LIST OF DELISTED PRODUCTS 27th November Not eligible for procurement with the Global Fund resources 2020
Delisted Supplier/ International Non-proprietary name Strength/ Dose Dosage form Manufacturing site Country Material Pack Reason for delisting from Manufacturer(s)
Cipla Limited L-139 to L-146, Verna Goa, November PET bottle; Lamivudine (3TC) 10 mg / ml Oral Solution Cipla Ltd. Indore, SEZ, India 100ml; 240ml product discontinued 2020 HDPE bottle Pithampur, Dist Dhar (M.P.)
Oral Solid Dosage Workshop II Polyamide(PA)/Alum change of status - Product November Disp tablet inium/Polyvinyl Dihydroartemisinin/Piperaquine phosphate 30mg +240mg Guilin No. 43, Qilidian Road, China 3' WhO PQ on 25th November 2020 FDC Chloride(PVC)/Alumi Guilin 541004, nium blister 2020 Guangxi
KRS Gardens Tablet Block 36/7, Suragajakkanahalli, November Strides Pharma Indlavadi cross, Anekal 28, 30, 56, 60, 84 ERP reviewed. Delisted at the Dolutegravir (as sodium salt) 50mg Tablets India HDPE Container 2020 Science Limited Taluk and 90 end of the valdity period Bengaluru, Karnataka – 562106
(Unit-II), Plot No: 19, 20 & 21, Western Sector, APSEZ, November Atchutapuram Mandal, ERP reviewed. Delisted at the Daclatasvir 30 mg Tablet Laurus Lab Ltd India HDPE Bottle 28, 500 2020 Visakhapatnam-District- end of the valdity period 531011, Andhra Pradesh
(Unit-II), Plot No: 19, 20 & 21, Western Sector, APSEZ, November ERP reviewed. Delisted at the 2020 Daclatasvir 60 mg Tablet Laurus Lab Ltd Atchutapuram Mandal, India HDPE Bottle 28, 500 Visakhapatnam-District- end of the valdity period 531011, Andhra Pradesh KRS Gardens Tablet Block 36/7, Suragajakkanahalli, November Strides Shasun 14’s, 15’s, 30’s or ERP reviewed. Delisted at the Ledipasvir+ sofosbuvir 90 mg+ 400 mg Tablet FDC Indlavadi cross, India HDPE Container 2020 Ltd 28’s Anekal Taluk end of the valdity period Bangalore- 562 106
F- 4 & F-12, MIDC, Mylan Malegaon, November Tablet, Film- change of status - Product Sofosbuvir/Velpatasvir 400mg+100mg Laboratories Sinnar, Nashik - 422 113 HDPE Bottle 28 2020 coated India Limited Maharashtra WhO PQ on 27th October 2020
List of delisted products, 27th November 2020 1/24 Delisted Supplier/ International Non-proprietary name Strength/ Dose Dosage form Manufacturing site Country Material Pack Reason for delisting from Manufacturer(s) Macleods Pharmaceuticals Limited, At, Oxalis Labs Macleods Village Theda, Al/PVC/PVDC change of status - Product November 28x10’s or Clofazimine 50mg tablet Pharmaceutic P.O Lodhimajra, India blister or Al/Al WhO PQ on 16th September 2020 10x10’s; 100 al Ltd Baddi, strip; HDPE Bottle 2020 Distt. Solan, Himachal Pradesh, 174101
Macleods Pharmaceuticals Limited, At, Oxalis Labs Macleods Village Theda, Al/PVC/PVDC change of status - Product 28x10’s or 8x6’s; November blister or Al/Al WhO PQ on 16th September 2020 Clofazimine 100mg tablet Pharmaceutic P.O Lodhimajra, India 100 al Ltd Baddi, strip; HDPE Bottle 2020 Distt. Solan, Himachal Pradesh, 174101
Plot No. L-139, S-103 Amber coloured July & M-62, Verna PET Bottle Lopinavir (LPV) + Ritonavir (RTV) (80 mg + 20 mg) / ml Oral Solution Cipla Ltd. India 160ml Voluntary withdrawal 2020 Industrial Estate, Verna Salcette, Goa Unit III, Survey No. 313 and 314, July Aurobindo Bachupally HDPE Bottle; 30, 60; Not anymore recommended for the Abacavir + Lamivudine 60 mg + 30 mg Tablet India 2020 Pharma Ltd Quthubullapur Blister 10*10 treatment of HIV/AIDS Mandal Hyderabad, Andhra Pradesh Ltd, F4 & F12 Malegaon MIDC, Sinnar, Nashik District, Maharashtra, 422 Mylan 113; Plot No 11, 12 & July Not anymore recommended for the Abacavir (as Sulfate)+ Lamivudine 60 mg + 30 mg Tablet Laboratories 13, Indore Special India HDPE bottle 30, 60 2020 treatment of HIV/AIDS Ltd Economic Zone, Pharma Zone, Phase II, Sector III, Pithampur, District Dhar, Madya Pradesh, 454 775 Hetero Labs Limited Unit V HDPE bottle 30 July Hetero labs SEZ Unit I in APIIC Not anymore recommended for the Abacavir+Lamivudine 60 mg + 30 mg Tablet 2020 limited SEZ Polepally Village, India treatment of HIV/AIDS Alu-Alu blisters 10X10 Jadcherla Mandal Mahaboob Nagar
List of delisted products, 27th November 2020 2/24 Delisted Supplier/ International Non-proprietary name Strength/ Dose Dosage form Manufacturing site Country Material Pack Reason for delisting from Manufacturer(s) Tablets for HDPE July A-33, MIDC 60, 120; Not anymore recommended for the Abacavir Sulfate + Lamivudine 60 mg + 30 mg oral Cipla Ltd. India container; 2020 Patalganga 10 treatment of HIV/AIDS suspension Blister Tablets for Mylan July Sinnar,Nashik, Not anymore recommended for the Abacavir Sulfate + Lamivudine 60 mg + 30 mg oral Laboratories India HDPE bottle 60 2020 Maharashtra treatment of HIV/AIDS suspension Ltd F- 4 & F-12, MIDC, Mylan July Malegaon, ERP reviewed. Delisted at the Ledipasvir+ sofosbuvir 90 mg+ 400 mg Tablet FDC Laboratories India HDPE Bottle 28 Sinnar, Nashik - 422 113 2020 Limited end of the valdity period Maharashtra,Plot No:19, 20 India & Efavirenz+ Lamivudine + Tenofovir 400 mg + 300 mg + 300 Laurus Lab 21,Western Sector, change of status - Product Apr-20 Tablet India HDPE Container 30, 90, 180 Disoproxil Fumarate mg Limited APSEZ, WhO PQ on 16th March 2020 Atchutapuram Mandal, Sun Shasun 600 mg + 200 mg + 300 Apr-20 Efavirenz + Emtricitabine + Tenofovir Tablet Pharmaceutic Pharmaceuticals Ltd, India HDPE Bottle 30 Voluntary withdrawal mg al Industries Periyakalapet, Plot No. P-1 & P-2, Emcure Dolutegravir + Lamivudine + Tenofovir disoproxil I.T.B.T. Park Phase II, ERP reviewed. Delisted at the 50mg+300mg + 300mg tablet FDC Pharmaceuticals India HDPE Container 30, 90 Apr-20 fumarate MIDC, Hinjawadi, Pune, Limited end of the valdity period MaharashtraF- 4 & F-12, – MIDC, 411057 Mylan Malegaon, ERP reviewed. Delisted at the Apr-20 Lopinavir + Ritonavir 40 mg+10 mg Oral granules Laboratories Sinnar, Nashik - 422 113 India Al/Al sachets 120 sachets/box Limited Maharashtra end of the valdity period AbbVie LTD, Barceloneta, PR 00617 product was listed twice in the list, Apr-20 Lopinavir (LPV) + Ritonavir (RTV) 200 mg + 50 mg Tablet AbbVie Ltd USA Bottle HDPE 120x1 for AbbVie Inc., North correction pf redundancy Chicago, IL 60064 USA product was listed twice in the list, Apr-20 Lopinavir (LPV) + Ritonavir (RTV) (80 mg + 20 mg) / ml Oral Solution AbbVie Ltd North Chicago Illinois,USA PET bottle 160ml correction pf redundancy Sunshine Lake Apr-20 Zidovudine 300mg Tablets HEC Pharma Pharma Co. Ltd, China HDPE Bottle 60 product discontinued GuangDong+H424 Combino Blister ; HDPE Not anymore listed on WHO PQ Apr-20 Zidovudine 300mg Capsules Medea, Barcelona Spain 60, 300 Pharm S.L. bottle webpage Combino HDPE bottle; Not anymore listed on WHO PQ Apr-20 Zidovudine 250mg Capsules Medea, Barcelona Spain 40, 300 Pharm S.L. Blister webpage
Combino Not anymore listed on WHO PQ Apr-20 Zidovudine 100mg Capsules Medea, Barcelona Spain Al Strip 100 Pharm S.L. webpage Meditabs Not anymore listed on WHO PQ Apr-20 Zidovudine 50mg/5ml Oral solution Specialities Maharastra India PET Bottle 100ml webpage Pvt Ltd PET Combino 200ml + 10ml Not anymore listed on WHO PQ Apr-20 Zidovudine 50mg/5ml Oral solution Medea, Barcelona Spain bottle+10ml Pharm S.L. sy webpage syringe F.Hoffman- RP Scherer, Baden; Germany; 180; Apr-20 Saquinavir 200mg Capsule HDPE bottle product discontinued La Roche Basel Switzerland 270 Tablet 60, 1000 A-42, MIDC, HDPE bottle Not anymore recommended for the Apr-20 Nevirapine (NVP) 100mg for Oral Cipla Ltd. India Patalganga Blister treatment of HIV/AIDS Suspension 10 Sun Dispersible Paonta Sahib, Not anymore recommended for the Apr-20 Nevirapine (NVP) 100mg Pharmaceutic India HDPE bottle 60 tablet Himachal Pradesh treatment of HIV/AIDS al Industries
List of delisted products, 27th November 2020 3/24 Delisted Supplier/ International Non-proprietary name Strength/ Dose Dosage form Manufacturing site Country Material Pack Reason for delisting from Manufacturer(s) Plot No: S-155 to S- 159, Phase III, HDPE bottle 30,60,90 Microlabs Not anymore recommended for the Apr-20 Nevirapine 100mg Tablet Verna Industrial India Ltd treatment of HIV/AIDS Estate, Verna, Goa- Blister 10 403722 Unit III Survey No. 313, Bachupally, Quthubullapur Mandal, Hyderabad, Aurobindo HDPE bottle; 60; Not anymore recommended for the Apr-20 Nevirapine (NVP) 200 mg Tablet Andhra Pradesh India Pharma Ltd Blister 10 treatment of HIV/AIDS Unit-VII (SEZ), Mahaboob Nagar (DT), Andhra Pradesh Plot 136,146(UNITIII&IV) India HDPE Bottle; 60, 1000 ; Not anymore recommended for the Apr-20 Nevirapine (NVP) 200 mg Tablet Cipla Ltd. , L147,L147-1 UNIT- Uganda Blister 10 treatment of HIV/AIDS VII-Goa; Meditab Specialties
Unit-III, Jeedimetla, 60, 100,500, Hetero labs HDPE bottle Not anymore recommended for the Apr-20 Nevirapine (NVP) 200 mg Tablet Hyderabad, Andhra India 1000 limited Blister; treatment of HIV/AIDS Pradesh 10;
Plot No 11, 12 & 13, Mylan Indore Special HDPE bottle; 56, 60; Not anymore recommended for the Apr-20 Nevirapine (NVP) 200 mg Tablet Laboratories India Economic Zone, Blister 10 treatment of HIV/AIDS Ltd Pharma Zone, Phase Sun Pharmaceutic Paonta Sahib, HDPE bottle ; 60, 1000; Not anymore recommended for the Apr-20 Nevirapine (NVP) 200 mg Tablet India al Industries Himachal Pradesh Blister 10 treatment of HIV/AIDS Ltd Strides 36/7, HDPE Not anymore recommended for the Apr-20 Nevirapine (NVP) 200 mg Tablet Arcolab Suragajakkanahalli India 60 Container treatment of HIV/AIDS Limited Indlavadi cross Aspen Port Elizabeth, Not anymore recommended for the Apr-20 Nevirapine (NVP) 200 mg Tablet Pharmacare South Africa Blister 10 Korsten treatment of HIV/AIDS Ltd. Boehringer Ingelheim Pharma GmbH & Co, KG, Boehringer Germany Not anymore recommended for the Apr-20 Nevirapine (NVP) 200 mg Tablet Ingelheim; Blister 60 Ingelheim Greece treatment of HIV/AIDS Boehringer Ingelheim Ellas A.E., Koropi Macleods HDPE bottle; 60; Not anymore recommended for the Apr-20 Nevirapine (NVP) 200 mg Tablet Pharmaceutic Kachigam, Daman India PVdC/PVC/Alu 6*10, 12*10 treatment of HIV/AIDS als Limited Blister Emcure 60; HDPE Bottle; Not anymore recommended for the Apr-20 Nevirapine (NVP) 200 mg Tablet Pharmaceutic Hinjwadi, Pune India Blister treatment of HIV/AIDS als Limited 10
List of delisted products, 27th November 2020 4/24 Delisted Supplier/ International Non-proprietary name Strength/ Dose Dosage form Manufacturing site Country Material Pack Reason for delisting from Manufacturer(s) Huahai Xunqiao, Linhai, Not anymore recommended for the Apr-20 Nevirapine (NVP) 200 mg Tablet Pharmaceutic China HDPE Bottle 60 Zhejiang treatment of HIV/AIDS al Microlabs HDPE 60 Not anymore recommended for the Apr-20 Nevirapine (NVP) 200 mg Tablet Verna, Goa India Ltd Blister 10 treatment of HIV/AIDS ScieGen Not anymore recommended for the Apr-20 Nevirapine (NVP) 200 mg Tablet Pharmaceutic Hauppauge, NY USA HDPE Bottle 30, 500 treatment of HIV/AIDS als
L138-147 L150 S103- 30; HDPE Bottle; Not anymore recommended for the Apr-20 Nevirapine (NVP) 400 mg Tablet Cipla Ltd. 105 S107-112 M61-63 India Blister treatment of HIV/AIDS Verna, Salcette, GOA 10
Plot No: S-155 to S- 159, Phase III, HDPE bottle 30,60,90 Microlabs Not anymore listed on WHO PQ Apr-20 Nevirapine 20mg Tablet Verna Industrial India Ltd webpage Estate, Verna, Goa- Blister 10 403722 Patheon Inc., Mississauga,Ontario, Canada; Altana Pharma, Oranienburg GmbH, Germany Gilead Oranienburg, Not anymore listed on WHO PQ Apr-20 Tenofovir Disoproxil Fumarate 300 mg Tablet Canada HDPE bottle 30 Sciences, Inc. Germany; webpage South Africa Aspen Pharmacare, OSD Facility, Korsten, Port Elizabeth, South Africa
Powder for Bristol-Myers Not anymore recommended for the Apr-20 Stavudine (d4T) 1 mg / ml Evansville, Indiana USA HDPE bottle 200ml Oral Solution Squibb treatment of HIV/AIDS
Powder for Bristol-Myers HDPE Not anymore recommended for the Apr-20 Stavudine (d4T) 1 mg / ml Meymac France 200ml Oral Solution Squibb Container treatment of HIV/AIDS
Powder for M-61, M-62, M-63, Not anymore recommended for the Apr-20 Stavudine (d4T) 1 mg / ml Cipla Ltd. India HDPE bottle 200ml Oral Solution Verna Goa treatment of HIV/AIDS
Emcure Pharmaceuticals USA, New Bristol-Myers USA HDPE bottle 60 Not anymore recommended for the Apr-20 Stavudine (d4T) 15 mg Capsule Jersey (manufacturing Squibb Blister 14 treatment of HIV/AIDS and primary packaging), USA. Bristol-Myers Squibb,
List of delisted products, 27th November 2020 5/24 Delisted Supplier/ International Non-proprietary name Strength/ Dose Dosage form Manufacturing site Country Material Pack Reason for delisting from Manufacturer(s)
Unit-III, 22-110, Industrial Hetero labs Not anymore recommended for the Apr-20 Stavudine (d4T) 15 mg Capsule Development Area, India HDPE Bottle 60, 100, 1000 limited treatment of HIV/AIDS Jeedimetla, Hyderabad
Aspen Port Elizabeth, Not anymore recommended for the Apr-20 Stavudine (d4T) 20 mg Capsule Pharmacare South Africa Glass bottle 60 Korsten treatment of HIV/AIDS Ltd.
Emcure Pharmaceuticals USA, Bristol-Myers USA HDPE bottle 60 Not anymore recommended for the Apr-20 Stavudine (d4T) 20 mg Capsule New Squibb Blister 14 treatment of HIV/AIDS Jersey (manufacturing Unit-III,and primary 22-110, Hetero labs Not anymore recommended for the Apr-20 Stavudine (d4T) 20 mg Capsule Industrial India HDPE Bottle 60, 100, 1000 limited treatment of HIV/AIDS Development Area,
Aspen Port Elizabeth, Not anymore recommended for the Apr-20 Stavudine (d4T) 30 mg Capsule Pharmacare South Africa Glass bottle 60 Korsten treatment of HIV/AIDS Ltd.
Macleods Not anymore recommended for the Apr-20 Stavudine (d4T) 30 mg Capsule Pharmaceutic Kachigam, Daman India HDPE Bottle 60 treatment of HIV/AIDS als Limited Emcure Pharmaceuticals USA, Bristol-Myers New USA HDPE bottle 60 Not anymore recommended for the Apr-20 Stavudine (d4T) 30 mg Capsule Squibb Jersey (manufacturing Blister 14 treatment of HIV/AIDS and primary packaging), USA. Mylan Sinnar,Nashik, HDPE Bottle; 60; Not anymore recommended for the Apr-20 Stavudine (d4T) 30 mg Capsule Laboratories India Maharashtra Blister 10 treatment of HIV/AIDS Ltd
36/7, Strides Suragajakkanahalli Not anymore recommended for the Apr-20 Stavudine (d4T) 30 mg Capsule Arcolab Indlavadi cross India HDPE bottle 60 treatment of HIV/AIDS Limited Anekal Taluk Bangalore Unit-III, 22-110, Industrial Hetero labs Not anymore recommended for the Apr-20 Stavudine (d4T) 30 mg Capsule Development Area, India HDPE Bottle 60, 100, 500 limited treatment of HIV/AIDS Jeedimetla, Hyderabad Tablets Mylan Sinnar,Nashik, Alu/Alu Blister; (1+2) per [300mg + 300mg] Not anymore recommended for the Apr-20 [Lamivudine+Tenofovir]+Nevirapine ( co- Laboratories Maharashtra India Blister in blister; +200mg treatment of HIV/AIDS packaged) Ltd Village Theda, Post Carton 3 blisters in a
List of delisted products, 27th November 2020 6/24 Delisted Supplier/ International Non-proprietary name Strength/ Dose Dosage form Manufacturing site Country Material Pack Reason for delisting from Manufacturer(s) Hetero Labs Limited 1 Blister [Lamivudine+Tenofovir disoproxil fumarate] Co-Blistered Hetero labs Not anymore recommended for the Apr-20 (300+300mg) + 200mg Unit III India Co Blister contains(1+2) + Nevirapine tablets limited treatment of HIV/AIDS 22-110, I D A, 10 blisters in a Macleods one carton [Lamivudine+Tenofovir disoproxil fumarate] Co-Blistered Not anymore recommended for the Apr-20 (300+300mg) + 200mg Pharmaceutic Kachigam, Damam India Alu/Alu blister contains one + Nevirapine tablets treatment of HIV/AIDS als Limited blister of one Unit III 22 - 110, 10 doses on one Co packaged Hetero labs PVC/Alu Not anymore recommended for the Apr-20 [Lamivudine + Zidovudine] + Nevirapine [150mg+300mg]+200mg Industrial India Tablet limited Blister; Blister blister sheet treatment of HIV/AIDS development Area, and 6 sheets Each card contains 6 Fairclough Road, lamivudine / Co packaged Pharmacare Not anymore recommended for the Apr-20 [Lamivudine + Zidovudine] + Nevirapine [150mg+300mg]+200mg Korsten, Port South Africa Blister cards. zidovudine Tablet Ltd. treatment of HIV/AIDS Elizabeth, 6020, tablets and 6 nevirapine tablets. 36/7, Strides Suragajakkanahalli Co packaged Not anymore recommended for the Apr-20 [Lamivudine + Zidovudine] + Nevirapine [150mg+300mg]+200mg Arcolab Indlavadi cross India HDPE Bottle (60)+60 Tablet treatment of HIV/AIDS Limited Anekal Taluk Bangalore Sinnar Nashik, Maharastra; Waluj, Aurangabad, Maharashtra, Mylan India; Mission HDPE bottle ; 150 mg + 200 mg + 300 60; Not anymore recommended for the Apr-20 Lamivudine + Nevirapine + Zidovudine Tablet Laboratories Vivacare Limited, India PVC/PVdC/Alu mg 6 X 10; treatment of HIV/AIDS Ltd Pithampur, Dhar, blister; M.P., India; Shasun Pharmaceutical Ltd, Periyakalapet, Puducherry Cipla Ltd, Goa,UNIT- III & UNIT-IV India; Cipla Ltd, Indore, SEZ; Mylan Pithambur, Dhar Dist., Madhya 150 mg + 200 mg + 300 India Not anymore recommended for the Apr-20 Lamivudine + Nevirapine + Zidovudine Tablet Cipla Ltd. Pradesh; HDPE bottle 30, 60, 500 mg Uganda treatment of HIV/AIDS Quality Chemical Industries Ltd, Kampala, Uganda; Cipla Ltd Baddi, Himachal Pradesh, India
Unit-III, Jeedimetla, Hyderabad, Andhra 150 mg + 200 mg + 300 Hetero labs Pradesh, India; Blister; 10; Not anymore recommended for the Apr-20 Lamivudine + Nevirapine + Zidovudine Tablet India mg limited Unit-V, Mahaboob HDPE bottle 60, 100, 500 treatment of HIV/AIDS Nagar, Andhra Pradesh
List of delisted products, 27th November 2020 7/24 Delisted Supplier/ International Non-proprietary name Strength/ Dose Dosage form Manufacturing site Country Material Pack Reason for delisting from Manufacturer(s) Paonta Sahib, Sun Himachal Pradesh; HDPE Bottle 150 mg + 200 mg + 300 Pharmaceutic 60, Not anymore recommended for the Apr-20 Lamivudine + Nevirapine + Zidovudine Tablet Shasun India /PVdc/PVC mg al Industries 10 treatment of HIV/AIDS Pharmaceutical Ltd, blister Ltd Puducherry, Macleods 150 mg + 200 mg + 300 Kachigam, Daman Not anymore recommended for the Apr-20 Lamivudine + Nevirapine + Zidovudine Tablet Pharmaceutic India HDPE Bottle 60 mg Baddi, H.P. treatment of HIV/AIDS als Limited Unit III, Survey No. 150 mg + 200 mg + 300 Aurobindo HDPE Bottle; 60; Not anymore recommended for the Apr-20 Lamivudine + Nevirapine + Zidovudine Tablet 313 &314 Bachupally, India mg Pharma Ltd Blister 10 treatment of HIV/AIDS Quthubullapur Strides Universal Corporation Ltd, PO Box 1748, Club 150 mg + 200 mg + 300 Film coated Pharma Not anymore recommended for the Road, Plot No 13777, Apr-20 Lamivudine + Nevirapine + Zidovudine India HDPE bottle 60 treatment of HIV/AIDS mg Tablet Science Kikuyu, 902, Kenya Limited Strides Pharma Science Plot No. S-155 to S- 150 mg + 200 mg + 300 Film coated Micro Labs Alu/PVC/PVdC Alu/PVC/PVdC Not anymore recommended for the Apr-20 Lamivudine + Nevirapine + Zidovudine 159 & N1, Phase III & India mg Tablet Ltd ; Bottle HDPE ; Bottle HDPE treatment of HIV/AIDS Phase IV, Verna Tablet for HDPE bottle; L-139 to L-146, UNIT- 30, 60, 1000; Not anymore recommended for the Apr-20 Lamivudine + Stavudine 30 mg + 6mg Oral Cipla Ltd. India Blister III & VI, Verna Goa 14 treatment of HIV/AIDS Suspension Tablet for HDPE bottle; L-139 to L-146, UNIT- 30, 60, 1000; Not anymore recommended for the Apr-20 Lamivudine + Stavudine 60 mg + 12mg Oral Cipla Ltd. India Blister III & VI, Verna Goa 14 treatment of HIV/AIDS Suspension Patalganga, Not anymore recommended for the Apr-20 Lamivudine + Stavudine 150 mg + 30 mg Tablet Cipla Ltd. L-139 to L-146, UNIT- India HDPE bottle 60, 30, 1000 treatment of HIV/AIDS III & VI, Verna Goa 36/7, Strides Suragajakkanahalli Not anymore recommended for the Apr-20 Lamivudine + Stavudine 150 mg + 30 mg Tablet Arcolab Indlavadi cross India HDPE Bottle 60 treatment of HIV/AIDS Limited Anekal Taluk Bangalore Macleods Not anymore recommended for the Apr-20 Lamivudine + Stavudine 150 mg + 30 mg Tablet Pharmaceutic Kachigam, Daman India HDPE Bottle 60 treatment of HIV/AIDS als Limited Unit III 22-110, Hetero labs I.D.A., Jeedimetla 30, 60, 100, Not anymore recommended for the Apr-20 Lamivudine + Stavudine 150 mg + 30 mg Tablet India HDPE Bottle limited Jeedimeta, 500 treatment of HIV/AIDS Hyderabad Pharmacare Not anymore recommended for the Apr-20 Lamivudine + Stavudine 150 mg + 30 mg Tablet Strides Ltd, Banglore India HDPE Bottle 60 Ltd. treatment of HIV/AIDS Dispersible Plot No. L-139, L146- Not anymore recommended for the Apr-20 Lamivudine + Nevirapine + Stavudine 30 mg + 50 mg + 6 mg Cipla Ltd. India HDPE bottle 60, 1000 Tablet Verna, Goa treatment of HIV/AIDS Dispersible Plot No. L-139, L146- Not anymore recommended for the Apr-20 Lamivudine + Nevirapine + Stavudine 60 mg + 100 mg + 12 mg Cipla Ltd. India HDPE Bottle 60, 1000 Tablet Verna, Goa treatment of HIV/AIDS Kurkumbh India , Not anymore recommended for the Apr-20 Lamivudine + Nevirapine + Stavudine 150 mg +200 mg+ 30 mg Tablet Cipla Ltd. Patalganga, India; India HDPE bottle 30; 60; 1000 treatment of HIV/AIDS Emcure Plot Not anymore recommended for the Apr-20 Lamivudine + Nevirapine + Stavudine 150 mg +200 mg+ 30 mg Tablet Pharmaceutic Hinjwadi, Pune India HDPE bottle 60 treatment of HIV/AIDS alsMylan Limited Sinnar,Nashik, Not anymore recommended for the Apr-20 Lamivudine + Nevirapine + Stavudine 150 mg +200 mg+ 30 mg Tablet Laboratories India HDPE Bottle 60 Maharashtra treatment of HIV/AIDS Ltd
List of delisted products, 27th November 2020 8/24 Delisted Supplier/ International Non-proprietary name Strength/ Dose Dosage form Manufacturing site Country Material Pack Reason for delisting from Manufacturer(s) Macleods Not anymore recommended for the Apr-20 Lamivudine + Nevirapine + Stavudine 150 mg +200 mg+ 30 mg Tablet Pharmaceutic Kachigam, Daman India HDPE Bottle 60 treatment of HIV/AIDS alsStrides Limited 36/7, Not anymore recommended for the Apr-20 Lamivudine + Nevirapine + Stavudine 150 mg +200 mg+ 30 mg Tablet Arcolab Suragajakkanahalli India HDPE Bottle 60 treatment of HIV/AIDS Limited Indlavadi cross Pharmacare Not anymore recommended for the Apr-20 Lamivudine + Nevirapine + Stavudine 150 mg +200 mg+ 30 mg Tablet Strides Ltd, Banglore India HDPE Bottle 60 Ltd. treatment of HIV/AIDS (1+2) per Mylan Tablets co- Sinnar,Nashik, blister, 3 Not anymore listed on US FDA Apr-20 (Emtricitabine + Nevirapine) +Tenofovir (200+200)+ 300 Laboratories India Alu/Alu blister packed Maharashtra blisters in a webpage Ltd carton Edict Pharmaceutic HDPE Not anymore listed on US FDA Apr-20 Efavirenz (EFV) 600 mg Tablet Chennai India 30 als Private container webpage Limited Mount Vernon, Indiana, USA; Anagni Powder for Bristol-Myers Not anymore listed on WHO PQ Apr-20 Didanosine (ddI) 2 g (Secondary USA Glass Bottle 2g Oral Solution Squibb webpage packaging and batch release), Italy
Powder for Bristol-Myers Meymac France Not anymore listed on WHO PQ Apr-20 Didanosine (ddI) 10 mg / ml HDPE bottle 2g Oral Solution Squibb Evansville, Indiana, USA webpage
Bristol-Myers Not anymore listed on WHO PQ Apr-20 Didanosine (ddI) 25 mg Tablet Emcure, New jersy USA HDPE bottle 60 Squibb webpage
Bristol-Myers Not anymore listed on WHO PQ Apr-20 Didanosine (ddI) 50 mg Tablet Emcure, New jersy USA HDPE bottle 60 Squibb webpage
Bristol-Myers Not anymore listed on WHO PQ Apr-20 Didanosine (ddI) 100 mg Tablet Emcure, New jersy USA HDPE bottle 60 Squibb webpage
Capsule Mylan Sinnar,Nashik, Not anymore listed on WHO PQ Apr-20 Didanosine (ddI) 125 mg Delayed Laboratories India HDPPE Bottle 30, 500 Maharashtra webpage release Ltd
Bristol-Myers Not anymore listed on WHO PQ Apr-20 Didanosine (ddI) 150 mg Tablet Emcure, New jersy USA HDPE bottle 60 Squibb webpage Capsule Mylan Sinnar,Nashik, Not anymore listed on WHO PQ Apr-20 Didanosine (ddI) 200 mg Delayed Laboratories India HDPE bottle 30, 500 Maharashtra webpage release Ltd Capsule Barr Not anymore listed on WHO PQ Apr-20 Didanosine (ddI) 200 mg Delayed Laboratories, Pomona, NY USA Bottle 30 webpage release Inc. Capsule Mylan Sinnar,Nashik, Not anymore listed on WHO PQ Apr-20 Didanosine (ddI) 250 mg Delayed Laboratories India HDPE Bottle 30, 500 Maharashtra webpage release Ltd Mount Vernon, Bristol-Myers Not anymore listed on WHO PQ Apr-20 Didanosine (ddI) 250 mg Capsule Indiana, USA; USA Blister 30 Squibb webpage Capsule Barr Anagni (Primary and Not anymore listed on WHO PQ Apr-20 Didanosine (ddI) 250 mg Delayed Laboratories, Pomona, NY USA Bottle 30 webpage release Inc.
List of delisted products, 27th November 2020 9/24 Delisted Supplier/ International Non-proprietary name Strength/ Dose Dosage form Manufacturing site Country Material Pack Reason for delisting from Manufacturer(s) Capsule Mylan Sinnar,Nashik, Not anymore listed on WHO PQ Apr-20 Didanosine (ddI) 400 mg Delayed Laboratories India HDPE Bottle 30, 500 Maharashtra webpage release Ltd Mount Vernon, Indiana, USA; Bristol-Myers Anagni (Primary and Not anymore listed on WHO PQ Apr-20 Didanosine (ddI) 400 mg Capsule USA Blister 30 Squibb secondary packaging webpage and batch release), Italy Capsule Barr Not anymore listed on WHO PQ Apr-20 Didanosine (ddI) 400 mg Delayed Laboratories, Pomona, NY USA Bottle 30 webpage release Inc. Mylan Laboratories Ltd, Plot No H-12 & Mylan H13 MIDC Waluj PVC/Alu blister Not anymore listed on WHO PQ Apr-20 Aciclovir 200 mg Tablet Laboratories Industrial Area, India PVC/PVdC/Alu 10x1 webpage Ltd Aurangabad, blister Maharashtra, 431 136, India Unit 5, Survey No 439, 440, 441 & 458 TSIIC Formulation Hetero labs SEZ, Polepally Not anymore listed on WHO PQ Apr-20 Aciclovir 400 mg Tablet India HDPE 500x1, 100x1 limited Village, Jadcherla webpage Container (M), Mahaboob Nagar District, Telangana, 509 301 Mylan Mylan Laboratories PVC/Alu blister Not anymore listed on WHO PQ Apr-20 Aciclovir 400 mg Tablet Laboratories Ltd, Plot No H-12 & India PVC/PVdC/Alu 10x1 webpage Ltd H13 MIDC Waluj blister Meditabs Not anymore listed on WHO PQ Apr-20 Abacavir (ABC) as sulfate 20 mg / ml Oral Solution Specialities Satara, Maharastra India PET Bottle 100ml webpage Pvt Ltd Unit III 22-110 Industrial Hetero labs development Area Not anymore listed on WHO PQ Feb-20 Abacavir (ABC) as sulfate 20 mg / ml Oral Solution India HDPE Bottle 240ml limited Jeedimetla, webpage Hyderabad Andhra Pradesh, India 10 PVC/Alu blister Not anymore recommended for the Feb-20 Ofloxacin 200mg Tablet Remedica Limassol Cyprus 100,500, HDPE bottle treatment of Tuberculosis 1000
HDPE Bottle; 100, 500, 1000; Not anymore recommended for the Feb-20 Ofloxacin 400mg Tablet Cipla Ltd Patalganga India Alu/PVC Blister 10 treatment of Tuberculosis
Micro Labs HDPE Bottle; 100 Not anymore recommended for the Feb-20 Ofloxacin 400mg Tablet Hosur, Tamilnadu India Ltd PV/Alu Blister 10 treatment of Tuberculosis 10 PVC/Alu blister Not anymore recommended for the Feb-20 Ofloxacin 400mg Tablet Remedica Limassol Cyprus 100,500, HDPE bottle treatment of Tuberculosis 1000 powder for Panpharma Not anymore recommended for the Feb-20 Kanamycin 1g Fougeres France Glass vial 50 injection Laboratory treatment of Tuberculosis
List of delisted products, 27th November 2020 10/24 Delisted Supplier/ International Non-proprietary name Strength/ Dose Dosage form Manufacturing site Country Material Pack Reason for delisting from Manufacturer(s) Unit 2, Plot No 25-27, Macleods Survey No 366, powder for Not anymore recommended for the Feb-20 Kanamycin (sulfate) 1g Pharmaceutica Premier Industrial India Glass vial 10ml 1 injection treatment of Tuberculosis l Ltd Estate, Kachigam, Daman, 396 210 Hisun Xialian Village, Xukou powder for Pharmaceutica Town, Hangzhou City, Not anymore recommended for the Feb-20 Kanamycin (acid sulfate) 1g China Vial Glass Type I 1x1 injection l (Hangzhou) Zhejiang Province treatment of Tuberculosis Co Ltd 311404 Unit 2, Plot No 25-27, Macleods Survey No 366, powder for Not anymore recommended for the Feb-20 Kanamycin (sulfate) 500mg Pharmaceutica Premier Industrial India Glass vial 10 ml 1 injection treatment of Tuberculosis l Ltd Estate, Kachigam, Daman, 396 210 Hisun Xialian Village, Xukou powder for Pharmaceutica Town, Hangzhou City, Not anymore recommended for the Feb-20 Kanamycin (acid sulfate) 500mg China Vial Glass Type I 1x1 injection l (Hangzhou) Zhejiang Province treatment of Tuberculosis Co Ltd 311404
Pharmaceutical Factory No. 38 Chuangye Road North, Jinwan district, Zhuhai, GuangdongBlock: solution for Production Line: P08 3ml Glass Not anymore recommended for the Feb-20 Kanamycin 500mg/2ml Livzon, China China 10 injection small volume injection ampoule treatment of Tuberculosis workshop for production Building number: P08 Zip:519045
Pharmaceutical Factory solution for 3ml Glass Not anymore recommended for the Feb-20 Kanamycin 1g/3ml Livzon, China No. 38 Chuangye Road China 10 injection ampoule treatment of Tuberculosis North, Jinwan district, solution for injection- Meiji Seika Not anymore recommended for the Feb-20 Kanamycin 1g/4ml Route of Tokyo Japan Glass ampoule 10 Pharma treatment of Tuberculosis administratio n:IM Rifa & Non-Rifa Bottle HDPE; Lupin India 1000 Not anymore recommended for the Feb-20 Isoniazid+Rifampicin 150mg+150mg Tablet Facilities, Block No 1 India Blister Ltd 28 treatment of Tuberculosis Cadila & 2, A-28/1 MIDC Alu/PVC/PVdC PVC/PVdcV/ Not anymore recommended for the Feb-20 Ethambutol + Isoniazid 400 mg + 150 mg Tablet Pharmaceutic Dholka, Ahmedabad India 10, 28 Alu blister treatment of Tuberculosis als Ltd powder for Not anymore recommended for the Feb-20 Capreomycin 1g Akorn Akorn, Illinois USA Glass vial 1, 1*10 injection treatment of Tuberculosis King Vianex S.A. - Plant C', powder for Not anymore recommended for the Feb-20 Capreomycin 1g Pharmaceutic 16th km Marathonos Greece Glass vial 1 injection treatment of Tuberculosis als Limited Ave., Pallini, Attiki, powder for Vianex S.A. - Plant C', Not anymore recommended for the Feb-20 Capreomycin 1g injection for Vianex 16th km Marathonos Greece Glass vial 1 treatment of Tuberculosis IM use Ave., Pallini, Attiki,
List of delisted products, 27th November 2020 11/24 Delisted Supplier/ International Non-proprietary name Strength/ Dose Dosage form Manufacturing site Country Material Pack Reason for delisting from Manufacturer(s) Hisun Fuyang, Hangzhou powder for Not anymore recommended for the Feb-20 Capreomycin 1g Pharmaceutic City, Zhejiang China Glass vial 1 injection treatment of Tuberculosis Aspenal Province powder for Korsten, Port Not anymore recommended for the Feb-20 Capreomycin 1g Pharmacare South Africa Glass vial 1 injection Elizabeth treatment of Tuberculosis MacleodsLtd Macleods Powder for Not anymore recommended for the Feb-20 Capreomycin 1g Pharmaceutic Pharmaceutical Ltd, India Glass vial 1 injection treatment of Tuberculosis alNCPC Ltd, Kachigam,North China Daman Powder for Not anymore recommended for the Feb-20 Capreomycin 1g International Pharmaceutical Co China Glass vial 1g vialx10 injection treatment of Tuberculosis Corp.,Mylan China Ltd,Mylan New Laboratories Preparation Powder for Not anymore recommended for the Feb-20 Capreomycin (sulfate) 1g Laboratories Limited [HSF], Plot India Type 1 glass vial 1gx1 injection treatment of Tuberculosis MacleodsLtd No. 14,Macleods Sipcot – II, Powder for Not anymore recommended for the Feb-20 Capreomycin (sulfate) 0.5g Pharmaceutica Pharmaceuticals Ltd, India Glass vial 10 ml Injection treatment of Tuberculosis ls Ltd. Unit 2, Plot No 25- Film coated 7 (2*7 tablets in Not anymore recommended for the Feb-20 Clarithromycin 250mg Remedica Limassol Cyprus Alu/PVC Tablet carton box) treatment of Tuberculosis Not anymore recommended for the Feb-20 Clarithromycin 250mg Tablet Medochemie Limassol Cyprus Blister 14 treatment of Tuberculosis PVC/PVdC Alu 6,7,8,10,12,14,1 Micro Labs Not anymore recommended for the Feb-20 Clarithromycin 250mg Tablet Hosur, Tamilnadu India Blister 6,20 Ltd treatment of Tuberculosis HEC Pharm HDPE bottle 100,500 Sunshine Lake Not anymore recommended for the Feb-20 Clarithromycin 250mg Tablet GmbH, China Blister 10 Pharma Co., Ltd. treatment of Tuberculosis SunshineGermany DongGuan, PVC/PVDC/Alu 6, 10, 12,14, 15, Not anymore recommended for the Feb-20 Clarithromycin 250mg Tablet Lake Pharma China GuangDong Province strip 16, 20, 24 treatment of Tuberculosis Co., Ltd. Film coated 7 (2*7 tablets in Not anymore recommended for the Feb-20 Clarithromycin 500mg Remedica Limassol Cyprus Alu/PVC Tablet carton box) treatment of Tuberculosis Not anymore recommended for the Feb-20 Clarithromycin 500mg Tablet Medochemie Limassol Cyprus Blister 14 treatment of Tuberculosis
Strandhaven Not anymore recommended for the Feb-20 Clarithromycin 500mg Tablet Essex UK Blister 14 UK treatment of Tuberculosis 6,7,8,10,12,14,1 Micro Labs Not anymore recommended for the Feb-20 Clarithromycin 500mg Tablet Hosur, Tamilnadu India Alu/PVC 6,20 Ltd treatment of Tuberculosis HEC Pharm 100,500 Sunshine Lake Not anymore recommended for the Feb-20 Clarithromycin 500mg Tablet GmbH, China Blister 10 Pharma Co., Ltd. treatment of Tuberculosis SunshineGermany DongGuan, PVC/PVDC/Alu 10, 14, 16, 20, Not anymore recommended for the Feb-20 Clarithromycin 500mg Tablet Lake Pharma China GuangDong Province strip 42, 100 treatment of Tuberculosis Co.,Mylan Ltd. Waluj, Aurangabad, Not anymore recommended for the Feb-20 Clarithromycin 500mg Tablet Laboratories India HDPE bottle 60 Maharashtra treatment of Tuberculosis EuropeanLtd European Egyptian Jan-20 Sofosbuvir 400 mg Tablet Egyptian Pharmaceuticals Egypt HDPE Bottle 28 GMP non compliance Pharmaceuticals Industries Co, PO Box 111,
PLOT NO. 1802-1805, S KANT Amodiaquine (as Hydrochloride) + Sulfadoxine/ Co-blistered G.I.D.C. PHASE III, VAPI Alu-PVC/PVdC co- GMP non compliance of FPP Jan-20 75mg+ 250mg/ 12.5mg HEALTHCARE INDIA 25', 50' Pyrimethamine Disp tablet 396 195. GUJARAT, blister manufacturing site LIMITED INDIA
PLOT NO. 1802-1805, S KANT Amodiaquine (as Hydrochloride) + Sulfadoxine/ Co-blistered G.I.D.C. PHASE III, VAPI Alu-PVC/PVdC co- GMP non compliance of FPP Jan-20 150mg +500mg/ 25mg HEALTHCARE INDIA 25', 50' Pyrimethamine Disp tablet 396 195. GUJARAT, blister manufacturing site LIMITED INDIA
List of delisted products, 27th November 2020 12/24 Delisted Supplier/ International Non-proprietary name Strength/ Dose Dosage form Manufacturing site Country Material Pack Reason for delisting from Manufacturer(s) Oral Solid Dosage Workshop II Disp tablet No. 43, Qilidian Road, Product WhO PQ on 19th Jan-20 Dihydroartemisinin/Piperaquine phosphate 20mg +160mg Guilin China PA/Alu/PVC/Alu 3x1 FDC Guilin 541004, November 2019 Guangxi
Oral Solid Dosage Workshop II Disp tablet No. 43, Qilidian Road, Product WhO PQ on 19th Jan-20 Dihydroartemisinin/Piperaquine phosphate 40mg +320mg Guilin China PA/Alu/PVC/Alu 3x1 FDC Guilin 541004, November 2019 Guangxi
Oral Solid Dosage Workshop II No. 43, Qilidian Road, Product WhO PQ on 19th Jan-20 Dihydroartemisinin/Piperaquine phosphate 80mg + 640mg Tablet FDC Guilin China PA/Alu/PVC/Alu 6x1 Guilin 541004, November 2019 Guangxi
Oral Solid Dosage Workshop II No. 43, Qilidian Road, Product WhO PQ on 19th Jan-20 Dihydroartemisinin/Piperaquine phosphate 40mg +320mg Tablet FDC Guilin China PA/Alu/PVC/Alu 9x1 Guilin 541004, November 2019 Guangxi
Unit III Survey No. 313, Bachupally, Quthubullapur, Hyderabad, Andhra Aurobindo HDPE bottle; 60; Nov-19 Zidovudine 300mg Tablets Pradesh India Voluntary withdrawal Pharma Ltd Blister 10 Unit-VII (SEZ), Mahaboob Nagar (DT), Andhra Pradesh Unit III Survey No 313 and 314, Bachupally Quthubullapur 100 HDPE bottle; Aurobindo Mandal Hyderabad, Nov-19 Zidovudine 100mg Capsules India Voluntary withdrawal Pharma Ltd Anda Pradesh Blister Unit-VII (SEZ), 10 Mahaboob Nagar (DT), Andhra Pradesh Unit III, Survey No. 313 &314 Bachupally, Aurobindo Nov-19 Stavudine (d4T) 30 mg Capsule Quthubullapur India HDPE bottle 60 Voluntary withdrawal Pharma Ltd Mandal Hyderabad, Andhra Pradesh
Unit III, Survey No. 313 &314 Bachupally, Aurobindo Nov-19 Stavudine (d4T) 20 mg Capsule Quthubullapur India HDPE bottle 60 Voluntary withdrawal Pharma Ltd Mandal Hyderabad, Andhra Pradesh
List of delisted products, 27th November 2020 13/24 Delisted Supplier/ International Non-proprietary name Strength/ Dose Dosage form Manufacturing site Country Material Pack Reason for delisting from Manufacturer(s)
Unit III, Survey No. 313 &314 Bachupally, Aurobindo Nov-19 Stavudine (d4T) 15 mg Capsule Quthubullapur India HDPE bottle 60 Voluntary withdrawal Pharma Ltd Mandal Hyderabad, Andhra Pradesh Unit III Survey, Hyderabad, Andhra Aurobindo HDPE bottle; 60; Nov-19 Lamivudine + Zidovudine 150 mg + 300 mg Tablet Pradesh India Voluntary withdrawal Pharma Ltd Blister 10 Unit-VII (SEZ), Andhra Pradesh UNIT III, Survey No. 313 and 314, Aurobindo Bachupally HDPE Bottle; 60, 1000; Nov-19 Lamivudine + Zidovudine 30 mg + 60 mg Tablet India Voluntary withdrawal Pharma Ltd Quthubullapur Blister 10 Mandal, Hyderabad, Andhra Pradesh Aurobindo Pharma 1 Blister [Lamivudine+Tenofovir disoproxil fumarate] Co-Blistered Aurobindo Limited, Unit VII contains(4+2) Nov-19 (300+300mg) + 200mg India Blister Voluntary withdrawal + Nevirapine tablets Pharma Ltd (SEZ) 15 blisters in a Andhra Pradesh box. Unit III Survey No. 313, Bachupally, Aurobindo HDPE Bottle; 30; Nov-19 Lamivudine (3TC) 300 mg Tablet Quthubullapur India Voluntary withdrawal Pharma Ltd Blister 10 Mandal, Hyderabad, Andhra Pradesh,
Unit III Survey No. 313, Bachupally, Quthubullapur Mandal, Hyderabad, Aurobindo HDPE Bottle; 60; Nov-19 Lamivudine (3TC) 150 mg Tablet Andhra Pradesh, India Voluntary withdrawal Pharma Ltd Blister 10 Unit-VII (SEZ), Mahaboob Nagar (DT), Andhra Pradesh Unit - III Survey No. 313 & 314, Aurobindo Bachupally, HDPE Bottle, 30, 500 Nov-19 Emtricitabine 200 mg Capsule India Voluntary withdrawal Pharma Ltd Quthubullapur Blister 10 Mandal Hyderabad, Andhra Pradesh Unit - III Survey No. 313 & 314, 6 blisters per 600 mg + [150 mg + 300 Aurobindo Bachupally, PVC/PE/Aclar- box Nov-19 Efavirenz + [Lamivudine + Zidovudine] Tablet India Voluntary withdrawal mg] Pharma Ltd Quthubullapur Al foil ; Carton Each blister has Mandal Hyderabad, 5 x (2+1) Andhra Pradesh
List of delisted products, 27th November 2020 14/24 Delisted Supplier/ International Non-proprietary name Strength/ Dose Dosage form Manufacturing site Country Material Pack Reason for delisting from Manufacturer(s)
Unit III, Survey No. 313 &314 Bachupally, Aurobindo HDPE Bottle; 30, 500; Nov-19 Efavirenz (EFV) 100mg Tablet Quthubullapur India Voluntary withdrawal Pharma Ltd Blister 10 Mandal Hyderabad, Andhra Pradesh
Unit III, Survey No. 313 &314 Bachupally, Quthubullapur Mandal Hyderabad, Aurobindo HDPE bottle; 30 Nov-19 Efavirenz (EFV) 50 mg Capsule Andhra Pradesh India Voluntary withdrawal Pharma Ltd Blister 10 Unit-VII (SEZ), Mahaboob Nagar (DT), Andhra Pradesh Unit - III Survey No. 313 & 314, Capsule Aurobindo Bachupally, HDPE bottle; 30, 500; Nov-19 Didanosine (ddI) 400 mg Delayed India Voluntary withdrawal Pharma Ltd Quthubullapur Blister 5 release Mandal Hyderabad, Andhra Pradesh Unit - III Survey No. 313 & 314, Capsule Aurobindo Bachupally, HDPE bottle; 30, 500 Nov-19 Didanosine (ddI) 250 mg Delayed India Voluntary withdrawal Pharma Ltd Quthubullapur Blister 10 release Mandal Hyderabad, Andhra Pradesh Unit - III Survey No. 313 & 314, Capsule Aurobindo Bachupally, HDPE Bottle 30, 500; Nov-19 Didanosine (ddI) 200 mg Delayed India Voluntary withdrawal Pharma Ltd Quthubullapur Blister 10 release Mandal Hyderabad, Andhra Pradesh Unit - III Survey No. 313 & 314, Capsule Aurobindo Bachupally, HDPE bottle 30, 500; Nov-19 Didanosine (ddI) 125 mg Delayed India Voluntary withdrawal Pharma Ltd Quthubullapur Blister 14 release Mandal Hyderabad, Andhra Pradesh Blister Card Unit III, Survey 313 & Contains: 314, Bachupally, 300 mg + 150 mg + 300 Aurobindo PVC / PVdC / 10 + 10 Nov-19 Abacavir + [Lamivudine + Zidovudine] Tablet Quthubullapur India Voluntary withdrawal mg Pharma Ltd Aluminum Foil Each Carton Mandal, Hyderbad, Contains: 60 + Andhra Pradesh, 60 (Unit-03) 92, Sipcot Industrial Micro Labs Complex, HDPE Container ERP reviewed. Delisted at the Nov-19 Levofloxacin 750mg tablet India 100 ; 10x10 Ltd Hosur – 635126, Blister pack end of the valdity period Tamilnadu
List of delisted products, 27th November 2020 15/24 Delisted Supplier/ International Non-proprietary name Strength/ Dose Dosage form Manufacturing site Country Material Pack Reason for delisting from Manufacturer(s) (Unit-03) (Unit-03) 92, Sipcot 92, Sipcot Industrial Industrial Micro Labs Complex, Product WhO PQ on the 22nd Nov-19 Levofloxacin 100mg disp tablet India Complex, 10X10 ; 10x2 Hosur – 635126, Ltd Hosur – 635126, October 2019 Tamilnadu Tamilnadu
Macleods HDPE container; Dispersible 1000; Sep 2019 Isoniazid + Pyrazinamide+Rifampicin 30 mg+ 150 mg+60mg Pharmaceutica Kachigam, Daman India Alu/PVC/PVdc Voluntary withdrawal Tablet 10, 28 l Ltd Blister Chikalthana, Dispersible Lupin India Aurangabad, India; Sep 2019 Isoniazid + Pyrazinamide+Rifampicin 30 mg+ 150 mg+60mg India Al/Al strip 15x6; 14x6 Voluntary withdrawal Tablet Ltd Bari Brahmana, Jammu (J&K), India Macleods HDPE container; Dispersible 1000; Sep 2019 Isoniazid + Rifampicin 30mg+ 60mg Pharmaceutica Kachigam, Daman India Alu/PVC/PVdc Voluntary withdrawal Tablet 10, 28 l Ltd Blister Chikalthana, DispersibleTa Lupin India Aurangabad; Sep 2019 Isoniazid + Rifampicin 30mg+ 60mg India Al/Al strip 15x6; 14x6 Voluntary withdrawal blet Ltd Bari Brahmana, Jammu (J&K) Macleods HDPE container; Dispersible 1000; Sep 2019 Isoniazid + Rifampicin 60mg + 60mg Pharmaceutica Kachigam, Daman India Alu/PVC/PVdc Voluntary withdrawal Tablet 10, 28 l Ltd Blister Macleods Alu/PVC/PVdC 10, 28; Sep 2019 Ethambutol + Isoniazid 400 mg + 150 mg Tablet Pharmaceutica Kachigam, Daman India Blister; Voluntary withdrawal 1000 l Ltd HDPE bottle Plot No. A-42 (Unit II), MIDC, Patalganga, Tablet Co- Al/PVC/PE/PVDC ERP reviewed. Delisted at the Sep 2019 Daclatasvir+Sofosbuvir 60 mg+ 400 mg Cipla Ltd District - Raigad, India 7' blister blister Maharashtra, end of the valdity period Pin code: 410 220 Plot No. A-42 (Unit II), MIDC, Patalganga, District - Raigad, HDPE bottle ; Alu- ERP reviewed. Delisted at the Sep 2019 Daclatasvir 60 mg Tablet Cipla Ltd India 28; 14x2 Maharashtra, PVC/PVdC blister end of the valdity period Pin code: 410 220
Hetero Labs Limited Unit- V, TSIIC Formulation SEZ, Sy No. 439, 440, 441 & 458, ERP reviewed. Delisted at the Sep 2019 Daclatasvir 60 mg Tablet Hetero Lab Ltd India HDPE Bottle 28 Polepally Village, end of the valdity period Jadcherla Mandal, Mahaboobnagar District, Telangana
Plot No. A-42 (Unit II), MIDC, Patalganga, District - Raigad, HDPE bottle ; Alu- ERP reviewed. Delisted at the Sep 2019 Daclatasvir 30 mg Tablet Cipla Ltd India 28; 14x2 Maharashtra, PVC/PVdC blister end of the valdity period Pin code: 410 220
List of delisted products, 27th November 2020 16/24 Delisted Supplier/ International Non-proprietary name Strength/ Dose Dosage form Manufacturing site Country Material Pack Reason for delisting from Manufacturer(s)
Unit- V, TSIIC Formulation SEZ, Sy No. 439, 440, 441 & 458, ERP reviewed. Delisted at the Sep 2019 Daclatasvir 30 mg Tablet Hetero Lab Ltd India HDPE Bottle 28 Polepally Village, end of the valdity period Jadcherla Mandal, Mahaboobnagar District, Telangana
Oxalis Labs Village Theda, P.O Lodhimajra, Baddi, Alu/PVC/PE/P Product WhO PQ on the Sep 2019 Artemether + Lumefantrine 40mg +240mg Tablet FDC Macleods India 10x10 Distt. Solan, VDC Blister 22nd August 2019 Himachal Pradesh, 174101 Village Ganguwala, Sun Paonta Sahib, Pharmaceutic District Sirmour – ERP reviewed. Delisted at the Sep 2019 Dolutegravir (as Sodium) tablets 50 mg tablets India HDPE Bottle 30, 90 al Industries 173025 end of the valdity period Limited Himachal Pradesh
Block N-2, Village Block N-2, Theda; Village Theda; Post Office Post Office Lamivudine+Tenofovir disoproxil fumarate + Lodhimajra Tehshil Lodhimajra Product WhO PQ on the15th May Sep 2019 300mg +300mg+ 400mg tablet FDC Macleods India 30, 90, 180 Efavirenz Baddi, Tehshil Baddi, 2019 Distt.Solan, Distt.Solan, Himachal Pradesh- Himachal 174101 Pradesh-174101 Sanofi Famar, Saint Genis July 2019 Chloroquine (as Sulfate) 5mg/ml ( as base) Syrup France Bottle 150ml Voluntary withdrawal Aventis Laval Sanofi Famar, Saint Genis Blister July 2019 Chloroquine (as Sulfate) 100mg ( as base) Tablet France 20,100 Voluntary withdrawal Aventis Laval Sanofi Famar, Saint Genis July 2019 Chloroquine (as Sulfate) 300mg ( as base) Tablet France Blister 4 Voluntary withdrawal Aventis Laval HDPE Bottle; 30, 100, 1000; July 2019 Moxifloxacin ( as hydrochloride) 400 mg Tablet Cipla Ltd Patalganga India Voluntary withdrawal Blister 5 July 2019 Amikacin ( as sulfate) 500 mg/2ml Injection Cipla Ltd Goa India Glass vial 2ml Voluntary withdrawal F- 4 & F-12, MIDC, Mylan Malegaon, HDPE bottle ; Alu- Product WhO PQ on the15th May July 2019 Daclatasvir (dihydrochloride) 60 mg Tablet Laboratories Sinnar, Nashik - 422 113 India 28; 10x1 PVC/PVdC blister 2019 Limited Maharashtra
F- 4 & F-12, MIDC, Mylan Malegaon, HDPE bottle ; Alu- Product WhO PQ on the15th May July 2019 Daclatasvir (dihydrochloride) 30 mg Tablet Laboratories Sinnar, Nashik - 422 113 India 28; 10x1 PVC/PVdC blister 2019 Limited Maharashtra
List of delisted products, 27th November 2020 17/24 Delisted Supplier/ International Non-proprietary name Strength/ Dose Dosage form Manufacturing site Country Material Pack Reason for delisting from Manufacturer(s)
FDF-Unit-2, Aurangabad site, (Plot No. H-12 and H-13), Mylan MIDC, Waluj Industrial Product WhO PQ on the11th June July 2019 Darunavir ethanolate 800mg Tablet India HDPE Container 30 Laboratories Ltd Area 2019 Aurangabad-431136 Maharashtra
Bock N2, Village Theda, P.O. Lodhimajra Dolutegravir + Lamivudine + Tenofovir disoproxil July 2019 50mg+300mg + 300mg tablet FDC Macleods Tehsil Baddi, Dist.: Solan, India HDPE Container 30, 90, 100, 180 ERP reviewed. Delisted at the end of the fumarate valdity period Himachal Pradesh, 174101
Sun Pharmaceutical Industries Limited Village Ganguwala, Sun Dolutegravir + Lamivudine + Tenofovir disoproxil Paonta Sahib, July 2019 50mg+300mg + 300mg tablet FDC Pharmaceutical India HDPE Container 30, 90 ERP reviewed. Delisted at the end of the fumarate District Sirmour – valdity period Industries Ltd 173025, Himachal Pradesh
Guilin Pharmaceutical Co.,Ltd Oral Solid Dosage Guilin Workshop II PA/Alu/PVC/Alu ERP reviewed Product-Validity July 2019 Dihydroartemisinin/Piperaquine phosphate 80mg + 640mg Tablet FDC China 1 x 6's Pharmaceuticals No. 43, Qilidian Road, blisters not extended until further notice Guilin 541004, Guangxi,
Guilin Pharmaceutical Co.,Ltd Oral Solid Dosage Guilin Workshop II PA/Alu/PVC/Alu ERP reviewed Product-Validity July 2019 Dihydroartemisinin/Piperaquine phosphate 40mg + 320mg Tablet FDC China 1 x 9's Pharmaceuticals No. 43, Qilidian Road, blisters not extended until further notice Guilin 541004, Guangxi,
ML08, Plot No 15/A, 2nd Phase, Micro Labs July 2019 Isoniazid 100mg disp tablet Kumbalgodu India Alu-Alu strips 10x10; 24x28 Shut down of Plant Ltd Industrial Area, Bangalore, 560 074 ML08, Plot No 15/A, 2nd Phase, Alu-Alu strips; Micro Labs Alu- July 2019 Moxifloxacin( as hydrochloride) 100mg disp tablet Kumbalgodu India 10x10; 10x1, 14x1 Shut down of Plant Ltd PVC/PE/PVDC Industrial Area, blisters Bangalore, 560 074 Kumbalgodu, Ethambutol Hydrochloride+ Isoniazid + 275 mg + 75 mg + 400 mg Micro Labs Bangalore, Alu/Alu strip 10x10, 24x28 July 2019 Tablet India Shut down of Plant Pyrazinamide + Rifampicin + 150 mg Ltd Karnataka, India HDPE Bottle 500
ML08, Plot No 15/A, 2nd Phase, Dispersible Micro Labs HDPE Bottle; 100x1,500x1,10 July 2019 Pyrazinamide 150mg Kumbalgodu India Shut down of Plant tablets Ltd Alu/Alu Strip 00x1 10x10 Industrial Area, Bangalore, 560 074
List of delisted products, 27th November 2020 18/24 Delisted Supplier/ International Non-proprietary name Strength/ Dose Dosage form Manufacturing site Country Material Pack Reason for delisting from Manufacturer(s) ML08, Plot No 15/A, 2nd Phase, Micro Labs July 2019 Linezolid 600mg Tablet Kumbalgodu India Strip,Alu/Alu 4x1 Shut down of Plant Ltd Industrial Area, Bangalore, 560 074 Strides Shasun ltd- 36/7, April Strides Shasun Suragajakkanahalli PVC/PE/PVDC Product WhO PQ on the 09th of Artemether + Lumefantrine 80mg+480mg Tablet FDC India 6x1 2019 Ltd - India Indlavadi Cross, Anekal blister February 2019 Taluk Bangalore Mylan Laboratories Ltd Mylan F-4, F-12, Malegaon April Voluntary withdrawal 2019 Darunavir 600mg Tablets Laboratories M.I.D.C, India HDPE Bottle 60; 180; 360 Ltd Sinnar, Nashik – 422113, Maharashtra state Aurobindo Pharma April Efavirenz+ Lamivudine + Tenofovir Disoproxil Aurobindo Limited Unit-VII (SEZ) Product WhO PQ on the 05th of 600 mg + 300 mg + 300 mg Tablet India HDPE Bottle 30, 90& 500 2019 Fumarate Pharma Ltd Mahaboob Nagar (Dt) April 2019 AP
Pharmaceutical Factory No. 38 Chuangye Road North, Jinwan district, Zhuhai, GuangdongBlock: April solution for Production Line: P08 3ml Glass Product WhO PQ on the 06th of Kanamycin 500mg/2ml Livzon, China TB327 10 2019 injection small volume injection ampoule February 2019 workshop for production Building number: P08 Zip:519045
Pharmaceutical Factory No. 38 Chuangye Road North, Jinwan district, Zhuhai, GuangdongBlock: Production Line: P08 April solution for 3ml Glass Product WhO PQ on the 06th of Kanamycin 1g/3ml Livzon, China small volume injection TB328 10 2019 February 2019 injection workshop for production ampoule Building number: P08 Zip:519045
Guilin April Alu/PA/Alu/PVC Temporary supsension of Amodiaquin(as Hydrochloride)+Artesunate (FDC) 67.5 mg + 25 mg Tablet Pharmaceutica Guilin, Guangxi, China China 3 2019 blister procuremenrt l Co. Ltd Guilin April Alu/PA/Alu/PVC Temporary supsension of Amodiaquin(as Hydrochloride)+Artesunate (FDC) 135 mg + 50 mg Tablet Pharmaceutica Guilin, Guangxi, China China 3 2019 blister procuremenrt l Co. Ltd Guilin April Alu/PA/Alu/PVC Temporary supsension of Amodiaquin(as Hydrochloride)+Artesunate (FDC) 270 mg +100 mg Tablet Pharmaceutica Guilin, Guangxi, China China 3, 6 2019 blister procuremenrt l Co. Ltd Guilin Pharmaceuticals Amodiaquine (as Hydrochloride) Co-Blistered Guilin 75mg+ (250mg/12.5mg) Co. Ltd, No. 43 Quilidian China Alu/PVC Blister 50x (3+1) ERP reviewed. Delisted at the end of the Jan-19 +(Sulfadoxine+Pyrimethamine) tablet Pharmaceuticals valdity period road
List of delisted products, 27th November 2020 19/24 Delisted Supplier/ International Non-proprietary name Strength/ Dose Dosage form Manufacturing site Country Material Pack Reason for delisting from Manufacturer(s) Abbott Jan-19 Lopinavir (LPV) + Ritonavir (RTV) 133.3 mg + 33.3 mg Capsule Laboratories RP Scherer, Florida USA HDPE bottle 90 Voluntary withdrawal Ltd. Abbott Bottle (HDPE) Jan-19 Lopinavir (LPV) + Ritonavir (RTV) 133.3 mg + 33.3 mg Capsule Soft Laboratories Queenborough, Kent UK 90, 180 Voluntary withdrawal Bottle (PVC) Ltd. Macleods Pharmaceuticals Ltd Phase I, Unit II, Plot No. Product WhO PQ on the 18h of Dec-18 Moxifloxacin 100mg disp tablet Macleods India Blister pack India 25-27 December 2018 Sr. No. 366, Kachigam, Daman Amoxycillin (as trihydrate)+ Clavulanic acid Product volontary withdrown Oct-18 500mg+125mg Tablet Apotex Inc Toronto Canada HDPE Bottle 100 (as potassium) his product from the WHO PQ
European Cairo Desert Road ERP reviewed Product-Validity Oct-18 Sofosbuvir 400 mg Tablet Egyptian Pharm. KM.25, El Manshia Alex, Egypt HDPE Bottle 28 not extended Ind. Amriya, Alexandria, Egypt
Strides Shasun ltd- 36/7, Suragajakkanahalli Strides Shasun ERP reviewed Product-Validity Oct-18 Sofosbuvir 400 mg Tablet Indlavadi Cross, Anekal India HDPE Bottle 28 Ltd not extended Taluk Bangalore-562 106 India
PVC/PE/PVdC/ Alu blister 30, Strides Arcolab, 60, 120, 240, Bangalore; 672, 1000; Ethambutol + Isoniazid + Pyrazinamide + 275 mg + 75 mg + 400 mg Sandoz Pty Sandoz, Kalwe, Navi Blister; Product volontary withdrown Oct-18 Tablet India Polypropylene Rifampicin + 150 mg Ltd Mumbai; HDPE Bottle his product from the WHO PQ containers Sandoz, Kolshet, 500,1000; Thane; HDPE bottle 500 Strides Arcolab, Bangalore; Blister ; 30, 60, 120, Sandoz Pty Sandoz, Kalwe, Navi 240, 28,672, Product volontary withdrown Oct-18 Isoniazid + Rifampicin 75 mg + 150 mg Tablet India Ltd Mumbai; HDPE bottle 1000; his product from the WHO PQ Sandoz, Kolshet, 500, 1000; Thane Product volontary withdrown Oct-18 Levofloxacin 250mg Tablet Apotex Inc Apotex Inc Toronto Canada HDPE Bottle 100 his product from the WHO PQ
Product volontary withdrown Oct-18 Levofloxacin 500mg Tablet Apotex Inc Apotex Inc Toronto Canada HDPE Bottle 100 his product from the WHO PQ
Product volontary withdrown Oct-18 Levofloxacin 750mg Tablet Apotex Inc Apotex Inc Toronto Canada HDPE Bottle 100 his product from the WHO PQ (Unit-03) 92, Sipcot Industrial Alu-Alu strips or Micro Labs Complex Alu- 10x10; Product WhO PQ on the 31th of Oct-18 Moxifloxacin 100mg disp tablet 05-07-19 Ltd Hosur – 635126 PVC/PE/PVDC 10x1, 14x1 October 2018 Tamilnadu, India blisters
List of delisted products, 27th November 2020 20/24 Delisted Supplier/ International Non-proprietary name Strength/ Dose Dosage form Manufacturing site Country Material Pack Reason for delisting from Manufacturer(s)
Tablet Co- Guilin ERP reviewed Product-Validity Oct-18 Artesunate + (Sulfadoxine+Pyrimethamine) 50mg+ (500mg+25mg) Guilin, Guangxi China PVC/Alu Blister (3 +1 ), (6 + 2) blister Pharmaceuticals not extended
Tablet Co- Guilin ERP reviewed Product-Validity Oct-18 Artesunate + (Sulfadoxine+Pyrimethamine) 100mg+ (500mg+25mg) Guilin, Guangxi China PVC/Alu Blister (3 +1 ), (6 + 3) blister Pharmaceuticals not extended Guilin Pharmaceuticals Guilin HDPE bottle; Product WhO PQ on the 31th of Oct-18 Sulfadoxine+Pyrimethamine 500mg+25mg Tablet FDC Co. Ltd, No. 43 Quilidian China 100's,1000's Pharmaceuticals Blister 3', 3x50, 3x100 October 2018 road, Plot No.P-2, I.T- B.T. Emcure Park, Phase II, August ERP reviewed Product-Validity Dolutegravir (as sodium salt) 50mg tablet Pharmaceuticals MIDC,Hinjwadi, Pune - India HDPE Container 30 2018 not extended Limited 411 057, Maharashtra Guilin Pharmaceuticals August Amodiaquine (as Hydrochloride) + Sulfadoxine/ Co-blistered Guilin Product WhO PQ on the 21th of 76.5mg+ 250mg/ 12.5mg Co. Ltd, No. 43 Quilidian China Alu/PVC Blister 50x (3+1) 2018 Pyrimethamine Disp tablet Pharmaceuticals August 2018 road, Guilin Guilin Pharmaceuticals August Amodiaquine (as Hydrochloride) + Sulfadoxine/ Co-blistered Guilin Product WhO PQ on the 21th of 153mg +500mg/ 25mg Co. Ltd, No. 43 Quilidian China Alu/PVC Blister 50x (3+1) 2018 Pyrimethamine Disp tablet Pharmaceuticals August 2018 road, Guilin SW Pharma August Powder for Panpharma, Product is not anymore Streptomycin 1 g GmbH France Bottle 1, 10 2018 injection (Former FATOL- Fougeres manufactured (RIEMSER) Arzneimittel) Macleods Pharmaceuticals Ltd August Powder for Phase I, Unit II, Plot No. Product WhO PQ on the 16th of Capreomycin USP 0.5g Macleods India Glass vial 10 ml 2018 Injection 25-27 August 2018 Sr. No. 366, Kachigam, Daman
Hetero Labs Limited Unit – III (Formulations), August Dolutegravir + Lamivudine + Tenofovir disoproxil Hetero Labs 30, 50,750 and Product received FDA tentative 50mg+300mg + 300mg tablet FDC # 22 – 110, IDA India HDPE Container 2018 fumarate Limited Jeedimetla, Hyderabad, 1500 approval NDA 210880 Telangana
Phase II, Unit II, Plot No. 25-27 10x10 Product WhO PQ on the 18th of Jul-18 Cycloserine USP 125mg capsule Macleods India Bister Sr. No. 366, 10x10 July 2018 Premier Ind. Estate, Kachigam, Daman
Unit – III (Formulations), # 22 – 110, IDA Hetero Labs Product WhO PQ on the 18th of Jul-18 Dolutegravir (as sodium salt) 50mg tablet Jeedimetla, Hyderabad, India HDPE Bottle 30' Limited July 2018 Telangana, India. Pin Code – 500 055
Strides Shasun ltd- 36/7, Strides Alu/Alu (Alu Suragajakkanahalli Product WhO PQ on the 19th of Jul-18 Artesunate 100 mg Suppository Shasun Ltd - India foil/OPA/Alu/P 2' Indlavadi Cross, June 2018 India VC) blister Anekal Taluk Bangalore 1 × 6’s Ipca Laboratories Ltd - Alu-Alu 1 × 12’s Plot No : 255/1, Village Dispersible IPCA blister and 30 × 1 × 6’s Product WhO PQ on the 19th of Jul-18 Artemether + Lumefantrine 20mg+120mg Athal, Dadra and Nagar Tablet Laboratories Ltd India PVC/ACLAR/PVC- 30 × 1 × 12’s June 2018 Haveli (U.T), Silvassa – Alu blister 30 × 6’s 396 230, India 30 × 12’s
List of delisted products, 27th November 2020 21/24 Delisted Supplier/ International Non-proprietary name Strength/ Dose Dosage form Manufacturing site Country Material Pack Reason for delisting from Manufacturer(s)
Unit II, Plot No. 25- Unit II, Plot No. 25-27 10x10 Product WhO PQ on the 14th of Mar-18 Ethambutol 100mg disp tablet Macleods 27 Sr. No. 366, India March 2018 Sr. No. 366, 6x10 Kachigam, Daman Kachigam, Daman Unit III, Survey No 51, Plot No 22-110 Hetero labs Voluntary withdrawal from WHO Mar-18 Ritonavir (RTV) 100 mg Tablet IDA, Jeedimetla, India HDPE Bottle 30x1; 120x1 limited Prequalification Hyderabad, Telangana, 500 055 PVDC/PVC/Alu Kachigam, Daman, 10; Mar-18 Zidovudine 300mg Tablets Macleods India blister; Voluntary withdrawal India 60 HDPE bottle Block N2 Village Theda, P.O. Lodhimajra, Blister pack 10x10 Product WHO PQ on the 22nd of Mar-18 Levofloxacin 100mg disp tablet Macleods Tehsil Baddi, India Alu/Alu strip 10x10 February 2018 District:-Solan pack Himachal Pradesh
Cipla Limited, D7, MIDC Industrial area Product WHO PQ on the 22nd of Kurkumbh Mar-18 Artesunate 100mg Suppository Cipla Limited India Alu/Alu Blister 2' February 2018 Dist Pune 413802 INDIA
Hetero labs Limited, February Hetero labs Unit-V, Jadcherla, Product WHO PQ on the 07th of Sofosbuvir 400 mg tablet India HDPE Bottle 28 2018 Limited Mahaboobnagar-509 February 2018 301, Telangana State
Cipla Limited, L-139 Jan-2018 Abacavir (ABC) as sulfate 20 mg / ml Oral Solution Cipla Ltd to L-146 Verna Goa; India HDPE Bottle 240ml, 100ml Voluntary withdrawal Indore Phase II, Unit II, Plot No. 25-27, Premier Ind. Estate, container pack 100 Kachigam, Daman Product WHO PQ on the 12th of Dec-2017 Rifampicin +Isoniazid + Pyrazinamide 75mg+50mg+ 150mg disp tablet Macleods India Alu/Alu strip 10 (3x10), (U.T). Oxalis Labs, Vill. december 2017 pack (10x10),28 Theda, P.O. Lodhimajra, Baddi, Dist. Solan (H.P.) Hisun Pharmaceuticals (Hangzhou) Co., Hisun Xialian Village, Xukou Powder for ERP reviewed Product-Validity not Oct-17 Kanamycin sulfate 0.5g Pharmaceutica Town, Fuyang City, China Glass vial 10ml Injection extended ls, China Hangzhou City, Zhejiang Provine 311404
List of delisted products, 27th November 2020 22/24 Delisted Supplier/ International Non-proprietary name Strength/ Dose Dosage form Manufacturing site Country Material Pack Reason for delisting from Manufacturer(s)
Hisun Pharmaceuticals (Hangzhou) Co., Hisun Xialian Village, Xukou Powder for ERP reviewed Product-Validity not Oct-17 Kanamycin sulfate 1 g Pharmaceutica Town, Fuyang City, China Glass vial 10ml Injection extended ls, China Hangzhou City, Zhejiang Provine 311404 Macleods Pharmaceuticals Ltd Macleods Plock N-2, Vill. Theda, Blister pack; ERP reviewed. Delisted at the end of the Oct-17 Linezolid 600 mg tablet Pharmaceutica India 10*10; 10*10, 5*4 P.O. Lodhimajra, Strip pack valdity period ls Ltd, India Baddi, Dist. Solan (H.P) Unit-III, 22-110, Industrial Hetero labs Oct-17 Zidovudine 300mg Tablets Development Area, India HDPE bottle 60, 500, 600 Voluntary withdrawal limited Jeedimetla, Hyderabad Unit-III, Jeedimetla, Hyderabad, Andhra Hetero labs Pradesh, India; Oct-17 Lamivudine + Nevirapine + Stavudine 150 mg +200 mg+ 30 mg Tablet India HDPE Bottle 60, 100, 500 Voluntary withdrawal limited Unit-V, Mahaboob Nagar, Andhra Pradesh, India Hetero Blister; HDPE Europe SL, Hetero Labs Ltd Unit bottle; Oct-17 Levofloxacin 500mg Tablet Spain India 5,10; 50; 10x10 Voluntary withdrawal V Andra Pradesh Al/PVC/Aclar Hetero Labs blister Ltd, India Hetero Blister;HDPE Europe SL Hetero Labs Ltd Unit bottle; Oct-17 Levofloxacin 250mg Tablet Spain India 10; 50; 10x10 Voluntary withdrawal V Andra Pradesh Al/PVC/Aclar Hetero Labs blister Ltd, India HDPE Bottle Lupin India 1000 Oct-17 Ethambutol + Isoniazid 400mg+150mg Tablet Aurangabad India Alu/PVC/PVDC Deliested from WHO PQ list Ltd 28 blister HDPE Bottle; Strides Strides Arcolab, 500,1000 Oct-17 Isoniazid + Rifampicin 75 mg + 150 mg Tablet India Alu/PVC/PVdc Deliested from WHO PQ list Arcolab ltd Bangalore 28,10 Blister Strides Arcolab, HDPE Bottle; Ethambutol + Isoniazid + Pyrazinamide + 275 mg + 75 mg + 400 mg Strides 1000 Oct-17 Tablet Bangalore; India Alu/PVC/PVdc Deliested from WHO PQ list Rifampicin + 150 mg Arcolab ltd 28,10 Blister Interpharm Shanghai Harvest Solution for ERP reviewed. Delisted at the end of the Aug-17 Kanamycin sulfate 1g Access Ltd Pharmaceutical Co., glass amp glass amp 4ml injection valdity period Hong Kong Ltd. Interpharm Shanghai Harvest Solution for ERP reviewed. Delisted at the end of the Aug-17 Kanamycin sulfate 0.5g Access Ltd Pharmaceutical Co., glass amp glass amp 4ml injection valdity period Hong Kong Ltd.
List of delisted products, 27th November 2020 23/24 Delisted Supplier/ International Non-proprietary name Strength/ Dose Dosage form Manufacturing site Country Material Pack Reason for delisting from Manufacturer(s) Phase II, Unit II, Sr No. 366, Mai Premier Ind. Estate, Alu/Alu strip Ethionamide 125mg disp tablet Macleods India 5x6 WHO PQ in the meantime 2017 Kachigam, Daman pack (U.T),
June Efavirenz+ Lamivudine + Tenofovir 600 mg + 300 mg + 300 Hetero labs Unit III Jeedimetla, Hyderabad Tablet & India HDPE Bottle 30 No longer tentatively approved by USFDA 2016 Disoproxil Fumarate mg limited UNIT V, Telengana Varichem March Lamivudine + Nevirapine + Stavudine 150 mg +200 mg+ 30 mg Tablet Pharmaceutic Harare Zimbabwe HDPE Bottle 60 Deliested from WHO PQ list 2016 als Varichem March Lamivudine + Zidovudine 150 mg + 300 mg Tablet Pharmaceutic Harare Zimbabwe HDPE Bottle 60 Deliested from WHO PQ list 2016 als ERP validity period until 31 dec 2015. The Jan Solan Linezolid 600mg Tablet Macleods India alu/PVC blister 10 product is classified under Himachal Pradesh 2016 CAT-3 and hence will be delisted. Jan Aspen Pharmacare Aspen Pharmacare Ltd Port Cycloserine 250 mg Capsule South Africa HDPE Bottle 100 De listed from WHO PQ list 2016 Ltd Elizabeth Unit III, Survey No 313 Aurobindo Pharma Bachyupally, Quthubullapur HDPE Bottle; 60, 1000; Abacavir (ABC) as sulfate 60 mg Tablet India Voluntary withdrawal Oct 2015 Ltd Mandal Hyderabad, Andhra Blister 10 Pradesh Unit III, Survey No. 313 &314 Aurobindo Pharma Bachupally, Quthubullapur HDPE bottle; 30; Efavirenz (EFV) 100 mg Capsule India Voluntary withdrawal Oct 2015 Ltd Mandal Hyderabad, Andhra Blister 10 Pradesh UNIT- III,Survey No. 313 and 314, Bachupally Quthubullapur 60, 1000; HDPE Bottle; Aurobindo Pharma Mandal, Hyderabad, Andhra Zidovudine 60mg Tablet India Voluntary withdrawal Oct 2015 Ltd Pradesh Blister Unit-VII (SEZ), Mahaboob 10 Nagar (DT), Andhra Pradesh Transfer of Marketing Authorisation to Ranbaxy Alu/Alu blister; Efavirenz + [Lamivudine + Stavudine] 600 mg + [150 mg + 30 mg] Tablet Paonta Sahib, Himachal Pradesh India 2+1; 30+15 Sunpharm by Ranbaxy not completed. Oct 2015 Laboratories Ltd Cardboard box Delisted from WHO PQ list Transfer of Marketing Authorisation to Ranbaxy Indinavir (IDV) as Sulfate 400 mg Capsule Paonta Sahib, Himachal Pradesh India HDPE Container 90, 180 Sunpharm by Ranbaxy not completed. Oct 2015 Laboratories Ltd Delisted from WHO PQ list Transfer of Marketing Authorisation to Ranbaxy Lamivudine + Nevirapine + Stavudine 150 mg +200 mg+ 30 mg Tablet Paonta Sahib, Himachal Pradesh India HDPE bottle, Blister 60 Sunpharm by Ranbaxy not completed. Oct 2015 Laboratories Ltd Delisted from WHO PQ list Transfer of Marketing Authorisation to Ranbaxy HDPE bottle 60 Lamivudine + Stavudine 150 mg + 30 mg Tablet Paonta Sahib, Himachal Pradesh India Sunpharm by Ranbaxy not completed. Oct 2015 Laboratories Ltd Blister; 10; Delisted from WHO PQ list
List of delisted products, 27th November 2020 24/24