBRETHINAssociates Pharma Astron (Pvt) Ltd Bafna TABLETS SRI LANKA 15-Jun-15 George Steuart Full BP 2.5MG BP BROMHEXINE HCL BROMHEXINE HCL 4MG+GUAIPHENESIN 0.05MG/5ML 50MG+MENTHOL BROMHEXINE HCL 4MG+GUAIPHENESIN 0.05MG/5ML 50MG+MENTHOL 1.5MG+BROMOHEXINE 50MG 2MG+GUAIFUNESINE SYRUP 15MG HCL 1.25MG+AMBROXOL +GUAIPHENESIN 50MG/5ML SYRUP 1.5MG/5ML SYRUP 1.5MG/5ML 2.5MG BP 2.5MG 2.5MG USP 6743 TABLET SULPHATE TERBUTALINE 6734 250MGTABLETS TERBINAFINE TERBIZED6735 125MG USP TABLETS TERBINAFINE TERBIDERM TABLETS6736 TABLETS 1.25MG+ TERBUTALINE Citihealth Imports Morison PLC6737 1.25MG+ TERBUTALINE ATCO 6738 TERBUTALINE 6739 SULPHATE TERBUTALINE 6740 SULPHATE TERBUTALINE 6741 SULPHATE TERBUTALINE 6742 TABLET SULPHATE TERBUTALINE 6744 B.P. SULPHATE TERBUTALINE 6745 TABLETS SULPHETE TERBUTALINE I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 537 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAPAKISTAN 04-Jun-18 03-Aug-14 Full Full PAKISTAN 26-Nov-14GERMANY Full 29-Oct-14INDIA Full 11-Sep-15INDIA Full PAKISTAN 06-Feb-14 23-Feb-18INDIA Full Full INDIA 31-Dec-14INDIA Full 01-Jul-14 Full INDIA 06-Nov-14 Full 13-Feb-16 Full (Pvt) Ltd B F Biosciences Ltd GA Bayer Pharma GERMANY 03-Feb-14 GA Bayer Pharma GERMANY Full 03-Feb-14OBS Pakistan (Pvt) Ltd Full Behring CSL GmbH Serum Institute of India (Pvt) Ltd Biological E Ltd INDIASerum Institute of India (Pvt) Ltd 15-Feb-18Brookes Pharma (Pvt) Ltd Full Healthcare Ltd Laboratories (Pvt) Ltd Medopharm (PVT Ltd (india) (Pvt) Ltd (Contd.) (Ceylon) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Services Pvt. Ltd (Pvt) Ltd Healthcare lanka Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd INJECTION Hemas INJECTION Hemas SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP T-PRESSINNOVAPRESSING INJECTION INJECTION TESTOVIRON Klintas (Pvt) Ltd Emerchemie NB DEPOT United Biotech TESTOVIRON DEPOT ANDREXTETAGAM-P CAPSULES INJECTIONN/A Mansel (Ceylon) ABC Pharma N/A INJECTIONN/A Citihealth Imports INJECTIONOXOFERIN Sunshine SOLUTION INJECTIONN/A Citihealth Imports Hemas TETRET-250 CAPSULES CAPSULESEMCYCLINE Ceyoka (Pvt) Ltd Kamazu (Pvt) Ltd CAPSULES Leben Syncom N/A Akbar OINTMENT Ceyoka (Pvt) Ltd Galentic Pharma 1.0MG/10ML VIAL 1.0MG/10ML VIAL FOR INJECTION 250MG/ SOULTION ML FOR INJECTION 250MG/ SOULTION ML CAPSULES 40MG HUMAN 250IU IN 1ML ADSORBED 40 IU in 0.5ML 0.5ML single dose 0.5ML SOLUTION 1.037MG/100ML 250MG 250MG 250MG 3% U S P OINTMENT 6746 TERLIPRESSIN INJECTION 6747 TERLIPRESSIN INJECTION 1MG/ 6748 OILY ENANTHATE TESTOSTERONE 6749 OILY ENANTHATE TESTOSTERONE 6750 UNDECANOATE TESTOSTERONE 6751 IMMUNOGLOBULIN , TETANUS 6752 VACCINE TOXOID TETANUS 6753ADSORBED VACCINE TETANUS 6754 ADSORBED BP VACCINE TETANUS 6755 TETRACHLORDECAOXIDE STERILE 6756 TETRACYCLINE CAPSULES B.P 6757 TETRACYCLINE CAPSULES B.P 6758 TETRACYCLINE CAPSULES B.P 6759 TETRACYCLINE HYDROCHLORIDE 538 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 23-Apr-17INDIA Full 05-Jun-14INDIA Full 18-Aug-16 Full 05-Jan-16 Full INDIAINDIA 24-Feb-14 Full 01-Sep-18INDIA Years Two INDIA 06-Jun-18 Years Two INDIA 23-Apr-16 Full SRI LANKA 08-May-14 01-Jul-17 Full PAKISTAN Full 01-Jan-14INDIA Full 04-Jul-16 Full Pharmaceuticals (India) Ltd Opthalmincs Centaur Pharmaceutical (Pvt) Ltd (india) (Pvt) Ltd Sanbe FarmaT P INDONESIA 09-May-18Years Two Pharmaceuticals Cadila Healthcare Ltd Modi Mundipharma Ltd Health Pell Tech Care (Pvt) Ltd Ratnamani Healthcare (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Glaxo Smithkiline Pakistan Ltd Adcock Ingram Ltd (Contd.) Health (Pvt) Ltd Ceyoka (Pvt) Ltd Galentic Pharma Lifeline Pharmaceuticals (Pvt) Ltd Pharma Associates The Madras Healthcare lanka Ltd Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd N/APharmaceuticlas (Pvt) Ltd Gamma Healthcare lanka Ltd OINTMENT TABLETS TABLETS TABLETS Sunshine SOLUTION SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP TETRACHEM OINTMENTTETROP PharmAce (Pvt) Ltd Aurochem OCUCYCLINE OINTMENT EYE OINTMENT George Steuart N/A Chamee Chemist Indiana NEUROSANBE FILM COA OPHTHALMIC N/ADERIPHYLLIN OD 300 PROLONED RE UNICONTIN 40PELLPENTA TABLETS CAPSULES Robert Hall & Co N/A Slim THEOFIN SYRUP ORAL TABLETSQUIBRON T/SR Lanka TABLETS Tabrane NUELIN SR-250 GlaxoSmithkiline TABLETS Sunshine OINTMENT USP 30MG/G USP OINTMENT 1% USP OPHTHALMIC OINTMENT 1% USP OPHTHALMIC OINTMENT 1% USP OPHTHALMIC OINTMENT 100MG+PYRIDOXINE HYDROCHLORIDE 200MG + 200MCG CYANOCOBALAMINE TABLETS 125MG BP TABLETS RELEASE 231MG 69MG+ETOPHYLLIN TABLETS RELEASE SUSTAINED 300MG 400MG RELEASE TABLETS 200MG RELEASE CAPSULES USP 125MG RELEASE TABLETS 25MG/5ML USP RELEASE 300MG 250MG RELEASE TABLETS 6760 TETRACYCLINE HYDROCHLORIDE 6761 TETRACYCLINE HYDROCHLORIDE 6762 TETRACYCLINE HYDROCHLORIDE 6763 TETRACYCLINE HYDROCHLORIDE 6764 THAIAMINE MONONITRATE 6765 THEOPHYLLINE PROLONGED 6766 THEOPHYLLINE 6767 THEOPHYLLINE CONTROLLED 6768 THEOPHYLLINE EXTENDED 6769 THEOPHYLLINE EXTENDED 6770 SOLUTION THEOPHYLLINE ORAL 6771 THEOPHYLLINE SUSTAINED 6772 THEOPHYLLINE SUSTAINED I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 539 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 AUSTRALIA 17-Dec-15 Full SRI LANKA 08-Aug-17Years Two BANGLADESH 19-Jun-14 Full INDIAINDIA 26-Apr-16INDIA Full 20-Nov-16 Full INDIA 21-May-18 Provisional INDIA 12-Nov-18 Years Two BANGLADESH 21-Nov-18 22-Apr-14 Years Two Full BANGLADESH 25-Mar-18 Years Two Ensign Laboratories Pty Ltd. For Innova Pharmaceuticals Australia (Pvt) Ltd Ltd Orion pharma Ltd BANGLADESH 13-Oct-17Globe Full Pharmaceuticals Ltd Healthcare Vital (Pvt) Ltd Kwality Pharmaceuticals Pvt Ltd Kwality Pharmaceuticals Pvt Ltd PharmaceuticalS (Pvt) Ltd PharmaceuticalS (Pvt) Ltd Pharmaceuticals Ltd General Pharmaceuticals Ltd Sanbe FarmaT P INDONESIA 28-Aug-14 Full (Contd.) Healthcare lanka Ltd Co Ltd (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd Health (Pvt) Ltd Pharmaceuticals (Pvt) Ltd TABLETS Lifeline SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP NUELIN SYRUPTHEOFIN PR 250 TABLETS Sunshine NUGESIC N/ATRIBION TABLETS Darley Butler & N/A Inter Pharm (Pvt) INJECTION Healthcare N/A Tabrane INJECTIONN/A International Yaden INJECTION International Yaden INJECTION International Yaden NEURO B TABLETSBOST PharmAce (Pvt) Ltd Square NEUROSANBE TABLETSPLUS George Steuart 26.67MG/5ML 250MG PROLONGED RELEASE BP 200MG+ CYANOCOBALAMIN BP 200MCG TABLETS 100MG+ 100MG+PYRIDOXINE HCL 1MG injection CYANOCOBALAMINE 100MG/2ML INJECTION BP 100MG/2ML INJECTION USP 50MG/ML INJECTION USP 200MG+ 100MG+PYRIDOXINE HCL 200MCG CYANOCOBALAMIN TABLETS 200MG+ 100MG+PYRIDOXINE HCL 200MCG CYANOCOBALAMIN TABLETS B12 B6+VITAMIN 50MG+VITAMIN 100MG+METHAMPYRONE 500MG CAPLET 6773 THEOPHYLLINE SYRUP 6774 BP THEOPHYLLINE TABLETS 6775 100MG+PYRIDOXINE THIAMINE BP 6776 THIAMINE HYDROCHLORIDE 6777 THIAMINE HYDROCHLORIDE 6778 THIAMINE HYDROCHLORIDE 6779 THIAMINE HYDROCHLORIDE 6780 100MG/ML THIAMINE INJECTION BP N/A6781 50MG/ML THIAMINE INJECTION BP N/A INJECTION6782 THIAMINE MONONITRATE Ceyoka (Pvt) Ltd Ciron Drugs & INJECTION6783 THIAMINE MONONITRATE Ceyoka (Pvt) Ltd Ciron Drugs & 6784 THIAMINE MONONITRATE 540 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 03-Mar-14 Full INDIAINDIA 14-Dec-17 Full INDIA 27-Apr-15INDIA Full 18-Jan-15INDIA Full 08-Apr-15BANGLADESH Full 30-Jan-18 06-May-14 Full INDIA Full INDIA 18-May-18 Full 17-Jun-16INDIA Full 02-Oct-17 Years Two INDIAUNITED KINGDOM 21-Mar-14 Full Delta Pharma Ltd BANGLADESH 14-Oct-14 Full Centurion Laboratories Pvt Ltd Aculife Healthcare (Pvt) Ltd Naprod Life Scienc (Pvt) Ltd Aculife Healthcare (Pvt) Ltd Neon Laboratories Ltd Pharmaceuticals Ltd PharmaceuticalS (Pvt) Ltd Glaxo Smithkiline Pharmaceuticlas Renata Limited BANGLADESH 29-Apr-15Pharmaceuticals Full ABAstra Zeneca SWEDEN 24-Apr-15Pharmaceuticals Full Smithkline Beecham Plc (Contd.) Drugs (Pvt) Ltd Healthcare lanka Ltd (Pvt) Ltd Healthcare lanka Ltd Ravilux Company (Pvt) Ltd Pharmaceuticlas (Pvt) Ltd Beecham (Pvt) Ltd (Pvt) Ltd (Ceylon) Ltd Pharmaceuticals (Pvt) Ltd INJECTION SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP DEBION TABLETS Kandana Food & THIONIRN/A INJECTIONTHIONIR Sunshine INJECTIONTHIOSOL INJECTION Ravilux Company GENISIA Sunshine POWDER N/A INJECTION PharmAce (Pvt) Ltd Square 100ELTROXIN TABLETS INJECTION Ceyoka (Pvt) Ltd GlaxoSmithkiline Ciron Drugs & TIMENTIN INJECTION Smithkline 100MG,PYRIDOXINE HCL BP BP 100MG,PYRIDOXINE HCL BP 200MG+ CYANOCOBALAMIN 0.20MG 1G INJECTION BP 500MG INJECTION BP 500MG INJECTION BP 500MG INJECTION BP 500MG INJECTION USP 500G BP 100MCG ACID 100MG CLAVULANIC 6785 BP THIAMINE MONONITRATE 6786 100MG BP TABLETS THIAMINE N/A6787 SODIUM FOR THIOPENTAL 6788 SODIUM FOR THIOPENTAL TABLETS6789 SODIUM FOR THIOPENTAL International Yaden 6790 SODIUM FOR THIOPENTAL 6791 SODIUM FOR THIOPENTAL 6792 SODIUM INJECTION THIOPENTAL 6793 TABLETS THYROXINE SODIUM IP 6794 2.5MGTABLETS TIBOLONE 6795 60MGTABLETS TICAGRELOR TIBION6796 90MG TICAGRELOR TABLETS TIGLOE-MD BRILINTA TABLETS TABLETS6797 90MG TICAGRELOR TABLETS 6798Associates Emerchemie NB Pharma TICARCILLIN SODIUM 1.5MG + TIGLOR TABLETS The Madras Hemas TABLETSAssociates Pharma Madras I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 541 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 SRI LANKA 01-Feb-18 Provisional INDIAINDIA 24-Mar-15 Full 23-Aug-17INDIA Full PAKISTAN 28-Feb-18 Years Two 28-Feb-16 Full FRANCE 17-Jul-14 Full INDIAPAKISTAN 05-Feb-18 Years Two 10-Feb-14DENMARK Full 30-Sep-15 Full c Stridden fi Pharmaceuticals (Pvt) Ltd GU Biopharma Pvt ltd SRS Pharmaceuticals (Pvt) Ltd Wings Biotech INDIA(Pvt) Ltd Remington 09-Mar-18pharmaceutical Years Two Industries (Pvt) Ltd Micro Labs Ltd INDIALaboratoire Merck Sharp & Dohme France for Merck Sharp & Dohme 09-Jan-14Ltd UK F D C Limited Full INDIACadila pharmaceuticals Ltd 19-Aug-15Elko Organization (Pvt) Ltd Full Laboratoires France Leo SA for Leo Pharmaceuticals (Contd.) N/APharmaceuticals (Pvt) Ltd Navesta Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Klintas (Pvt) Ltd United Biotech Co Ltd Ltd Ltd Healthcare lanka Ltd Sunshine Healthcare lanka Ltd (Ceylon) Ltd Pharmaceuticals (Pvt) Ltd INJECTION INJECTION OINTMENT SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP TICLAV 3.2TICLAV POWDER FOR TYLINTIGSAN INJECTIONSHELLVIT-OS Slim INJECTION INJECTIONEGYTIG Innovate International Yaden BLOTIM 0.5% POWDER / EYE DROPS Delmege Forsyth & LOPRESTIMOPTOL EYE DROPS EYE DROPS SMM Halcyon (Pvt) Baur & Co (Pvt) A IOTIMOCUPRES-E EYE DROPS OPHTHALMIC Sunshine BETALOLINNOHEP EYE DROPS Emerchemie NB INJECTION Hemas CLAVULANIC ACID FOR INJECTION CLAVULANIC 3.2G USP 50MG 50MG 50MG/ VIAL 50MG/ VIAL 0.50% 5MG/ML SOLUTION 0.5% 0.5% SOLUTION USP 0.5% SOLUTION USP 0.5% SOLUTION USP IU/ML 6799 TICARCILLIN SODIUM+ 6800 TIGECYCLINE FOR INJECTION 6801 TIGECYCLINE FOR INJECTION 6802 TIGECYCLINE INJECTION USP 6803 TIGECYCLINE INJECTION USP 6804 EYE DROPS MALEATE TIMOLOL 6805 EYE DROPS IP MALEATE TIMOLOL 6806 OPHTHALMIC MALEATE TIMOLOL 6807 OPHTHALMIC MALEATE TIMOLOL 6808 OPHTHALMIC MALEATE TIMOLOL 6809 OPHTHALMIC MALEATE TIMOLOL 6810 SODIUM 10000ANTI-XA TINZAPARIN 542 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 11-Apr-15 Full DENMARK 15-Jun-14 Full DENMARK/ FRANCE SRI LANKA 21-Dec-17 Full INDIAINDIA 18-Mar-14INDIA Full 24-Apr-18PAKISTAN Full 18-Mar-14 02-Aug-17INDIA Years Two Full 15-Feb-17PAKISTAN Full 30-Jan-18 Full Laboratories LEO France for Leo S.A Pharmaceutical ProductsLeo A/S DENMARK Laboratories LEO France for Leo S.A Pharmaceutical ProductsLeo A/S DENMARK SA LEO Pharma DENMARK 15-Sep-17Sciences (Pvt) Ltd Full Cipla LtdCipla Ltd INDIAUnichem Laboratories INDIAAtoz 03-Dec-14Pharmaceuticals (Pvt) Ltd Full 10-May-18Years Two Unichem Laboratories Martin Daw Marker Ltd Atoz Pharmaceuticals (Pvt) Ltd Merck (Pvt) Ltd PAKISTANLaboratories (Pvt) 02-Aug-17Ltd Years Two (Contd.) Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd N/A(Pvt) Ltd Emergen Life Breathe Free Lanka (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Ltd (Pvt) Ltd Ltd (Ceylon) Ltd (Pvt) Ltd (Ceylon) Ltd FOR INHALATION INHALATION SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP INNOHEP INJECTIONINNOHEP Hemas TIOHALE 18 INJECTION Hemas POWDER DRY HFATIOVA CAP DP TIOVA INHALER POWDER Breathe Free Lanka INNOHEP INJECTION Hemas XA IU/ML XA XA IU/ML XA CAPSULES POWDER INHALATION TIOTROPIUM BROMIDE 18MCG (AS ) BP MONOHYDRATE 9MCG/DOSE 18MCG FOR INHALATION IU/ML 6811 SODIUM 10000ANTI-XA TINZAPARIN 6813ANTI- SODIUM 20,000 TINZAPARIN 6812ANTI- SODIUM 20,000 TINZAPARIN 6814 TIOTROPIUM BROMIDE DRY 6815 TIOTROPIUM BROMIDE INHALER 6816 TIOTROPIUM BROMIDE POWDER 6817 2MGTABLETS TIZANIDINE 6818 2MGTABLETS TIZANIDINE TIZIGESIC6819 4MGTABLETS TIZANIDINE MULAX-2 TABLETS6820 4MG USP TABLETS TIZANIDINE TIZIGESIC Baur & Co (Pvt) A TABLETS TIZOREL6821 4MG USP TABLETS TIZANIDINE Asian Pharma Euro MULAX-4 TABLETS6822 TABLETS 4MG USP TABLETS TIZANIDINE Baur & Co (Pvt) A TIZOREL6823 TABLETS Emerchemie NB 4MG USP TABLETS TIZANIDINE AGILE FORTEAsian Pharma Euro TABLETS TABLETS Emerchemie NB PharmAce (Pvt) Ltd Wilshire I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 543 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAPAKISTAN 24-Mar-18 Years Two 30-Mar-16PAKISTAN Full 28-Dec-17 Years Two PAKISTAN 30-Mar-16PAKISTAN Full 30-Jan-18 Full PAKISTAN 26-Feb-16BELGIUM Full 29-Jan-17INDIA Full BELGIUM 01-Jun-18 Years Two 29-Jan-17BELGIUM Full 29-Jan-16PAKISTAN Full 16-Aug-18 Years Two Triveni Triveni Formulations Ltd & Well Well Pharma (Pvt) Ltd (Pvt ) Ltd Merck (Pvt) Ltd PAKISTAN & Well Well Pharma (Pvt) Ltd 02-Aug-17Years Two Laboratories (Pvt) Ltd Schazoo Pharmaceutical Laboratories (Pvt) Ltd Alcon- S A Couvreur N V Sunwaya Rohto Pharmaceutical Pvt Ltd Couvreur N V Alcon- S A Couvreur N V Remington pharmaceutical Industries (Pvt) Ltd (Contd.) Edna Medicals (Pvt) Ltd Baur & Co (Pvt) A Ltd (Pvt) Ltd Morison PLC Alcon- S A Ltd Delmege Forsyth & Co Ltd (Pvt) Ltd Laboratories (Pvt) Ltd (Ceylon) Ltd Laboratories (Pvt) Ltd OPHTHALMIC SUSPENSION SUSPENSION SUSPENSION OINTMENT SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP TOBREX EYE TOBRA DROPS EYE OINTMENT Morison PLCTOBRADEX Alcon Couvreur BELGIUM OPHTHALMIC DMTOBRAWAY 23-Nov-17 EYE DROPS Full International Yaden TOBRADEX OPHTHALMIC TOBRADEX OINTMENTAMGYDEX Baur & Co (Pvt) A OPHTHALMIC DEXAMETHASASONE 1% OPTHALMIC SOLUTION USP 0.3%+DEXAMETHASONE 0.1% EYE DROP 0.3%+DEXAMETHASONE 0.1% EYE DROP 0.3%+DEXAMETHASONE 0.1% EYE DROP 0.3%+DEXAMETHASONE 0.1% EYE OINTMANT 0.3%+DEXAMETHASONE 0.1% USP OPHTHALMIC OINTMANT 6831 0.3% + TOBRAMYCIN 6824 2MG USP TABLETS TIZANIDINE 6825 MYOXYL 2MG USP TABLETS TIZANIDINE MUSREL6826 TABLETS 2MG USP TABLETS TIZANIDINE 6827 MAXLAX TABLETS 2MG USP TABLETS TIZANIDINE Pharma Avenier 6828 TIZOREL 2MG USP TABLETS TIZANIDINE Associated TABLETS MUSREL6829 TABLETS 2MG USP TABLETS TIZANIDINE Ceyoka (Pvt) Ltd Genix Pharma AGILE TABLETS Emerchemie NB 6830 EAR DROPS 0.3% TOBRAMYCIN Associated TABLETS PharmAce (Pvt) Ltd6832 Wilshire TOBRAMYCIN 6833 TOBRAMYCIN 6834 TOBRAMYCIN 6835 TOBRAMYCIN 6836 TOBRAMYCIN 544 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAPAKISTAN 27-Apr-16 01-Mar-18 Full BANGLADESH Full 31-Oct-17 Years Two PAKISTAN 01-Aug-15PAKISTAN Full 14-Nov-15PAKISTAN Full 31-Oct-14CHINA Full BELGIUM 25-May-15BELGIUM 29-Jan-17 Full Full INDIA 29-Jan-17 Full INDIA 02-Jul-15PAKISTAN Full 14-Sep-17 15-Jun-18 Provisional Full Ltd Remington pharmaceutical Industries (Pvt) Ltd Pharmaceuticals Industry Ltd Remington pharmaceutical Industries (Pvt) Ltd Elko Organization (Pvt) Ltd Remington pharmaceutical Industries (Pvt) Ltd Ashford Laboratories Ltd Alocon Couvreur N V N V Amanta Healthcare Ltd Scott Edil Pharmacia Ltd Remington pharmaceutical Industries (Pvt) Ltd (Contd.) Delmege Forsyth & Co Ltd Co Ltd Emerchemie NB (Ceylon) Ltd (Pvt) Ltd Ltd Citihealth Imports (Pvt) Ltd C Medical (Pvt) T P Ltd Co Ltd Co Ltd SUSPENSION SUSPENSION OPHTHALMIC SOLUTION SOLUTION SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP DEXATOB EYE DROPSAMGYDEX Chamee Chemist Axa Parenterals OPHTHALMIC TOMYCIN-D EYE DROPSTOBEC-D Medinex (Pvt) Ltd The IBN SINA EAR DROPSSANTODEX Delmege Forsyth & OPHTHALMIC OCUSYNTOBREX EYE DROPSTOBREX Ceylon Teastar EYE DROPSALEMBIC Baur & Co (Pvt) A ALEMTOB EYE DROPSN/A Morison PLCNEBRA Alocon Couvreur OPHTHALMIC EYE DROPS Delmege Forsyth & 0.3%+DEXAMETHASONE USP 0.1% 0.3%+DEXAMETHASONE USP EYE DROP DEXAMETHASASONE 1MG/ML OPTHALMIC SUSPENSION DEXAMETHASASONE 1MG/ML OPTHALMIC SUSPENSION DEXAMETHASASONE 1MG/ML OPTHALMIC SUSPENSION USP DEXAMETHASASONE 1MG/ML OPTHALMIC SUSPENSION USP SOLUTION 0.3% USP SOLUTION 0.3% W/V SOLUTION 0.3% W/V 0.3% W/V SOLUTION USP 0.3% W/V SOLUTION USP 0.3% W/V SOLUTION USP 6837 TOBRAMYCIN 6838 3MG + TOBRAMYCIN 6839 3MG + TOBRAMYCIN 6840 3MG + TOBRAMYCIN 6841 3MG + TOBRAMYCIN 6842 0.3% EYE OINTMENT TOBRAMYCIN NEBRA6843 OPHTHALMIC TOBRAMYCIN OINTMENT6844 OPHTHALMIC TOBRAMYCIN Delmege Forsyth & 6845 OPHTHALMIC TOBRAMYCIN 6846 OPHTHALMIC TOBRAMYCIN 6847 OPHTHALMIC TOBRAMYCIN 6848 OPHTHALMIC TOBRAMYCIN I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 545 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 JAPAN 29-Jun-17JAPAN Full 29-Jun-17SRI LANKA Full 13-Jan-16SRI LANKA Full 14-Jun-15BANGLADESH 19-Dec-18 Full Years Two INDIAINDIA 06-Mar-16INDIA Full 21-Nov-15 Full INDIA 10-Feb-15 Full INDIA 26-Nov-18 Years Two 10-Feb-15INDIA Full 16-Jun-15 Full Chugai Pharma Manufacturing Co Ltd Japan made La for F Hoffmann Roche Ltd Chugai Pharma Manufacturing Co Ltd Japan made La for F Hoffmann Roche Ltd Ltd (Ceylon) (Pvt) Ltd Eskayef Pharmaceuticals Ltd (Pvt) Ltd Zim Laboratories Ltd Sun Pharmaceutical industries Centurion Laboratories Pvt Ltd Sun Pharmaceutical industries Renata Limited BANGLADESHSun 24-Apr-14Pharmaceutical industries Full Cilaga AG SWITZERLAND 22-Oct-15 Full (Contd.) Ltd Ltd Pharmatec (Pvt) Ltd Belco Pharma Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Ceylon) Ltd Healthcare lanka Ltd (Ceylon) Ltd (Pvt) Ltd SOLUTION SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP ACTEMRA SOLUTIONACTEMRA Baur & Co (Pvt) A SOLUTION Baur & Co (Pvt) A N/ATOLADINE TOPICAL CAPSULESROLITEN Tabrane N/A TABLETS Hemas ROLITEN TABLETSTOLTER TABLETS International Yaden Hemas TABLETS Emerchemie NB VIAL VIAL 1% USP RELEASE CAPSULES 2MG 2MG TABLETS 1MG 1MG 1MG 6849 INJECTION 20MG TOCILIZUMAB 6850 INJECTION 20MG TOCILIZUMAB 6851 B.PTABLETS 500MG TOLBUTAMIDE N/A6852 B.PTABLETS 500MG TOLBUTAMIDE N/A6853 ACID TOLFENAMIC 200MGTABLETS TUFNIL TABLETS6854 SOLUTION TOPICAL TABLETS TOLNAFTATE N/A TABLETS6855 EXTENDED TOLTERODINE N/A Sunshine 6856 TARTRATE - L TOLTERODINE Inter Pharm (Pvt) M S J Industries 6857 TABLETS TARTRATE TOLTERODINE 6858 TABLETS TARTRATE TOLTERODINE 6859 TABLETS TARTRATE TOLTERODINE 6860 100MGTABLETS TOPIRAMATE TOPIROL-1006861 100MGTABLETS TOPIRAMATE TABLETS TOPAMAX-100 Emerchemie NB TABLETS Pettah Pharmacy 546 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAPAKISTAN 11-Jun-17 13-Sep-14 Full PAKISTAN Full 10-Feb-18SWITZERLAND 22-Oct-14 Full Full INDIAPAKISTAN 07-Jul-15 10-Feb-18PAKISTAN Full Full 16-Jun-18 Provisional INDIAPAKISTAN 23-Apr-14 13-Sep-15 Full Full INDIAINDIA 20-Feb-18 Full 04-Jan-14 Full Torrent Torrent Pharmaceuticals Ltd Medizan Laboratories (Pvt) Ltd OBS Pakistan (Pvt) Ltd Cilag AG Switzerland for jansswn-cilag AG Sun Pharmaceutical industries OBS Pakistan (Pvt) Ltd Hilton Pharma (Pvt) Ltd Torrent Pharmaceuticals Ltd Medizan Laboratories (Pvt) Ltd Cilaga AGPharma Fabrikon SWITZERLAND INDIA 22-Oct-14Pharma Fabrikon INDIA Full 12-Mar-18Sun Pharmaceutical industries Full 12-Mar-18Pharmaceuticals Full (Contd.) Ltd Pharmaceuticals (Pvt) Ltd Mansel (Ceylon) (Pvt) Ltd (Pvt) Ltd (Ceylon) Ltd (Ceylon) Ltd Healthcare lanka Ltd Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd (Ceylon) Ltd TABLETS SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP 6862 25MGTABLETS TOPIRAMATE 25 EPIMATE 6863 25MGTABLETS TOPIRAMATE TABLETS 25 SEZIRIL 6864 25MGTABLETS TOPIRAMATE Edna Medicals (Pvt) 6865 TABLETS 25MGTABLETS TOPIRAMATE TOMIGRAINE FILM COA Ceyline 25MG TOPAMAX 6866 25MGTABLETS TOPIRAMATE TABLETS TOPIROL-256867 Pettah Pharmacy 50MGTABLETS TOPIRAMATE TABLETS6868 50MGTABLETS TOPIRAMATE TOMIGRAINE Emerchemie NB TABLETS 50 HITOP 6869 50MGTABLETS TOPIRAMATE Emerchemie NB 50 EPIMATE TABLETS6870 50MGTABLETS TOPIRAMATE TABLETS Sunshine 50 SEZIRIL 6871 50MGTABLETS TOPIRAMATE Edna Medicals (Pvt) 6872 TABLETS 25MG IP TABLETS TOPIRAMATE TOPAMAX-50 25 TOPORE 6873 TABLETS 50MG IP TABLETS Ceyline TOPIRAMATE 50 TOPORE TABLETS6874 50MG USP TABLETS Pettah Pharmacy TOPIRAMATE TOPIROL-50 TABLETS Novachem Lanka 6875 TABLETS 50MG USP TABLETS TOPIRAMATE NEUROTOP Novachem Lanka Emerchemie NB TABLETSAssociates Pharma The Madras I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 547 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAPAKISTAN 02-Sep-15 10-Feb-18INDIA Full Full INDIA 13-Aug-14INDIA Full 08-Sep-15INDIA Full 27-Feb-18 Full PAKISTAN 26-Jul-15 10-Feb-18INDIA Full Full INDIA 02-Sep-14 Full PAKISTAN 26-Jul-14 09-Mar-17 Full INDIA Full INDIA 10-Nov-17 Years Two INDIA 24-Feb-15INDIA Full 16-Sep-16 Full 25-Mar-15 Full Cadila Healthcare Ltd OBS Pakistan (Pvt) Ltd Coast West Pharmaceurical works Ltd Laboratories XL (Pvt) Ltd Sun Pharmaceutical industries Coast West Pharmaceurical works Ltd OBS Pakistan (Pvt) Ltd Cadila Healthcare Ltd Coast West Pharmaceurical works Ltd Hilton Pharma (Pvt) Ltd Limited Unichem Laboratories G D Laboratories (India) Pvt Ltd Marksons Pharma Ltd (Contd.) Pharmaceuticals (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd Ltd (Ceylon) Ltd (Pvt) Ltd Mansel (Ceylon) (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Healthcare lanka Ltd Ltd Pharmaceuticals (Pvt) Ltd Plc TABLETS SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP 6876 50MG USP TABLETS TOPIRAMATE TOPIRAM6877 50MG USP TABLETS TOPIRAMATE TOMIGRAINE TABLETS6878 50MG USP TABLETS TOPIRAMATE TABLETS 50 TOPVEX Hemas 6879 Mansel (Ceylon) 50MG USP TABLETS TOPIRAMATE TABLETS EPISQUIT6880 50MG USP TABLETS TOPIRAMATE Global Impex AV TOPIROL-50 TABLETS6881 TABLETS 100MG USP TABLETS TOPIRAMATE 100 TOPVEX SMM Halcyon (Pvt) Emerchemie NB 6882 TABLETS 25MG USP TABLETS TOPIRAMATE TOMIGRAINE6883 Global Impex AV 25MG USP TABLETS TOPIRAMATE FILM COA TOPIRAM6884 25MG USP TABLETS TOPIRAMATE 25 TOPVEX TABLETS6885 25MG USP TABLETS TOPIRAMATE TABLETS Hemas 25 HITOP 6886 Global Impex AV INJECTION 2.5MG TOPOTECAN TABLETS6887 CANOL 50MG CAPSULES BP TRAMADOL DOMADOL Sunshine 6888 50MG CAPSULES BP TRAMADOL INJECTION TRAMANISE 50 CAPSULES CAPSULES6889 50MG CAPSULES BP Ceyoka (Pvt) Ltd TRAMADOL Baur & Co (Pvt) A TRAMAMARK VENUS Remedies Lifeline CAPSULES Browns & Company 548 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 BANGLADESH 29-Oct-14INDIA Full 16-Sep-17 Years Two INDIAGERMANY 10-Feb-14 16-Nov-16INDIA Full Full INDIA 10-Apr-15BANGLADESH Full 26-Jun-14 13-Dec-14 Full Full BANGLADESH 07-Oct-14 Full INDIAINDIA 26-Jun-15BANGLADESH Full 26-May-15 24-Sep-17 Years Two INDIA Full INDIA 08-Jun-17 Years Two INDIA 07-Jun-17 Years Two 29-Jan-18 Full Healthcare Pharmaceuticals Scott Edil Pharmacia Ltd Kopran Ltd Laboratories XL INDIA(Pvt) Ltd Losan Pharma GmbH Otto-Hahn 15-Jun-15 Healthcare Vital Full (Pvt) Ltd Cadila Healthcare Ltd Incepta Pharmaceuticals Ltd Chemical Industries Cadila Healthcare Ltd Scott Edil Pharmacia Ltd Healthcare Pharmaceuticals Unichem Laboratories Unichem Laboratories Human Verve Care Laboratories (Contd.) Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Healthcare lanka Ltd (Pvt) Ltd Healthcare lanka Ltd Ltd (Pvt) Ltd Ltd Ltd Agency Pvt Ltd (Pvt) Ltd Ltd Ltd Ltd TABLETS Akbar SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP TRAMADOL DENK TRAMADOL 50 TRAMOVITTRAMAZAC INJECTION International Yaden INJECTIONWINPAIN Sunshine TENDIA CAPSULES Citihealth Imports TRAMAZAC CAPSULES CAPSULES CIC Holdings PLCN/A Advanced Sunshine SYNDOL 10MGDOMADOL INJECTION INJECTION INJECTION 50MGDOMADOL C Medical (Pvt) T P Baur & Co (Pvt) A INJECTION Citihealth Imports VERDOL Baur & Co (Pvt) A INJECTION Leader Pharma TABLETS 50MG TABLETS 50MG/ML 100MG/2ML 50MG CAPSULES 50MG CAPSULES BP 50MG CAPSULES BP INJECTION 100MG in 2ML INJECTION 100MG in 2ML INJECTION 100MG in 2ML INJ ML INJECTION 50MG/ML 6890 50MG CAPSULES BP TRAMADOL SYNDOL6891 50MG CAPSULES BP TRAMADOL N/A6892 50MG CAPSULES BP CAPSULES TRAMADOL TRASIC6893 Citihealth Imports 50MG CAPSULES BP TRAMADOL 50 TRAMXL CAPSULES6894 EFFERVESCENT TRAMADOL CAPSULES C Medical (Pvt) T P CAPSULES Alaris Lanka (Pvt) 6895 HYDROCHLORIDE TRAMADOL SMM Halcyon (Pvt) 6896 HYDROCHLORIDE TRAMADOL 6897 HYDROCHLORIDE TRAMADOL 6898 HYDROCHLORIDE TRAMADOL 6899 HYDROCHLORIDE TRAMADOL 6900 HYDROCHLORIDE TRAMADOL 6901 HYDROCHLORIDE TRAMADOL 6902 HYDROCHLORIDE TRAMADOL 6903 HYDROHLORIDE 50MG/ TRAMADOL 6904 HYDROHLORIDE TRAMADOL I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 549 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIA 02-Mar-18 Years Two INDIAPAKISTAN 18-Jun-17 Years Two 23-Apr-14 Full PAKISTAN 16-Sep-14 Full INDIAINDIA 23-Apr-15PAKISTAN Full 27-May-14 02-Nov-14PAKISTAN Full Full 05-Jun-17 Years Two PAKISTAN 09-Apr-16 Full PAKISTANBANGLADESH 08-Apr-18 05-Dec-17 Years Two Full c Stridden fi Claris Lifescience Ltd Win Medicare ltd INDIAPharmaceuticalS (Pvt) Ltd 13-Dec-15Hilton Pharma (Pvt) Ltd Full Cipla LtdPharmaceuticals INDIA(Pvt) Ltd 12-Mar-14 Full GU Biopharma Pvt ltd Pharmaceuticals Pharmaceuticals (Pvt) Ltd Hilton Pharma (Pvt) Ltd (Pvt ) Ltd Renata Limited BANGLADESH 27-Apr-18(Pvt ) Ltd Full Incepta Pharmaceuticals Ltd (Contd.) Pharmaceuticals (Pvt) Ltd Ltd Healthcare lanka Ltd (Pvt) Ltd Healthcare lanka Ltd (Ceylon) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP TAMADOL INJECTIONURGENDOL Akbar INJECTION Robert Hall & Co 500ANEPTIL TABLETS PharmAce (Pvt) Ltd Alina Combine TRXAMIC 500 TABLETS 250ANEPTIL Associates CAPSULES Pharma The Madras TRANSAMIN PharmAce (Pvt) Ltd Alina Combine CAPSULESHAEMIC Sunshine XAMIC 500 CAPSULESHAEMIC CAPSULES Ceyoka (Pvt) Ltd Genix Pharma INTRAX Emerchemie NB CAPSULES Ceyoka (Pvt) Ltd CAPSULES Genix Pharma Citihealth Imports TRANAMIC TABLETS Slim INJECTION 50MG/ML INJECTION 50MG/ML TABLETS TABLETS 250MG 250MG 250MG 500MG 500MG 500MG TABLETS 6911 ACID 500MG BP TRANEXAMIC 6905 HYDROHLORIDE TRAMADOL 6906 HYDROHLORIDE TRAMADOL 6907 INJECTION 5MG/ML TRAMADOL CITRAMA6908 TRANEXAMIC ACID 250ML/5ML INJECTION TRANSAMIN6909ACID 500MG BP TRANEXAMIC Ceyoka (Pvt) Ltd INJECTION6910 Ciron Drugs & ACID 500MG BP TRANFIB TRANEXAMIC Sunshine TABLETS Breathe Free Lanka 6912 ACID 500MG BP TRANEXAMIC 6913 TRANEXAMIC ACID CAPSULES 6914 TRANEXAMIC ACID CAPSULES 6915 TRANEXAMIC ACID CAPSULES 6916 TRANEXAMIC ACID CAPSULES 6917 TRANEXAMIC ACID CAPSULES 6918 TRANEXAMIC ACID CAPSULES 550 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 BANGLADESH 27-Nov-18 Full BANGLADESH 07-Jan-15 Full BANGLADESH 27-Nov-17 Years Two BANGLADESH 05-Dec-17 Years Two PAKISTAN 29-Sep-14PAKISTAN Full 08-Jul-15PAKISTAN Full 26-Jul-16BANGLADESH 16-Feb-14 Full Full PAKISTANPAKISTAN 04-Jul-17 Full 14-Jun-14INDIA Full INDIA 09-May-15 Full 27-Jan-16 Full Globe Pharmaceuticals Ltd Pharmaceuticals Ltd Globe Pharmaceuticals Ltd (Pvt) LtdAGP PAKISTANIncepta Pharmaceuticals Ltd 27-Nov-17Years Two Hilton Pharma (Pvt) Ltd Laboratories (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals Ltd (Pvt ) Ltd Hilton Pharma (Pvt) Ltd Healthcare Vital (Pvt) Ltd Marksons Pharma Ltd (Contd.) (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd Healthcare lanka Ltd Healthcare lanka Ltd (Pvt) Ltd Plc SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP FIBROSTAT CAPSULESFRABEX 500 Healthcare Tabrane CAPSULESFIBROSTAT PharmAce (Pvt) Ltd Square CAPSULESMAXNA Healthcare Tabrane INTRAX CAPSULESTRANSAMIN Mansel (Ceylon) CAPSULES CAPSULES Citihealth Imports TRANEX Sunshine 250ANEPTIL CAPSULES INJECTION Morison PLCFRABEX 500 PharmAce (Pvt) Ltd Alina Combine ATCO INJECTIONHAEMIC PharmAce (Pvt) Ltd Square TRANSAMIN INJECTION INJECTIONNOBLEED Ceyoka (Pvt) Ltd Sunshine Genix Pharma TRANMARK INJECTION INJECTION International Yaden Browns & Company 500MG 500MG 500MG 500MG 500MG 500MG 500MG 250MG/5ML 500MG/5ML 500MG/5ML 500MG/5ML (500MG/5ML) 100MG/ML (500MG/5ML) 100MG/ML 6919 TRANEXAMIC ACID CAPSULES 6920 TRANEXAMIC ACID CAPSULES 6921 TRANEXAMIC ACID CAPSULES 6922 TRANEXAMIC ACID CAPSULES 6923 TRANEXAMIC ACID CAPSULES 6924 TRANEXAMIC ACID CAPSULES 6925 TRANEXAMIC ACID CAPSULES 6926 TRANEXAMIC ACID INJECTION 6927 TRANEXAMIC ACID INJECTION 6928 TRANEXAMIC ACID INJECTION 6929 TRANEXAMIC ACID INJECTION 6930 ACID INJECTION BP TRANEXAMIC 6931 ACID INJECTION BP TRANEXAMIC I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 551 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 BANGLADESH 23-Jan-18 Full INDIA 25-Oct-18 Years Two BANGLADESH 23-Jan-18 Full INDIAINDIA 29-Jun-17 Years Two 16-May-18 Full RUSSIA 18-Feb-18RUSSIA Years Two 18-Feb-18INDIA Years Two 05-Jul-18 Provisional c Stridden fi Globe Pharmaceuticals Ltd Agio Pharmaceuticals Ltd (Pvt) LtdAGP PAKISTANGlobe Pharmaceuticals Ltd 27-Nov-17Years Two GU Biopharma Pvt ltd Macleods Pharmaceuticals Ltd AryoGen Pharmed IRANAryoGen Pharmed IRAN 06-Mar-18 Provisional joint Stock 06-Mar-18Company Years Two joint Stock Company Biocon Limited For Mylan Laboratories Limited Biocon Limited INDIA 25-Jul-18 Provisional (Contd.) (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Slim Pharmaceuticals (Pvt) Ltd Slim Pharmaceuticals (Pvt) Ltd Ltd Medmart Pharma (Pvt) Ltd INJECTION INJECTION FOR INHALATION SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP FIBROSTAT INJECTIONXANTRA Healthcare Tabrane MAXNA INJECTIONFIBROSTAT Citihealth Imports INJECTION INJECTIONTRANAMIC Mansel (Ceylon) Healthcare Tabrane INJECTION 500TRENAXA Slim TABLETS TRUSTARYO Pettah Pharmacy POWDER FOR TRUSTARYO POWDER / HERTICAD INFUSIONHERTICAD PharmAce (Pvt) Ltd BIOCAD Closed INFUSION 440HERTRAZ INJECTION PharmAce (Pvt) Ltd BIOCAD Closed Markss HLC (Pvt) CANMAB 440 POWDER DRY 500MG/5ML 500MG/5ML 500MG/5ML 500MG/5ML 500MG/5ML 500MG INFUSION 150MG CONCENTRATE INFUSION 440MG CONCENTRATE SOLUTION FOR INFUSION 440MG SOLUTION FOR INFUSION 440MG ORIGIN) POWDER 440MG (rDNA FOR INJECTION ORIGIN) POWDER 440MG (rDNA FOR INJECTION 6932 ACID INJECTION BP TRANEXAMIC 6933 ACID INJECTION BP TRANEXAMIC 6934 ACID INJECTION BP TRANEXAMIC 6935 ACID INJECTION BP TRANEXAMIC 6936 ACID INJECTION BP TRANEXAMIC 6937 TRANEXAMIC ACID BP TABLETS 6938 TRASTUZUMAB POWDER FOR 6939 TRASTUZUMAB POWDER FOR 6940 TRASTUZUMAB POWDER FOR 6941 TRASTUZUMAB POWDER FOR 6942 TRASTUZUMAB FOR INJECTION 6943 TRASTUZUMAB FOR INJECTION 552 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 15-Nov-15 Full 07-Dec-17 Years Two SWITZERLAND/ GERMANY SWITZERLAND 14-Jun-14 Full BELGIUM 02-Jul-18 Years Two UNITED KINGDOM PAKISTAN 20-May-14GERMANY Full 19-Aug-17 Years Two F Hoffman-La F Hoffman-La Roche Ltd. Switzerland by Roche Diagnostcs GmBh-Gemany F Hoffman-La Roche Ltd Genentech Inc SWITZERLAND 02-Apr-14AryoGen Pharmed IRAN Full AryoGen Pharmed IRAN 06-Mar-18 Provisional ALCon Couvreur N V 06-Mar-18Years Two Alcon Couvreur BELGIUMALCon Couvreur N V 07-Dec-17Years Two Aristopharma Ltd BANGLADESH 13-Mar-14Elko Organization Full (Pvt) Ltd Catalent Germany Eberbach Gmbh,Germany for Cheplapharm Arineimittel Gmbh Germany (Contd.) Ltd Ltd Slim Pharmaceuticals (Pvt) Ltd Slim Pharmaceuticals (Pvt) Ltd Ltd Ltd Ltd Pharmaceuticals (Pvt) Ltd Ltd (Ceylon) Ltd Ltd INFUSION INJECTION EYE DROPS Morison PLC Alcon Couvreur BELGIUMEYE DROPS 14-Nov-17 Hemas Full SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP HERCEPTIN INJECTIONHERCEPTIN Baur & Co (Pvt) A INJECTION TRUSTARYO Baur & Co (Pvt) A POWDER FOR TRUSTARYO POWDER FOR TRAVDUO TRAVATAN EYE DROPS Baur & Co (Pvt) A CTRAVATAN EYE DROPSIZBA Baur & Co (Pvt) A AVATAN EYE DROPS Baur & Co (Pvt) A LYOPHILIZED POWDER FOR LYOPHILIZED RECONSTITUTIONS IV INFUSION DROPS 0.004% W/V SOLUTION 30MCG/ML (0.003%) SOLUTION 30MCG/ML LYOPHILIZED POWDER FOR LYOPHILIZED INJECTION FOR INFUSION CONCENTRATE 150MG FOR INFUSION CONCENTRATE 440MG EYE DROPS 5MG/ML /ML (0.003%) SOLUTION 30MCG/ML 6945 TRASTUZUMAB INJECTION 150MG/ 6953 STERILE EYE TRAVOPROST 6951 EYE DROPS TRAVOPROST 6944 TRASTUZUMAB INJECTION 150MG HERCEPTIN INJECTION Baur & Co (Pvt) A 6946 TRASTUZUMAB INJECTION 440MG 6947 TRASTUZUMAB POWDER FOR 6948 TRASTUZUMAB POWDER FOR 6949 40MCG+TIMOLOL TRAVOPROST 6950 EYE DROPS 40MCG TRAVOPROST 6952 EYE DROPS TRAVOPROST 6954 TRETINOIN 0.05% CREAM6955 TRETINOIN CAPSULES 10MG TRACNESAN VESANOID CREAM CAPSULES Emerchemie NB Baur & Co (Pvt) A I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 553 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIA 21-Jun-14INDIA Full INDIA 24-Mar-15 Full KOREA 04-May-18 Years Two BANGLADESH 13-Aug-16 18-Jun-16 Full Full BANGLADESH 16-Oct-17 Full PAKISTAN 01-Mar-18GERMANY Full 09-Feb-14INDIA Full INDIA 07-Aug-15INDIA Full 17-Dec-15INDIA Full 12-Sep-16 Full 19-Sep-18 Years Two Unijules Life Sciences Ltd Troikaa Pharmaceuticals Ltd Agio Pharmaceuticals Ltd Pharmaceuticals Co Ltd Pharmaceuticals Ltd Pharmaceuticals Ltd Remington pharmaceutical Industries (Pvt) Ltd Catalent German Eberbach Gmbh Laboratories (Pvt) Ltd Laboratories XL (Pvt) Ltd Centurion Laboratories Pvt Ltd Mercury Laboratories Ltd (Contd.) Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Co Ltd Ltd (Pvt) Ltd (Pvt) Ltd Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP UNINOIN CREAM CREAMTRETIN-A Lifeline TESS CREAMORAGEL N/A PASTETRIAM PASTE DENTAL Citihealth Imports Slim Astron (Pvt) LtdCENOLON INJECTION SRI LANKA INJECTION Pharma AssociatesTRISPRAY 12-Jun-14 Shin Poong Full BOTTLE SPRAY AQNOSOLONE PharmAce (Pvt) Ltd Square SPRAY NASAL Delmege Forsyth & Incepta N/ASYCAZINE 5 TABLETS TABLETSN/A Ceyoka (Pvt) Ltd SMM Halcyon (Pvt) N/A Leben TABLETS International Yaden TABLETS International Yaden BUSSAL PASTE O.1% W/W PASTE BUSSAL W/W W/W 0.1% USP PASTE DENTAL 40MG/ML INJECTABLE 40MG/ML BP INJECTABLE 55MCG SPRAY SPRAY NASAL 55MCG SPRAY SPRAY NASAL TABLETS 5MG 5MG 100MG 6958 TRIAMCINOLONE ACETONIDE 6956 0.025% TRETINOIN CREAM USP 6957 0.025% TRETINOIN CREAM USP 6959 TRIAMCINOLONE ACETONIDE 6960 TRIAMCINOLONE ACETONIDE 6961 TRIAMCINOLONE ACETONIDE 6962 TRIAMCINOLONE ACETONIDE 6963 TRIAMCINOLONE ACETONIDE 6964 TRIBENOSIDE CAPSULES 400MG GLYVENOL6965 TRIFLUOPERAZINE 5MG IP CAPSULES6966 BP TRIFLUOPERAZINE TABLETS Baur & Co (Pvt) A 6967 BP TRIFLUOPERAZINE TABLETS 6968 BP TRIMETHOPRIM TABLETS 554 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIA 06-Aug-18 Years Two BELGIUMINDIA 29-Jan-16 Full PAKISTAN 24-May-18 Years Two 28-Sep-18MACAU Years Two BUlGARIA 01-Apr-14 23-Dec-17 Full PORTUGAL Full 04-Jan-18 Provisional KOREAINDIA 24-Nov-14 Full 26-Jun-18 Full Mercury Laboratories Ltd Ferring GMBH GERMANYFerring GMBH 09-Nov-17Years Two GERMANY 09-Dec-17Couvreur N V Years Two Sunway Rohto Pharmaceutical Pvt Ltd Sante (Private) Limited Ashford Laboratories Ltd BulBio National Center of Infection & Prsitic Disease Labesfal Laboratories A Almtro S F D C Limited INDIA G Life Sciences L Ltd Cadila Healthcare 26-Jul-16Ltd Full Win Medicare ltd INDIA 29-Nov-15 Full (Contd.) (Pvt) Ltd Healthcare lanka Ltd Healthcare lanka Ltd (Pvt) Ltd (Ceylon) Ltd (Pvt) Ltd (Pvt) Ltd Markss HLC (Pvt) Ltd Services Pvt. Ltd Pharmaceuticals (Pvt) Ltd Ltd Healthcare lanka Ltd INJECTION Henlleys Group FILM COA TABLETS SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP N/ADECAPETYL INJECTION TABLETSDECAPETYL Sunshine International INJECTION Yaden MYDRIACYL Sunshine EYE DROPSTROPICACYL Morison PLC EYE DROPSTROPIC International Yaden Alcon- A S N/A EYE DROPS PPD Tuberculin Emerchemie NB Mammaltan EYE DROPS KETOSTERIL TABLETS Ceylon Teastar FOLLIMONPOSTINE 75 INJECTION INJECTION ABC Pharma FORTEUDIHEP TABLETS Hemas Robert Hall & Co 200MG 0.1MG 3.75MG POWDER & SOLVENT SUSPENSION SOLUTION 1% SOLUTION USP 1% SOLUTION USP 1% SOLUTION USP TU FOR HUMAN USE 5 DERIVATIVE 1ML 38G+THREONINE 53MG+TRYPTOPHAN ACETATE 23MG+LYSINE 2 105MG+CALCIUM 4 METHYL 68MG OXO-3-PHENYLPROPIONATE 2 OXO CALEIUM 3-METHYL IU 75 IU 300MGTABLETS 6969 BP TRIMETHOPRIM TABLETS 6970 INJECTION ACETATE TRIPTORELIN 6971 INJECTION ACETATE TRIPTORELIN 6972 TROPICAMIDE OPTHALMIC 6973 TROPICAMIDE OPTHALMIC 6974 TROPICAMIDE OPTHALMIC 6975 TROPICAMIDE OPTHALMIC 6976 TUBERCULIN PURIFED PROTEIN 6977 TYROSINE 30G+HISTIDINEV 6978 12% CREAM UREA 6979 UROFOLLITROPHIN INJECTION 75 6980 UROFOLLITROPHIN INJECTION BP COTARYL6981 URSODEXYCHLOLIC ACID BP CREAM Sunshine I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 555 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 PAKISTAN 04-Jan-14PAKISTAN Full 04-Jan-14 Full INDIAINDIA 05-Nov-18 Years Two INDIA 28-Jun-17 Years Two 07-Aug-17 Years Two CANADA 12-Mar-14INDIA Full SRI LANKA 07-Aug-14 22-Feb-18INDIA Provisional Full INDIA 08-May-15 Full INDIA 15-Jul-15 Full 17-Jun-18 Years Two Micro Labs Ltd INDIA CCL Pharmaceuticals (Pvt) Ltd 30-Jun-15 CCL Pharmaceuticals (Pvt) Ltd Full Win Medicare Ltd INDIA Treffer Pharmaceuticals 12-Dec-17Sava Healtheare Ltd Full Cadila Healthcare Ltd Patheon Inc. Canada for F La Roche Hoffman ltd Ltd Priivate Limited Ratnamani Healthcare (Pvt) Ltd Centurion Laboratories Pvt Ltd Centurion Laboratories Pvt Ltd (Contd.) (Pvt) Ltd Pharmaceuticals Lanka (Pvt) Ltd Pharmaceuticals Lanka (Pvt) Ltd Ltd (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd (Ceylon) Ltd Pharmaceuticals (Pvt) Ltd Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP URSODOX 250TRIPTOR CAPSULES CAPSULES Salveo Pharma 500TRIPTOR CCL CAPSULESUDIHEP CCL N/A TABLETS Robert Hall & Co TABLETS International Yaden GANZOSVIRALGEN TABLETSN/A TABLETS Chamee Chemist Bajaj Healthcare N/AN/A TABLETSCENTREX Lanka Tabrane TABLETS Celogen Lanka TABLETS International Yaden International Yaden CAPSULES BP 250MG CAPSULES BP CAPSULES 250MG CAPSULES 500MG 150MG 150MG BP 450MG 450MG 450MG 450MG 500MG 6982 URSODEXYCHLOLIC ACID 6983 URSODEXYCHLOLIC ACID 6984 URSODEXYCHLOLIC ACID 6985 URSODEXYCHLOLIC ACID TABLETS 6986 URSODEXYCHLOLIC ACID TABLETS 6987 250MG CAPSULES USP URSODIOL BIO-URSO6988 250MG CAPSULES USP URSODIOL URSODIL CAPSULES6989 300MG CAPSULES USP URSODIOL Emerchemie NB UDILIV 300 CAPSULES6990 450MGTABLETS VALGANCICLOVIR VALCYTE Hemas TABLETS6991 TABLETS USP TABLETS VALGANCICLOVIR CIC Holdings PLC Abbott India Ltd6992 USP Baur & Co (Pvt) INDIA TABLETS A VALGANCICLOVIR 6993 USP TABLETS VALGANCICLOVIR 29-Jul-146994 USP TABLETS VALGANCICLOVIR Full 6995 USP TABLETS VALGANCICLOVIR 556 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 07-Apr-16 Full INDIASWITZERLAND/ ITALY 16-Jul-17 Years Two INDIASWITZERLAND 15-Dec-15 09-May-18 Years Two Full INDIASWITZERLAND 15-Oct-14 29-Sep-15INDIA Full Full INDIA 16-Jul-14INDIA Full 22-Jun-15INDIA Full 16-Jul-15INDIA Full 26-Sep-18 Years Two INDIA 19-Jun-17 Years Two INDIA 19-Jun-14 Full 13-Aug-17 Years Two West Coast West Pharmaceurical works Ltd Novartis Farma Italy for S.pA Novartis pharma AG Cadila Healthcare Ltd Novartis pharmaceuticals Ltd Cadila Healthcare Ltd Novartis Farmaceutica S.A Coast West Pharmaceurical works Ltd Healthcare Pharmaceuticals Coast West Pharmaceurical works Ltd Swiss Paranterals (Pvt) Ltd Scott Edil Pharmacia Ltd Pharmaceutica (Pvt) Ltd Swiss Paranterals (Pvt) Ltd (Contd.) (Pvt) Ltd Ltd Healthcare lanka Ltd C Medical (Pvt) T P Ltd Ltd Ltd Ltd Healthcare lanka Ltd Baur & Co (Pvt) A Ltd (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd INJECTION TABLETS SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP VALVEX TH VALVEX TABLETSCO-DIOVAN Global Impex AV TABLETS Baur & Co (Pvt) A VALAZYD TABLETS Sunshine 1.0GMVAN-CP POWDER / N/AVANCOSAM INJECTION INJECTION 500VAN-CP Chamee Chemist C Medical (Pvt) T P INJECTION Samrudh C Medical (Pvt) T P 160MG+HYDROCHLOROTHIAZIDE 12.5MG TABLETS 160MG+HYDROCHLOROTHIAZIDE 12.5MG TABLETS 80MG+HYDROCHLOROTHIAZIDE TABLETS 12.5MG USP FOR INJECTION USP 1000MG FOR INJECTION USP 1000MG FOR INJECTION USP 1G WITH FOR INJECTION USP FOR INJECTION WATR 500MG FOR INJECTION USP 6996 VALSARTAN 6997 VALSARTAN 6998 VALSARTAN 6999 160MGTABLETS VALSARTAN DIOVAN7000 160MGTABLETS VALSARTAN 7001 160MGTABLETS VALSARTAN VALTAN TABLETS 160 VALAZYD 7002 80MGTABLETS VALSARTAN Baur & Co (Pvt) A TABLETS TABLETS7003 160MG USP TABLETS VALSARTAN DIOVAN 160 VALVEX Ceyoka (Pvt) Ltd Sunshine ENGLISH 7004 80MG USP TABLETS TABLETS VALSARTAN FILM COA DISYS7005 80MG USP TABLETS PAKISTAN VALSARTAN Global Impex AV 80 VALVEX 04-Jan-187006 Provisional HYDROCHLORIDE TABLETS VANCOMYCIN TABLETS7007 HYDROCHLORIDE VANCOMYCIN Citihealth Imports Global Impex AV 7008 HYDROCHLORIDE VANCOMYCIN 7009 HYDROCHLORIDE VANCOMYCIN I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 557 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIA 20-Feb-16 Full INDIABELGIUM 24-Mar-15 Full 13-Jul-15INDIA Full INDIA 20-Jan-18INDIA Full 09-Jul-14INDIA Full 22-Mar-18 Provisional INDIA 20-Jan-18INDIA Full 24-Jan-14INDIA Full 04-Aug-15INDIA Full 25-Nov-15 Full INDIA 05-Jan-18 Years Two INDIA 16-Aug-14 Full INDIA 16-Aug-14 Full 25-Sep-16 Full c Stridden fi United Biotech (Pvt) Ltd GU Biopharma Pvt ltd Glaxo Smithkiline A Biologicals S (Pvt) Ltd SG Pharma (Pvt) Ltd Kwality Pharmaceuticals Pvt Ltd (Pvt) Ltd Neon Laboratories Ltd Gland Pharma (Pvt) Ltd Sun Pharmaceutical industries Inventia Healthcare (Pvt) Ltd Sun Pharmaceutical industries Sun Pharmaceutical industries Torrent Pharmaceuticals Ltd (Contd.) Ltd Pharmaceuticlas (Pvt) Ltd Pharmacy (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd Services Pvt. Ltd (Ceylon) Ltd (Ceylon) Ltd (Ceylon) Ltd (Ceylon) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd INJECTION New Arumed (Pvt) SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP VANCOTECH VANCOTECH 500CP VARILRIXVASMED INJECTION GlaxoSmithkiline PETRESIN INJECTIONN/A INJECTION Klintas (Pvt) Ltd United Biotech The Esses VASMED INJECTIONNEOVEC INJECTION International Yaden SURVEC Klintas (Pvt) Ltd INJECTIONVENIZ XR 37.5 United Biotech Ravilux Company INJECTION CAPSULES SR ABC Pharma NEUROFAX Emerchemie NB TABLETS S.R Emerchemie NB VENIZ XR 150 CAPSULESVENIZ XR 150 Emerchemie NB CAPSULES ODVENLIFT Emerchemie NB CAPSULES Hemas VANCOCIN INJECTION Slim FOR INJECTION USP 500MG FOR INJECTION USP LIVE ATTENUATED 200 PFU ATTENUATED LIVE UNITS/ML UNITS/ML UNITS/ML UNITS/ML INJECTION 10MG INJECTION 10MG EXTENDED RELEASE 37.5MG EXTENDED RELEASE 37.5MG RELEASE CAPSULES 150MG RELEASE CAPSULES 150MG RELEASE CAPSULES 37.5MG FOR INJECTION USP 500MG FOR INJECTION USP 7011 HYDROCHLORIDE VANCOMYCIN 7010 HYDROCHLORIDE VANCOMYCIN 7012 STRAIN ) (OKA VACCINE VARICELLA 7013 20 INJECTION IP VASOPRESSIN 7014 20 INJECTION IP VASOPRESSIN 7015 20 INJECTION IP VASOPRESSIN 7016 20 INJECTION IP VASOPRESSIN 7017 VECURONIUM BROMIDE FOR 7018 VECURONIUM BROMIDE FOR 7019 CAPSULES VENLAFAXINE 7020 CAPSULES VENLAFAXINE 7021 EXTENDED VENLAFAXINE 7022 EXTENDED VENLAFAXINE 7023 EXTENDED VENLAFAXINE 558 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 01-Jan-18 Full INDIA 23-Sep-16 Full INDIA 08-Feb-18 Years Two INDIA 17-May-18 Provisional INDIA 05-Jan-17INDIA Full 28-Jan-18 Years Two 25-Jan-18 Years Two INDIAINDIA 19-Sep-18 Years Two INDIA 22-Jul-17SRI LANKA Full 13-Jun-18 08-Aug-17 Years Two Full BANGLADESH 04-Jun-16 Full BANGLADESH 16-Aug-18 Full Sun Pharmaceutical industries Torrent Pharmaceuticals Ltd Centurion Laboratories Pvt Ltd Centurion Laboratories Pvt Ltd Inventia Healthcare (Pvt) Ltd Pvt Ltd Pvt Ltd Mercury Laboratories Ltd Sciences (Pvt) Ltd Treffer Pharmaceuticals Pharmaceuticals Manufacturer Corporation Pharmaceuticals Ltd General Pharmaceuticals Ltd (Contd.) (Ceylon) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd (Ceylon) Ltd (Pvt) Ltd Pharma Associates Samarth Life (Pvt) Ltd Health (Pvt) Ltd SOLUTION SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP VENIZ XR 75 CAPSULES ODVENLIFT Emerchemie NB CAPSULESN/A Hemas N/A CAPSULES SRNEUROFAX International Yaden CAPSULES CAPSULES Emerchemie NB International Yaden VENISH 37.5 TABLETSCALAN-SR PharmAce (Pvt) Ltd TABLETS Consern Pharma N/A Morison PLCVPLN/A Searle-Pakistan INJECTION PAKISTAN International Yaden INJECTABLE 14-Nov-14 TABLETS Full International Yaden 5MG/2ML RELEASE CAPSULES USP 75MG RELEASE CAPSULES USP 75MG RELEASE CAPSULES USP 37.5MG RELEASE CAPSULES BP 75MG RELEASE CAPSULES BP RELEASE CAPSULES 75MG 37.5MG TABLETS RELEASE SUSTAINED 240MG 5MG/2ML 240MG BP TABLETS 7032 INJECTION BP VERAPAMIL 7024 EXTENDED VENLAFAXINE 7025 EXTENDED VENLAFAXINE 7026 PROLONGED VENLAFAXINE 7027 PROLONGED VENLAFAXINE 7028 SUSTAINED VENLAFAXINE 7029 37.5MGTABLETS VENLAFAXINE VENISH 37.57030 USP TABLETS VENLAFAXINE TABLETS7031 HYDROCLORIDE VERAPAMIL PharmAce (Pvt) Ltd Consern Pharma 7033 INJECTION BP VERAPAMIL 7034 PROLONGED RELEASE VERAPAMIL 7035 40MG B.P TABLETS VERAPAMIL N/A7036 50MGTABLETS VIDAGLIPTIN 50 VIGLITA 7037 TABLETS 50MGTABLETS VILDAGLIPTIN TABLETS VIPTIN N/A PharmAce (Pvt) Ltd Square TABLETS State George Steuart I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 559 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 SWEDEN 03-Dec-14 Full BANGLADESH 16-Feb-18 Years Two PAKISTAN 13-Nov-15SPAIN Full PAKISTAN 31-Aug-16 14-Sep-17 Years Two Full BANGLADESH 30-Jan-18 Full BANGLADESH 30-Jun-16INDIA Full INDIA 14-Sep-17 Years Two INDIA 14-Sep-17 Years Two INDIA 01-Dec-14INDIA Full 25-Feb-15INDIA Full 25-Feb-15 Full 14-Sep-17 Full Aristopharma Ltd BANGLADESH 26-Jan-15Novartis Pharma Full Stein .AG Switzerland for novatis Pharma Shcweiz AG Switzerland The Acme Laboratories Ltd Ferozsons Laboratories Ltd Novartis Farmaceutica S.A Scotmann Pharmaceuticals Globe Pharmaceuticals Ltd Healthcare Pharmaceuticals United Biotech (Pvt) Ltd United Biotech (Pvt) Ltd Naprod Life Scienc (Pvt) Ltd (Pvt) Ltd Belco Pharma (Pvt) Ltd United Biotech (Pvt) Ltd (Contd.) Health (Pvt) Ltd Health (Pvt) Ltd (Pvt) Ltd Agency Pvt Ltd Health (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Ltd Ltd (Ceylon) Ltd Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP UNIBLASTIN INJECTIONUNICRISTIN George Steuart VINSTIN INJECTION George Steuart AQUES CYTOWIN INJECTION INJECTION AQUESCYTOWIN Pharmatec (Pvt) Ltd INJECTION Belco Pharma Ravilux Company VINOTEC Leader Pharma INJECTION George Steuart 10MG/10ML 1MG INJECTION USP 1MG INJECTION USP 1MG/ML INJECTION USP 1MG/ML INJECTION USP 10MG/ML 7038 50MG VILDAGLIPTIN TABLETS VILDA7039 50MGTABLETS VILDAGLIPTIN 50 GALVUS TABLETS TABLETS7040 50MGTABLETS VILDAGLIPTIN Hemas Baur & Co (Pvt) A 7041 VILDAPIN 50MGTABLETS VILDAGLIPTIN 7042 VALIANT 50MGTABLETS VILDAGLIPTIN TABLETS7043 50 GALVUS 50MGTABLETS VILDAGLIPTIN Mega Pharma (Pvt) TABLETS GLACIN 50 TABLETS7044 50MGTABLETS VILDAGLIPTIN Emerchemie NB Baur & Co (Pvt) TABLETS A 50 SUCOVIL 7045 50MGTABLETS VILDAGLIPTIN Slim TABLETS7046 50MG REDIA VINBLASTINE SULPHATE Healthcare Tabrane 7047 TABLETS FOR VINCRISTINE SULPHATE 7048 FOR Citihealth Imports VINCRISTINE SULPHATE 7049 VINCRISTINE SULPHATE 7050 VINCRISTINE SULPHATE 7051 VINORELBINE INJECTION USP 560 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 18-Jan-17INDIA Full 09-Nov-17 Years Two 16-Oct-14PAKISTAN Full 12-Dec-17 Years Two PAKISTAN 09-Aug-17BANGLADESH Full 02-Apr-18 Years Two INDIASRI LANKA 04-May-18 24-May-18INDIAYears Two Full INDIA 28-Nov-15INDIA Full 14-Aug-16GERMANY Full 27-Mar-15 06-Mar-14 Full Full Fresenius Kabi Oncology Ltd United Biotech (Pvt) Ltd Dr Reddy's Laboratories Ltd Merck (Pvt) Ltd PAKISTAN Merck Sharp T P Dohme pharma 12-Dec-17Tbk Years Two Remington pharmaceutical Industries (Pvt) Ltd Eskayef Bangladesh Ltd Care (Pvt) Ltd Priivate Limited Asoj Soft Caps (Pvt) Ltd (Pvt) Ltd Care (Pvt) Ltd Denk Pharma GmbH & Co. (Contd.) Ltd Health (Pvt) Ltd (Ceylon) Ltd (Ceylon) Ltd (Ceylon) Ltd Pharma Associates Softgel Health International Yaden (Pvt) Ltd Pharma Associates Softgel Health Pharmaceuticals (Pvt) Ltd Co Ltd Healthcare lanka Ltd N/A Celogen Lanka CAPSULES CAPSULES CAPSULES CAPSULES SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP VINELBINEVINOTEC 50 INJECTION INJECTIONBECOZINC Markss HLC (Pvt) George Steuart NEUROBION SYRUP TABLETSNEUROBION Emerchemie NB TABLETS Emerchemie NB MINTERRA Emerchemie NB CAPSULES N/ARECTAL-4 Astron (Pvt) Ltd SRI LANKA GELETIN SOFT 25-May-18Years Two ACTIVO 100N/A GELETIN SOFT N/A CAPSULES B DENKVIT PharmAce (Pvt) Ltd GELETIN SOFT Softech Pharma TABLETS Akbar 10MG/ML 50MG/5ML C & ZINC WITH + VIT. 200MCG TABLETS B12 200MCG RELEASE CAPSULES 400IU CAPSULES USP IU CAPSULES GELATIN IU & SOFT NIPPLE WITH A 100MG+PYRIDOXINE 200MG 7058 SUPPLEMENT & MINERAL VITAMIN VISAVIT TABLETS Delmege Forsyth & 7052 VINORELBINE INJECTION USP 7053 VINORELBINE INJECTION USP 7054 FORTIFIED COMPLEX SYRUP VIT.B 7055 200MG+VIT.B 100MG+VIT.B6 VIT.B1 7056 200MG+VIT. 100MG+VIT.B6 VIT.B1 7057 DELAYED & MINERAL VITAMIN 7059TABLETS & MINERAL VITAMIN VITRUM SILVER7060 D3 4000IU & VITAMIN A VITAMIN TABLETS7061 CAPSULES 100,000 IUA VITAMIN Sunshine RETIGEN7062 CAPSULES 100,000 IU A VITAMIN 7063 100,000 CAPSULES USP A GELATIN SOFT VITAMIN 7064 100,000 CAPSULES USP A VITAMIN 7065 B COMPLEX (THIAMIN VITAMIN I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 561 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIA 12-Oct-14INDONESIA Full 27-Nov-17 Years Two INDONESIA 10-May-18 Years Two THAILAND 25-Feb-18 Years Two INDIA 10-Jan-14PAKISTAN Full 16-Jul-16INDIA Full INDIA 11-Sep-15 Full INDIA 11-Sep-15 Full INDONESIA 19-Feb-15 10-May-18 Full Years Two Pharmaceutical (Pvt) Ltd Caprifamindo PT Laboratories for sanbe farma PT Merck Sharp PT Dohme Pharma Tbk Mega Lifesciences Public Company (Pvt) Ltd Pharmaceutical (Pvt) Ltd Pharmaceuticals & Chemical Works Ltd Ltd Pharmaceuticals Ltd Tbk. JI Merck PT B Simotupang T Merck Limited INDIAMerck Limited INDIA 17-Mar-19 Provisional 17-Mar-17Years Two (Contd.) (Ceylon) Ltd (Ceylon) Ltd (Ceylon) Ltd Pharmaceuticals (Pvt) Ltd Ltd (Ceylon) Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP CYNOCOB FORTE INJECTION PharmAce (Pvt) Ltd DCI SANGOBION CAPSULES Emerchemie NB SYRUPBINOVA SYRUP SYRUPBINOVA SYRUP Harcourts (Pvt) Ltd Coral Laboratories N/A Harcourts (Pvt) Ltd Coral Laboratories SANGOBION TABLETS SYRUP Pharma AssociatesPOLYBION Bafna Emerchemie NB INJECTION Emerchemie NB 1000MCG CAPSULES B2 2MG+DEXPANTHEOL 5MG, VIT. 3MG & Nicotinamide 20mg B2 2MG+DEXPANTHEOL 5MG, VIT. 3MG & Nicotinamide 20mg SOLUBLE WATER SYRUP INJECTION 7066 B 12 INJECTION IP VITAMIN 7067 C B COMPLEX & VITAMIN VITAMIN BECOSULES7068 C B COMPLEX & VITAMIN VITAMIN BECOM-C CAPSULES7069 N/AAND IRON B COMPLEX VITAMIN TABLETS7070 B COMPLEX CAPSULE VITAMIN Lifeline B NAT Astron (Pvt) Ltd7071 B COMPLEX INJECTION VITAMIN SRI LANKA B PLUS 29-Sep-177072 CAPSULES B COMPLEX INJECTION VITAMIN Full ESTYPLEX 57073 Baur & Co (Pvt) A B COMPLEX SYRUP VITAMIN INJECTION INJECTION PharmAce (Pvt) Ltd SYRUP7074 KANAVIT DCI BI VIT B COMPLEX SYRUP VITAMIN SYRUP CIC Holdings PLC (India) Ltd Tablets INDIA7075 BI VIT B COMPLEX SYRUP VITAMIN Ceyoka (Pvt) Ltd ISIS 17-Feb-167076 TABLETS B COMPLEX VITAMIN Full 7077 B COMPLEX WITH IRON VITAMIN 7078 B12 B COMPLEX, VITAMIN VITAMIN POLYBION7079 B12 B COMPLEX, VITAMIN VITAMIN INJECTION Emerchemie NB 562 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 BANGLADESH 18-Oct-15 Full INDONESIA 20-Apr-18 Years Two AUSTRALIA 23-Sep-17 Full AUSTRALIA 23-Sep-17 Full PAKISTAN 14-Sep-17 Years Two PAKISTAN 25-Nov-17 Years Two BANGLADESH 16-May-16 Full Merck (Pvt) Ltd PAKISTANMerck (Pvt) Ltd PAKISTAN 12-Oct-17Years Two Eskayef Bangaladesh Ltd 12-Oct-17Years Two Meprofarm JI T P Soekarno Hatta Hovid SDN Bhd MALAYSIAHovid SDN Bhd 21-Oct-14 MALAYSIA Full Contract Manufacuring & 28-Jan-15Packging Services pty Ltd Full Sanbe FarmaT P INDONESIA 20-Apr-14Contract Manufacuring Full Hovid SDN Bhd MALAYSIAScotmann 28-Jan-15Pharmaceuticals Full Scotmann Pharmaceuticals Drug International Ltd (Contd.) (Ceylon) Ltd (Ceylon) Ltd Sunshine Healthcare lanka Ltd (Ceylon) Ltd Pharmaceuticals (Pvt) Ltd Lanka (Pvt) Ltd Alaris Lanka (Pvt) Ltd Alaris Lanka (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd TABLETS CHEWABLE TABLETS TABLETS SYRUP Slim SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP NEUROBION INJECTIONNEUROBION Emerchemie NB INJECTIONSOLBION Emerchemie NB NEUROBION FILM COA INJECTIONNEUROVIT Emerchemie NB TABLETSCHEWETTE-C TABLETS Thorn CEE STRAWBERRY Hadley Bevan APPLECEE PINE CHEWABLE ABSORBA 400E-CAP CAPSULES Pharma Tropical 12 100MCG 12 100MCG TABLETS B12 200MCG 200MG+VIT. B12 5MG B6 100MG+VITAMIN INJJECTION B12 100MCG 50MG+VITAMIN 100MG 500MG 500MG CAPSULES 400MG 7080 B B1 100MG+B6 100mg+Vit. VITAMIN 7081 B B1 100MG+B6 100mg+Vit. VITAMIN 7082 B1 100MG+VIT.B6 VITAMIN 7083 B1 100MG+VITAMIN VITAMIN 7084 B1 97MG+VITAMIN.B6 VITAMIN 7085 TABLETS C CHEWABLE VITAMIN 7086 TABLETS C CHEWABLE VITAMIN 7087 1G C 1G EFFERVESCENT VITAMIN BIFERCE7088 TABLETS C CHEWABLE VITAMIN TABLETS7089 100MG BP TABLETS C VITAMIN Lifeline CHEWETTE-C7090 D3 1000IU SYRUP VITAMIN TABLETS7091 Thorn D3 INJECCTION 5MG VITAMIN D SUNNY D SUNNY 7092 GELATIN E SOFT VITAMIN INJECTION Slim I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 563 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 05-Nov-16 Full 04-May-17THAILAND Full 08-Jan-15THAILAND Full BANGLADESH 29-Jul-17 16-May-16 Full INDIA Full INDIA 02-Nov-17 Years Two 14-May-15 Full BANGLADESH 22-Feb-14 Full BANGLADESH 02-Feb-15 Full INDIAINDIA 13-May-14INDIA Full 02-Nov-17 Years Two 20-Oct-15 Full Cadila pharmaceuticals Ltd Care (Pvt) Ltd Merck Limited INDIAMega Lifesciences (Pvt) Ltd Mega Lifesciences 17-Mar-17(Pvt) Ltd Drug International Full Ltd Renown Pharmaceuticals Pvt Ltd (Pvt) Ltd Merck Limited INDIAMerck Limited INDIAGlobe 17-Mar-17Pharmaceuticals Ltd Full 30-Jan-17Globe Pharmaceuticals Ltd Full (Pvt) Ltd Renown Pharmaceuticals Pvt Ltd Stallion Laboratories Pvt Ltd (Contd.) Healthcare lanka Ltd Pharma Associates Softgel Health (Ceylon) Ltd Ltd Ltd (Pvt) Ltd (Pvt) Ltd (Ceylon) Ltd (Ceylon) Ltd (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd CAPSULES SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP VIT ECVIT 400TOCOSOFT CAPSULES GELETIN SOFT EVION Sunshine CAPSULES Emerchemie NB CAPSULES CAPSULES GELATIN CAPSULES GELATIN 7093 GEL C SOFT E & VITAMIN VITAMIN 7094 SOFT E 400MG USP VITAMIN 7095 SOFT E 400MG USP VITAMIN 7096 E CAPSULE 400IU VITAMIN 7097 E CAPSULE 400IU VITAMIN NUENAT7098 200MG E CAPSULES USP VITAMIN 200 E-CAP ENAT-4007099 CAPSULES 200MG E CAPSULES USP VITAMIN RENOCARE 200 CAPSULES Baur & Co (Pvt) CAPSULES CAPSULES A 7100 200MG E CAPSULES USP VITAMIN Pharma Tropical Baur & Co (Pvt) International A Yaden E-Soft 2007101 200MG E CAPSULES USP VITAMIN EVION 200 CAPSULES7102 600MG E CAPSULES USP VITAMIN EVION PharmAce (Pvt) Ltd CAPSULES Softech Pharma 7103 200MG E CAPSULES BP VITAMIN Emerchemie NB ECOVIT-S CAPSULES7104 400MG E CAPSULES BP VITAMIN CAPSULES Emerchemie NB 400 ECOBIT 7105 400MG E CAPSULES USP VITAMIN Healthcare Tabrane CAPSULES E-soft 4007106 400MG E CAPSULES USP VITAMIN Healthcare Tabrane RENOCARE 400 CAPSULES CAPSULES7107 400MG E CAPSULES USP VITAMIN PharmAce (Pvt) Ltd International Yaden E-STAL Softech Pharma CAPSULES Siba Healthcare 564 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIA 12-Sep-14INDIA Full 18-Apr-18 Provisional PAKISTAN 02-Dec-15 Full INDIA 06-Jun-18 Years Two INDIA 09-Apr-18 Years Two PAKISTAN 12-Nov-18 Years Two INDIA 15-Aug-17 Full INDIA 28-Jun-18 Full INDIA 11-Oct-16 Full INDIAINDIA 15-Aug-17INDIA Full 28-Jun-17 Full 26-Feb-14 Full Stallion Laboratories Pvt Ltd Meyer Organics (Pvt) Ltd Tabros Pharma Tabros (Pvt) Ltd Ltd United Biotech (Pvt) Ltd Anfarn Hellas S AAnfarn Hellas S GREECEFerozsons 17-Aug-18Laboratories Ltd Years Two Centurion Laboratories Pvt Ltd Ltd United Biotech (Pvt) Ltd Centurion Laboratories Pvt Ltd Ltd Cadila Healthcare Ltd Cipla Ltd INDIA 05-Apr-15 Full (Contd.) Ltd (Pvt) Ltd Laboratories (Pvt) Ltd Axia (Pvt) Ltd MSN Laboratories Health (Pvt) Ltd Yaden International Yaden (Pvt) Ltd (Ceylon) Ltd (Pvt) Ltd Health (Pvt) Ltd Pharmaceuticals (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd INJECTION INFUSION SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP DIACAREMENOPACE CAPSULES CAPSULES N/A SMM Halcyon (Pvt) Astron (Pvt) Ltd SRI LANKA 21-Oct-17 Full ZEEST TABLETS Associated VORIOLE IV POWDER / VONAZ 200 INJECTION George Steuart VORTIMAL SOLUTION ZOFARIN 5ZOFARIN TABLETSWARF Hemas TABLETS Breathe Free Lanka ANTIOXIDANTS CAPSULES SUPPLEMENT CAPSULES SUPPLEMENT OIL AND WATER SOLUBLE AND WATER OIL 200MG 200MG POWDER FOR SOLUTION INFUSION USP IP 7111 TABLETS WITH MINERAL VITAMINS 7110 & MINERALS WITH VITAMINS 7112 VORICONAZOLE FOR INJECTION 7113 VORICONAZOLE FOR INJECTION 7114 VORICONAZOLE LYOPHILLZED 7115 200MGTABLETS VORICONAZOLE VORIF TABLETS Emerchemie NB 7116 200MGTABLETS VORICONAZOLE N/A TABLETS International Yaden 7117 200MGTABLETS VORICONAZOLE VORIOLE 200 TABLETS Axia (Pvt) Ltd MSN Laboratories 7118 200MGTABLETS VORICONAZOLE VONAZ 200 TABLETS George Steuart 7119 200MGTABLETS VORICONAZOLE N/A TABLETS International Yaden 7108 & MINERALS CAPSULES VITAMINS SENATOGEN7109 CAPSULES & MINERALS VITAMINS Siba Healthcare 7120 50MGTABLETS VORICONAZOLE VORIOLE 507121 TABLETS SODIUM 5MG WARFARIN TABLETS7122 1MG TABLETS SODIUM WARFARIN Axia (Pvt) Ltd MSN Laboratories I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 565 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 31-Aug-17 Full INDIA 26-Feb-14 Full 20-Jan-14INDIA Full INDIA 09-Apr-16INDIA Full 09-Aug-14INDIA Full 09-Apr-18 Provisional INDIA 09-Apr-18 Full INDIA 03-Jul-17 Years Two PAKISTAN 08-Jan-15 02-Dec-15 Full INDIA Full INDIA 24-Jun-17 Years Two 18-Aug-15 Full Cadila Healthcare Ltd Cadila Healthcare Ltd Cadila Healthcare Ltd Cipla LtdCenturion Laboratories Pvt INDIALtd (Pvt) Ltd 28-Apr-18Centurion Years Two Laboratories Pvt Ltd Centurion Laboratories Pvt Ltd Aculife Healthcare (Pvt) Ltd Amanta Healthcare Ltd Pharma Tabros (Pvt) Ltd Glaxo Smithkiline Pharmaceuticlas PharmaceuticalS (Pvt) Ltd (Contd.) Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Pharmaceuticals (Pvt) Ltd Laboratories (Pvt) Ltd Pharmaceuticlas (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd (Pvt) Ltd Healthcare lanka Ltd SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP ZOFARIN 1ZOFARIN TABLETS 10ZOFARIN Hemas TABLETS 3ZOFARIN Hemas TABLETS Hemas N/AZEEST INJECTIONEMODERM Akbar TABLETS CREAMCIROVIN Associated GlaxoSmithkiline DROPS NASAL Ceyoka (Pvt) Ltd Ciron Drugs & 1MG 10MG 3MG STERILISED BP TABLETS WITH MINERALS 0.2% 0.05% BP 7123 USP TABLETS SODIUM WARFARIN 7124 USP TABLETS SODIUM WARFARIN 7125 USP TABLETS SODIUM WARFARIN 7126 5MG IPTABLETS WARFARIN 7127 1MG BP TABLETS WARFARIN WARF N/A7128 1MG BP TABLETS WARFARIN TABLETS7129 3MG BP TABLETS WARFARIN 1 AZWAR Breathe Free Lanka TABLETS N/A7130 5MG BP TABLETS WARFARIN TABLETS International Yaden N/A7131 Chamee Chemist FOR INJECTION B.P WATER Alvita Pharma TABLETS7132 N/A FOR INJECTION WATER International Yaden TABLETS7133 & OIL SOLUBLE VITAMINS WATER International Yaden INJECTION7134 CREAM PARAFFIN WHITE SOFT Sunshine 7135 DROPS NASAL XYLOMETAZOLINE 566 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIAINDIA 05-Oct-15 Full INDIA 17-Jan-18 Provisional 17-Jan-16 Full BANGLADESH 18-Jan-14 Full INDIAINDIA 19-Sep-17 Years Two INDIA 08-Apr-15BANGLADESH Full 19-Sep-17 24-Mar-17 Years Two Full BANGLADESH 08-Nov-15 Full INDIAINDIA 15-May-16BANGLADESH Full 23-Dec-17 27-Apr-16 Full Full PharmaceuticalS (Pvt) Ltd Cadila pharmaceuticals Ltd Cadila pharmaceuticals Ltd Hetero Drugs Ltd INDIAEskayef Bangaladesh Ltd 24-Aug-17Years Two Concept Pharmaceuticals Ltd Ltd Concept Pharmaceuticals Ltd Pharmaceuticals Ltd Cephalosporins Ltd Centurion Laboratories Pvt Ltd Apex Laboratories Ltd Globe Pharmaceuticals Ltd (Contd.) Healthcare lanka Ltd Healthcare lanka Ltd Healthcare lanka Ltd (Pvt) Ltd Ltd Healthcare Tabrane (Pvt) Ltd (Pvt) Ltd International (Pvt) Ltd International (Pvt) Ltd NASAL DROPSNASAL Sunshine SOLUTION SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP CIROVIN DECON NASAL DROPS NASAL DROPS Ceyoka (Pvt) Ltd Ciron Drugs & DECON DROPS NASAL Sunshine XINC B TABLETS Sunshine DE-RASHSQUARE ZINE 20 OINTMENT TABLETS PharmAce (Pvt) Ltd Square N/A PharmAce (Pvt) Ltd Square ASCAZIN TABLETSZIKID SYRUP CAPSULES ORAL International Yaden Baur & Co (Pvt) A DROPS BP 0.1% DROPS BP HYDROCHLORIDE NASAL 0,1% W/V SOLUTION USP HYDROCHLORIDE NASAL 0.05% SOLUTION USP 1 IN 2000 TABLETS COATED 40G/100G 20MG TABLETS 20MG TABLETS CAPSULES 140MG 10MG/5ML USP 7136 NASAL HCL XYLOMETAZOLINE 7137 XYLOMETAZOLINE 7138 XYLOMETAZOLINE 7139 300MG SUPTABLETS ZIDOVUDINE ZIDO-H7140 B COMPLEX FILM ZINC & VITAMIN TABLETS7141 20MG/5ML SYRUP ACETATE ZINC ZINCOCEPT Mansel (Ceylon) 7142 20MG/5ML SYRUP ACETATE ZINC SYRUP CORZNC SYRUP7143 SYRUP 20MG/5ML SYRUP ACETATE ZINC ZINCOCEPT Softcare 7144 Harcourts (Pvt) Ltd BP ZINC OXIDE OINTMENT SYRUP Coral Laboratories 7145 DISPERSIBLE ZINC SULPHATE Softcare 7146 DISPERSIBLE ZINC SULPHATE 7147 MONOHYDRATE ZINC SULPHATE 7148 SOLUTION ORAL ZINC SULPHATE I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 567 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 PAKISTAN 20-Jan-16BANGLADESH 07-Jun-17 Full Full SWITZERLAND 20-Dec-14 Full INDIAINDIA 08-Apr-14INDIA Full 24-Mar-16 Full 10-May-18 Full ICELANDINDIA 31-May-18 Years Two SWITZERLAND 28-Jun-15 20-Sep-16SWITZERLAND Full Full 10-May-18 Years Two INDIA 23-Jan-19 Full (Pvt ) Ltd Pharmaceuticals Ltd Novartis Pharma Stein .AG Switzerland for novatis Pharma Shcweiz AG Switzerland Sun Pharmaceutical industries Gland Pharma (Pvt) Ltd Celon Laboratories Ltd Natco Pharma Ltd INDIANatco Pharma Ltd INDIA 21-Oct-17Years Two Getwell Pharmaceuticals 21-Oct-17Years Two Pharmaceutical Pvt Ltd Novartis Pharma A G Fresenius Kabi Austria Gmbh Austria Fresenius kabi Ab Sweden Sava Healtheare Ltd (Contd.) Ceyoka (Pvt) Ltd Genix Pharma Baur & Co (Pvt) A Ltd Pharmaceuticals (Pvt) Ltd Services Pvt. Ltd Ltd Baur & Co (Pvt) A Ltd (Ceylon) Ltd (Pvt) Ltd Healthcare lanka Ltd Healthcare lanka Ltd The Esses Pharmacy (Pvt) Ltd SOLUTION INFUSION INFUSION INJECTION SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP ZN-ONCE SYEUPZESUP ORAL SYRUPZOMETA PharmAce (Pvt) Ltd Square SOLUTION ZOBONE INJ INJECTIONLYOPHILISED Hemas TABLETS ABC Pharma ACLASTAACLASTA INJECTION Baur & Co (Pvt) A SOLUTION ZOLMINAP SPRAY NASAL Emerchemie NB SUSPENSION 10mg/5ml 10MG/5ML SUSPENSION USP SOLUTION FOR CONCENTRATE INFUSION LYOPHILIZED INJECTION 4MG/VIAL LYOPHILIZED INJECTION 4MG/VIAL INFUSION 5MG/100ML INFUSION 5MG/100ML W/V 7149 ORAL ZINC SULPHATE 7150 ORAL ZINC SULPHATE 7151 ZOLEDRONIC ACID 4MG/5ML 7152ACID FOR ZOLEDRONIC 7153ACID FOR ZOLEDRONIC 7154ACID INJECTION 4MG ZOLEDRONIC CELDRON 47155ACID INJECTION 4MG ZOLEDRONIC ZOLDONAT INJECTION Medmart Pharma 7156 INJECTIONACID INJECTION 4MG ZOLEDRONIC ZOLDONAT Sunshine 7157 INJECTIONACID INJECTION 4MG ZOLEDRONIC ZOLDRON7158 Sunshine ACID INJECTION 4MG ZOLEDRONIC AMNOL POWDER / 7159ACID SOLUTION FOR ZOLEDRONIC INJECTION7160ACID SOLUTION FOR ZOLEDRONIC Ceyoka (Pvt) Ltd Kavbir 7161 5% SPRAY NASAL ZOLMITRIPTAN 568 I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 INDIABANGLADESH 14-Nov-15 23-Jan-18 Provisional Full INDIAINDIA 29-Jan-15 Full INDIA 31-Jan-18 Provisional 03-Dec-16ARGENTINA Full 28-Jan-15INDIA Full 29-Apr-16 Full Sava Healtheare Ltd Pharmaceuticals Ltd Cadila Healthcare Ltd Centaur Pharmaceutical (Pvt) Ltd Acme Formulation (Pvt) Ltd-india for Abbott India Ltd LaboratoriesIPCA INDIALaboratoires Bago S. A 01-Sep-16Sun Pharmaceutical Full industries SA H Lundbeck DENMARK SA H Lundbeck 12-Oct-18 DENMARK Full 30-Jun-14 Full (Contd.) (Ceylon) Ltd Healthcare lanka Ltd Ltd (Ceylon) Ltd Emerchemie NB (Ceylon) Ltd Healthcare lanka Ltd Healthcare lanka Ltd Pharmaceuticals (Pvt) Ltd Health (Pvt) Ltd TABLETS INJECTION Sunshine SCHEDULE - II (GROUP B) SCHEDULE - II (GROUP ZOLMINAP SPRAY NASAL Emerchemie NB ZOLFRESH 5 TABLETSSOVE 5 Sunshine NOCTE TABLETSNITREST TABLETS Emar Pharma (Pvt) CLOPIXOL- FILM COA ACUPHASE Emerchemie NB DEPOTCLOPIXOL INJECTION Sunshine W/V TABLETS TABLETS 10MG 10MG INJECTION 100MG/2ML 200MG/ML(1ML) 7162 5% SPRAY NASAL ZOLMITRIPTAN 7163 2.5MGTABLETS ZOLMITRIPTAN NOMI 2.57164 2.5MG TABLETS ZOLMITRIPTAN ZOLAN TABLETS7165 10MGTARTRATE ZOLPIDEM PharmAce (Pvt) Ltd Square TABLETS7166 ZOLPIREX 5MG ZOLPIDEM TARTRATE Hemas TABLETS7167 5MG ZOLPIDEM TARTRATE 7168 George Steuart TABLETS ZOLPIDEM TARTRATE 7169 TABLETS ZOLPIDEM TARTRATE 7170 ACETATE ZUCLOPENTHIXOL 7171 DECANOATE ZUCLOPENTHIXOL I fldgi ( Î& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 569 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 VIII COLUMN- VII COLUMN- Issue Date Reg. Type VI INDIA 04-May-18 Provisional INDIA 02-Jun-16 Full INDIA 04-May-18 Provisional INDIA 04-May-18 Provisional INDIA 04-May-18 Years Two INDIA 02-May-15 Full INDIA 23-Jun-17 Full BELGIUM 05-Feb-18 Years Two BELGIUM 10-Apr-14 Full Country cals cals cals cals cals cals cals cals cals cals cals ti ti ti ti ti ti onal ti Kwality Kwality Pharmaceu Pvt Ltd Verve Human Care Laboratories Kwality Kwality Pharmaceu Pvt Ltd Kwality Kwality Pharmaceu Pvt Ltd Kwality Kwality Pharmaceu Pvt Ltd Verve Human Care Laboratories Pharmaceu Pharma Sparsha Interna Pvt Ltd N V Pharmaceu N V cal (Pvt) cal ti onal (Pvt) onal onal (Pvt) onal onal (Pvt) onal onal (Pvt) onal ti ti ti ti

ah Pharmacy (Pvt) Ltd Janasen ah Pharmacy (Pvt) Ltd Janasen tt tt Ltd Pvt Ltd Ltd Ltd Ltd Pvt Ltd Pe Ltd SCHEDULE - III Dosage Form Importer Name Manufacturer Man- TRANSDERMAL PAT *** TABLETS Interna Yaden VERMOR 1 INJECTION Leader Pharma Agency *** TABLETS Interna Yaden *** INJECTION Interna Yaden *** TABLETS Interna Yaden Name VERMOR 10 INJECTION Leader Pharma Agency DUROGESIC DUROGESIC TTS DUROGESIC PATCHFEN-TOUCH Pe TRANSDERMAL Pharmaceu Kent

COLUMN-I COLUMN-II COLUMN-III COLUMN-IV COLUMN-V COLUMN- MORPHINE SULPHATE INJECTION BP INJECTION MORPHINE SULPHATE 15MG /ML MORPHINE SULPHATE CONTROLLED CONTROLLED MORPHINE SULPHATE 30MG TABLETS RELEASE MORPHINE SULPHATE INJECTION BP INJECTION MORPHINE SULPHATE 2MG /2ML MORPHINE SULPHATE CONTROLLED CONTROLLED MORPHINE SULPHATE 15MG TABLETS RELEASE MORPHINE SULPHATE CONTROLLED CONTROLLED MORPHINE SULPHATE 10MG TABLETS RELEASE Generic Name Brand MORPHINE SULPHATE INJECTION B.P INJECTION MORPHINE SULPHATE 15MG IN 1ML FENTANYL TRANSDERMAL PATCH TRANSDERMAL PATCH FENTANYL 50MCG/H FENTANYL TRANSDERMAL PATCHES TRANSDERMAL PATCHES FENTANYL 100MCG/H TRANSDERMAL PATCHES FENTANYL 5MG OF (20CM CONTAIN 50MCG/Hr FENTANYL) 8 7 9 6 5 4 1 2 3 570 I fldgi ( ^I& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2019'10'09 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 09.10.2019 28-Sep-16 Full INDIA 04-May-18 Full INDIA 04-May-18 Full INDIA 04-May-18 Full INDIA 04-May-18 Provisional INDIA 04-May-18 Provisional INDIA 19-May-16 Full INDIA 02-Jun-15 Full UNITED KINGDOM GERMANY 04-Nov-14 Full cals cals cals cals cals cals ti ti ti Verve Human Care Laboratories Verve Human Care Laboratories Verve Human Care Laboratories Kwality Pharmaceu Pvt Ltd Kwality Kwality Pharmaceu Pvt Ltd Hameln Pharmaceu Verve Human Care Laboratories GmbH/Germany GmbH/Germany Australia Hospira (Pvt) Ltd Ltd Laboratories Verve Human Care Laboratories cals cals ti onal (Pvt) onal onal (Pvt) onal ti ti (Contd.) Pvt Ltd Pvt Ltd Pvt Ltd Ltd Yaden Interna Yaden Ltd Pvt Ltd (Pvt) Ltd Pvt Ltd SCHEDULE - III TABLETS Leader Pharma Agency TABLETS Leader Pharma Agency INJECTION Akbar Pharmaceu SOLUTION VERMOR SR 10 VERMOR SR 30 VERMOR 15 TABLETS Leader Pharma Agency PETHIDINE HAMELN *** INJECTABLE VARPAT 75VARPAT INJECTION Leader Pharma Agency PRINTED AT THE DEPARTMENT OF GOVERNMENT PRINTING, SRI LANKA. OF GOVERNMENT THE DEPARTMENT AT PRINTED MORPHINE SULPHATE PROLONGED PROLONGED MORPHINE SULPHATE BP 10MG TABLETS RELEASE MORPHINE SULPHATE PROLONGED PROLONGED MORPHINE SULPHATE BP 60MG TABLETS RELEASE MORPHINE SULPHATE TABLETS BP TABLETS MORPHINE SULPHATE 15MG MORPHINE TABLETS BP 15MGMORPHINE TABLETS *** PETHIDINE HYDROCHLORIDE 50MG/1ML INJECTION TABLETS Interna Yaden MORPHINE SULPHATE INJECTION BP INJECTION MORPHINE SULPHATE 2MG /2ML PETHIDINE INJECTION B.P 50MG/1MLPETHIDINE INJECTION 50 VERPAT INJECTION Leader Pharma Agency PETHIDINE INJECTION B.P 50MG/1MLPETHIDINE INJECTION **** INJECTION Niix Holdings (Pvt) Ltd Macarthys PETHIDINE INJECTION B.P 75MG/ PETHIDINE INJECTION 1.5ML 11 12 13 14 15 10 16 17 18 10 - 805