May 2017 Pharmadocx

LIST OF NEW DRUGS 1961 – MAY 2017 download from http://www.pharmadocx.com Page - 1

NEW DRUG LIST 1961- MAY 2017

PHARMADOCX (Pharma Consultant)

Consultant for Setting up:

Pharmaceuticals, Cosmetics, Medicals Devices, Bandages and Diagnostic Kit Factory & Grant of ISO, WHO GMP

Office. : Opp. Dewan Mill,Old D.C. Road, Sonepat-131001 Ph. 0130-2200630, (M) +91-9896133556, E-mail : [email protected], Web : www.pharmadocx.com Blog: http://pharmadocx.wordpress.com, Skype : Yashdeep Pharmaceuticals

PHARMADOCX (Pharmaceutical Consultant) Ph 9896133556 Mail [email protected] (Contact for Setting up Pharma, Cosmetics, Medical Devices Plant, WHOGMP) LIST OF NEW DRUGS 1961 – MAY 2017 download from http://www.pharmadocx.com Page - 2 COMPANY PROFILE

Founded in 2007, Pharmadocx is an India based FDA consultation firm providing consultation services to Pharmaceutical & allied industries. OUR ACTIVITIES:- Designing of plant, supervision of construction of plant & FDA approval. Upgradation of existing plant as per WHOGMP. WHO GMP certification of plant. Preparation of Registration Dossiers. Pharmadocx provides services for following types of plants. Pharmaceutical Formulation, API, Homoeopathic & Herbal formulation plants, Medical Devices Plant, Surgical Dressing Plant, Medical Oxygen Plant, Diagnostic Kits & Cosmetics Plant. PHARMACEUTICAL STATIONARY

We are pleased to offer Pharmaceutical, Cosmetics & Medical Devices Stationary. Various types of registers are needed for maintaining records as per Schedule M, M-I, M-II, M-III U, U1. We can provide following pre printed registers, duly bound, page numbered, as per Drugs & Cosmetics Rules:-

1. Production Register 2. Raw Material Stock Register ( As per Schedule U for Drugs) 3. Raw Material Stock Register ( As per Schedule U1 for Cosmetics) 4. Raw Material Sampling Register 5. RLAF Log Book Register 6. Packing Material Stock Register 7. Finished Goods Stock Register 8. Chemical Stock Register 9. Control/ Retain Sample Register 10.Potable/ Purified Water Tank Cleaning Record Register 11. Temperature / Humidity Record Register 12. RM/ PM/FG Entry Register in Lab 13.Daily pH Meter Standardisation Register 14.Equipment operation & cleaning log book Register 15.Building Maintenance Record 16.Service Record of Machine

Name of Drug Approval Date 1 tablet of Tenofovir disoproxil 300mg + Lamivudine 300mg & 2 23/06/2010 tablet of Nevirapine 200mg combipack 1 tablet of Atazanavir 300mg & 1 tablet of ritonavir Ritonavir 100mg & FDC 19/07/10 of Tenofovir Disoproxil fumarate 300mg + Lamivudine 300mg (Each Co- pack contains :- 1 capsule of Atazanavir 300mg & 1 Tablet of Ritonavir 100mg & 1 Tablet of FDC of Tenofovir Disoproxil Fumarate 300mg + Lamivudine 300mg) 1 tablet of Tenofovir disoproxil 300mg + Lamivudine 300mg & 2 tablet of 23/06/2010 Nevirapine 200mg combipack 1-(2-tetrahydrofuryl)-5-flourouracil Jun, 1977 2-Bromo-2-nitropropan-1,3-diol Sep,1972 2-Pyrrolidone Acetamide Dec,1977 2-Pyrrolidone Acetamide Capsule 400 mg Jan,1978 2-Pyrrolidone Acetamide Injection 200mg/ml Jan,1978 2-thymyl-oxy-methyl glyoxalidine hydrochloride Nasal Spray Jan,1971 3 tablets of artesunate 100mg + 3 tablets of Artesuante 50mg & 2 28/05/2010 tablets of FDC of Pyrimethamine 25mg + Sulphadoxine 500mg combipack 3 tablets of artesunate 100mg + 3 tablets of Artesuante 50mg & 2 tablets of 28/05/2010 FDC of Pyrimethamine 25mg + Sulphadoxine 500mg combipack 3,5-Dinitro-o-toluamide Jan,1972 40mg of elemental iron in a complex of iron polymaltose + Vit. B6- 2mg + Feb-77 Vit. B12 40mcg tablet 50mg of elemental iron in a complex of iron polymaltose aq. solution + Vit. Feb-77 B6 2mg + Vit. B12 5mcg Syrup 5-Aminosalicyclic acid Jun-89 5-Fluorouracil Capsule 250 mg Nov,1977 5-Fluorouracil Oral Solution 250mg/5ml Jan,1979 5-Methylsulphadiazine 02.05.1997 6 aminopenicillanic acid Capsule, 250 & 500 mg May,1974 6 aminopenicillanic acid Injection 250 & 500 mg Aug,1979 6 aminopenicillanic acid Oral Suspension 125mg/5ml, 250mg/5ml Aug,1979 7 pills of 0.5mg Norethindrone & 35 mcg ethinylestradiol Tablets, 7 pills Jan-88 of 0.75mg Norethindrone & 35 mcg ethinylestradiol Tablets and 7 pills of 1mg Norethindrone & 35 mcg ethinylestradiol Tablets Abacavir 22.03.2002 Abacavir Sulfate Tablet 60mg 1.08.2009 Abacavir Sulphate syrup 20mg/ml 29/08/06 Abatacept powder for injection 250mg/vial 22.07.08 Abatacept Injection 250mg/vial (Addl. Indication) 20.02.09 Abatacept Injection 250mg/vial (additional indication) 10.04.09 Abciximab 21.03.1996 Abiraterone acetate Tablet 250 mg (Additional Indication) 27.3.15 Abiraterone Acetate Tablet 250 mg (Additional Indication) 12.08.2016 Abiraterone Acetate Tablets 250mg 16.12.11 Acamprosate Calcium 30.10.2002 PHARMADOCX (Pharmaceutical Consultant) Ph 9896133556 Mail [email protected] (Contact for Setting up Pharma, Cosmetics, Medical Devices Plant, WHOGMP) LIST OF NEW DRUGS 1961 – MAY 2017 download from http://www.pharmadocx.com Page - 4

Acarbose 06.03.1997 Acarbose 25mg/50mg + Metformin 500mg/500mg FC Tablet 23.02.2009 Acarbose tabs 50mg/100mg 6-Mar-97 Acebrophylline capsules 100mg 29.05.08 Acebrophylline SR Tablet 200 mg 23.11.10 Acebrophylline Syrup 10mg/ ml 09.01.09 Acebrophylline Syrup 10mg/ml (Additional Indication) 30.03.09 Acebutolol HCl 200mg + HCTZ 12.5mg Aug-86 Acebutolol Hydrochloride injection 5 mg Dec-85 Acebutolol Hydrochloride capsule 100 mg/ 200 mg/ 400 mg Dec-85 Aceclofenac 15-09-2003 Aceclofenac gel 1.5% alongwith linseed oil, menthol, Salicylate, Capsaicin 06/08/2005 gel Aceclofenac (100 mg) + Paracetamol (500 mg) 29-06-2004 Aceclofenac 1% w/w + Menthol 5% Spray 28/05/2010 Aceclofenac 100mg + Tizanidine 2mg film coated tablets 23.02.09 Aceclofenac 100mg + Paracetamol 500mg tablets 08.07.2004 Aceclofenac 200mg (S.R) tablet 22/02/2006 Aceclofenac 200mg / 200mg SR + Rabeprazole 10mg / 20mg Capsule 01.07.2009 Aceclofenac dispersible tablet 100mg (new dosage form) 21/12/06 Aceclofenac gel 1.5% alongwith Linseed Oil, Menthol, Salicylate, Capsaicin 8/6/2005 Aceclofenac Inj. (150mg/ml) 28/09/06 Aceclofenac Inj. 50mg/ml (additional strength) 12/1/2006 Aceclofenac injection (150mg/3ml) 19.02.07 Aceclofenac injection 150mg/ml 23.01.08 Aceclofenac IP (Sustained released pellets) 200mg/200mg + 04.01.12 Thiocolchicoside IP (Sustained released pellets) 8mg/16mg Capsules. (New Dosage Form) Aceclofenac Roll - On 1% 24.10.08 Aceclofenac 100mg + Tizanidine 2mg film coated tablets 23.02.09 Aceclofenac (100mg) + Thiocolchicoside (4 mg) tablets (Additional 11.08.2009 strength) Aceclofenac (100mg) + Thiocolchicoside (8 mg) tablets 3.08.2009 Acesulfame Potassium 05.04.2005 Acetyl Cysteine Eye Drops 5% w/v 14.12.2010 Acetyl salicylic acid 100mg + Cal. Carbonate 30mg + Anhydrous citric acid Sep-91 10mg Tablet Acetylsalicyclic acid 350mg + Al. Hydroxide 90mg + Mg. Hydroxide tablet Nov-81 Acipimox Capsules 250mg. 26.11.2009 Acitretin 9/9/2005 Aclarubicin HCl Mar-88 Aclarubicin Inj. Mar-88 Acotiamide Hydrochloride Bulk & Tablet 100mg 06.07.2016 Acrivastine Capsules 8mg 26.09.11 Actarit 100mg Tablets 22.07.08 Activated Dimethicone 50mg + Magnesium Hydroxide 250mg+ Dried 28/05/2010 Aluminium Hydroxide250 mg + Sorbitol (70%)1.25 gm /5ml Solution PHARMADOCX (Pharmaceutical Consultant) Ph 9896133556 Mail [email protected] (Contact for Setting up Pharma, Cosmetics, Medical Devices Plant, WHOGMP) LIST OF NEW DRUGS 1961 – MAY 2017 download from http://www.pharmadocx.com Page - 5

Activated Methylpolysiloxane 125mg + Magnesium Hydroxide 100mg + Jun-73 Aluminium Hydroxide 5gm per 5ml solution Acyclovir 1985 to 87 Acyclovir 50g + Hydrocortisone 10mg Cream 30.08.11 Acyclovir SR Tablet 1200 mg 11.09.10 Acyclovir Tablets/ Cream/ Ointment/ Ophthalmic Ointment May-87 Adapalene 0.1% + Benzoyl Peroxide 2.5% gel 24.10.08 Adapalene1mg +Clindamycin Phosphate eq. to Clindamycin 10mg per gram 01.05.2003 Gel Adefovir Dipivoxil 4/3/2004 Ademetionine enteric coated Tablets 200mg/400mg 01.09.10 Adenosine 09.07.1997 Adenosine injection 6 mg /2ml 8-Jul-97 Adenosylcobalamin 15mcg + Ferrous Ascorbate 100mg + Folic Acid IP 21.03.11 1.5mg + Zinc Sulphate USP Eq. to Elemental Zinc 22.5mg tablet Afatinib Tablets 20mg/30mg/40mg/50mg (Free base) corresponding to 27.09.2016 Afatinib dimaleate 29.56mg/44.34mg/59.12mg/73.9mg (Additional Indication) Agomelatine Tablets 25mg 10.09.2012 Akiskiren Hemifumarate eq. to Aliskiren 12.10.11 150mg/150mg/300mg/300mg +Amlodipine Besilate IP eq. to Amlodipine 5mg/10mg/5mg/10mg Tablets Albendazole 3\1979 to 7/1981 Albendazole 400 mg + Ivermectin 6 mg tablet 25.04.2009 Albendazole Suspension 2.5 % w/v & 10% w/v Oct, 1979 Albendazolesuspension200mg/5ml Feb-86 Albendazole tablet 200mg / 400 mg Feb-86 Albendazole tablet 400mg and suspension 400mg/10ml (Additional 28/11/2011 Indication) Albendazole 400 mg + Ivermectin 6 mg tablet 25.04.2009 Alcaftadine Eye Drops 0.25% w/v & Bulk 21.11.2016 Alclometasone Dipropionate 1985 to 87 Alclometasone Dipropionate cream/ointment 0.05% Jul-87 Alendronate 70mg + Colealciferol 140mcg (5600 IU) Tablets 10.11.2009 Alendronate Sodium 18-Sep-97 Alendronate Sodium (equiv. to Alendronic acid 70mg) + Cholecalciferol 02/01/2006 70mcg (equiv. to 2800 I.U Vit.D) Tablet Alendronate Sodium tab -10mg 18-Sep-97 Alfuzocin Hcl. ER (10mg) + Dutasteride 0.5mg tablet 14.06.07 Aliskiren 150/150/300/300mg + HCTZ 12.5/25/12.5/25mg tablets 08.05.08 Aliskiren 150/160mg + Valsartan 300/320mg tablets 19/01/2010 Aliskiren Tablet 150mg/300mg 08.06.07 Alkyl dimethyl benzoyl ammonium chloride 5% + Nonyl phenolethoxide 6% 23.08.1999 + Inert ingredient 89% Allergen extracts Jan,1979 Almotriptan Tablet 6.25mg/12.5mg 05.10.12 Alogliptin Tablet 6.25 mg/12.5 mg/ 25 mg 27 08 14 PHARMADOCX (Pharmaceutical Consultant) Ph 9896133556 Mail [email protected] (Contact for Setting up Pharma, Cosmetics, Medical Devices Plant, WHOGMP) LIST OF NEW DRUGS 1961 – MAY 2017 download from http://www.pharmadocx.com Page - 6

Alpha chymotrypsin 60mg + Ethyl nicotinate 200mg per 20gm ointment Sep-71 Alpha chloropyridazine sodium10gm + trimethoprim 2gm per 00gm powder May-90 for vetarnary use Alpha Lipoic acid 100mg + Folic acid 1.5mg + Methylcobalamin 1500mcg + 10.08.11 Pyridoxine Hydrochloride 3mg + Vitamin D3 1000 IU Tablets Alpha Lipoic Acid USP 100mg + Methylcobalamin 1500mcg + Vitamin B6 03.01.11 IP 3mg + Folic Acid IP 1.5mg + Benfotiamine 50mg + Biotin USP 5mg + Chromium Picolinate USP Eq. to Chromuim 200mcg Capsule Alphachymotrypsin injection 5mg/vial Aug,1973 Alphachymotrypsin Tablet 25 chg units Jul,1975 Alprazolam Dispersible Tab. 0.125mg/0.25mg/0.50mg 20/09/06 Alprazolam SR 0.25mg + Sertraline (As Hcl) 25mg/50mg tablet 9/8/2006 Alprazolam SR 0.25mg + Sertraline (As Hcl) 25mg/50mg tablet 08/09/2006 Alprazolam SR tab 1.5mg Alprazolam sublingual tablets 0.5mg/1mg (New dosage form) 27/10/2011 Alprazolam tablets 0.25 mg/0 .5 mg/ 1 mg Jun-88 Alprostadil Injection 09.05.2002 Altretamine 29.03.1995 Altretamine caps -50mg 29-Mar-05 Aluminium hydroxide paste eq. to Dried Aluminium hydroxide gel IP 250mg 30.04.15 + Magnesium hydroxide paste eq. to Magnesium hydroxide IP 250mg + Simethicone Emulsion USP eq. to Simethicone 50mg + Oxetacaine BP 10mg Each 5 ml Contains: Aluminium sodium silicate + Magnesium hydroxide + Methypolysiloxane Jun-67 Tablet Amantadine Hydrochloride Dec,1972 Ambodryl 100mg + Aspirin 190mg + Phenacetin 65mg + Caffiene 15mg + Nov-70 Phenylephrine HCl 10mg + Aluminium hydroxide gel 100mg tablet Ambrisentan film coated Tablets 5 mg / 10mg 24/05/2010 Ambroxol (as Hcl) S.R. 7.5mg+ Doxycyline Hcl 100mg tablet 23.08.2001 Ambroxol + loratadine + Guaifenesin Syrup (30mg + 5mg + 50mg per 18.08.08 5ml) Ambroxol 30mg + Gnaiphenesin 100mg + Menthol 1mg + Psendoephedrine 29.10.1999 60mg per 5ml syrup Ambroxol Hcl 30mg + Guaiphenesin 200mg tablet 10.09.2001 Ambroxol HCl 75mg (S.R) + Desloratadine 5mg Capsule. 11/10/2005 Ambroxol tablet/liquid/drops [1. Each tab. Contains, Ambroxol HCL-30mg, 1-Dec-95 2. Each 5ml liquid contains, Ambroxol HCL-30mg, 3. Each ml drops contains, Ambroxol HCL-7.5mg] Ambroxol + Doxycyline 23.08.2001 Ambroxol + loratadine + Guaifenesin Syrup (30mg + 5mg + 50mg per 5ml) 18.08.08 Ambroxol 30 mg+ Terbutaline 2.5 mg + Guaiphenesin 100mg + Menthol 2.5 27.10.2009 mg per 5 ml syrup Ambroxol 30mg + Levo salbutamol 1mg+Guiphenesin 50mg /5ml syrup 19.03.09 Ambroxol 30mg + Terbutaline 2.5mg + Guaiphenesin 100mg + Menthol 2.5 27.10.2009 mg per 5 ml syrup (additional strength)

Ambroxol HCl 15mg + Salbulamol 1mg + Guaiphenesin 50mg + Methol 16.06.1999 1mg per 5 ml syrup Ambroxol HCl 15mg + Guaiphenesin 100mg + Ethanol 95% eq.to. Ethanol 18.08.2000 5% v/v per 5 ml oral liquid Ambroxol HCl 30mg + Guaiphenesin 100mg + Terbutaline sulphate 2.5mg 26.03.08 per 10ml Syrup Ambroxol HCl 75mg (S.R) + Desloratadine 5mg Capsule. 11/10/2005 Ambroxol HCl. 15mg + Guiphenesin 50mg + Terbutalin sulphate 1.25mg + 26.03.08 Menthol 2.5mg per 5 ml of syrup Ambroxol Hydrochloride 01.12.1995 Ambroxol 30mg + Levo salbutamol 1mg+ Guiphenesin 50mg /5ml syrup 19.03.09 Ambroxol+Pseudoephedmine+Chlorpheniramin e maleats 26.02.1998 tabs/suspension/syrup Amifostine Sep-84 Amikacin 1985 to 87 Amikacin injection Jun-86 Amiloride 5mg / 5mg + Frusemide 20mg/40mg tablet Jun-89 Amiloride 5mg + HCTZ 50mg Tablet Sep-79 Amiloride HCl 3/1979 to 7/1981 Amiloride HCl Tablet 5 mg Sep, 1979 Amiloride+ Frusemide Jun-89 Amineptine Jan-88 Amino acid 5% w/v IV Infusion with & without electrolytes 07.02.2001 Amino Acid, Glucose Parentral Solution (Solution for intravenous infusion) 08.07.08 Aminoglutethimide Aug-85 Aminomix-2 Infusion Solution Solution A 500ml & 7 Solution B 500ml 04.07.2000 Aminophylline CR 225/350mg 21.03.07 Aminosidine Sulphate Inj. Vial, 500mg May, 1976 Amiodarone HCl Apr-90 Amiodarone Injection (additional Indication). 5/10/2007 Amisulpiride 300mg tablets (Additional Strength) 20.03.08 Amisulpiride SR Tablet 100 mg 27.11.2009 Amisulpiride Tablet (50/100/200mg) 1/8/2006 Amisulpride 400mg tablet (additional strength) 1/12/2006 Amisulpride S.R.Bilayered tablet 200/400mg 03.11.08 Amitraz Aug. 1996 Amitraz 2%w/v pour on solution 12/6/2010 Amitriptyline Hydrochloride IP 4%w/w + Ketamine HCL eq. to Ketamine 2% 13.10.10 w/w per gm cream. Amitriptyline Hydrochloride IP 4%w/w + Ketamine HCL eq. to Ketamine 2% 13.10.10 w/w per gm cream. Amitryptylline Hydrochloride Tablet 75 mg Oct,1978 Amlexanox Oral Paste (5%) 16.05.07 Amlodipine 93.05.01 Amlodipine (5mg) + Nebivolol (5mg) tablet (addl. Strength) 06-09-2007. Amlodipine Besylate IP Eq. to Amlodipine 10mg/5mg/2.5mg + 12.10.10 Telmisartan 80mg/40mg/ 20mg + HCTZ 25mg/12.5mg/12.5mg tablet PHARMADOCX (Pharmaceutical Consultant) Ph 9896133556 Mail [email protected] (Contact for Setting up Pharma, Cosmetics, Medical Devices Plant, WHOGMP) LIST OF NEW DRUGS 1961 – MAY 2017 download from http://www.pharmadocx.com Page - 8

Amlodipine (5 mg) + Ramipril (2.5 mg) tablet 24-09-2004 Amlodipine (5mg) + Nebivolol (5mg) tablet (addl. Strength). 6/9/2007 Amlodipine (as besylate ) 5mg + Losartan Pot. 50mg tablet. 12/08/2005 Amlodipine (As besylate )5mg/10mg + Perindopril 4mg tablet 23.02.07 Amlodipine (As besylate) 10mg + Perindopril 8mg tablets (additional 07.05.07 strength) Amlodipine (as besylate) -2.5mg/5mg + Benazepril-10mg/20mg capsule 22.03.2002 Amlodipine (as besylate) 5mg + Bisoprolol 5mg Tablet (Addl. Strength) 30-11-2005 Amlodipine (as besylate) 5mg + HCTZ 12.5mg Tablet 24/04/2006 Amlodipine (As besylate) 5mg + Metoprolol (As succinate) ER 25mg 14.02.07 (additional strength) Amlodipine (as besylate) 5mg + Metoprolol Succinate equivalent to 5/6/2006 Metoprolol Tartrate 50mg. Amlodipine (As besylate) 5mg/10mg + Perindopril 4mg tablet 23.02.07 Amlodipine (as besylate) 5mg/2.5mg + HCTZ12.5mg/12.5mg Tablet 24/04/2006 Amlodipine (As besylate) 5mg/5mg/10mg + valsartan 80mg/160mg/160mg 21.02.07 tablet Amlodipine + Enalapril 16.11.1995 Amlodipine + Metoprolol (2.5/5 mg + 25/50mg (ER)) Tablets 10.11.08 Amlodipine + Metoprolol (2.5mg/5mg + 25mg/50mg (ER) Tablets(additional 10.11.08 strength) Amlodipine 10mg/10mg+ Telmisartan 40mg/80mg Tablets (Additional 31.05.11 Strength) Amlodipine 2.5/5/5mg + Metoprolol 25/50/25mg Capsules 16.07.2008 Amlodipine 25mg + Metoprolol 25mg (additional lower strength) 1/11/2006 Amlodipine 25mg + Metoprolol 25mg (additional lower strength) tablet 11/01/2006 Amlodipine 5 mg + Ramipril 2.5mg capsule 04.10.2004 Amlodipine 5mg/10mg/5mg/10mg/10mg + Valsartan 160mg/160mg/160mg/ 24.11.2009 160mg/320mg + Hydrochlorothizide 2.5mg/12.5mg/25mg/ 25mg/ 25mg Tablets Amlodipine 5mg/2.5mg + Enalapril Maleate 5mg/2.5mg tablets 16.11.1995 Amlodipine 5mg/2.5mg + Valsartan 320mg/80mg + HCTZ 12.5mg/12.5mg 21.09.10 tablet (additional strength) Amlodipine besilate IP Eq. to Amlodipine 10mg + Indapamide SR 1.5 mg 02.01.2013 Tablet (Additional Strength) Amlodipine Besilate IP Eq. to Amlodipine 5mg + Indapamide USP SR 1.5mg 05.01.11 Tablet Amlodipine Besilate IP eq. to Amlodipine 5mg + Perindopril Erbumine BP 20.12.11 8mg Tablets (Additional Strength) Amlodipine Besilate IP eq.to Amlodipine 10mg/5mg/5mg/5mg/2.5mg + 23.11.11 Olmesartan Medoxomil 40mg/40mg/20mg/5mg/5mg + Hydrochlorothiazide IP 25mg/12.5mg/12.5mg/12.5mg/12.5mg Tablet Amlodipine Besilate tablets 5/10 mg 19-May-93 Amlodipine Besylate BP Eq. to Amlodpine 5mg + Losartan Potassium USP 14.05.2008 25mg/50mg film coated tablets Amlodipine besylate eq. to Amlodipine 5mg + Atenolol 50mg Besylate 16.05.1996 uncoated tablets PHARMADOCX (Pharmaceutical Consultant) Ph 9896133556 Mail [email protected] (Contact for Setting up Pharma, Cosmetics, Medical Devices Plant, WHOGMP) LIST OF NEW DRUGS 1961 – MAY 2017 download from http://www.pharmadocx.com Page - 9

Amlodipine besylate Eq. to Amlodipine 5mg + Lisinoril eq. to Lisinopril 27.03.1997 anhydrous 5mg tablet Amlodipine Besylate eq.to Amlodipine 5mg + Atorvastatin calcium eq. to 11.02.2004 Atorvastatin 10mg each tablets Amlodipine Besylate IP Eq. to Amlodipine 10mg/5mg/2.5mg +Telmisartan 12.10.10 80mg/40mg/20mg + HCTZ 25mg/12.5mg/12.5mg tablet Amlodipine Orally Disintegrating Strips 2.5mg/5mg/10mg 07.01.2016 Amlodipine Tablets 5mg/10mg (additional indication) 02.05.2009 Amlodipine5mg + Ramipril10mg/5mg Tablets (additional strength) 03/10/2010 Ammoidin + Amidine Jul-67 Ammonium Lactate Cream 12% w/w 03.12.2010 Amorolfine 25-11-2003 Amoscanate 1985 to 87 Amoscanate tablet 250 mg Nov-85 Amoxapine 1985 to 87 Amoxapine tablet 25/ 50/ 100 mg Nov-85 Amoxicillin 125mg + Carbocistine 75mg per 5ml syrup Apr-91 Amoxicillin 250/500mg + Carbocistine 150mg/150mg capsule Apr-91 Amoxicillin 250mg + Lacto- Bacillus 1.7 billion Spores 31.01.08 Amoxicillin 250mg/125mg + Cloxacillin 250mg/125mg + Lactic Acid 30.01.08 Bacillus 1.7 Billion spores Amoxicillin Dispersible Tablet 125 mg Mar,1980 Amoxicillin trihydrate IP e.q. to Amoxicillin 400 mg Caluvulanate Potassium 08.06.15 e.q. to Clavulanic acid 57 mg Dispersible Tablet: Each dispersible tablet contains: Amoxicillin Trihydrate IP eq to Amoxicillin 80 mg+ Potassium Clavulanate 13.02.15 IP eq to Clavulanic Acid 11.4 mg (additional Strength) Each 1 ml of the constituted suspension contains Amoxicillin trihydrate USP e.q. to Amoxicillin 400 mg Caluvulanate 08.06.15 Potassium e.q. to Clavulanic acid 57 mg Oral Suspension: Each 5ml of reconstituted suspension contains: Amoxicillin+ Carbocistine Apr-91 Amoxycillin Dec,1978 Amoxycillin (Present as amoxicillin trihydrate IP) 500mg + Clavulanic Acid 06.01.1995 (Present as potassium clavulanate USP) 125mg film coated tablets Amoxycillin + Clavulanic acid Feb-87 Amoxycillin + Clavulanic acid(1gm + 62.5mg ) FC Tablets 25.11.08 Amoxycillin + Sulbactum 21.06.1996 Amoxycillin 1000mg + Clavulanate Potassium 62.5mg E.R tablet 06/08/2006 Amoxycillin 125mg/250mg/500mg + Lactobacillus 1.66 billion Spores 31.01.08 (Capsules) Amoxycillin 250mg + Clavulanic acid 150mg dispersible tablet 23.12.1999 Amoxycillin 250mg + Cloxacillin 250mg + Lactobacillus 2 billion spores 30.01.08 capsules Amoxycillin 250mg + Dicloxacillin 250mg + Lactobacillus 2.5 million spores 29.01.2008 capsules Amoxycillin 250mg + Dicloxacillin 250mg cap. 28/08/06 PHARMADOCX (Pharmaceutical Consultant) Ph 9896133556 Mail [email protected] (Contact for Setting up Pharma, Cosmetics, Medical Devices Plant, WHOGMP) LIST OF NEW DRUGS 1961 – MAY 2017 download from http://www.pharmadocx.com Page - 10

Amoxycillin 500mg + Potassium Clavulanate 100mg injection 03.10.1994 Amoxycillin 500mg/1gm + Clavulanic acid 100mg/200mg each vial Injection May-87 Amoxycillin 875mg + Clavulanic Acid 125mg tablets 27.01.1999 Amoxycillin Capsule 250mg & 500mg Jan,1979 Amoxycillin Injection 250mg/500mg/1g/vial Jun,1979 Amoxycillin Oral Suspension 200/400 mg per 5ml 9/8/2010 Amoxycillin Paediatric Suspension 125mg/1.25 ml Jan,1979 Amoxycillin Sodium IP Eq. to Amoxycillin 200mg/2000mg/3000mg + 30.04.15 Sulbactam Sodium USP Eq. to Sulbactam 100mg/1000mg/1500mg 2. One ampoule of Sterile water for injection IP 5ml/15ml/15ml Each combipack contains: 1. One vial Containing: Amoxycillin Syrup 125mg/5ml & 250mg/5ml Jan,1979 Amoxycillin trihydrate 250mg + Potassium Clavulanic eq. to Clavulanic acid Feb-87 125mg each tablet Amoxycillin trihydrate IP e.q. to Amoxycillin 200 mg + Potassium 15.07.15 caluvulanate e.q. to Clavulanic acid 28.5 mg Each uncoated dispersible tablet contains: Amoxycillin trihydrate IP e.q. to Amoxycillin 200 mg Caluvulanate Potassium 18.02.16 e.q. to Clavulanic acid 28.5 mg Each 5ml of reconstituted suspension contains: Amoxycillin trihydrate IP e.q. to anhydrous Amoxycillin 250 mg/125 mg 05.01.16 Caluvulanate Potassium e.q. to Clavulanic acid 62.5 mg/31.25mg Each uncoated dispersible tablet contains: Amphotericin B Emulsion 5mg/ml (Addl. Indication) 18.7.2009 Amphotericin B Lipid suspension 50mg/ vial (Addl. Strength) 12.12.08 Amphotericin B Lipid suspension injection (25mg/vial) with lipid suspension 03.06.08 Ampicillin + Probenecid 83/01/01 Ampicillin + Sulbactum Sep-91 Ampicillin 250mg + Dicloxacillin 250mg tablet 13/12/06 Ampicillin 3.5gm + Probenecid 1.0gm single vial Feb-83 Ampicillin Sodium 0.25/0.5gm + Sulbactum Sodium 1gm/2gm per vial 06.05.1992 Injection Ampicillin Sodium 0.5gm + Sulbactum Sodium 1gm per vial Injection Sep-91 Amrinone Lactate May-88 Amsacrine Injection Feb-92 Amtolmetin Guacil tablets 600mg 07.03.08 Amylase + Cellulose + Protinase + Pencreatic enzyme + Lipase Capsule Dec-71 Amylobarbitone + Trifluperazine Dihydrochloride Capsule Feb-67 Anastrazole 10.02.2003 Anidulafungin Injection (Lyophilized powder) 50mg/100mg per vial 23.02.09 Anti-Rabies Vaccine Mar-89 Apixaban Tablets 2.5/5mg (add. Indication) 29.05.15 Apixaban Tablets 2.5mg 03.08.2012 Apixaban tablets 2.5mg/5mg (Additional Strength & Additional Indication) 16.05.2014 Apomorphine HCL-2mg/3mg Sublingual tablet. 12.11.07 Apraclonidine Ophthalmic Sol. 15.03.2002 Apramycin Sulphate 22.07.1997 Aprepitant 40mg capsules (additional strength) 24.04.07 PHARMADOCX (Pharmaceutical Consultant) Ph 9896133556 Mail [email protected] (Contact for Setting up Pharma, Cosmetics, Medical Devices Plant, WHOGMP) LIST OF NEW DRUGS 1961 – MAY 2017 download from http://www.pharmadocx.com Page - 11

Aprepitant cap (80mg/125mg) 30/08/06 Aprotonin Nov,1973 Aprotonin Injection 100000 KIU/5ml, 200000KIU/10ml Jan,1974 Aremther 20mg + Lumefantrine 120mg tablet 26.12.2002 Arformoterol (as Tartrate ) 15mcg / 2ml Inhalation Solution 29.05.09 Aripiprazole 11.06.2003 Armodafinil uncoated tablet 50/150/250mg 23/04/2010 Arteether 14-Jan-97 Arteether injection 150mg/ml 03.12.2010 Arteether injection I.M. -150mg per vial 14-Jan-97 Artemether + Lumefantrine (80mg + 480mg/5ml) Dry syrup 30.09.08 Artemether + Lumefantrine Dispersible tablet (40/80mg + 240/480mg ) 05.08.08 (Additional Strength) Artemether 20mg + Lumefantrine 120mg Dispersible tablet (Additional 08.02.2010 Strength) Artemether 20mg + Lumefantrine 120mg Syrup 05.01.2011 Artemether 40mg/80mg + Lumefantrine 240mg/480mg tablets (additional 24.06.08 Strength) Artemether 40mg/80mg + Lumefantrine 240mg/480mg tablets (additional 24.06.08 Strength) Artemether 60mg +Lumefantrine 360mg (additional Strength) uncoated 29.07.13 Tablets Artemether Capsule 40mg 3-Aug-96 Artemether Injection -80mg 2-Aug-96 Arterolane Maleate 150mg + Piperaquine Phosphate 750mg Tablet 19.10.11 Arterolane Maleate 150mg + Piperaquine Phosphate 750mg Tablet 19.10.11 Artesunate Aug. 1996 Artesunate (25/50/100mg) + Amodiaquine (67.5 mg/135/270mg) bilayerd 01.09.2009 Tablets Artesunate 150mg/200mg + Sulphadoxine 500mg/750mg + Pyrimethamine 25.07.2006 25/37.5mg Combipack Artesunate injection 60mg 2-Sep-96 Artesunate injection. Each combipack contains: "Artesunate for injection 13.11.2013 120mg ( Each vial contains Artesunate IP 120mg), Sodium bicarbonate injection IP 5%w/v (Each 2ml ampoule contains: Sodium Bicarbonate IP 5% w/v), Sodium chloride Injection IP 0.9% w/v (Each 10ml ampoule contains: Sodium chloride IP 0.9% w/v)" Artesunate powder for injection 60mg/vial alongwith 6ml ampoule of 02.07.2014 phosphate buffer solution (pH 8.0;0.30M) Artesunate tabs 50mg 7-Oct-96 Arthemether Injection Aug. 1996 Articaine Hydrochloride Aug-86 Asenapine Maleate Sublingual Tablets 5mg/10mg 07.04.11 Asiaticoside Nov,1976 Aspirin 150mg + Clopidogrel (as bisulphate) 300mg tablet (addl. Strength) 22/06/2006 Aspirin 25mg+ Dipyridamole BP 200mg (ER) capsule 27.02.2003 Aspirin 75mg/75mg + Clopidogrel 150mg/150mg Tablet 26.11.2002 PHARMADOCX (Pharmaceutical Consultant) Ph 9896133556 Mail [email protected] (Contact for Setting up Pharma, Cosmetics, Medical Devices Plant, WHOGMP) LIST OF NEW DRUGS 1961 – MAY 2017 download from http://www.pharmadocx.com Page - 12

Aspirin (EC Tablets) 75mg/75mg/150mg +Rosuvastatin (Granules) 30.03.11 5mg/10mg/10mg Capsules Aspirin 150mg + Clopidogrel (as bisulphate) 300mg tablet (addl. Strength) 22/06/2006 Aspirin 150mg + Clopidogrel 300mg Tablet (additional strength) 26.11.2002 Aspirin 150mg + ISMN 60mg SR Tablets 07.11.2002 Aspirin 75mg / 150mg + Glycine 37.5mg/75mg tablet 08/10/2006 Aspirin 75mg + Simvastatin 10mg/20mg + Lisinopril 5mg/10mg + Atenolol 1/6/2010 25mg/50mg Tablets Aspirin Bolus (Vet.) 6gm/bolus) 21-11-2005 Astemizole Feb-88 Astemizole Susp. Aug-88 Atazanavir (100/150/200mg) 24/04/2006 Atazanavir + Ritonavir (300mg + 100mg) FC Tablets 04.11.08 Atazanavir 150mg + Ritonavir 50mg capsules 12/12/2006 Atazanavir 300mg capsules (Additional strength) 08.01.08 Atenolol 1985 to 87 Atenolol 25/50mg + Chlorthalidone 6.25 mg tablets 31.01.2008 Atenolol (25mg, 50mg) + HCTZ (12.5mg) 13-01-2005 Atenolol (25mg, 50mg) + HCTZ (12.5mg, 12.5 mg ) Tablet 13-01-2005 Atenolol + Amlodipine 20.05.1996 Atenolol 25mg/50mg + Indapamide SR 1.5mg 21.05.07 Atenolol 25mg/50mg + Indapamide SR 1.5mg tablet 21.05.07 Atenolol 50mg + HCTZ 25mg (addl. Strength) 02/03/2006 Atenolol BP 50mg + Nifedipine SR 20mg capsule Jan-90 Atenolol tablet 50 mg/ 100 mg Sep-85 Atomoxetine (as HCl) Sachet (10/18/25/40mg) 15-12-2005 Atomoxetine 60mg capsule (Addl. Strength) 27/02/2006 Atomoxetine HCl (10,18, 25 & 40mg ) capsule 9/11/2004 Atorvastatin 17.09.99 Atorvastatin (10mg/20mg) + Ezetimibe (10mg) Tablet 13.08.2004 Atorvastatin (40mg) + Ezetimibe (10mg) Tablet (addl. Strength). 30-07-2007 Atorvastatin + Metformin (10mg + 500mg SR) Tablets 04.12.08 Atorvastatin 10mg + Aspirin 75/150mg Capsules 18.01.08 Atorvastatin 10mg + Fenofibrate 80mg tablet (Additional Indication) 25.01.08 Atorvastatin 10mg + Ramipril 5mg + Aspirin (EC pellets) 75mg/150mg + 04/05/2010 Metoprolol (ER tablets) 25mg Capsules Atorvastatin 10mg/20mg + Ezetimibe10mg/10mg tablet 08.11.2004 Atorvastatin 20mg + Ramipril 2.5mg/5mg Capsules (additional strength) 17/03/2010 Atorvastatin 5/10/5mg + Telmisartan 20/20/40 mg 22.05.2008 Atorvastatin 5mg + Fenofibrate 160mg (additional strength) tablets 12/01/2006 Atorvastatin Calcium (10mg ) + Ramipril (2.5mg/5mg) tablet 15-10-2007 Atorvastatin Calcium (10mg) + Fenofibrate (145mg) (addl. strength) 30-10-2007 Atorvastatin Calcium (10mg) + Ramipril (2.5mg/5mg) tablet 15-10-2007 Atorvastatin calcium 5mg/10mg/20mg/40mg/80mg (Additional Dosage Form) 20/04/2011 Atorvastatin Calcium 80mg tablets (Additional Strength) 25.02.08 Atorvastatin Calcium eq. Atorvastatin 10 mg + Fenofibrate (micronised) 24.12.2004 160mg film coated tablets PHARMADOCX (Pharmaceutical Consultant) Ph 9896133556 Mail [email protected] (Contact for Setting up Pharma, Cosmetics, Medical Devices Plant, WHOGMP) LIST OF NEW DRUGS 1961 – MAY 2017 download from http://www.pharmadocx.com Page - 13

Atorvastatin Calcium IP Eq. to Atorvastatin 5mg + Fenofibrate BP 145mg 29.04.2010 film coated tablet (additional strengths) Atorvastatin10mg + Ramipril 5mg + Aspirin (EC pellets) 75mg/150mg + 5/4/2010 Metoprolol (ER tablets) 25mg Capsules Atorvastin 10mg/20mg + Ezatimib 10mg/10mg tablet 13.08.2004 Atorvaststin 10mg + Nicotinic Acid 375mg/500mg (ER) Tablets 28.07.2005 Atosiban Acetate Injection 6.75mg/0.9ml and Bulk 16.09.15 Atracurium Dibesylate Injection Jan-86 Atropine Sulphate 0.06mg + Hyoscyamine sulphate 0.30mg + Scopolamine Dec-69 hydrobromide 0.035mg + Phenobarbatal 64.8mg capsule Auranofin capsules 3 mg Dec-87 Autolysate of β-subtilis + β- megatherium Jul-75 Axitinib Tablet 1mg/5mg 18.09.14 Azabiperidol Sep,1981 Azacitidine 23 07 14 Azacitidine 100 mg / vial 29 04 14 Azacitidine Lyophilized powder for Injection 100mg/vial (Intravenous or 04.08.2016 Subcutaneous) Azathioprine 1969 to 74 Azathioprine 25mg Tablets 19.12.08 Azatidine Maleate Tablet 1 mg Nov, 1980 Azelaic acid Cream (15%) 23-02-2005 Azelaic Acid 8/7/2003 Azelastine HCL 15.01.1997 Azelastine Nasal spray 0.01gm per 10ml 15-Jul-97 Azilsartan Medoxomil Bulk & 40mg/80mg Tablets 09.12.2016 Azithromycin + Dexamethasone (10mg + 1mg) Eye Drops 21.10.08 Azithromycin 500mg + Ambroxol S.R (75mg) Tablet 5/7/2007 Azithromycin capsules/suspension [Each capsule contains : Azithromycin 13-May-94 dihydrate equl to 250mg of base 2. Each 5ml contains: Azithromycin- 200mg/50mg] Azithromycin eye drops 1% 06.06.07 Azithromycin SR Granules for Oral Suspension 1gm (Addl. Strength) 5/4/2010 Azithromycin Tablet 250mg/500mg 6.3.13 Azithromycin SR Granules for oral suspension 2000mg 26.6.2009 Aztreonam 01.11.2002 For ready made Pharmaceutical Stationary like Raw Material [email protected] Stock Register, Control Sample Register, Production Register Etc. Contact Pharmadocx 9896133556 b -arteether Injection (150 mg/2 ml) 1/9/2004 Bacampicillin tablet 400 mg Oct-85 Bacillocid special May-92 Bacillus calmette guerin vaccine Jun-92 Bacillus Clausii Spores (2 Billion) Capsules (additional dosage form) 28.01.2005 Baclofen 29.09.1995 Baclofen E.R capsule (30mg) 01.08.2006 PHARMADOCX (Pharmaceutical Consultant) Ph 9896133556 Mail [email protected] (Contact for Setting up Pharma, Cosmetics, Medical Devices Plant, WHOGMP) LIST OF NEW DRUGS 1961 – MAY 2017 download from http://www.pharmadocx.com Page - 14

Baclofen ER (GRS) Capsule 45mg/60mg (additional strength) 22.02.07 Baclofen ER Capsule 10 mg/50 mg (Additional Strength) 17.02.11 Balanced salt intra ocular irrigating solution enriched with glutathione 26-04-2005 Dextrose, bicarbonate Balofloxacin Tablet 100mg 22.12.2009 Balsalezide Disodium 12.11.2002 Bambuterol 13.12.99 Basiliximab Inj. 28.05.99 Beclomethasone + Neomycin Apr-74 Beclomethasone Dipropionate Feb,1973 Beclomethasone Dipropionate 0.025% + Chinoform 3% Ointment & Cream Apr-74 Beclomethasone Dipropionate 0.025% + Neomycin Sulphate 0.5% Ointment Apr-74 & Cream Beclomethasone Dipropionate 0.025% cream & ointment Apr,1974 Beclomethasone Dipropionate 0.25mg + Econazole 10mg + Neomycin 5mg 30.01.08 per gm of Cream Beclomethasone Dipropionate IP 100mcg + Formoterol Fumarate Dihydrate 05.01.11 BP Eq. to Formoterol Fumarate 6 mcg Metered Dose Inhaler Beclomethasone Dipropionate IP 0.025% w/w + Neomycin sulphate IP 0.5% 15.09.10 w/w cream Beclomethasone Dipropionate MDI 50 mcg Dec,1975 Bedaquiline Tablet 100 mg 14.01.2015 Bemiparin Sodium Solution for injection (5000/7500/10,000 I.U). 08.06.2006 Benazapril + HCTZ 21.05.1998 Benazapril Hcl 5mg/10mg/20mg/20mg+ Hydrochlorothiazide 21.05.1998 6.25mg/12.5mg/12.5mg/25 mg tablet Benazepril Hcl Nov. 1992 Benazepril Hcl tabs 5mg/10mg/20mg 22-Apr-96 Bendamustine Hydrochloride Injection 100mg/vial (Additional Indication) 18/05/2011 Bendamustine Hydrochloride lyophilised injection 25mg (Additional 19.9.2014 strength) Bendamustine Hydrochloride Lyophilized powder Injection 100mg/ vial 16.05.09 Bendrofluazide 24.07.2003 Benidipine Hcl tabs 4mg/8mg 12-Aug-96 Benorylate Dec,1978 Benorylate Suspension 2g/5ml Dec,1978 Benorylate Tablet 250 mg Dec,1978 Benoxinate Hydrochloride oph. Solution Nov-92 Benserazide Hydrochloride 1985 to 87 Benzafibrate retard tablet 400 mg Apr-93 Benzoyl peroxide 10%w/w + Precipitated Sulphur 5%w/w per 20gm cream Aug-75 Benzoyl Peroxide Medicated Solution (each textured pad contains 14.05.08 4.5%/6.5%/8.5% of solution Benzydamine Apr-88 Bepotastine Besilate Bulk 23.11.2016 Bepotastine Besilate Bulk & Bepotastine Besilate 1.5 %w/v Ophthalmic 08.06.16 solution PHARMADOCX (Pharmaceutical Consultant) Ph 9896133556 Mail [email protected] (Contact for Setting up Pharma, Cosmetics, Medical Devices Plant, WHOGMP) LIST OF NEW DRUGS 1961 – MAY 2017 download from http://www.pharmadocx.com Page - 15

Besifloxacin Ophthalmic Suspension 0.6% w/v 31.05.11 Betacarotene + Vitamin + Selenium 10.10.2001 Betahistine Di hydrochloride CR capsule 24/32/48mg 17.12.2009 Betahistine Dihydrochloride SR Tablets 24mg/32mg/48mg 14.3.13 Betahistine Dihyrochloride Apr,1975 Betahistine Mesilate Tablet 6mg/12mg 20.02.09 Betamethasone 0.05% +Miconazole 2% Cream 12.03.08 Betamethasone Diprop 0.064%+ Salicylic acid-3% each ml lotion 14.05.2002 Betamethasone Diprop. 0.064mg+Gentamycin Sulphate Eq to Gentamycin 25.09.2002 1mg per ml spension Lotion Betamethasone Dipropionate 03.1979 to 7/1981 Betamethasone Dipropionate 6.43 mg + Betamethasone Sodium Phosphate Jul-84 2.63 mg each vial Betamethasone Dipropionate Ointment 0.5mg/g Sep, 1979 Betamethasone-17-benzoate Dec,1973 Beta-methyl Digoxin Dec,1977 Beta-methyl Digoxin Injection 0.1 mg Mar,1978 Beta-methyl Digoxin Liquid 0.6 mg Mar,1978 Beta-methyl Digoxin Tablet 0.1 mg & 0.05 mg Mar,1978 Betaxolol Hydrochloride ophthalmic 0.5 %W/V/ 5 ml May-92 Beverine Hydrochloride Tablets, 50mg Mar,1971 Bezafibrate Jan-88 Bicalutamide 07.03.2002 Bicalutamide Tablet 150 mg.(Additional Strength and Indication) 05.01.11 Biclotymol 1985 to 87 Biclotymol 0.150gm + Glyceryl Galacolate 0.200gm+Pholcodine May-86 0.100gm+Chlorphenaramine maleate 0.01gm per 100ml (for children) Biclotymol 0.198gm + Glyceryl Galacolate 0.200gm + Pholcodine 0.133gm+ May-86 Chlorphenaramine maleate 0.0133gm per 100ml Syrup (for adult) Bifonazole 28-11-97 Bifonazole cream/solution/powder [1gm of cream/powder contains 28-11-97 Bifonazole-0.01gm and 1ml of solution contains Bifanazole-0.01gm] Bimatoprost 300mg + Timolol (as maleate) 5mg/ml eye drops 07/05/2006 Bimatoprost (Opthalmic Solution) 08.01.2002 Bimatoprost 0.3mg + Timolol Maleate IP Eq. to Timolol 5.0mg eye drops 28.08.2006 Bimatoprost Eye Drps 0.1mg/ml 5/8/2010 Bimatoprost Ophthalmic Solution 0.01% w/v (Additional Strength) 09.10.10 Bimatoprost (Ophthalmic Sol.) 08.01.2002 Bimatoprost Opthalmic solution 0.03% 30.03.09 Bioceramic composite materials: a) Each glass vial contains; Hydroxyapatite 22.11.2002 100% granules b) each glass contains: hydroxyapatite 90% granules +β tri clacium phosphate 10% granules c) Each vial contains: Hydroxyapatite paste as 30% and 18% suspension Biperiden lactate Injection 5 mg Oct,1972 Biperlden Hydrochloride 1969 to 74 Biphenyl acetic acid gel -3.00%w/w 27-Apr-98 Bisoprolol Fumarate Feb-92 PHARMADOCX (Pharmaceutical Consultant) Ph 9896133556 Mail [email protected] (Contact for Setting up Pharma, Cosmetics, Medical Devices Plant, WHOGMP) LIST OF NEW DRUGS 1961 – MAY 2017 download from http://www.pharmadocx.com Page - 16

Bisoprolol Fumarate (2:1) 2.5mg/5mg+ Hydrochlorthiazide -6.25mg/6.25 mg 13.05.1999 Tablet Bivalirudin Injection (250mg/vial) 25-08-2005 Bleomycin Dec,1973 Bleomycin Injection Feb-87 Bleomycin Injection 5 mg Oct,1978 Bleomycin Oil Suspension injection. Sep-85 Blonanserin Tablet 2mg/4mg/8mg 24.04.12 Bortezomib 2mg/vial (additional pack size) 28.03.07 Bortezomib for injection (3.5mg/vial) 18-05-2005 Bortezomib for injection 3.5mg (Sub-cutaneous route of administration as an 28.01.14 alternate to intravenous route) (Additional route of administration) Bortezomib inj.3.5mg/vial (Additional Indication) 09.10.08 Bortezomib Injection (additional indication) 05-09-2007. Bosentan (as monohydrate) Tablets 62.5/125mg 23.6.2009 Boswellia Serrata 0.05gm/gm of Cream 28.03.08 Botulinum toxin type A 50 Units/Vial and 100 Units/Vial (Additional 2/6/2011 Indication) Botulinum Toxin.A 100 unit [Each Vial contains Clostridium botulinum toxin 13-Jan-94 type-A - Hemagglutinin Complex 100units. Human. Serum albumin-0.5mg Nacl-0.9mg] Brimonidine Tartrate 18.05.1999 Brimonidine Tartrate (2mg/1.5mg) + Timolol (as HCl) (5mg/5mg per) ml 25-11-2005 Brimonidine Tartrate Opthalmic solution 0.1% (with purite as preservation 07.03.08 0.005%) (additional strength) Brimonidine topical gel 0.33%(Add. Dosage form/indication) 18.6.15 Brimonidine Tartrate 18.05.99 Brin zolamide - 1.0% w/v Timolol maleate – 0.683% w/v Eq. to Timolol 0.5% 13.04.2016 w/v Ophthalmic suspension Brin zolamide 10mg Brimonidine Tartrate eq. to Brimonidine 2mg 06.01.17 Ophthalmic suspension Brinzolamide Ophthalmic Suspension 1%w/v 26.05.11 Bromfenac Sodium Eye Drop (0.09%) 14.08.08 Bromhexine Hydrochloride 3/1979 to 7/1981 Bromhexine Hydrochloride Elixir 4mg/5ml Sep, 1979 Bromhexine Hydrochloride Tablet 8 mg Sep, 1979 Bromocriptine Mesylate 1985 to 87 Bromocriptine Mesylate tab. 2.5 mg, 5 mg and 10 mg Jul-87 Bromocriptine Mesylate Tablet IP 0.8mg, (additional Indication) 22.10.2009 Broncho-Vaxom Feb, 2001 Broncospasmin elixir 10 mg/ 5ml Oct. 87 Broncospasmin injection 0.09 mg/ml Oct. 87 Broncospasmin respiratory solution 10 mg/ml oct.87 Broncospasmin tablet 20 mg Oct. 87 Bronopol (2-Bromo-2-nitroman-1, 3-diol) Broxyquinoline + Brobenzoxalidine May-63 Buclizine Hcl 25mg Tablet (Additional Indication) 16/01/2010 PHARMADOCX (Pharmaceutical Consultant) Ph 9896133556 Mail [email protected] (Contact for Setting up Pharma, Cosmetics, Medical Devices Plant, WHOGMP) LIST OF NEW DRUGS 1961 – MAY 2017 download from http://www.pharmadocx.com Page - 17

Buclizine HCl tablet (25mg) & Syrup 6mg/5ml 28/06/2006 Budesonide Feb-88 Budesonide + Formoterol (80/160mcg + 4.5mcg) Inhalational Powder 17.10.08 (Additional Indication) Budesonide IP 1mg/0.5mg + Formoterol Fumarate Dihydrate IP eq to 04.01.12 Formoterol Fumarate 20mcg/20mcg Respirator suspension. (Additional Indication) Budesonide IP 1mg/0.5mg + Formoterol Fumarate Dihydrate IP eq to 21.11.11 Formoterol Fumarate 20mcg/20mcg Respirator suspension. (Additional Strength) Bulaquine compound 21.12.99 Bumetanide 3/1979 to 7/1981 Bumetanide 0.5mg+Potassium Chloride 523 mg tablet Jan-83 Bumetianide Injection 0.25 mg/ml Aug, 1980 Bumetianide Tablet 1 mg Aug, 1980 Bupivacaine Hydrochloride Hyperbaric solution 10mg/ml Dec,1974 Bupivacine Hydrochloride Sep,1972 Buprenorphine 1985 to 87 Buprenorphine (0.4mg) + Naloxone (0.1mg) sublingual tablet 04/06/2005 Buprenorphine + Naloxone (2 mg/0.4mg + 0.5/0.1 mg) Tablets 02.12.08 Buprenorphine HCl eq.to. Buprenorphine 2mg + Naloxone Hcl eq.to. 01.08.2004 Naloxone 0.5mg sublingnal tablets Buprenorphine sublingual tablets 0.2 mg Dec.87 Buprenorphine Transdermal Patch Each Transdermal Patch having an area 03.09.09 of 6.25cm², 12.5cm², and 25cm²contains: Buprenorphine…5mg/10mg/20mg having release rate of 5mcg, 10mcg, 20mcg Buprenorphine per hour respectively(over a period of 7 days). Bupropion SR 10.04.2001 Buserelin Acetate (Lutenizing Hormone) Apr-86 Buserelin Acetate injection 1mg/ml (Additional Indication) 08.09.10 Buserlin Acetate 1985 to 87 Buspirone HCl Oct-90 Butafostane 10gm + Cyanocobalamine 0.005gm per 100ml Solution. 04.03.1998

Butalex Apr-91 Butaphosphan 100g + Methyl Hydroxybenzoate 1gm + Cyanocobalamin50 19.03.09 gm Oral powder (Veterinary Drug) Butarphenol tartrate 10mg/ml nasal spray 26.11.07 Butarphenol Tartarate 11.09.2002 Butenafine HCl 0mg + Betamethasone Dipropionate eq. to Betamethasone 15.03.2002 0.5mg cream Butenafine HCl cream 14.02.2001 Surgical dressing machines @ Rs. 1 lac. 98961- 33556 Cabazitaxel Injection 60mg / 1.5ml 16.11.11 Cabergoline 05.09.2002 PHARMADOCX (Pharmaceutical Consultant) Ph 9896133556 Mail [email protected] (Contact for Setting up Pharma, Cosmetics, Medical Devices Plant, WHOGMP) LIST OF NEW DRUGS 1961 – MAY 2017 download from http://www.pharmadocx.com Page - 18

Cabergoline 1 mg/2 mg/4 mg tablets 7/5/2004 Cabergoline 1mg tablet (additional strength) 06.03.07 Cabergoline 1mg Tablets (Additional indication) 01.10.08 Caffeine 100mg + Ergotamine tartrate 1mg + Analgin 250mg + Mar-76 Trifluperazine HCl 1mg Capsule Caffeine Citrate 20mg / ml (equivalent to 10mg of Caffeine base) Oral 18.7.2009 Solution (Addl. Dosage form) Caffeine(as Citrate) 10mg / ml Injection 16.05.09 Calamine 8% + Liquid Paraffin10% lotion 26.02.09 Calcipotriol 50mcg + Betamethasone 0.5mg Ointment 16.08.2005 Calcipotriol Gel 0.005% (additional dosage form) 3.10.2009 Calcitriol 0.25mcg + Calcium 200mg + Zinc 7.5mg Capsules 11.04.2008 Calcitriol + Calcium + Zinc (0.25mcg + 200mg + 7.5mg) Capsules 04.11.08 Calcitriol Inj. 19.03.1994 Calcitriol Soft Gelatine Caps 0.5mcg & 0.25mcg 27-Aug-93 Calcium (as Calcium Citrate Malate) + Colecalciferol (as Colecalciferol 30.09.08 Concentrate) + Folic Acid (250mg + 100IU + 50mcg) Tablets Calcium (as Calcium Citrate Malate) + Colecalciferol (as Colecalciferol 30.09.08 Concentrate) + Folic Acid (250mg + 100IU + 50mcg) Tablets Calcium acetate 435mg + Magnesium carbonate 235mg tablets 03/05/2010 Calcium and Magnesium 24% (Veterinary) injectable solution. 13.09.08 Calcium carbonate 600mg +Simethicone 80mg Chewable tablet 28/05/2010 Calcium citrate maleate Eq.to elemental calcium 250mg +Vitamin D3 IP 200 13.10.10 IU tablet Calcium Dobesilate caps -500mg 22-Sep-97 Calcium gluconate 50mg + Iso thipendyl HCl 4mg + Acetylsalicylic acid Jun-72 200mg + Caffine 30mg per dosage Calcium Hypochlorite 4gm Sachet (Calcium Hypochlorite 0.542% Other 23.11.08 Ingredients: 99.458%) Calcium Pidolate equivalent to Calcium 500mg + Vit-D3 250 IU powder for 23-10-2007 oral use Calcium Pidolate equivalent to Calcium 500mg + Vit-D3 250 IU 23-10-2007 Calcium Polycarbophil (500mg) Tablet 6/7/2005 Calender pack containing 21 days1. Levonorgestrel 0.05mg + Jun-81 Ethinyloestradiol 0.03mg Tablet 2. Levonorgestrel 0.075mg + Ethinyloestradiol 0.04mg Tablet 3. Levonorgestrel 0.125mg + Ethinyloestradiol 0.03mg Tablet and 7 inactive tablets extra Calf lung surfactant Intratracheal Suspension containing Phospholipids.... 17.02.11 35mg (containing 26 mg phosphatidylcholine of which 16mg is disaturated phosphatidylcholine) Proteins....0.65mg (including 0.26mg of surfactant associated proteins B) per ml Camostat Mesylate tablets 100mg 29.01.08 Canagliflozin Tablet 100/300mg 17.11.14 Candesartan 31.08.2000 Candesartan Cilexetil- 16mg+ Hydrochlorothiazide -12.5mg tablet 03.01.2002 Candur P. Parvovirus Jul-92 PHARMADOCX (Pharmaceutical Consultant) Ph 9896133556 Mail [email protected] (Contact for Setting up Pharma, Cosmetics, Medical Devices Plant, WHOGMP) LIST OF NEW DRUGS 1961 – MAY 2017 download from http://www.pharmadocx.com Page - 19

Canine Distemper Nov-86 Cape aloes 16mg + Podophyllin resin 4.2mg + Licorice powder 5.462 mg per Oct-72 Tablet Capecitabin Tablet (150mg/500mg). (for additional indication) 16-07-2007 Capecitabine 12.10.2000 Capecitabine 150/500mg Tablets (addl. Indication) 02.09.08 Captopril 1985 to 87 Captopril 25/50mg + HCTZ 15/25mg Jul-89 Captopril tablet 25/50 mg Oct-85 Carbadox 1975 to 76 Carbencillin Sodium 1969 to 74 Carbencillin Sodium Injection 1 g vial Aug,1973 Carbenoxolone sodium 1969 to 74 Carbenoxolone sodium Tablet 50 mg Jan,1974 Carbidopa (Anhydrous) 50mg + Levodopa-200mg C.R.tablet 12.10.1994 Carbocaine injection 2 % -20 mg Feb.87 Carbocisteine 1985 to 87 Carboinoxamine Maleate + Ammonium Chloride + Sodium Citrate (Each 5 24.12.08 ml contains: 2 mg + 120 mg + 120 mg) syrup Carboinoxamine Maleate + Ammonium Chloride + Sodium Citrate (Each 5 24.12.08 ml contains: 2 mg + 120 mg + 120 mg) syrup Carboplatin Mar-89 Carboprost Tromethamine 1985 to 87 Carboprost Tromethamine Sterile Solution 250 mcg/ml Mar, 1979 Carboquone 1985 to 87 Carboquone inj. 1 mg/ vial Aug-85 Carboquone tablet 0.25 mg/ 0.5 mg Aug-85 Carboxy Methyl Cellulose Sodium Lubricant Eye Drops 0.5% w/v (Unit dose 27.5.13 pack without preservative) Carenecaine 2% with Adrenaline & Carenecaine 4% with Adrenaline Feb-87 Injection Carfilzomib Sterile Lyophilized powder for Injection 60 mg/vial 21.03.1996 Carmustine (polifeprosan 20 with carmustine Implant (Wafer) 31.01.08 Carmustine for inj. 100 mg 10/6/2010 Caroverine cap. 20mg & Inj. 40mg/2ml 23/08/06 Carteolol Hcl opthalmic solution 2% w/v 9-Jul-96 Carteolol Hcl tabs 5mg, 9-Jul-96 Carvedilol 12.5/25mg tablet 16-Oct-98 Carvedilol Phosphate ER tablet 10/20/40/80mg 11.12.2009 Carvedilol Tablets 3.125/6.25/12.5/25mg (additional indication) 09.05.2009 Caspofungin Acetate injection (50mg/70mg per vial) 23-12-2005 Caspofungin acetate Injection (Addl. Indication) 31.01.09 Catalin (Sodium 1-hydroxy-5-oxo-5H-Pyrido(3.2-a) phenoxazine-3- Jan,1976 carboxylate) Cefaclor Apr-91 Cefadroxil Feb-89 Cefadroxil oral suspension 125/250 per 5 ml Feb-89 PHARMADOCX (Pharmaceutical Consultant) Ph 9896133556 Mail [email protected] (Contact for Setting up Pharma, Cosmetics, Medical Devices Plant, WHOGMP) LIST OF NEW DRUGS 1961 – MAY 2017 download from http://www.pharmadocx.com Page - 20

Cefadroxil (as monohydrate) 125mg + Clavulanic acid (as potassium) 31.25 25.07.08 per 5ml Syrup (Additional strength) Cefadroxil500mg+Clavulanicacid125mgtablet 30.08.2006 Cefadroxil 500mg/250/250+Clavulanic acid 125/62.5/62.5 mg film coated 30.08.2006 tablet. Dispersible tablet, dry syrup ( each 5 ml contains) Cefadroxil tablet/ capsule 500mg/ 1 gm Feb-89 Cefalexine + Bromhexine 16.09.1994 Cefataxime sodium 500 mg + sulbactum 250 / 500 mg inj. 24.12.2003 Cefazolin Sodium inj. 250 mg, 500 mg & 1 gm. per vial Sep-85 Cefdinir 10.10.2001 Cefdinir 250mg dispersible tablets & oral suspension 250mg/5ml 29.04.08 Cefdinir Dispersible tablet (125mg) 27-05-2004 Cefditeron (as pivoxil) 200mg tablet 3/3/2006 Cefditoren pivoxil 400mg tablets (Additional Strength) 11.03.08 Cefditorene pivoxil dispersible tablet (30mg/50mg) (New Dosage form for 08.06.07 children) Cefepem (as Hcl) 0.5/1gm/2gm + Amikacin (as sulphate) 11.08.2006 0.125/0.250/0.5gm Injection Cefepem (as Hcl) 0.5/1gm + Amikacin (as sulphate) 0.125/0.250gm Inj. 11/8/2006 Cefepime (250mg) + Tazobactam (31.25mg) Injection (addl. Strength) 30-07-2007. Cefepime (As Hcl) 500mg/1000mg + Tazobactum (as Sodium) 30/08/06 62.5mg/125mg per injection Cefepime (as hydrochloride) 2000/1000/500mg + Sulbactam (as sodium) 24.01.08 1000/500/250mg per vial of injection Cefepime Injection (New indication) 14-06-2007 Cefepime injection 500mg/1gm/2gm (For additional indication) 14.06.07 Cefepine HCl 30.10.2002 Cefetamet Pivoxil Hcl oral suspension 250mg/ml 16/02/2006 Cefetamet Pivoxil Suspension 250 mg/5ml 9/8/2004 Cefetemet-piroxil 14.11.2002 Cefixime Mar-93 Cefixime (50mg/100mg) + Clavulanic acid 31.125mg/62.5mg per ml dry 29/08/06 syrup & tablet Cefixime (SR) 400mg +Moxifloxacin (SR) 400 mg Tablets 08.08.11 Cefixime 100mg/200mg + Cloxacillin (as Sodium) 500mg/500mg + 31/08/06 Lactobacillus (45 /90 Million spore) tablet Cefixime 100mg/200mg + Cloxacillin 500mg/500mg tablets 12/2/2010 Cefixime 100mg/200mg + Ofloxacin 100mg/200mg Tablets 26/04/2010 Cefixime200mg+DicloxacillinER500mgTablets 22.09.2009 Cefixime 200mg + Cloxacillin 500mg (ER) + Lactobacillus 90 million Spore 14/11/06 tab. (additional strength) tablet Cefixime 200mg + Pot. Clavulanate (125mg) tablet 20/07/2006 Cefixime 200mg/100mg + Lactic acid bacillus 2.5 billion spores tablet & 07.01.08 dispersible tablet Cefixime capsules 100mg/200mg/400mg 24.02.93 Cefixime dispersible tablet 400mg (new dosage Form) 22/11/06 Cefixime SR 200mg/400mg + Ofloxacin SR 200mg/400mg Tablet 31.08.10 PHARMADOCX (Pharmaceutical Consultant) Ph 9896133556 Mail [email protected] (Contact for Setting up Pharma, Cosmetics, Medical Devices Plant, WHOGMP) LIST OF NEW DRUGS 1961 – MAY 2017 download from http://www.pharmadocx.com Page - 21

Cefixime Tablets 200mg & Cefixime Oral Suspension 100mg/5ml 22.2.13 Cefixime Trihydrate IP Eq. to Anhydrous Cefixime 100mg/200mg + 20.04.11 Ofloxacin IP 100mg/200mg Dispersible Tablet (Additional dosage form ) Cefoperazone + Sulbactum 16.03.2000 Cefoperazone 500/1000mg + Tazobactum 62.5/125mg Injection 4.11.2009 Cefoperazone sod. Eq. to Cefoperazone 1g/2g + Sulbactum Sod. Eq. to 12.06.2001 Sulbactum 0.5g/1g each vial Injection Cefoperazone sodium injection IM/IV 1.08.1993 Cefotaxim (As sodium) 0.5mg/1gm + Sulbactam (As sodium) 250mg/500mg 18.05.07 injection (for additional indication) Cefotaxime sodium 1985 to 87 Cefotaxime sodium + Sulbactam sodium for injection (Additional Indication) 24.06.08 Cefotaxime Sodium injection 0.25, 0.5, 1 and 2 gm./ vial Jun-87 Cefovecin( as sodium) 80mg/ ml Lyophilised powder for 03.10.09 injection (Veterinary) Cefpirome 26.09.1997 Cefpirome (as sulphate) 500/1000mg/2000mg + Sulbactam (as sodium) 24.01.08 250mg/500mg/1000mg powder for injection Cefpirome injection 0.25g/0.5g/1.0g/2gm per vial 26-Sep-97 Cefpodoxime (as Proxetil) (100mg/200mg) + Clavulanic acid (62.5/125mg) 30-07-2007 tablet. Cefpodoxime 100/200mg + Dicloxacillin ER 500/500mg Tablet 08/06/2010 Cefpodoxime 100mg + Clavulanate Potassium 62.5 mg Dispersible 31.01.2008 Tablet/Dry Syrup Cefpodoxime 100mg + Ofloxacin 100mg Dispersible Tablet (Additional 29.11.2012 Dosage form) Cefpodoxime 200/100mg + Clavulanate Potassium 125/62.5mg Tablets 30.07.2007 Cefpodoxime 50mg + Clavulanic acid 31.25mg dispersible tablet & dry 31.01.08 syrup (Additional strength) Cefpodoxime IP 100mg/100mg/200mg/200mg + Ofloxacin IP 16.04.11 100mg/200mg/100mg/200mg Tablets Cefpodoxime Proxetil 14.03.1996 Cefpodoxime Proxetil Sept. 1997 Cefpodoxime Proxetil tab/syrup [Each tab contains, Cefpodoxime Froxetil- 19-Sep-97 100mg, Each 5ml suspension contains Cefpodoxime Proxetil-40mg] Cefprozil 10.01.2003 Cefprozil 250mg/500mg + Clav. Acid-62.5mg /125mg. Tab 12.11.07 Cefprozil Dispersible Tablet (125 mg/ 250 mg) 22-06-2004 Cefprozil Powder for oral suspension (125mg/5ml) 06.01.2006 Ceftaroline Fosamil Injection 600 mg/Vial 09.05.2016 Ceftazidime 250mg + Tazobactam 31.25mg Injection 31.07.2007 Ceftazidime 500mg + Tobramycin 60mg per vial (Injection) 08.01.08 Ceftazidime 500mg/1000mg + Sulbactam (As Sodium) 250mg/500mg For 08.06.07 injection Ceftazidime + Sulbactam (500/1000mg + 250/500mg) Injection 24.12.08 Ceftazidime + Tobramycin injection (1gm + 120mg) (Additional Strength) 05.08.08 Ceftazidime 500mg + Tobramycin 60mg per injection 08.01.2008 PHARMADOCX (Pharmaceutical Consultant) Ph 9896133556 Mail [email protected] (Contact for Setting up Pharma, Cosmetics, Medical Devices Plant, WHOGMP) LIST OF NEW DRUGS 1961 – MAY 2017 download from http://www.pharmadocx.com Page - 22

Ceftazidime 500mg /1000mg + Tazobactum (as sodium) 62.5mg/125mg per 30/08/06 vial for injection Ceftazidime 500mg + Tobramycin 60mg per vial (Injection) 08.01.08 Ceftazidime 500mg/1000mg + Sulbactam (As Sodium) 250mg/500mg For 08.06.07 injection Ceftazidime Pentahydrate Jun-88 Ceftazidine (2gm) + Sulbactam (1gm) Injection (addl. strength for additional 9/6/2007 indication) Ceftibuten (Finished formulation) Nov, 1996 Ceftibuten Capsule/Suspension [Each capsules contains ceftibuten 19-Nov-96 200mg/400mg Each 5ml suspension contains ceftibuten 90mg/180mg ] Ceftiofur Crystalline free acid Suspension equi to Ceftiofur ---- 200 26.09.08 mg(veterinary) Ceftiofur HCl Suspension (as HCl salt) ----125mg (veterinary) 26.09.08 Ceftiofur HCl Suspension(as HCl salt) ----500mg (veterinary) 26.09.08 Ceftiofur Sodium & Ceftiofur HCl 08.10.2002 Ceftizoxime Sod. Sterile May-90 Ceftriaxone – 2gm+ Tazobactum 250mg for injection 21.11.07 Ceftriaxone (as sodium) (500mg/1000mg) + Sulbactam (as sodium) 12/08/2005 (250mg/500mg) powder for injection Ceftriaxone (as sodium) (500mg/100mg) + Tazobactum (12.5mg/62.5mg) 21.07.2005 injection Ceftriaxone (As sodium) 125mg/250mg + Sulbactam (As sodium) 01.03.07 62.5mg/125mg For injection (additional strength) injection Ceftriaxone (as sodium) 250mg + Tazobactam 31.25 mg for injection (addl. 07/05/2006 Strength) Ceftriaxone + Sulbactam injection (Additional Indication) 18.08.08 Ceftriaxone 0.125/0.25/0.5/1g + Tazobactam 15.625/31.25/62.5/125mg 21.07.2005 injection Ceftriaxone 2gm + Sulbactam 1gm injection (Additional Indication) 18.08.08 Ceftriaxone –2gm+ Tazobactum 250mg for injection 21.11.07 Ceftriaxone sodium Apr-88 Ceftriaxone Sodium eq. to Ceftriaxone Sodium 1000mg/2000mg + Sulbactam 21.09.11 Sodium eq. Sulbactam 500mg/1000mg.injection Cefuroxime Jun-88 Cefuroxime 250mg + Clavulanic Acid 125mg FC tablet/Dry syrup 10.05.2007 Cefuroxime Axetil May-90 Cefuroxime Axetil (250mg) + Clavulanic Acid (125mg) Tablet 27-09-2007 Cefuroxime Axetil ER tablets (500 mg/1000mg) 6/10/2004 Cefuroxime injection 250 mg/ 500 mg / 1 gm. per vial Jun-88 Cefuroxime Sodium 250mg intramammay infusion for Veterinary (PFS) (New 13/12/2011 dosage form) Cefuroxime Sodium 750/1500mg + Sulbactam Sodium 375/750mg Injection 07/06/2010 Cefuroxime-125/250/500mg +Clavulanic Acid-31.25/62.5/125mg film coated 10/05/2007 tablet Celecoxib 22.02.2000 Celecoxib 100/200mg +Diacerein 50/50mg 19/07/10 PHARMADOCX (Pharmaceutical Consultant) Ph 9896133556 Mail [email protected] (Contact for Setting up Pharma, Cosmetics, Medical Devices Plant, WHOGMP) LIST OF NEW DRUGS 1961 – MAY 2017 download from http://www.pharmadocx.com Page - 23

Celecoxib Injection (100 mg/ml) 28-10-2004 Celecoxib Mouth Dissolving Tablet 50/100/200 mg 25/02/2010 Celiprolol Hydrochloride tablets100mg/200mg/400mg 1-Dec-94 Centbucidine 1985 to 87 Centbucidine (0.5%) + Feracrylem (3%) 11/01/2005 Centbucridine inj. 0.5 % Aug-85 Centbutindole Dec.86 Centbutindole tablets 1.5 mg Feb.87 Centchroman Tab. 30mg Nov-90 Centpropazine caps -20mg Aud-1996 Cephacetril concentrated infusion 235 mg May-92 Cephacetril Sodium May-92 Cephalaxin anhydrous 250mg + Carbocisteine 150mg per 5 ml suspension 30.10.1994 Cephalaxin monohydrate eq. to cephalexin 500mg/250mg + Carbocisteine 30.10.1994 150mg/150mg Capsules Cephalexin 1969 to 74 Cephalexin IP (as monohydrate) 200mg + Kanamycin IP (as monosulphate) 07.03.12 100,000 IU Suspension per 10 gm Intramammary Suspension Cephalexin monohydrate eq. to cephalaxin 125mg/250mg+ Bromhexine Hcl 27.01.1995 eq. to Bromhexine 2mg/4mg per 5ml of reconstituted suspension Cephalexin tablet 1gm Oct-88 Cephalexin-250mg/500mg + Bromhexine (as HCl) 4MG/8MG Capsules 16.09.1994 Cephalothin Sodium Dec,1980 Cephradine 1975 to 76 Cephradine Capsule 250/500 mg Mar,1976 Cephradine Injection 250mg/500mg/1g/vial Mar,1976 Cephradine Suspension 250/5ml Mar, 1976 Cerebrolysin solution for injection. Each ml contains: Porcine brain derived 25.07.2014 peptide preparation (Cerebrolysine concentrate) 215.2mg Cerebroprotein Hydrolysate injection (Lyophilised) …..1050mg / 2100mg 04.11.10 (approx) equivalent to nitrogen….30mg / 60mg respectively. Ceritinib 150 mg Hard Gelatin Capsules 13.01.2015 Cerivastatin 11.05.2000 Cetirizine 1-Jun-93 Cetirizine Dihydrochloride 5mg (Immediate release) + Pseudoephedrine HCl 09.09.1997 120mg (SR) tablet Cetirizine Dihydrochloride tablets5/10/20 mg 25-Jun-93 Cetirizine HCl drops (10mg/ml) 8/11/2005 Cetrimide15% w/v + Chlorhexidine Gluconate 7.5% v/v + Isopropyl Alcohol 09.02.09 7.5% v/v Concentrate Solution Cetrizine + pseudoephedrine 09.09.1997 Cetrizine10mg+Ambroxol75mgSRTablet 13.04.2009 Cetrizine5/10mg+Ambroxol30mgper 5mlsyrup 23.02.09 Cetrizine 5/10mg + Ambroxol 30mg per 5ml syrup 23.02.09 Cetrorelix Acetate injection 0.25mg/0.5ml in 0.5 ml prefilled syringe. 26.08.2015 (Additional pack size) Chandonium Iodide injection 2mg / ml Mar-94 PHARMADOCX (Pharmaceutical Consultant) Ph 9896133556 Mail [email protected] (Contact for Setting up Pharma, Cosmetics, Medical Devices Plant, WHOGMP) LIST OF NEW DRUGS 1961 – MAY 2017 download from http://www.pharmadocx.com Page - 24

Chelated Amino acid based mineral Jul-93 Chemically Modified Sodium Hyaluronate and Caboxymethylcellulose 11/2/2010 Absorbable Adhesion Barrier. Chenodeoxycholic acid 1985 to 87 Chloramphenicol Oct,1972 Chlordentoin 1% + Benzyl bromide chloride 0.05% per 100gm cream Sep-70 Chlordiazepoxide 5mg + Clidimium bromide 2.5mg per tablet Jul-73 Chlorhexidine gluconate IP 1%w/v + Ethyl Alcohol IP 61%w/v Solution 29.12.2010 Chlorohexidine Gluconate Gel 0.2% 30.12.2009 Chlorohexidine Gluconate Mouth wash 0.1% 30.12.2009 Chloroquine Phosphate eye drops (0.3mg/ml) 13-07-2005 Chlorpheniramine Maleate IP 2mg + Dextromethorphan Hydrobromide IP Approved for 10mg + Phenylephrine Hydrochloride IP 5mg Softgel Capsule more than 4 years Chlorpheniramine maleate 4 mg Codeine phosphate 10 mg Each 5 ml 21.08.15 conatins: Chlorpheniramine maleate USP Sustained Release Tablet 8 mg Apr,1978 Chlorphenoxamine Embonate Syrup 17.5mg/5ml Mar, 1979 Chlorphenoxamine HCl 12mg + Caffeine 30mg Tablet Jul-72 Chlorphenoxamine Hydrochloride Tablets 12 mg Mar,1971 Chlorpromazine 50mg + Trifluroperazine 5mg + Trihexyphenidyl 2mg tablet May-79 Chlorthalidone Tablet 6.25mg 03.10.09 Cholestyramine Powder for oral suspension (4gm/sachet) 30/03/2006 Choline Fenofibrate DR Capsule 45mg/135mg & DR Tablet 45mg/135mg. 01.11.12 Choline Salicylate solution 8.7% Nov,1978 Ciclesonide 100mg/200mg + Formoterol 6mcg/6mcg + Tiotropium 31.01.2008 9mcg/9mcg Rotacaps Ciclesonide 160mcg/320mcg + Formoterol Fumarate (12mcg) (Dry powder 27.02.07 inhaler additional strength) Ciclesonide 160mcg/320mcg cap. for inhalation 28/11/06 Ciclesonide 160mcg/320mcg/Formoterol 12mcg + Tiotropium 18mcg Dry 31.01.08 powder inhaler Ciclesonide 200mcg + Formoterol 6mcg +Tiotropium 9mcg MDI 13.04.2009 Ciclesonide Inhaler 80/160mcg per actuation 2/6/2006 Ciclesonide Nasal Spray 50mcg/spray 08.06.07 Ciclesonide rotacaps (200/400mcg) 19/05/2006 Ciclesonide 200mcg + Formoterol 6mcg + Tiotropium 9mcg MDI 13.04.2009 Ciclopirox Olamine solution/ cream 10 mg/ ml Oct-85 Ciclopiroxalmine 1985 to 87 Ciclosonide 80mcg/160mcg/200mcg/400mcg + Formoterol 29.08.2006 4.5mcg/4.5mcg/6mcg/6mcg Inhaler & Rotacaps Ciclosonide160 mcg/320 mcg + Formoterol fumarate 12mcg (dry powder 27.02.2007 Inhaler) Ciclsonide 100mcg/ 200mcg/400mcg + Formotorol Fumarate 6mg rotacaps 29/08/06 Ciclsonide 80mcg/160mcg + Formotorol 4.5mg inhaler 29/08/06 Cifixime 200mg + Erdosteine 300mg Capsules 21.03.07 Cilnidipine Tabs. 5mg, 10mg 21.03.07 Cilostazol 23-01-2003 PHARMADOCX (Pharmaceutical Consultant) Ph 9896133556 Mail [email protected] (Contact for Setting up Pharma, Cosmetics, Medical Devices Plant, WHOGMP) LIST OF NEW DRUGS 1961 – MAY 2017 download from http://www.pharmadocx.com Page - 25

Cilostazole E.R Tablet (100mg/200mg) 30-10-2007 Cimetidine 03.1979 to 7/1981 Cimetidine inj. 100 mg/ ml Sep-85 Cimetidine Syrup 200mg/5ml May,1980 Cimetidine Tablet/Capsule 200 mg May,1980 Cimetropium Bromide tablet 50mg 31.01.08 Cinacalet (as HCl) Tablet 30/60/90mg 14.01.09 Cinitapride (as hydrogen tartrate) 1mg tablet 04.01.08 Cinitapride (ER) 3mg + Omeprazole (EC) 20mg Capsules 05/12/2010 Cinitapride Hydrogen Tartrate ER Tablet 3mg 26.11.2009 Cinnarazine 1985 to 87 Cinnarazine 20mg + Domperidone 15mg tablet 01/02/1992 Cinnarizine 20mg + Dimenhydrinate 40mg tablets 02/03/2010 Cinnarizine tablet 25 mg/15 mg Aug-85 Ciprofibrate tabs -100mg 1-May-98 Ciprofloxacin 0.3%w/v+ Dexomethasone 0.1% w/v eye drops 17.09.1999 Ciprofloxacin 1g SR Aug, 2001 Ciprofloxacin 200mg/100 ml + Ornidazole 500mg/100 ml IV infusion as 20.04.207 combipack Ciprofloxacin HCl eq. to Ciprofloxacin 500mg + Ornidazole 500mg film 03.02.2003 coated tablet Ciprofloxacin Hydrochloride eye drops 0.3% w/v Feb-91 Ciprofloxacin Hydrochloride Monohydrate infusion 100 mg/ 50 ml & 200 May-89 mg/100 ml Ciprofloxacin Hydrochloride Monohydrate tab 250/ 500/ 700 mg of May-89 Cisapride Nov-92 Cisapride + M.P.S. Chewable tablet 03.05.1993 Cisatracurium Besylate Bulk & 2mg/ml injection 14.03.16 Cisplatin Apr-82 Cisplatin injection 10 mg/ 50 mg per vial Apr-82 Citalopram Hydrobromide 03.10.2001 Citicholine 500mg + Piracetam 400mg Tablets 16/03/2010 Citicholine Syrup 750mg/5ml 04.01.08 Citicholine Tablet 500 mg & Injection 250 mg/ml 20-08-2004 Citicholine(as Sod.)-200mg/500mg/750mg granules per sachet. 26.11.07 Citicoline 500mg +Piracetam 400mg per 5 ml syrup (additonal dosage) 11.10.10 Citicoline Chewable tablet (500mg) 18.08.08 Citicoline CR Tab 1000mg 16.09.08 Citicoline Oral Drops 30.09.08 Citicoline tablet 200mg (additional strength) 25.05.07 Citicoline Troches 200/500mg 31.10.08 Citicoline (750mg) tablet (additional strength), syrup 500mg/5ml (new 10.04.07 dosage Form) (not For children) Cladribine 9/9/2003 Clarithromycin tablets -250mg/500mg 22-Mar-95 Clavulanic Acid 1985 to 87

Clavulanic acid (As potassium salt) 200mg + Amoxycillin (As sodium 07.08.1990 salt) 1gm injection Clebopride (as Malate) (1)Tablets...0.5 mg Ph. Eur. (2.) Syrup...0.1 mg / ml 04.11.10 Ph. Eur. (3.) Injection...1 mg / 2mlPh. Eur. Clemastine Apr, 1979 Clenbuterol Hydrochloride Solution for injection 30mcg/ml 01.07.2012 Clestabol 500mg+Neomycin Sulphate 500mg per 100gm cream Jun-85 Clidinium bromide 2.5mg + Diazepam 2.5mg + Analgin 500mg tablet Sep-79 Clindamycin Oct,1981 Clindamycin 1% + Benzoyl peroxide 5% cream 10.9.2004 Clindamycin 1% + Isotretinoin 0.05% gel 08.03.07 Clindamycin 1%+Tretinoin 0.025% Topical gel 18.11.1996 Clindamycin Gel 1% Oct-92 Clindamycin Palmitate Hcl For Oral Solution 75mg/5ml. 14.12.2010 Clindamycin Phosphate eq. to Clindamycin 1% w/w + Hydrous Benzoyl 30.08.11 Peroxide eq. to Anhydrous Benzoyl peroxide 2.5% w/w topical gel Clindamycin Phosphate Inj. 150mg/ml & Clindamycin HCl Capsules 02.05.2009 150mg/300mg (additional indication) Clinidium Bromide 2.5 mg + chlordiazepoxide 5mg Jul-73 Clinidium Bromide 2.5 mg + diazepam 2.5mg + Analgin 500 mg Sep-79 Clobazam 11-Nov-97 Clobazam tablets 5mg/10mg/20mg 11-Nov-97 Clobestasol Propionate (0.05%) + Calcipotriol Ointment (0.005%) Ointment. 20/07/2006 Clobetasol Propionate 1985 to 87 Clobetasol Propionate 0.05 % w/w + Ammonium lactate 12 % w/w gel 07.08.1996 Clobetasone -17- butyrate cream/ointment 0.05% Sep-86 Clobetasone butyrate 1985 to 87 Clobetasone butyrate creams/ointments 0.05 % Dec.86 Clomiphene Citrate 1969 to 74 Clomiphene Citrate B.P. Tablet, 50mg Feb,1974 Clomipramine HCL Feb-92 Clomipramine HCl capsule 50 mg Feb-92 Clomipramine HCl tablets HCL 10 mg/ 25 mg/ 50 mg Feb-92 Clonazepam 25.01.1995 Clonazepam IR 0.5mg/0.5mg+ Paroxetine CR 12.5/25mg Capsule 07/08/2010 Clonazepam IR 0.5mg/0.5mg+ Paroxetine CR 12.5/25mg 8/7/2010 Clonazepam tablets 0.5mg/1.0mg/2.0mg 25-Jan-95 Clonidine HCL 1975 to 76 Clonidine HCl 0.1mg/0.2mg + Chlorthalidone 15mg/15mg Tablet Dec-77 Clonidine HCl 100mcg + HCTZ 20mg Tablet/Capsule Jul-75 Clonidine Hcl Injection 150mcg/ml Jun, 1976 Clonidine Hcl Tablet /Capsule 100 mcg Jul,1975 Clonidine Hcl Tablet 150 mcg Jul,1975 Clopidogrel Bisulphate eq. to Clopidogrel 75mg Aspirin 100mg tablets 04.08.2004 (additional strength) Clopamide 03.1979 to 07.1981 PHARMADOCX (Pharmaceutical Consultant) Ph 9896133556 Mail [email protected] (Contact for Setting up Pharma, Cosmetics, Medical Devices Plant, WHOGMP) LIST OF NEW DRUGS 1961 – MAY 2017 download from http://www.pharmadocx.com Page - 27

Clopamide Tablet 20 mg Jul, 1979 Clopedogrel 75mg + Aspirin 75 mg/150 mg tablet 26.11.2006 Clopedogrel bisulphate eq. to Clopidogrel 75mg + Aspirin IP (as enteric 27.11.2002 coated tablets) 5mg/ 150mg capsule Clopidal Jan,1972 Clopidogrel 300mg Tablet (addl. Strength) 02.09.08 Clopidogrel Tablet 22.02.2001 Clorazimine 1969 to 74 Closantel 15% oral solution 3-Oct-94 Closantel Injection100mg/ ml (forverterinary use.) 05.02.09 Closantel veterinary drug Oct-94 Clostebol acetate 1985 to 87 Clostimethate Sodium of 1,00,000 IU Injection 31.01.08 Clostridium botulinum toxin type A-Hemagglutinin complex 100 units Human 13.01.1994 Serum Albumium 0.5mg+ NaCl 0.9 mg Clostridium Botulinum Toxin Type-A Injection 100Units/Vial (Additional 3/6/2011 Indication) Clostridium botulinum type A toxin treatment Hemagglutinin complex 22.04.2008 Clostridium Botulinum type-A toxin haemagglutinin complex (Additional 22.04.08 Indication) Clotrimazole 1975 to 76 Clotrimazole (10mg) + Methyl-prednisolone aceponate 1mg/gm of cream. 12-7-2007. Clotrimazole 1gm/100gm cream Jun,1975 Clotrimazole 1gm/100ml Solution Jun,1975 Clotrimazole soft gel pessary 100 mg 17-Feb-98 Clotrimazole Vaginal Tablets 0.1gm Jun,1975 Clottable protein 75-115mg + Trace of Fibronogen 70-110mg + Plasma 30.05.2000 Fibronectin 2- 9mg + Factor XIII 10-50 U2 + Plasminogen 40-120mcg + Aprotinin solution 300 KIU/ml3 per ml of reonstituted tissueol solution Cloxacillin + Colistine 04.03.1998 Cloxacillin benzathine intra-mammary infusion 500 mg Oct.87 Cloxacillin sodium 200mg + Colistine sulphate 50000 units per 10 ml 04.03.1998 Intrammamary infusion (vet) Clozapine 07.03.1995 Clozapine Tablet 200mg (Addl. Strength) 19.08.2009 Clozapine tablets 25mg/100mg 7-Mar-95 Cobalt glutamate + Copper Glycinate Aug-61 Colesevelam Hydrochloride Tablets 625mg & Sachets for oral suspension 29.08.2012 3.75gm/1.875gm. Colfosceril Palmitate dec. 1993 Colfosceril Palmitate injection 108mg per vial 1-Dec-93 Coligen Jun-90 Coligen veterinary drug Jun-90 Colistimethate Sodium powder for solution for inhalation 500000IU/ 28.7.2009 1000000IU/ 2000000IU Colistimethate Sodium powder for solution for injection/infusion 500000IU 20.7.2009 and 2000000IU (additional Strength) PHARMADOCX (Pharmaceutical Consultant) Ph 9896133556 Mail [email protected] (Contact for Setting up Pharma, Cosmetics, Medical Devices Plant, WHOGMP) LIST OF NEW DRUGS 1961 – MAY 2017 download from http://www.pharmadocx.com Page - 28

Colistin Sulphate (300000 IU) 0.154gm + Pectin0.196gm + Kaolin 2.625gm Sep-69 per 30ml suspension Collagen with gentamicin implant 06.05.1998 Collagenase 5-May-94 Collagenase Ointment 250 units 5-May-94 Comb kit of two capsule of Azaranari 150 mg each + 1 tablet of Ritonavir 02.04.07 100mg Comb pack of 1 bottle of ciprofloxacin Injection (200mg/100ml) & 1 bottle of 20.04.07 Ornidazole injection 500mg/100ml) Combi kit of 5 tablets each I) Pseudoephedrine HCl 120mg ER+Cetirizine 01.08.2004 HCl 5.0mg (orange tablet) & II) Pseudoephedrine Hcl ER 120mg +Tripolidine2.5mg (Blue tablets) Combi pack of 1 tablet of Residronate sodium (35mg) + 6 tablet of calcium 01.05.07 carbonate equivalent to 500mg calcium each Combikit of 2 tablet of Stavudine (40mg) + Lamivudine (150mg) each & 1 06/07/2005 tablet of Efavirenz (600mg) Combikit 4 tablets of Alendronate sodium trihydrate equivalent to Alendronic 23.01.08 acid 70mg each + 24 tablets of Calcium carbonate 1250mg (equivalent to 500mg Calcium) + cholecalciferol-250IU Combikit 4 tablets of Alendronate sodium trihydrate equivalent to Alendronic 23.01.08 acid 70mg each + 24 tablets of Calcium carbonate 1250mg (equivalent to 500mg Calcium) + cholecalciferol-250IU Combikit of 10 ml of Oxymetazoline 0.05% & 15 ml of NaCl solution 2% 12.10.2001 Combikit of one film coated tablet of Risendronate Sodium 35mg & six film 05.07.2007 coated tablet of Calcium Carbonate 1250 mg (Eq. to 500mg Cl) Combikit of 1 capsule of Glucosamine Sulphate 500mg & Chondroitin 30.09.2002 Sulphate capsule 400mg Combikit of 1 tablet of Efavirenz 600mg , 1 tablet of Lamivudine 300mg & 20.09.2004 1 capsule of Didavosine (250 mg/400mg) (delayed Release) Combikit of 1 tablet of Pioglitazone HCl eq. to Pioglitazone-15mg & 2 Tablet 18.02.2002 of Metformin HCl 500mg Combikit of 2 enteric coated tablet of Pantoprazole 40mg, 2 film coated tablet 15.10.1999 of Amoxycillin 750mg & 2 film coated tablet of Tinidazole 500mg Combikit of 2 tablet of Lamivudine (150mg) + Zidovudine (300mg) each 07.06.2005 and 1 tablet of Egavirenz (600mg) Combikit of 2 tablets of Stavudine 30mg/40mg + Lamuvidine 150mg/150mg 22.11.2004 & 1 tablets of Nevirapine 200mg. Combikit of 2 tablets of Stavudine 40mg + Lamuvidine 150mg & 1 tablets of 07.06.2005 Egavirenz (600mg) Combikit of Tamsulosin HCl 0.4mg M.R capsule (10 no.) & Dutasteride Soft 19/01/2006 Gelatin Capsule 0.5mg (10no.) Combination of L Oxethazaine + Aluminium hydroxide + Magnesium Jun-66 Hydroxide Combination of Lactic Acid Bacteria (VSL#3) Sachet 8.4.13 Combipack (Triple chambered bag) of amino acid + electrolytes; Dextrose 01.11.2003 15% / 30% IV fat emulsion Combipack of 1 vial of Ifosfamide 1gm & Mesna 100mg/ml 30.07.1999

Combipack containing : 1 capsule of Omeprazole 20mg cap, 1 tablet of 09.09.1997 Amoxycillin 750mg & 1 tablet of Tinidazole 500 mg Combipack containing: 1capsule of Omeprazole 20mg cap, 1 tablet of 09.09.1997 Clarithromycin 250mg tab & 1 tablet of Tinidazole 500mg tab II. Omeprazole 20mg cap + Amoxycillin 750mg tab + Tinidazole 500 mg Combipack of 2 capsule of Omeprazole 20mg, 2 Tablets of Clarithromycin 01.10.2002 500mg & 4 capsule of Amoxycillin 500mg. Combipack of 21 tablet of Quinine sulphate 600mg each & 8 capsule of 08/10/2006 Doxycycline (as Hcl) 100mg each Combipack of 1 bottle of ciprofloxacin Injection (200mg/100ml) & 1 bottle of 20.04.07 Ornidazole injection 500mg/100ml) Combipack of 1 tab of Estradiol 2mg & 1 tab of Estradiol 2mg+ 01.02.2000 Dydrogestrone 10mg Combipack of 1 tablet of Fluconazole 150mg, 1 film coated tablet of 07.06.1999 Azithormycin dihydrate eq. to Azithromycin 1gm & 2 fillm caoted tablet of Secnidazole 1gm Combipack of 1 tablet of Gestodene 60mcg + Ethinyl estradiol 15mcg & 24 17.02.2000 tablets + 4 dummy tablets per pack Combipack of 12 Artesunate –50mg tablets & 6 Mefloquin-250mg tablets 12.6.07 Combipack of 12 tablet of Artesunate (50mg) each + 3 tablet of each 01-08-2007. containing Sulfadoxine (500mg) + Pyrmethamine (25mg) Tablet. (Addl. Strength) Combipack of 21 active tablet contains Noretihsterone acetate 1mg + Ethinyl Oct-75 oestradioal 30mcg & 7 Haematinic tablets contain Ferrous Fumarate 60mg Combipack of 21 tablet of Quinin sulphate 600mg each & 8 capsule of 10.08.2006 Doxycycline (as Hcl) 100mg each) Combipack of 21 tablets of FDC of Ethinylestradiol IP 0.03 mg + 13.10.10 Levonorgestrel IP 0.15 mg and 7 tablets of Ferrous Fumarate IP 75mg (Eq. to 24.375 mg of Ferrous iron) combipack of 22 tablets of Lynestrenol 1mg + Ethynyloestradiol 50mcg & 6 Jun-80 placebo tablets of Ferrous Fumerate 60mg combipack of 28 Tablets of Cyproteron acetate 2mg & 7 Tablets of Ethinyl 20.02.2003 Estradiol 0.035mg. Combipack of 7 blue tab of Desogestrel 0.025mg+ethinyl estradiol 0.04mg & 29.05.2000 15 white tab of Desogestrel 0.125mg+ethiyl estradiol 0.03mg Combipack of artesunate tablet and FDC Tablet of sulphadoxine + 15.7.2009 pyrimethamine Composition: A. combipack of 1 stip of 3 tablets ofartesunate 25 mg and 1 strip of 1 tablet of sulphadoxine 125mg + pyrimethamine 6.25mg B. combipack of 1 stip of 3 tablets of artesunate 50 mg and 1 strip of 1 tablet of sulphadoxine 500mg+ pyrimethamine 25 mg C. Combipack of 1 stip of 3 tablets ofartesunate 100 mg and 1 strip of 2 tablet of sulphadoxine 500mg+ pyrimethamine 25 mg D. combipack of 1 stip of 3 tablets ofartesunate 200 mg and 1 strip of 3 tablet of sulphadoxine 500mg+ pyrimethamine 25 mg. Combipack of Desogestral and Ethinyl Estradiol 29.05.2000

Combipack of Estradiol + Dydrogesterone : 1. Each pack contains 28 tablets 14.11.2006 of Estradiol 1 mg + Dydrogesterone 5 mg. 2. Each combipack contains 28 tablet: each of 14 tablets contains estradiol 1mg & other each of 14 tablets contain estradiol 1 mg + Dydrogesterone 10 mg. Combipack of FDC Gestodene 60mg + Ethinyl Estradiol 0.15mg & 4 Dummy 18.07.2000 Tablets Combipack of one bottle of (1000ml) contains: Amino acid 7% 28.08.2000 w/v+glucose 10% with electroytes injectable filled upto 750ml & one bottle fat emulsion 20% w/v in 250ml combipack of one cap. Of aprepitant .125mg & two cap. Of aprepitant 80mg 10/10/2006 each (combipack) Combipack of two tablet of chloroquine phosphate (250mg) each + 14 tablet 10-10-2007. of Proguanil HCl (100mg) each Combipack of artesunate tablet and FDC Tablet of sulphadoxine + 15.7.2009 pyrimethamine Composition: A. combipack of 1 stip of 3 tablets ofartesunate 25 mg and 1 strip of 1 tablet of sulphadoxine 125mg+ pyrimethamine 6.25 mg B. combipack of 1 stip of 3 tablets ofartesunate 50 mg and 1 strip of 1 tablet of sulphadoxine 500mg+ pyrimethamine 25 mg C. combipack of 1 stip of 3 tablets ofartesunate 100 mg and 1 strip of 2 tablet of sulphadoxine 500mg+ pyrimethamine 25 mg D.combipack of 1 stip of 3 tablets ofartesunate 200 mg and 1 strip of 3 tablet of sulphadoxine 500mg+ pyrimethamine 25 mg. Combipack 04.06.14 Each strip contains- A. Sitagliptin Phosphate film coated tablets Each film coated tablet contains: sitagliptin Phosphate monohydrate Eq to 100 mg of sitagliptin B. Metformin Hydrochloride Sustained release Tablet IP Each uncoated tablet contains 1000 mg of metformin Hydrochloride IP (additional strength) Comipack of Ibandronic acid 150mg + Calcium carbonate 500mg + Calcitriol 05.03.2009 0.25mg + Zinc sulphate 20mg Complex 15 cream 10.01.1997 Conivaptan Hydrochloride Injection 20mg/4ml. 21.08.2012 Conjugated Estrogens 0.3/0.45mg + Medroxy Progesterone Acetate 1.5/1.5mg 26.10.2004 Tablets Conjugated Estrogens 0.625mg/0.625mg + MPA 2.5mg/5mg sugar coated 13.09.1999 tablet Coseal Surgical Sealent 2/4/8ml (Addl. Indication) 6/2/2010 Coumaphos 3% + Propoxur 2% + Sulphanilamide 5% powder for vet 23.04.2002 Cralanthamine Hydrobromide Tablet & Injection Dec,1978 Creatine Phospate 14.01.1997 Creatine Phospate Inj [Each vial contains creatine phospate 500mg/1g] 20-Jan-97 Crizotinib hard gelatin Capsules 200mg/250mg 16.12.11 Cross linked Hyaluronic Acid 24mg + Lidocaine 3mg Pre-filled syrings 28/05/2010 Cross linked Hyaluronic Acid 24mg + Lidocaine 3mg Pre-filled syrings 28/05/2010 Cumophos (Vet.) Jul-93

Cyanocobalamin 15mcg+Chromium Picolinate USP 250mcg+Folic Acid USP 6/7/2010 1500 mcg+Nicotinamlide IP100 mg+Pyridoxine 3mg +Selenius Acid USP 100mcg+Zinc Sulfate Monohydrate USP 61.8 mg eq. to 22.5 mg Cyanocobalamine + Zinc tannic acid complex Jan-61 Cyclandelate 1969 to 74 Cyclandelate Capsule 200 mg Jul,1977 Cyclandelate Tablet 200 mg Feb,1973 Cyclo Pentolate HCl Ophthalmic Solution Mar-90 Cyclobenzaprine 7.5mg tablets (Additional Strength) 18.08.08 Cyclobenzaprine HCl ER Capsule 15/30mg 17.12.08 Cyclobenzaprine Hcl. Tablets 5mg/10mg 31.01.08 Cyclosporin Eye drops (0.1%) (addl. Strength) 02.06.2006 Cyclosporine Jun-88 Cyclosporine oral solution Jun-88 Cypermethrin 1.0% w/w + Miconazole Nitrate IP 2.0%w/w shampoo for topical application to hair coat. (veterinary product) Cypermethrin High-cis (VET) Sep-96 Cypermethrin High-cis (VET) 100mg 16-Sep-96 Cyproheptadine Hydrochloride Tablet 4 mg Jan,1973 Cyproterone Acetate 2 mg + ethinyl estradiol 0.035mg tablet 20.02.2003 Cyproterone Tablet 10.06.2003 Cytarabine Injection 100mg Additional Packsize (20ml) 10/2/2010 Cytrabine Injection Jun, 1980 Diagnostic Kits Plant @ Rs. 10 Lac 98961- 33556 Dabigatran Etexilate Mesilate hard gelatin capsule 75/110/150mg (Additional 17.11.14 Indication) Dabigatran Etexilate( as Mesilate) hard gelatin Capsules 75mg/110mg/150mg 12.12.11 DabigatranEtexilateMesilateeq to DabigatranEtexilate 75mg/110mg/150mg 11.2.13 Dabrafenib 50 mg/75 mg Capsules (Dabrafenib Mesylate) Daclatasvir Dihydrochloride bulk & Tablet 30mg/60mg 14.12.2015 Daclizumab 12.10.2000 Dalteparin Sodium Injection(Additional Indication) 30.01.08 Danazol capsule 100mg/200mg Mar-82 Danofloxacin Mesylate injection (vet) 250 mg 28-Jul-95 Dapagliflozin Tablet 5mg/10mg 25.02.2015 Dapoxetine (as Hydrochloride) Tablets …30mg/60mg 13.11.10 Daptomycin powder for concentrate for solution for infusion (350mg/500mg 28.01.08 per vial) Darifenacin (as hydrobromide) 7.5mg/15mg ER tablets 31.01.08 Darunavir(as ethanolate) Tablet 300mg 19.03.09 DarunavirEthanolate 800mg film coated tablet (Additional Strength) 04.05.2016 Dasatinib tablet 20mg/50mg/70mg tablet 30/08/06 Dasatinib Tablets 100mg (addl. Strength) 10.07.2009 Daunorubicin 1969 to 74

Debriphor beads Aug-86 Decapeptide 22.10.2001 Decitabine Injection 30mg/vial (Additional pack size) 13.2.15 Decitabine lyophilised powder for injection 50mg/20ml vial (additional 09.04.2014 indication) Decitabine Lyophilized powder for injection 50mg/20ml vial 25.04.2009 Deferasirox 100 mg dis.tablet (addl. strength) 28.11.07 Deferasirox dispersible tablet (400mg) (addl. Strength). 17-08-2007 Deferasirox Dispersible tablet 100/400mg (Additional indication) 26.9.2014 Deferasirox dispersible tablet 125/250/500mg. 10.07.2006 Deferasirox film coated tablet 90mg/180mg/360mg (Additional strength) 05.05.2016 Deferasirox Tablet for Oral Suspension (Additional Sosage Form) 14.12.2010 Deflazacort (1,6,30mg) tablet 02.11.2004 Deflazacort Oral Suspension (6mg/5ml) (New dosage form) 15-06-2007 Deflazacort Tablet 18mg (Additional Strength) 30/01/2010 Deflazocort 24mg tablets (Additional strength) 14.05.08 Deflazocort oral suspension (6mg/5ml) (new Dosage Form) 15.06.07 Degarelix for Injection 80mg / 120mg per vial 19.01.12 Deltamethrin (0.50% m/v) and Piperonyl Butoxide (2.0% m/v) per ml Pour– 29.10.2009 On Solution Deltamethrine Jun-90 Desamino-oxytocin 1969 to 74 Desflurane liquid for inhalation (240mg/bottle). 22/02/2006 Desloratadine (2.5mg) + Ambroxol (30mg) +Guiphenasine (50mg) + Menthol 02.03.2005 1mg/5ml Syrup Desloratadine 2.5mg/5mg + Pseudoephodrine (SR) 120mg/180mg tablet 29.01.2004 Desloratidine Antiallergic 30.10.2001 Desmopressin Aug-89 Desmopressin Acetate tablet 0.1/0.2 mg 12.12.08 Desmopressin Nasal Sol/ Nasal Spray/ Injection Aug-89 Desmoprission lyophilisate Oral tablets 60mcg/120mcg/240mcg per tablets 08.05.08 Desogestrel Jan-89 Desogestrel + Ethinylestradiol Nov-83 Desogestrel 0.15 mg+Ethinylestradiol 0.03 mg each tablets Nov-83 Desonide 07.03.1997 Desoximetasone Jul,1975 Desoximetasone Ointment 0.05% Jul,1979 Desoximetasone Ointment 2.5mg/gm Sep,1975 Desvenlafaxine (as Succinate) ER Tablets 50mg/100mg 18.7.2009 Dexamethasone 0.125mg + Indomethacin 25mg Capsule Nov-71 Dexamethasone Intravitreal Implant 0.7mg (in solid polymer drug delivery 16/01/2010 system) Dexarazoxane powder for Injection 26.02.2002 Dexchloropheniramine maleate Tablet 2 mg Jul,1976 Dexfenfluramine HCl Jun-92 Dexfenfluramine HCl capsule 15 mg Jun-92

Dexibuprofen 200mg/300mg + Paracetamol 500mg soft gelatin capsule or 10.08.2006 tablet Dexibuprofen Suspension 50mg/5ml 14.08.08 Dexibuprofen Tablet (200mg/300mg/400mg) 06.02.2006 Dexketoprofen (as Trometamol ) tablets 12.5mg/25mg 28.03.08 Dexketoprofen 1.25% w/w + Linseed Oil 3.0%w/w + Menthol 5%w/w + 07/06/2010 Methyl Salicylate 10%w/w (12.5mg) Gel Dexketoprofen 12.5 mg/25 mg + Paracetamol 500 mg film coated tablets 18.05.2009 Dexketoprofen 50mg + Dicyclomine 20mg per 2ml Injection 28.04.11 Dexketoprofen Trometamol 25mg + Thiocolchicoside 4mg tablets 20/05/2010 Dexketoprofen Trometamol ER Tablet 50 mg (Additional Strength) 21.02.11 Dexketoprofen Trometamol Gel 12.5mg/gm 13.10.2009 Dexketoprofen Trometamol Injection 50mg/2ml 22.10.2009 Dexketoprofen 12.5 mg/25 mg + Paracetamol 500 mg film coated tablets 18.05.2009 Dexketoprofen1.25% w/w +Linseed Oil 3.0%w/w +Menthol 5%w/w +Methyl 6/7/2010 Salicylate 10%w/w (12.5mg) Dexlansoprazole Delayed Release Capsule 30/60 mg & Bulk 02.05.1997 Dexmedetomidine HCl Injection (Additional Indication) 14.11.2009 Dexmedetomidine ( as HCl) 100mcg /ml Injection 29.05.09 Dexrabeprazole 10mg (EC) + Domperidone 30mg SR Capsules 09.06.08 Dexrabeprazole Sodium E. coated tablet 5mg/10mg. 13-06-2007 Dextranomer 1985 to 87 Dextranomer sachet 4 gm. & 6 gm. per sachet Sep-85 Dextrometharpahan HBr-10mg + Chlorphenaramine maleate-2mg /5ml syrup. 12.11.07 Dextromethorphan Extended Release Oral Suspension 30 mg per 5 ml 17.01.11 Dextromethorphan Hydrobromide Extended Release suspension 30mg/5ml 01.08.2013. (Additional Dosage Form) Dextromethorphan Orodispersible strip 5.5mg/11mg 28.01.08 Di iodochlorhydroxyquinoline 300mg + Berberine Hcl 40mg + Homatropine Jan-70 methylbromide 0.8mg tablet Diacerein 12.03.2004 Diacerein Modified Release Capsule 100mg 20.11.2009 Diacerin 50mg + Aceclofenac 100mg tablets 11.04.08 Diacerin 50mg + Glucosamine 1500mg Tablets 09.04.2008 Diacerin 50mg + Glucosamine sulphate 500mg tablets. 21.04.08 Diacerin 50mg + MSM 250mg + Glucosamine 750mg Tablet 01.06.2009 Diazepam + Paracetamol Oct-77 Diazepam + Sorbide Dihitrate Dec-79 Diazepam 2.5mg + Sorbide Dihitrate 10mg Tablet Dec-79 Diazepam 5mg + Paracetamol 500mg tablet Oct-77 Diazepam Injection 5mg/ml Dec,1977 Diazinon (vet.) Apr-90 Diazinon Flea Drops Spot on Dogs 30.0% w/w 11.11.11 Diazoxide Aug, 1978 Diclofenac 100mg (EC) + Thiocolchicoside 8mg Capsule 06.07.2010 Diclofenac (as EC Tablets) 25mg + Paracetamol 325 mg Capsule (Additional 31.05.11 Strength) PHARMADOCX (Pharmaceutical Consultant) Ph 9896133556 Mail [email protected] (Contact for Setting up Pharma, Cosmetics, Medical Devices Plant, WHOGMP) LIST OF NEW DRUGS 1961 – MAY 2017 download from http://www.pharmadocx.com Page - 34

Diclofenac + Thiocolchicoside (50 mg + 4 mg) Capsules (additional strength) 24.12.08 Diclofenac + Thiocolchicoside (50mg (EC) + 8mg) Capsules 21.10.08 Diclofenac 10mg + Serratiopeptidase 10/15mg tab & Cap. On 20/8/08 24.01.2008 Diclofenac 50mg + Chlorzoxazone500mg Tablets 16/03/2010 Diclofenac 50mg + Serratiopeptidase (enteric coated pellet) 15 mg capsule 08.04.2008 Diclofenac 50mg + Serratiopeptidase 10mg enteric coated tablet 24.01.08 Diclofenac Colestyramine 145.6 mg corresponding to 75mg Diclofenac 19.05.11 Sodium Capsules. Diclofenac Colestyramine 145.6mg Capsule Corresponding to Diclofenac 25.2.13 Sodium 75mg (Additional Indication) Diclofenac Diethyl amine transdermal patch 100 mg/37.5 sq cm (Additional 4.12.2009 Strength) Diclofenac Diethylamine 1.16% w/w eq.to Diclofenac Sodium 1% w/w + 09.06.2008 (Methysalicylate, Linseed Oil, Menthol) Diclofenac Diethylamine BP 2.32 % w/v Eq to Diclofenac Sodium 2.00 % 01.01.2013 w/v + Methyl Salicylate IP 10.00% w/v + Menthol 5.00 % w/v + Absolute Alcohol IP 10.00 % v/v Topical Solution (Additional Strength) Diclofenac Diethylamine BP 2.32 % w/v Eq to Diclofenac Sodium 2.00 % 01.01.2013 w/v + Methyl Salicylate IP 10.00% w/v + Menthol 5.00 % w/v + Absolute Alcohol IP 10.00 % v/v Topical Solution (Additional Strength) Diclofenac Diethylamine BP 4.64 % w/v Eq. to Diclofenac Sodium IP 4.00 21.12.12 % + Absolute Alcohol IP 10.00 % v/v Topical Solution Diclofenac Diethylamine BP 4.64 % w/v Eq. to Diclofenac Sodium IP 4.00 % 21.12.12 + Absolute Alcohol IP 10.00 % v/v Topical Solution Diclofenac Diethylamine BP eq to Diclofenac sodium 1 % w/w Methyl 28.01.91 salicylate IP 10 % w/w Menthol IP 5 % w/w Linsed oil BP 3.0 w/w Gel contains: Diclofenac Gel 1gm Mar-91 Diclofenac Potassium 50mg + metaxalone 400 mg tablet 22.02.2005 Diclofenac Potassium 50mg + Serratiopeptidase (as enteric coated pellets) 08.04.08 15mg capsules (Additional Strength) Diclofenac Sodium 1985 to 87 Diclofenac sodium (SR) 100mg + Eperisone Hydrochloride (SR) 150mg 24.08.11 Capsules Diclofenac Sodium (75/50mg) as (E.C) + Misoprostol 200mcg. 28/02/2006 Diclofenac Sodium (75mg/ml) Injection (addl. Strength). 30-07-2007 Diclofenac sodium (SR) 100mg + Eperisonen Hydrochloride (SR) 150mg 24.08.11 Capsules Diclofenac Sodium 100mg (SR Pellets) + Rabeprazole Sodium 20mg (E.C 31.01.08 Pellets) Capsules Diclofenac Sodium 1mg + Gentamycin Sodium 3mg per ml 26.03.1999 Diclofenac sodium 50mg + Dicyclomine HCl 20mg per ml of injection 28.01.08 Diclofenac Sodium 50mg + Codeine Phosphate 50mg tablets 02.06.08 Diclofenac sodium 50mg + Dicyclomine HCl 20mg per ml of injection 28.01.08 Diclofenac Sodium 50mg + Paracetamol 500mg tablets 30.01.08 Diclofenac sodium injection 75 mg/ 3 ml ampoule Jun-87

Diclofenac Sodium Injection 75mg/2ml 4.12.12 Diclofenac Sodium IP (as sustained release Pellets) 100mg + Thiocolchicoside 15.11.11 (as sustained release pellets) 16mg Capsule. (New Dosage Form) Diclofenac Sodium IP (Enteric coated granules) 50mg + Eperisone Hcl IP 06.01.12 (Tablet) 50mg Hard Gelatin Capsules. (New Dosage Form) Diclofenac sodium opthalmic solution sterile 0.1% (1mg/ml) 27-Jan-95 Diclofenac Sodium SR Tab. 75/100mg Jan-88 Diclofenac sodium SR Tablet 150 mg 26/03/2010 Diclofenac Sodium Sustained Release Tablet (Two layered tablets) 150mg. 20.12.13 Each tablet contains Diclofenac Sodium IP-125 mg Slow Release, Diclofenac Sodium IP-25 mg Immediate Release(Additional Dosage Form) Diclofenac Sodium tablet 25/50 mg Sep-85 Diclofenac Transdermal Patch (200 mg/75 Cm2) 06.10.2004 Diclofenac Transdermal patch 100 mg/50 Cm2 10.08.2004 Dicloxacillin Sodium Jul, 1978 Dicloxacillin Sodium Capsule 125 mg & 250 mg Aug,1979 Dicloxacillin Sodium Oral Solution 62.5 mg Sep,1979 Dicyclomine2.5mg + Dried Aluminimum Hydroxide200mg + Light 03/05/2010 Magnesium Oxide100mg + Simethicone 20mg per 5ml suspension. Dicyclomine2.5mg + Dried Aluminimum Hydroxide200mg + Light 5/3/2010 Magnesium Oxide100mg + Simethicone 20mg per 5ml suspension. Didanosine 15.11.2000 Didanosine Powder for oral solution (2gm/4gm per bottles) 26-08-2005 Diethylamine Salicylate 10 gm + Nopoxamine 1gm Mar-80 Diethylamine Salicylate 10 gm + Nopoxamine 1gm per 100gm ointment Mar-80 Diethylamine Salicylate Cream 10% w/w Mar,1978 Diflorasone Diacetate Cream (0.5mg/gm) 08.02.2005 Difluprednate 0.05% w/v + Moxifloxacin 0.5% w/v Eye Drops 22.09.11 Difluprednate 0.05% w/v + Moxifloxacin 0.5% w/v Eye Drops 22.09.11 Difluprednate Opthalmic Emulsion 0.05% w/v 30/03/2010 Dihydroxy acetate 15%w/v + Alcohol 95% - 45%w/v lotion Oct-71 Dihydroxyacetone Lotion Oct,1971 Dilazep HCL 3/1979 to 7/1981 Dilazep Tablets 50 mg Nov,1979 Diltiazam 1985 to 87 Diltiazem Hcl. 2% gel 07.02.07 Diltiazem MR Tab. 30/60mg Jul-89 Diltiazem SR Tab. 90/120mg Jul-89 Dimethothrazine 1969 to 74 Dimethyl Fumarate delayed release 120 mg/240 mg Tablet 27 08 14 Dimethyl polysiloxone 100mg + Enzyme concentrate Aspergilluss oryzae Aug-78 120mg + Protease 126 units + Cellulase 185 units + Hemicellulose 64 units + Amylase 1.3 units + papaverine HCl 25mg Capsule Dimethylpolysiloxane 1969 to 74 Dimetridazole Aug,1975 Diminazene Diaceturate 70 mg+ Phenazone BP 375 mg + chlorocresol IP 09.03.15 0.1% w/v Injectable dosing form (veterinary product) Each ml contains: PHARMADOCX (Pharmaceutical Consultant) Ph 9896133556 Mail [email protected] (Contact for Setting up Pharma, Cosmetics, Medical Devices Plant, WHOGMP) LIST OF NEW DRUGS 1961 – MAY 2017 download from http://www.pharmadocx.com Page - 36

Dinoprostone (PGE2) Feb-90 Dinoprostone tablet 0.5 mg Feb-90 Dioctyl Sodium Sulfosuccinate USP Ear Drop 5% Sep,1979 Diosmin Tablet/Capsule 150 mg Jun,1979 Diphenoxylate HCl 1969 to 74 Diphenoxylate HCl 2.5mg + Atropine Sulphate 0.025mg tablet Jul-69 Dipivefrin HCL 16.05.1996 Diptheria+Tetanus Toxoid + Pertussis vaccine adsorbed and Haemophilu b 12.10.1999 CRM 197 Conjugate vaccine Disodium chromoglycate Nasal drops 2% Sep,1976 Disodium Pamidronate Inj. 21.02.1995 Disopyramide Jan-77 DisopyramideCapsule100mg Jun,1977 Disopyramide inj. 100 mg/5 ml & 150 mg/7.5 ml Aug-83 Divalproax Sodium 17.01.2002 Divalproex Sodium E.R. Tablets (750mg/1000 mg) 24-06-2004 Divalproex Sodium Oral Solution 500mg/5ml (Additional Dosage Form) 23.12.13 DL- Norgestrel 300mcg + Ethinyl oestradiol 30mcg Tablet Oct-76 DL- Norgestrel + Ethinyl estradiol Apr-71 DL Norgestrel + 17 alpha hydroxy progesterone caproate + Norethisterone Jan-69 acetate + 17 alpha acetoxy progesterone DL-norgestrel 0.25mg + Ethinyl estradiol 0.05mg Tablet Sep-71 DL-Norgestrel 0.5mg + Ethinyl estradiol 0.03mg Tablet Aug-74 D-norgestrel 0.25mg + Ethinyl estradiol 0.05mg Tablet Apr-71 D-Norgestrol Tablet 0.03 mg Apr,1974 Dobutamine Oct-93 Dobutamine HCL Inj. (infusion concentrate) 50 mg/ ml 4-Oct-93 Docetaxel injection 20.06.1996 Docetaxel injection concentrate 31.03.2008 Docetaxel injection concentrate 80mg/2ml, 20mg/0.5ml (Additional Indication 17.12.08 ) Docetaxel injection concentration -80mg (2ml/vial) & 20mg (0.5ml/vial) 20-Jun-96 Dolutegravir 50 mg Tablet & Bulk (Dolutegravir Sodium) 07.11.2016 Domperidone 1985 to 87 Domperidone (10mg) + Activaed dimethicone (125mg) chewable tablet 22-11-2005 Domperidone tablet 10 mg, oral drops 10 mg/ml and suspension 10 mg/ml, Nov-87 rectal suppositories 30 mg Donarol Jan-82 Donepezil Hydrochloride Orodispersible Tablet 5mg/10mg 15.10.2009 Donepezil Sustained Release Tablet 23mg (Modified Dosage Form) 3/6/2011 Donepezil HCl 20.03.2001 Dopamine HCl cardiac drug 3/1979 to 7/1981 Dopamine HCl Injection 200 mg/5ml Jan,1980 Dopamine HCl-80/160/320mg + Dextrose hydrous-5gm each 100ml contains 02.04.2002 injection Doramectin 17.10.1997 Doramectin 1% injection solution (vet) 17-Oct-97 PHARMADOCX (Pharmaceutical Consultant) Ph 9896133556 Mail [email protected] (Contact for Setting up Pharma, Cosmetics, Medical Devices Plant, WHOGMP) LIST OF NEW DRUGS 1961 – MAY 2017 download from http://www.pharmadocx.com Page - 37

Doripenem 500 mg powder for injection (Additional Indication) 10/8/2010 Doripenem (as monohydrate) Injection 250mg/500mg 16.02.09 Dorzolamide 03.10.2003 Dorzolamide (20 mg) + Timolol (5 mg) per ml Eye drops 01.09.2004 Dorzolamide 2% + Timolol 0.5% eye drops 28.08.2004 Dosulepin Hcl Tablet 25mg/75mg (Additional Indication) 8/4/2010 Dosulepine Hcl 50mg/75mg + Methylcobalamin 1500mcg/1500mcg Tablets 08.12.11 Dosulepine Hcl 50mg/75mg + Methylcobalamin 1500mcg/1500mcg Tablets 08.12.11 Dothiepin Hydrochloride May, 1977 Doxapram Hydrochloride Sep-97 Doxapram Hydrochloride Injection 20mg/vial Nov,1978 Doxazosin (as Mesylate) 4mg/8mg E.R. Tablet 30-11-2005 Doxazosin Mesylate 11.03.99 Doxepin Hydrochloride 1969 to 74 Doxepin Hydrochloride tablets/Capsule/Dragee Sep,1972 Doxercalciferol (0.5/ 2.5mcg) Soft Gelatin Capsule (Additional Indication) 05.08.08 Doxercalciferol 0.5mcg/2.5mcg Soft Gelatin capsules 29.05.08 Doxifluridine Capsules 100mg/200mg 31.01.08 Doxofylline 400 mg + Ambroxol 30 mg Tablets 23.12.2009 Doxofylline ER tablets 400mg/800mg (addl. Strength) 12.03.08 Doxofylline MR Tablet 650 mg 11/3/2010 Doxofylline Syrup (20mg/ml) 30/03/2006 Doxofylline Tablet (400mg) 08.02.2006 Doxophylline (SR) 400mg/800mg + Montelukast 10mg/10mg Tablets 04/07/2010 Doxophylline injection-10mg /ml 31.12.07 Doxophylline-400mg + Salbutamol(as sulphate)-2mg/4mg Tablets 29.11.07 Doxorubicin HCl 1975 to 76 Doxorubicin HCl Pegylated Liposomal Injection (20/50MG) (Additional 23.08.08 Indication) Doxorubicin hydrochloride Injection 10 mg/vial Apr,1975 Doxorubicin inj. 10 mg Jul-86 Doxycycline Hydrochloride Tablet 100 mg Dec,1972 Doxycycline-100mg + L.bacillus spores-5 billion capsule pellets 12.11.07 Doxycycline-100mg +L.bacillus spores-5 billion 12.11.07 doxyphylline2mg +Terbutaline120mgper5mlSyrup 24.12.2008 Doxyphylline 400 mg + Terbutaline 5mg tablets 23.02.09 D-pencillamine 1969 to 74 D-pencillamine Tablets, 300mg Jul, 1974 DPT-ACT HiB Vaccine Jan-98 Dried Aluminium Hydroxide Gel IP 600mg + Magnesium Hydroxide IP 05.10.10 300mg + Simethicone IP 25mg + Oxetacaine BP 10mg per 5ml suspension Dried Ferrous Sulphate Enteric Coated IP 150mg eq. to Elemental Iron 45 mg 30.04.15 Folic acid 0.4 mg (Additional strength) Each enteric coated tablet contains: Dried ferrous sulphate eq. to 50mg of elemental iron + Ascorbic acid 300mg + Dec-73 Sod. Bicarbomate 84mg + Talcum 12mg capsule

Dried Ferrous Sulphate IP 150mg (As Enteric Coated granules) eq. to 30.04.15 Elemental Iron 45 mg Folic acid 0.5 mg. (Additional dosage form) Each hard gelatin capsule contains: Dried IVY Leaf Extract (0.7gm/100ml) 15-09-2005 Dried yeast powder 250mg + Saccharomyces ceribial containig NLT 10 Jan-71 million living cells Capsule Dronedarone( as Hydrochloride) film coated tablet .... 400 mg. 8/4/2010 Drosperinone (3mg) + Ethinylestradiol (0.035mg tablet) 11.05.2005 Drosperinone + Ethinylestradiol tablets Same as approved 09.10.10 Drospirenone 3mg + Ethinyl estradiol 0.02mg tablets (Additional Strength) 28.03.08 Drospirenone 3mg/3mg + Ethinyl Estradiol 0.02mg/0.03mg Tablets 28.03.2008 Drotaverine + Aceclofenac (80mg + 100mg) Tablets 15.09.08 Drotrecogin alpha 23.07.2002 DTP + Hepatitis b Vaccine (Multidose vial of 5 ml) containing 10 doses. 27.07.2000 D-trans Fentantyl Transdermal patches 05.04.2006 D-Trans Fentanyl Metrix system (12mcg/hr.) (Additional Strength) 07.01.08 Duloxetine HCl (60mg) tablet (additional strength) 28-02-2005 Duloxetine HCl (20,30,40mg) Tablet 2/11/2004 Dutasteride 16-02-2004 Dybendal 0.5%w/w + Allantoin 0.2%w/w + Boric Acid 1%w/w + Menthol May-73 0.08% v/w Dynoprostinj.5mg May.86 www.pharmadocx.co Want to setup Cosmetics Plant @ Rs. 5 lac m Each Combikit contains Part A - One film coated tablet of Tenofovir 23.08.11 Disoproxil Fumarate 300mg eq. to Tenofovir 245mg + Emtricitabine 200mg. Part B - One film coated tablet of Atazanavir sulphate eq. to Atazanavir 300mg + Ritonavir 100mg Each Combipack of 21 tablets contains : A) FDC of Norgestrel & Ethinyl 27.07.11 estradiol tablets IP Each sugar coated white tablet contains: Norgestrel 0.30mg & Ethinyl estradiol 0.03mg B) 7 tablets of Ferrous Fumarate: Each sugar coated tablet contains : - Ferrous Fumarate 75mg eq. to 24.375mg of ferrous iron Each ml contains Calamine 15% w/v + Zinc oxide 5% w/v + Bentonite 3% 08.05.2009 w/v + Glycerin 5%w/v + Sodium citrate 0.05 % w/v lotion Each 10 ml (two teaspoonfuls) of oral dosage form(tonic) contains: 1.25 g of liver fraction derived from 31.25 g of fresh liver yeast Extract 0.4 g + Nicotinic acid IP 24 mg+ Ethanol (95%) IP 1 ml + Alcohol Content 9.4 % v/v (veterinary product) Each 1000 ml of emulsion contains: Medium chain triglycerides 100 gm + 17.11.14 Soya oil 80 gm + Omega-3 acid triglycerides 20 gm + egg lecithin 12 gm + Glycerl 25 gm + Sodium oleate 0.30 gm + Alpha-tocopherol 0.20 gm + Ascorbypalmitate0.30 gm + Sodium hydroxide max. 0.06 gm + water for injection 784 gm emulsion for infusion Each 1000 ml of emulsion contains: Medium chain triglycerides 100 gm + 14.05.2009 Soya oil 80 gm + Omega-3 acid triglycerides 20 gm + egg lecithin 12 gm + Glycerl 25 gm + Sodium oleate 0.30 gm + Alpha -tocopherol 0.20 gm +Ascorbypalmitate 0.30 gm + Sodium hydroxide max. 0.06 gm + water for injection 784 gm emulsion for infusion PHARMADOCX (Pharmaceutical Consultant) Ph 9896133556 Mail [email protected] (Contact for Setting up Pharma, Cosmetics, Medical Devices Plant, WHOGMP) LIST OF NEW DRUGS 1961 – MAY 2017 download from http://www.pharmadocx.com Page - 39

Each 15 gm sachet contains: Lactulose 10 gm + Ispaghula husk 3.50 gm 14.05.2009 granules Each 15 gm sachet contains: Lactulose 10 gm + Ispaghula husk 3.50 gm 16.05.2009 granules Each 5 ml reconstituted syrup contains:Amoxycillin as trihydrate 125mg + 16.05.2009 Clavulanic Acid 31.25mg as potassium salt suspension Each 5ml contains Codeine Phosphate 10mg + Triprolidine HCl 1.25mg syrup 07.08.1990 Each bowel preparatory kit contains: One enteric coated tablet Biscodyl IP 18.02.2003 5mg & One sachet of powder for reconstitution contains: Polyethylene glycol 3350NF: 210gm + Sodium Bicarbonate IP 2.86gm + Sodium Chloride IP 5.6gm + Potassium Chloride IP 0.74gm Each bowel preparatory kit contains: One sachet of powder for reconstitution 11.02.11 contains: Polyethylene glycol 3350NF: 210gm + Sodium Bicarbonate IP 2.86gm + Sodium Chloride IP 5.6gm + Potassium Chloride IP 0.74gm Each capsule contains: Indacaterol Maleate 110 mcg Glycopyrronium 11.02.11 Bromide 50mcg inhalation powder, hard gelatin capsules Each Combikit contains: Part A - One film coated tablet of Tenofovir 22.07.14 Disoproxil Fumarate 300mg eq. to Tenofovir 245mg + Emtricitabine 200mg. Part B - One film coated tablet of Atazanavir sulphate eq. to Atazanavir 300mg + Ritonavir 100mg For the treatment of HIV infection in adults. Each combipack contains : A) One tablet of Risedronate Sodium - Each film 23.08.11 coated tablet contains: Risedronate Sodium (as Risedronate Sodium Hemi- Pentahydrate)-35mg B) Six Capsules of FDC of Calcitriol + Calcium carbonate + Zinc Each soft gelatin capsule contains: Calcitriol IP-0.25mcg Calcium Carbonate IP - 500mg (eq. to. elemental calcium 200mg) Zinc (as Zinc Sulphate USP) 7.5 mg Each Combipack contains Part (A) One Strip of FDC of Ramipril + 30.09.11 Amlodipine Tablets;- Each uncoated tablet contains Ramipril IP - 5mg, Amlodipine besylate IP eq to Amlodipine 5mg B) Each Film coated tablet contains ;- Atorvastatin Calcium IP eq to Atorvastatin 10mg/20mg. Each combipack contains: 21 pills of FDC of levonorgestrel + ethinylestradiol 28.11.11 tablets IP: Each sugar coated tablet contains: Levonorgestrel IP 150mcg + ethinylestradiol IP 30 mcg 7 pills of placebo/inert tablets Each Combipack contains: -A) One tablet of Risedronate Sodium -Each film 01.04.14 coated tablet contains: Risedronate Sodium (as Risedronate Sodium Hemi- Pentahydrate) - 35 mg B) Six Capsules of FDC of Calcitriol +Calcium carbonate + Zinc Each soft gelatin capsule contains : - Calcitriol IP - 0.25mcg Calcium Carbonate IP - 500mg (eq. to elemental calcium 200mg) Zinc (as Zinc Sulphate USP) 7.5 mg Each combipack contains: A. Each 5 ml of constituted suspension contains: 1. 30.09.11 Amoxicillin Trihydarte IP eq to Amoxicillin 200 mg + Potassium Clavulanate IP eq to Clavulanic acid 28.5 mg 2. Amoxicillin Trihydarte IP eq to Amoxicillin 400 mg + Potassium Clavulanate IP eq to Clavulanic acid 57 mg B. One vial of purified water IP Each Vial contains: Purified water IP 30 ml (additional Pack)

Each combipack contains: One tablet of Tenofovir Disoproxil FumArate + 13.02.15 Emtricitabine IP Each film coated tablet contains: Tenofovir Disoproxil Fumarate IP 300 mg Emtricitabine IP 200 mg Two tablets of Nevirapine IP Each tablet contains: Nevirapine IP 200 mg Each Combipack of 21 tablets contains : A) FDC of Norgestrel & Ethinyl 03.04.14 estradiol tablets IP Each sugar coated white tablet contains: Norgestrel 0.30mg & Ethinyl estradiol 0.03mg B) 7 tablets of Ferrous Fumarate: Each sugar coated tablet contains : -Ferrous Fumarate 75mg eq. to 24.375mg of ferrous iron Each film coated tablets contains: Indapamine USP(as sustained release form) 27.07.11 1.5 mg + Amlodipine Besilate IP Eq to Amlodipine 2.5 mg (additional strength) Each film coated bilayred tablet contains: Metoprolol 25mg/50mg + 09.05.14 Chlorthalidone 12.5mg Each film coated bilayred tablet contains: Metoprolol 25mg/50mg + 13.04.2009 Chlorthalidone 6.25 mg /12.5mg Each freeze-dried vial contains: Tiletamine (as Hydrochloride ) 125 mg/250 25.04.2009 mg+ Zolezepam(as hydrochloride) 125 mg/250 mg freeze dried powder for injectable (veterinary product) Each gm contains:- Capae Extract 0.1 gm+ Heparin Sodium I.P 50 IU + 20.01.14 Allantoin B.P 0.01gm Gel Each gm contains: Halobetasol 0.05% w/w + Mupirocin 2.0 % w/w gel 15.03.2002 Each gm contains: Halobetasol 0.05% w/w + Mupirocin 2.0 % w/w gel 16.05.09 Each gm of ointment contains Mometasone Furoate 0.1% + Salicylic Acid 5 16.05.09 % ointment Each gram contains Mometasone Furoate IP 1mg + Salicylic Acid IP 50 mg 24.12.02 ointment (additional indication) Each kit Contains: 1. 5 sachets of Oral Rehydration Salts (4.4 g each) Each 19.02.14 sachet contains: Combikit of Dextrose Anhydrous IP 2.70g + Sodium Chloride IP 0.52g + Sodium Citrate IP 0.58g + Potassium Chloride IP 0.30g 2. 14 tablets of elemental zinc Each uncoated dispersible tablet contains: Zinc Sulphate monohydrate IP Eq. to elemental Zinc 20mg. Each ml contains Calamine 15% w/v + Zinc oxide 5% w/v + Bentonite 3% 30.04.15 w/v+Glycerin 5%w/v + Sodium citrate 0.05 % w/v lotion Each ml contains Dorzolamide Hydrochloride 2mg/ml + Timolol Maleate 08.05.2009 5mg/ml ophthalmic solution (preservative free formulation of the approved FDC) Each ml contains Minoxidil IP 5 %+ Finasteride IP 0.1% lipid Solution for 18.11.13 topical application Each mouth dissolving tablet contains: Escitalopram Oxalate IP Eq to 07.02.14 Escitalopram 10 mg + Clonazepam IP 0.5 mg (additional dosage form) Each sustained release tablet contains: Thiocolchicoside IP 8/16mg + 04.04.14 Lornoxicam 8/16mg (Additional Strength) Each sustained release tablet contains: Tolperisone HCl 450mg + Diclofenac 08.04.2013 Sodium IP 100mg (additional strength) Each uncoated bilayered tablet contains:Telmisartan Ph. Eur IP 80mg + 12.04.2013 Hydrochlorothiazide Ph. Eur 25mg (additional strength) PHARMADOCX (Pharmaceutical Consultant) Ph 9896133556 Mail [email protected] (Contact for Setting up Pharma, Cosmetics, Medical Devices Plant, WHOGMP) LIST OF NEW DRUGS 1961 – MAY 2017 download from http://www.pharmadocx.com Page - 41

Each uncoated tablet Contains: Ivermectin IP 2 mg + Praziquantel IP 50 mg 14.05.2013 (veterinary product) Ebastine 13.02.15 Eberconazole 1% w/w + Mometasone Furate USP 0.1% w/w cream 28.09.2001 Eberconazole cream (1%) 13.10.10 Econazole 22.03.07 Econazole Nitrate Cream 1% 3.1979 to 7.1981 Econazole Nitrate Vaginal Tablets 150 mg Dec,1980 Econazole ophthalmic ointment 1% Dec,1980 Efavirenz Sep-85 Efavirenz Oral Solution (30mg/ml) 06.06.2001 Eflornithine HCl Cream (139mg/gm) 25-08-2005 Eicosapentaenoic acid (EPA) 180mg + Docoshexaenoic acid (DHA) 120mg 22/03/2006 Elemental iron (as carbonyl modified release) 45mg + Folic acid 1.5mg + Sep-89 vitamin B12-15mcg film coated tablet Eletriptan Hydrobromide Tablets 20mg/40mg 19.04.2004 Eltrmbopag Olamine 25mg and 50mg (Additional Indication) 25.08.11 Eltrombopag (as Olamine) Tablets ...25mg / 50mg 14.09.2016 Eltrombopag Olamine tablet 25/50mg (Additional Indication) 16.10.10 Emphagliflozin Tablet 10mg/10mg 07.04.2014 Emt ricitabine 200mg Tenofovir Disoproxil Fumarate 300mg eq. to Tenofovir 07.05.2015 Disoproxil 245mg Tablet (additional Indication) Emtricitabine (200mg) capsule 16.06.2016 Enalapril (2.5mg/5mg) + HCTZ (12.5) Tablet (Addl. Strength) 09.06.2005 Enalapril + HCTZ 17-10-2005 Enalapril 10mg/20mg + HCTZ 12.5mg/25mg tablet 08.10.1992 Enalapril Maleate 08.10.1992 Enoxaparin Sodium Injection (Addl.Indication) Aug-89 Enoxaparin Sodium Injection 300mg/3ml multidose cartridge (Additional 19.08.2009 Dosage Form) Enrofloxacin 31.03.2016 Enrofloxacin 200 mg + Bromhexine HCl IP 15 mg oral solution. (veterinary 20-Jan-94 product) Enrofloxacin 5% oral solution and injection [1. Each ml of Injection contains 31.01.08 Enrofloxacin-100mg/50mg 2. Each ml of oral solution contains Enrofloxacin - 50mg/100mg] Entacapone (200mg) tablet 20-Jan-94 Entecavir Tablet (0.5mg/1.0mg) & oral solution (0.05mg/0.05mg) per ml. 30-12-2004 Enzalutamide 40 mg soft Capsule 05.12.2005 Epalrestat 50mg + Methylcobalamin 500mcg Tablets 18. 12 .2015 Eperisone 50 mg + Paracetamol 500 mg Tablets 16.11.11 Eperisone Hcl (50mg ) tablet 10.11.2009 Eperisone Hydrochloride Sustained Release Capsule 75mg/150mg (Modified 23/08/06 Dosage Form) Ephedrine Sulphate Sustained Release Capsule 75 mg 24/06/2011 Epicillin May,1971 PHARMADOCX (Pharmaceutical Consultant) Ph 9896133556 Mail [email protected] (Contact for Setting up Pharma, Cosmetics, Medical Devices Plant, WHOGMP) LIST OF NEW DRUGS 1961 – MAY 2017 download from http://www.pharmadocx.com Page - 42

Epigrowth factor 1 gm + Silversulphadiazine Cream 1969 to 74 Epinastine Hcl (0.05%) Opthlamic solution 19.10.2004 Epirubicin injection 22/09/06 Eplerenone Tablet (25mg/50mg) 1985 to 87 Eplerenone Tablets 25mg/50mg (Additional Indication) 10.06.2005 Eplerstat tablet 50mg 14.09.2016 Eprosartan Mesylate 400 mg / 600mg Tablets 25.05.07 Epsilon amino caporic acid Injection 250 mg 11.10.08 Eptifibatide Mar,1971 Eptifibatide IV Injection 25.08.99 Equine Influenza 25.08.99 Equino Influenza and Equine Rhinopneumonitis Vaccine (Vet.) 01.03.1989 Erdosteine 150mg + Guaiphenesin 50mg + Terbutaline 1.25mg per 5ml syrup Mar-89 Erdosteine (150mg/300mg) Capsules 08/08/2006 Erdosteine 150mg + Guaiphenesin 50mg + Terbutaline 1.25mg per 5ml syrup 11/3/2005 Erdosteine Powder for oral suspension 35mg/ml 8/8/2006 Ergometrine + Oxytocin 28.07.1995 Ergometrine 500mcg+Oxytocin 5 units per ml injection 6/2/2006 Ergometrine powder for oral suspension 35 mg/ml 06.02.2006 Eribulin mesylate solution for injection 0.88mg / 2ml vial 28.07.1995 Eribulin mesylate solution for injection 0.88mg in 2ml vial (Add. Indication) 27.01.12 Erlotinib HCl 25/100 mg Tablet (Additional Indication) 18.2.15 Erlotinib HCl Tablet 150 mg (Additional Indication) 3/7/2010 Erlotinib Hydrochloride (25mg/100mg/150mg Tablet 04.01.11 Ertapenem For injection (1gm/vial) 13-07-2005 Ertapenem for injection 1gm/vial (additional indication) 10.04.07 Erythromycin + Benzyl Alcohol + Lidocaine Mar-74 Erythromycin Propionate eq.to. 50mg of Erythromycin + Benzyl alcohol 15.01.08 0.02ml + Lidocaine 0.02gm per ml Inj. Erythropoietin (r DNA) Jan-93 Erythropoietin 2000 IU/4000 IU + Mannitol 40mg/40MG + NaCl 7mg/7MG + Mar-74 Monobasic Sod. Phosphate 2.8mg/2.8mg + Dibasic Sod. Phosphate 8mg/8mg + Human Albumin 5mg/5mg Lyophilised 2 ml Inj. Escitalopram (10mg) + Clonazepam (0.5mg) 15/06/1905 Escitalopram (as oxalate) 10mg + Clonazepam 0.5mg Tablet 27-08-2004 Escitalopram 5mg + Clonazepam 0.5mg Tablet 31.08.2004 Escitalopram Oxalate. 13.12.2007 Escitlopram (as oxalate) 10mg + Clonazepam-0.5mg tablet (addl. Strength). 24.01.2003 Eslicarbazepine Acetate Tablets 200mg/ 400mg/ 600mg/ 800mg 12.12.07 Esmolo Hydrochloride Aug-94 Esmolol HCl 07.03.11 Esmolol HCl injection [1. Each 10ml ampoule contians: 2.5/gm of Esmolol Aug-94 HCl. 2. Each 10ml vial contains: 100mg of Esmolol HCl] Esomeprazole 40mg (E.C.) + Itopride 150mg SR Capsules 26-Aug-94 Esomeprazole (with Sodium bicarbonate as Buffer) 13/11/06 Esomeprazole (with Sodium bicarbonate as buffer) 20mg/40mg tablets 14.05.2008

Esomeprazole 40 mg (as delayed release pellets) + Levosulpiride 75 mg (As 14.05.08 extended release tablet) hard gelatine capsule. Esomeprazole 40mg (E.C.) + Itopride 150mg SR Capsules 13.02.14 Esomeprazole Delayed Release Granules for Oral Suspension: Each 1g sachet 13/11/06 contains: Esomeprazole Magnesium I.P(as trihydrate) equivalent to Esomeprazole 10 mg as enteric coated granules (Additional Dosage Form) Esomeprazole magnesium Delayed Release Tablets 20mg/40mg (Additional 13/05/2011 Indication) Esomeprazole Magnesium eq. to Esomeprazole 20mg/40mg (as enteric coated 6/4/2011 Pelets) + Domperidone maleate BP Eq. to Domperidone 30mg/30mg SR Capsules Esomeprazole Sodium For injection 01.06.2004 Esomeprazole Magnesium 4/4/2005 Estemestane 04.12.2001 Estradiol - Each Combipack contains 28 film coated Dydrogesterone tablets 18.10.2001 each containing estradiol 1 mg + dydrogestrone 5 mg tablet Estradiol +Dydrogesterone- Each Combipack: 28 film coated tablets each of 14.11.2006 14 tablets contains estradiol 1 mg + other each of 14 tablets contains estradiol 1 mg + dydrogesterone 10 mg tablets Estradiol +Hydrogesterone 14.11.2006 Estradiol topical emulsion 2.5mg/gm 01.02.2000 Estramustine Phosphate capsule 16.03.07 Estriol Succinate Tablet 2 mg Jul-86 Estrogen vaginal tablet 25mcg Mar, 1980 Eszopiclone tablet (1mg/2mg/3mg) 2/11/2006 Etanercept-Recomb. 07.02.07 Ethacranic Acid U.S.P 07.12.2001 Ethacridine Lactate 1969 to 74 Ethacridinelactate100mg/200mg 1969to71 Ethacridine lactate Injection 1mg/ml Jun-83 Ethacrynic Acid U.S.P Tablet 25mg/ 50 mg Oct, 1977 Ethamsylate Feb,1973 Ethamsylate Inj. 250mg May-88 Ethamsylate tablet 250 mg/ 500 mg Sep-91 Ethyl esters of iodized fatty acids of poppy seed oil solution for injection 48%. May-88 Ethynodial diacetate 1mg + Mestranal 0.05mg tablet 22.08.2012 Ethynodiol diacetate 1mg + Ethinyloestradiol 0.05mg Jan-71 Etidronate-Disodium tablets 200mg Feb-70 Etizolam 0.25 mg tablet (Additional Strength) 10-Mar-95 Etizolam CR Tablets 1.5 mg/3 mg (modified Dosage Form) 3/7/2010 Etizolam Tablet (0.5mg/1mg). 19-12-2011 Etodolac 29-10-2007 Etodolac ER Tablets 400 mg/500 mg 10.04.1997 Etodolac tablet & Capsules [Each tab contains Etodolac BP-200MG/400MG 09.05.2007 Each caps contains Etodolac-300mg ] Etodolac 300/300mg +Thiocolchicoside 4/8mg 10-Apr-97 Etodolac 300mg + Paracetamol 500mg film coated tablet 19/07/10 PHARMADOCX (Pharmaceutical Consultant) Ph 9896133556 Mail [email protected] (Contact for Setting up Pharma, Cosmetics, Medical Devices Plant, WHOGMP) LIST OF NEW DRUGS 1961 – MAY 2017 download from http://www.pharmadocx.com Page - 44

Etodolac 400mg + Paracetamol IP 500mg tablet (additional strength) 20.10.2009 Etodolac 400mg/400mg + Thiocolchicoside 4mg/8mg tablet (additional 01.10.10 strength) Etodolac i.m injection 400mg/2ml (Additional dosage form) 09.09.10 Etodolac USP 400mg +Tolperisone HCL 150mg tablet 42352 Etofylline-300mg, Salbutamol (as sulphate)- 4mg SR Capsules 11.10.10 Etomidate 14.06.1993 Etomidate inj.2 mg/ ml 1985 to 87 Etonogestrel (11.7mg) + Ethinylestradiol (2.7mg) Contraceptive rings 15-02-2005 Etophylline + salbutamol 15-02-2005 Etoposide Capsule 14.06.1993 Etoposide injection 100mg/ 5 ml ampoule Mar-88 Etoricoxib 5/3/2004 Etoricoxib + PCM (60mg + 500mg) Tablets 05.03.2004 Etoricoxib 1%+ Menthol 5% Spray 30.09.08 Etoricoxib 10mg + Methyl Salicylate 100mg + Mentol 50mg + Linseed oil 14/12/06 30mg per gm. of Gel Etoricoxib 10mg + Methyl salicylate 20mg per gm. of cream 14.12.2006 Etoricoxib Capsule or injection 21.03.07 Etoricoxib injection 90mg/ml Jan-88 Etoricoxib roll on Topical Solution 1% v/v 28.03.2008 Etravirine Tablet 100mg 16.09.2008 Euphorbia Prostrata Dry Extract (ethanolic 80% (v/v) (35-70) :100mg tablet 29.02.08 Euphorbia Prostrata Dry Extract :100mg tablet (addl. Indication) 29.02.08 Euphorbia Prostrata dry extract ethanolic 80%v/v[(35-70):1] cream 1% w/w 14.11.2009 Everolimus 2.5mg/5mg/10mg Tablets 21.3.13 Everolimus Dispersible Tablets (1.0 mg/0.25 mg) Everolimus Tablet 5 mg/10 mg (additional Indication) 21-12-2011 Everolimus tablets 2.5mg. 5mg and 10mg 27-12-2011 Everolimus Tablets (0.25 mg/ 0.5 mg/0.75 mg/1.0 mg) (additional Indication) 30-08-2004 Everolimus 5/10mg Tablets (Addl. Indication) 30-08-2004 Exemestane 25mg Tablet (Addl. Indication) 29.08.2009 Exenatide 2 mg powder and solvent for prolonged release suspension for 9/9/2015 injection in a prefilled pen (S.C. Injection) (Additional strength) Exenatide Inj. (Additional Indication) 24/05/2010 Exenatide injection (Each 2ml vial contains- Exenatide 5mcg/10mcg per 09.10.10 0.2ml ) (Additional Strength) Exenatide Injection -pre-filled pen (250mcg/ml). 30.01.2008 Extract of centella asiatica 06.07.2007 Extract of centella asiatica 2% injection 1975 to 76 Extract of centella asiatica 200 mg Tablet May, 1976 Extract of centella asiatica Ointment 1% May, 1976 Extract of centella asiatica Powder 2% May, 1976 Ezetimibe 18-12-2003 Ezetimibe 10 mg + Fenofibrate 145 mg Film coated tablets 18.12.2003 Ezetimibe 10 mg + Simvastatin 40 mg (additional strength) Each Uncoated 01.09.2009 tablet contains PHARMADOCX (Pharmaceutical Consultant) Ph 9896133556 Mail [email protected] (Contact for Setting up Pharma, Cosmetics, Medical Devices Plant, WHOGMP) LIST OF NEW DRUGS 1961 – MAY 2017 download from http://www.pharmadocx.com Page - 45

Ezetimibe 10mg + Fenofibrate 160mg tablet 07.01.15 Ezetimibe 10mg/10mg + Simvastatin 10mg/20mg FC Tablet 04.04.07 Famciclovir Tablet 11.05.2005 Famotidine 11.04.2002 Famotidine Injection May-89 Faropenam Sodium Extended Release Tablet 225/300/450 mg 8/3/2010 Farvovirus vaccine 07/11/2005 www.pharmadocx.co Omeprazole Domperidone Pellets Factory @ Rs. 1 Crore m FDC of Papain + Urea Ointment Mar-89 FDC of Aeterolane Malate (150mg) + Piperaquine Phosphate (750mg) Tablet 11.10.2013 FDC of Amlodipine (5mg) + Bisoprolol (2.5mg) 21-07-2005 FDC of Amlodipine (5mg/10 mg) + Atorvastatin (10/20/40 mg) 20-10-2004 FDC of Amlodipine (5mg/10mg) + Atorvastatin (10/20/40 mg) Tablet 20-10-2004 FDC of Amlodipine (5mg/5mg) + Bisoprolol (2.5mg/5mg) tablet 21-07-2005 FDC of Atorvastatin (10mg) + Niacin (375mg/500mg E.R) Capsule 26-07-2005 FDC of Atorvastatin Calcium (10mg) + Finofibrate (160mg) tablet 22-12-2004 FDC of Atorvastatin (10 mg/20 mg) + Ezetimibe (10 mg) Table 13-08-2004 FDC of Buprenorphin 2 mg + Naloxone (0.5 mg) 19-08-2004 FDC of Ceftriaxone (500mg/1000mg) + Tazobactum (62.5mg/125mg) 12/8/2005 Injection FDC of Ceftriaxone (500mg/100mg) + Tazobactum (12.5mg/62.5mg) 21-07-2005 Injection FDC of Epi-Growth Factor (1 gm) + Silversulphadiazine Cream 19-10-2004 FDC of Esomeprazole 20 mg/40 mg + Domperidone 30 mg SR Capsule 29-06-2004 FDC of Gabapentin (300mg) + Methylcobalamin (500mcg) Tablet 08/05/2005 FDC of Gatifloxacin (400mg) + Ambroxol HCl (75mg) tablet 21-12-2004 FDC of Gatifloxacin 0.3% + Dexamethasone Phos. 0.1% w/w Eye drops 15-06-2004 FDC of Glibenclamide 2.5 mg/ 5 mg + Metformin SR 500 mg tablet 20-08-2004 FDC of Glimepiride (1mg/2mg) + Pioglitazone (15mg) + Metformin (500mg 16.08.2005 E.R) uncoated Tablet FDC of Glimepiride (1mg/2mg) + Pioglitazone (15mg)+ Metformin (500mg 12/8/2005 E.R) Tablet FDC of Lamivudine 300 mg (E.R) + Zidovudine 600 mg (E.R) + Nevirapine 15-07-2004 400 mg tablets FDC of Levocetirizine (5mg) + Ambroxol (75mg S.R) Capsule 29-07-2005 FDC of Lovastatin (20mg) + Nicacin ER (500mg) tablet 20-12-2004 FDC of Methylcobalamin (1500mcg E.R) + Pyridoxine (20mg) + Folic Acid 16-09-2005 (5mg) Tablet FDC of Methylcobalamin (1500mcg E.R) + Pyridoxine (20mg) + Folic Acid 16-09-2005 (5mg) Tablet FDC of Nebivolol HCl (5mg) + Hydrochlorothiazide (12.5mg) tablet 22-12-2004 FDC of Nebivolol (5 mg) + S(-) Amlodipine (2.5 mg ) tablet 14-09-2004 FDC of Olmesartan Medoxomil (20mg/40mg/40mg) + 12/02/2005 HCTZ(12.5mg/12.5mg/25mg) FDC of Rabeprazole (20 mg) + Mosapride S.R. (15 mg) Tablet 27-07-2004 FDC of Rabeprazole Sodium (20 mg) + Domperidone(30 mg) S.R Capsule 4/10/2004 PHARMADOCX (Pharmaceutical Consultant) Ph 9896133556 Mail [email protected] (Contact for Setting up Pharma, Cosmetics, Medical Devices Plant, WHOGMP) LIST OF NEW DRUGS 1961 – MAY 2017 download from http://www.pharmadocx.com Page - 46

FDC of S-Metoprolol Succinate Tartrate equivalent to Metoprolol Tartrate 11/11/2005 (E.R) 25/50mg + HCTZ (12.5mg) Tablet. FDC of Sucralfate 0.07 + metronidazole 0.01 gm + Lignocain 0.04 gm per 19-08-2004 gram of cream Febuxostat 40mg Additional Strength 11/7/2005 Febuxostat Tablets 80mg / 120mg 14.11.2009 Felodipine May-91 Fenbandazole + Oxycloganide May-91 Fenbandazole 175mg + Oxycloganide 525mg bolus 04.10.1999 Fenbandazole(vet) 2.5%(w/w)/1.5%(w/w) + Oxyclonazide (vet) 7.5%w/w /4.5 04.10.1999 % (w/w) per ml Fenbendazole Jan,1979 Fenbendazole Jan-83 Fenfluramine Hydrochloride Jan,1972 Fenfluramine Hydrochloride Tablets 20 mg 1969 to 74 Fenofibrate 1969 to 74 Fenofovir Disoproxil fumarate 300mg + Lamivudine 300mg + Efavirenz 22.12.99 600mg tablets Fenoverine 8/10/2003 Fenpipramide Methobromide and para-piperdinoethoxy o-carboxymethoxy 08.10.2003 benzophenol hydrochloride Fenticonazole Nitrate Vaginal Capsule 600 mg 10.08.2016 Feracrylum (1%) + Metronidazole 1%) Gel 16-09-2005 Feracrylum (1%) + Metronidazole 1%) 16-09-2005 Feracrylum 1% mouth gargle 10mg/ml 16-09-2005 Feracrylum 3% gel 28.09.2006 Feracrylum 3% solution 13.02.2002 Feracrylum 3% w/w + centbucridine 0.5 w/w gel May-92 Feracrylum Acid Polyelectrolyte 31.12.2004 Feropenem Sodium (150mg/200mg) Tablet 21-07-2005 Ferric Carboxymaltose equivalent to elemental Iron…50mg/ml Injection 31.07.2005 Ferric Sodium Citrate Apr,1972 Ferrous bisglycinate 60mg + Zinc sulphate monohydrate Eq. to Zinc 14mg 13.10.10 + Copper as copper sulphate 1 mg + Selenium as selenomethionine 70mcg + Vitamin B6 IP 10mg + Methylcobalamin 1500mcg + Folic acid 5mg + Fish oil 10/40 (DHA 200mg) 500mg capsule. Ferrous glycine Sulphate CR 100mg (eq. To elemental iron)+Folic acid 03.11.1992 0.5mg tablet Ferrous ascorbate (equivalent to 50mg Iron) + Folic acid 1.5mg. 8/6/2006 Ferrous ascorbate (equivalent to 50mg Iron) + Folic acid 1.5mg. Film coated 08.06.2006 tablet Ferrous Ascorbate + Folic Acid + Zinc FC Tablets (100mg + 1.5 mg + 22.5 08.06.2006 mg) Ferrous Ascorbate + Folic Acid suspension (eq. to elemental iron 30 mg + 550 18.08.08 mcg per 5 ml) Ferrous Ascorbate + Folic Acid Suspension (Equiv. to elemental iron 30mg + 27.08.2008 550mcg per 5ml) (New Dosage Form) PHARMADOCX (Pharmaceutical Consultant) Ph 9896133556 Mail [email protected] (Contact for Setting up Pharma, Cosmetics, Medical Devices Plant, WHOGMP) LIST OF NEW DRUGS 1961 – MAY 2017 download from http://www.pharmadocx.com Page - 47

Ferrous Ascorbate 100mg + Folic Acid IP 1.5mg + Cyanocobalamin IP 27.08.08 15mcg + Zinc Sulphate Monohydrate Eq. to Elemental Zinc 22.5mg Tablet Ferrous ascorbate 100mg + Folic acid 1.1 mg tablet and Omega-3-fatty acid 01/08/2010 200mg capsules combikit Ferrous Ascorbate 100mg + Folic Acid IP 1.5mg + Cyanocobalamin IP 05.01.11 15mcg + Zinc Sulphate Monohydrate Eq. to Elemental Zinc 22.5mg Tablet Ferrous Ascorbate 50 mg + Folic acid 1/1.5 mg FC Tablet 19.10.11 Ferrous ascorbate eq to Elemental Iron 100 mg/50 mg Folic acid IP 1.5 mg 08.11.2006 Each film coated tablet contains: Ferrous Ascorbate eq. to elemental iron 100mg + Folic acid IP 1.1mg + Old drug Methylcobalamin 1.5mg +Zinc Sulphate monohydrate IP eq to elemental Zinc 22.5mg Tablets. (Additional strength) Ferrous bisglycinate 60mg + Folic acid 1mg + Zinc Bis glycinate 15mg + 14.10.2008 Methylcobalamine 500mcg FC Tablet Ferrous bisglycinate 60mg + Zinc sulphate monohydrate Eq. to Zinc 14mg + 13.10.10 Copper as copper sulphate 1 mg + Selenium as selenomethionine 70mcg + Vitamin B6 IP 10mg + Methylcobalamin 1500mcg + Folic acid 5mg + Fish oil 10/40 (DHA 200mg) 500mg capsule. Ferrous Sulphate eq. to Elemental Iron 100mg/20mg + Folic Acid IP 15.07.13 0.5mg/0.1mg Enteric coated tablets (Additional Dosage Form) Ferrous Sulphate Sustained Release Tablet 150 mg Jan,1971 Ferrous Sulphate Sustained Release Tablet 160 mg Nov,1972 Fexofenadine 60mg + Pseudoephedrine 120mg CR Capsule 17.12.2003 Fexofenadine + Pseudoephedrine 17.12.2003 Fexofenadine 120mg + Montelukast 10mg Chewable tablet (additional 17.09.1999 Dosage form) Fexofenadine 120mg + Psendoephedrine sulphate USP in ER form 180mg 16-Sep-98 tablet Fexofenadine Hcl 16-Sep-98 Fexofenadine Hcl tablet -120mg/180mg 16.09.1998 Fexofenadine suspension (30mg/5ml) 16.09.1998 Fiararubicin HCL Inj. 19.01.2007 Fibrinolysin + Desoxyribonuclease May-91 Filgrastim Injection 9-Oct-96 Finasteride Sep-93 Finasteride tablets 5mg Oct-96 Fipronil 9.8% (S)-Methoprene 11.8% Frontline Plus (Dogs) contains: Fipronil Oct-96 9.8% (S)-Methoprene 8.8% Spot-on-solution (veterinary formulation) Frontline Plus (Cats) contains: Flavonoids Extracted from Rutacea (Aurantiaceae) containing standard 16.01.17 amount of Diosmin Flavophospholipol Jun-78 Flavoxate HCl Sep-89 Flavoxate HCl Tablet 100 mg 3/1979 to 7/1981 Flecainide Acetate Nov,1980 Flecainide Acetate 100 mg Tablet & 150 mg/ml Mar-93 Fluconazole 26.04.93 PHARMADOCX (Pharmaceutical Consultant) Ph 9896133556 Mail [email protected] (Contact for Setting up Pharma, Cosmetics, Medical Devices Plant, WHOGMP) LIST OF NEW DRUGS 1961 – MAY 2017 download from http://www.pharmadocx.com Page - 48

Fluconazole Capsules50mg/100mg/200mg/150mg and Fluconazole injection Jan-93 -2mg/ml Fluconazole (2%) + Zinc Pyrethione (1%) suspension 22-02-2005 Fluconazole + Secnidazole + Azithromycin 22.02.2005 Fluconazole + Zinc Pyrethrone (Each 30/60ml bottle contains: 2% + 1%) 07.06.1999 Lotion Fluconazole 0.3% w/v 15.09.2008 Fluconazole Dispersible tablets 50mg 22.04.08 Fluconazole For Oral suspension 50/200 mg per 5ml (Pack Size : 35ml) 22.04.2008 Fluconazole Gel (0.5%) 12/8/2004 Fluconazole tablet 300mg (Additional strength) 12.08.2004 Fludarabine Phosphate IV Inj. 26.06.99 Flumequine Vet. 26.06.1999 Flumethasone Pivalate + lodochlorohydroxyquinoline 1985 to 87 Flumethasone Pivalate 0.02% + lodochlorohydroxyquinoline 1% ear drops Oct-72 Flumethrin Nov-90 Flunarizine HCl 29.10.1997 Flunisolide Nov-90 Flunisolide Nasal Spray 0.025% w/w Nov-93 Fluocortolene + Flucortolene Caproate Jul-68 Fluocortolene + Neomycin Nov-78 Fluocortolone 2.5mg + Fluocartalone caproate 2.5mg + Neomycin Sulphate Nov-78 5mg per gm ointment Fluocortolone caproate 0.25gm + Flucortolone Trimethylacetate 0.25gm per Jun-78 100gm cream Fluocortolone trimethylacetae 0.612mg + Flucartolone caproate 0.630mg + Oct-78 Clemizole undecyclate 5mg + Cinclocamic HCl 1mg Suppositories Fluocortolone trimethylacetae 0.92mg + Flucartolone caproate 0.95mg + Oct-78 Clemizole undecyclate 10mg + Cinclocamic HCl per gm ointment Fluorescein Sodium Solution for Injection (100mg/ml) 2/3/2006 Fluorometholone + Gentamycin 02.03.2006 Fluorometholone 0.1% and Fluorometholone tarte liquifilm 0.25% opthalmic 28.07.2000 suspension Fluorometholone 1mg + Neomycin sulphate 3.5mg (as base) + Benzalkonium 04.09.1996 chloride 0.04mg per ml Ophthalmic suspension Fluorometholone USP1mg + Gentamicin 3mg (as sulphate) per ml eye drops 28.07.2000 Fluoxetine Hydrochloride Mar-90 Fluoxetine Hydrochloride Cap 20 mg Mar-90 Flupenthixol Jan,1977 Flupenthixol dihydrochloride eq. to flupenthixol 0.5mg + Melitracen Hcl eq. 01.01.1977 to Melitracen 10mg sugar coated Tablet Flupenthixol Tablet (Flupenthixol Hydrochloride equivalent to Flupenthixol 23.07.1981 0.5mg/ 1mg) Flupentixol Hydrochloride Tablet 0.5 mg Feb,1977 Fluperdnilamidiene + Gentamycin Sep,1972 Fluphenazine Deconate Depot Injection 20 mg/ml Feb-80 Fluphenazine Deconate Injection 2mg/ml Sep,1973 PHARMADOCX (Pharmaceutical Consultant) Ph 9896133556 Mail [email protected] (Contact for Setting up Pharma, Cosmetics, Medical Devices Plant, WHOGMP) LIST OF NEW DRUGS 1961 – MAY 2017 download from http://www.pharmadocx.com Page - 49

Fluphenozine Deconate 12/6/2010 Flupirtine Maleate Capsules 100mg 1969 to 74 Flupirtine Maleate Sustained Release Tablets 400mg 18.10.12 Fluprednidene acetate 0.1% + Gentamicin as Sulphate 0.1% Cream Feb-80 Fluprednylidene acetate 0.1% + Gentamicin Sulphate 0.1% + 5-Chloro - 8- Oct-78 hydroxygluconate 0.5% Cream Fluprednylidine 21-Acetate Dec,1977 Fluprednylidine 21-Acetate Cream 0.1% Dec-77 Fluraltadone Dec-77 Flurazepam Aug-85 Flurazepam capsules 15 mg/ 30 mg 1985 to 87 Flurbiprofen Jul-89 Flurbiprofen Eye drops 0.03% 03.1979 to 07. 1981 Flurbiprofen plaster 20 mg (7cm X 10cm) 11.12.2009 Flurbiprofen Sodium 0.03% Ophthalmic solution USP 14.11.2009 Flurbiprofen SR Cap. 200mg Jun-90 Flurbiprofen Tablet 50 mg & 100 mg Jul, 1979 flurometholone 28.04.1997 Flurometholone + Gentamicin sulphate 01.07.1996 Flurometholone + Neomycin sulphate 28.04.1997 Flurometholone 10 mg + Gentamicin 3 mg (as sulphate) per ml Eye Drops 04.9.1996 Flutamide Jun-86 Flutamide tablet 1985 to 87 Fluticasone Propionate 29.03.2000 Fluticasone Propionate 500mcg/250mcg/100mcg + Salmeterol (as the 18.03.1996 xinofoate) 50mcg Accuhaler Fluticasone Propionate 50mcg/125mcg/250mcg + Salmeterol xinafoate 29.03.2000 25mcg /25mcg /25mcg Powder for inhalation Fluticasone Propionate 50mcg/125mcg/250mcg + Salmeterol xinafoate 25/05/2010 25mcg/25mcg/25mcg Powder for inhalation Fluticasone Propionate ointment 18-Mar-96 Fluticasone furoate Nasal spray 27.5mcg per spray 19.03.09 Fluvastatin Tablet (As calcium) 10mg/20mg/40mg (additional strength) 29.01.07 Fluvastatin Sodium 29.01.2007 Fluvestrant 250mg/5ml Injection(Additional Dosage Regime) 25.11.2003 Fluvoxamine Maleate100/150mg ER Tablets 19.08.2009 Fluvoxamine Maleate 21.02.2000 Folic Acid 0.5mg + Ferrous Sulphate 150mg Capsule 21.02.2000 Fomepizole Bulk & Fomepizole Injection 1.5gm/Ampoule 14.03.16 Fondaparinax Sodium injection (Additional Indication) 28.01.08 Fondaparinax Sodium 28.01.2008 Formestane Depot Injection 22.10.2003 Formestane Depot Injection (I.M.) 250mg 06.03.1995 Formoteral Fumarate 6mcg/6mcg + Budesonide B.P. 100/200mg Capsule 17.08.2001 Inhaler Formoterol fumarate 4mcg/6mcg+Budesonide-80mcg/160mcg 16.10.2003 PHARMADOCX (Pharmaceutical Consultant) Ph 9896133556 Mail [email protected] (Contact for Setting up Pharma, Cosmetics, Medical Devices Plant, WHOGMP) LIST OF NEW DRUGS 1961 – MAY 2017 download from http://www.pharmadocx.com Page - 50

Formoterol 4.5mcg/4.5mcg + Budesonide 80/160 mcg Inhaler 16.10.2003 Formoterol 6 mcg + Mometasone furoate 100/ 200/ 400mcg Metered dose 16.10.2003 Inhaler & Dry Powder Inhalation Formoterol 6 mcg + Mometasone furoate 100/200/400mcg Metered dose 30.12.2009 Inhaler & Dry Powder Inhalation Formoterol Fumarate (6mcg) + Fluticasone Propionate (100/250/500mcg) dry 10/5/2006 powder inhaler Formoterol Fumarate (6mcg/6mcg/6mcg) + Fluticasone Propionate 10.05.2006 (100/250/500mcg) dry powder inhaler & MDI Formoterol fumarate 6mcg + Fluficasone propinate 50mcg/125mcg/250mcg 14/10/06 MDI Formoterol fumarate 6mcg+Budesonide- 400mcg capsule 07.03.2002 Formotnol fumarate 6mcg + Budesonide BP 400mcg per actuation inhaler 23.04.2002 MDI/DPI Formotorol fumarate-6mcg/6mcg + Budesonide 100mcg/200mcg per 19.11.2001 actuation Forskolin Eye drop (1%). 27/07/2006 Fortison liquid / powder pepti 2000 liquid powder 27.07.2006 Fosaprepitant (as Dimeglumine) for Injection 150mg. 27.01.1995 Fosfomycin Tromethamine Sachet 3gms 09.10.08 Fosinopril Sodium 09.10.2008 Fosinopril Sodium Tablet 10.01.2002 Fosphenytoin Sod. 10.01.2002 Fotemustine IV Injection (Finished formulation) 28.10.1993 Framycetin Sulphate + Hydrocortisone Acetate + Miconazole nitrate 01.12.1996 Framycetin sulphate 1% + Dexamethasone 0.1%+Clotrimazole 1% Cream Mar-87 Framycetin Sulphate 1% + Hydrocortisone Acetate 1% + Miconazole nitrate Apr-87 2% Fresemide + Potassium chloride Mar-89 Fresemide 20mg + Potassium chloride 750mg each tablet Mar-89 Frusemide + Spironolactone 07.03.1989 Frusemide 20mg/20mg + Spironolactone 50mg/100mg each capsule/tablet 01.07.1984 Frusemide 40mg/20mg + Potassium Chloride 600mg/300mg tablet 26.02.1993 Fucidic Acid hemihydrate Mar-92 Fulvestrant Inj. 250mg/5ml prefilled syringe 30/08/06 Furaltadone 30/08/06 Furaltadone powder 20 % w/w Aug,1973 Furazolidone + meteronidazole + pectin + kaolin Jan,1977 Fusagurgin Mar-79 Fusagurgin aerosol 25 mg Jan-77 futraful5flurouracil 24.01.08 Gabapentin Jun-97 Gabapentin 100mg + methylcobalamin 500mcg tablets (Additional Strength) 03.08.1995 Gabapentin 300mg + methylcobalamin 500mcg tablets (Additional Strength) 24.01.2008 Gabapentin caps 300mg/400mg 05.08.2005 Gabapentin ER 450/600/900mg tablet 15/12/06 Gabapentin SR 600mg tablets 15.12.2006 PHARMADOCX (Pharmaceutical Consultant) Ph 9896133556 Mail [email protected] (Contact for Setting up Pharma, Cosmetics, Medical Devices Plant, WHOGMP) LIST OF NEW DRUGS 1961 – MAY 2017 download from http://www.pharmadocx.com Page - 51

Gadobenate dimeglumine IV Injection (Gadobenate dimuglimine 529mg 30.01.2008 equivalent to Gadobenate acid 334mg + Meglumine 195 mg) (Additional Indication) Gadobenate(Dimeglumine IV Injection) 07.03.2003 Gadobutrol solution for injection 07.03.2003 Gadodiamide IV Injection 21-Jan-94 Gadodiamide IV injection (Each Iml Injection contains-Gadodiamide 287mg 21.01.1994 equl to 0.5m mol (in 10ml vial) Gadopentetic acid dimeglumine salt May-92 Gadopentetic acid dimeglumine salt injection 469.01 mg (0.5mmol) May-92 (Additional indication) Gadoteric acid 27.932gm+ Meglunine 9.76gm each 100ml for I.V. Inj. 23.2.15 Gadoversetamide Injection 04.06.2003 Gamma benzene Hexachloride IP 0.10% w/v Proflavin Hemisulphate 0.10% 04.06.2003 w/v Cetrimide IP 0.45 % w/v (veterinary product) (Additional dosage form) Spray dosing form contains: Gamma benzene Hexachloride IP 0.10% w/w Proflavin Hemisulphate 15.03.16 0.10%w/w Cetrimide IP 0.45 % w/w (veterinary product) Cream contains Ganciclovir 13.02.15 Garason eye drops/ointment 05.04.2000 Garenoxacin Mesylate tablets 200mg 01/11/1977 Gatanthamine HCL Tablet/Inj 03.10.2001 Gatifloxacin 01/12/1978 Gatifloxacin (0.3%) + Prednisolone Acetate (1%) eye drops 03.01.2000 Gatifloxacin 0.3% + Loteprednol Etabonate 0.5% + Benzalkonium Chloride 19.05.11 0.01% w/v Opthalmic suspension Gatifloxacin 3mg + Dexamethasone 1mg Eye Drop 18.06.2004 Gatifloxacin (0.3%) + Prednisolone Acetate (1%) eye drops 18.06.2004 Gatifloxacin (200mg) +Ornidazole (500mg) tablet 2/6/2006 Gatifloxacin (as sequihydrate)-3mg + Flurbiprofen sod.-0.3mg/ml eye drops. 02.06.2006 Gatifloxacin (as sesquihydrate) 3 mg + Flurbiprofen sodium 0.3 mg/ ml Eye 06.06.2205 Drops Gatifloxacin 0.3 % +Dexamethasone phosphate 0.1 % w/w eye drops 29.11.2007 Gatifloxacin 0.3% + Ketorolac Tramthamine 0.4% eye Drop 15.06.2004 Gatifloxacin 0.3% + Loteprednol Etabonate 0.5% + Benzalkonium Chloride 24.07.08 0.01% w/v Opthalmic suspension Gatifloxacin 400mg + Ambroxol 75mg Tablet 21.02.11 Gatifloxacin Eye drop 5 mg/ml 21.12.2004 Gatifloxacin Eye Ointment (1%) 6/10/2004 Gatifloxacin IP eq. to Gatifloxacin (Anhydrous) 3.0 mg + Difluprednate 06.10.2004 0.5mg + Benzalkonium Chloride IP (As preservative) 0.01% w/v Eye Drops Gatifloxacin sesquihydroate eq. Gatifloxacin 400mg + Ambroxol HCl SR 24.10.11 75mg film coated bilayered Tablet Gefitinib 15.06.2004 Gefitinib tab 250mg (Additional Indication) 17-02-2004 Gemcitabine HCl injection 2gm/vial (Additional Strength) 3/7/2010

Gemcitabine HCl injection ready to use infusion bags Gemcitabine HCL 17.06.2014 equivalent to Gemcitabine 10mg per mL (100,120,130,140,150, 160,170,180,190 and 200mL) (Approved as infusion bags) Gemcitabine Hydrochloride for injection 2g/vial (New dosage form) 27/10/2011 Gemcitabine in combine with cisplatin 27/10/2011 Gemcitabine Injection 24-Jan-96 Gemcitabine Injection 38mg/ml 24-Jan-96 Gemcitabine (1.4 gm/vial) 5.12.12 Gemfibrozil 01.09.2004 Gemfibrozil Capsule USP & Gemfibrozil Tablet USP 200mg/600mg (Addl. Aug-88 Indication) Gemfibrozil Capsules 300 mg /900 mg Aug-88 Gemifloxacin (as msylate) 320mg tablet Aug-88 Gemifloxacin + Ambroxol (320mg + 75mg SR) FC Tablets 30/08/06 Gemigliptin 50mg tablets 30/08/06 Gemtuzumab 21.08.15 Genirelix 12.09.2002 Genotropin 4IU/12IU/16IU injection 08.02.2001 Genotropin injection Jan,1978 Gentamycin Injection 2 mg/ml Sep-94 Gestodene + Ethinylestradiol 03.02.14 Gestodene 75 mcg+ Ethinylestradiol BP 20 mcg sugar coated tablet(additional Jul-88 strength) Gestodene 75mcg + Ethinylestradiol 30mcg tablet 03.02.14 Ginkgo biloba extract Jul-88 Ginkgo biloba extract Tablet 120mg (Additional strength) Sep-92 Ginkgo Biloba film coated tab. 40 mg Sep-92 Glatiramer Acetate injection (20mg/ml) 21.02.07 Glatiramer Acetate Injection (20mg/ ml) & Pre-filled syringe (20mg/ml) 21.02.07 Glibenclamide 30.11.1995 Glibenclamide 2.5mg+Metformin 400mg Film coated Tablets 1969 to 74 Glibenclamide +Metformin 20.08.2004 Glibenclamide 2.5/5mg Metformin HCl IP 500mg (SR) Each tablet contains: 30.11.1995 Glibenclamide 2.5mg/5mg + Metformin 500mg/500mg SR tablet 18.01.17 Glibenclamide 5mg + Pioglitazone 15mg + Metformin500mg film coated 20.08.2004 tablets Glibenclamide 5mg+ Metfermin 500mg Tablets 26.11.1996 Glibenclamide IP 2.5mg + Metformin IP 400mg film coated tablets 06.02.1996 Glibenclamide 5mg + Pioglitazone 15mg + Metformin500mg film coated 23.02.09 tablets Glibeneclamide 5mg + Metformin SR 850mg tablet (additional strength) 15.02.07 Gliclazide 15.02.07 Gliclazide 40/80mg + Metformin 500mg + Pioglitazone15mg Tablet Nov-88 Gliclazide 40mg/80mg + Metformin Hcl 500mg + Rosiglitazone 2mg tablet 19/07/10 Gliclazide M.R. (30mg/60mg)+ Metformin HCl (500mg) ER Tablet 22/08/06 Gliclazide M.R. (30mg/60mg/ 80mg)+Metformin HCl 27-04-2005 (500mg/500mg/500mg) ER Tablet PHARMADOCX (Pharmaceutical Consultant) Ph 9896133556 Mail [email protected] (Contact for Setting up Pharma, Cosmetics, Medical Devices Plant, WHOGMP) LIST OF NEW DRUGS 1961 – MAY 2017 download from http://www.pharmadocx.com Page - 53

Glimeperide (1 mg /2mg) + Pioglitazone 15 mg + metformin 500 mg ER FC 12.12.2003 Tablet Glimeperide 1mg+Rosiglitazone 4mg 16.08.2005 Glimepiride 22.01.99 Glimepiride 1/2 mg + Metformin 500 mg + Atorvastatin 10 mg tablets 22.01.1999 Glimepiride 1mg/2mg + Metformin 500mg SR Tablet 13.11.2002 Glimepiride 1mg/2mg. + Metformin SR 1000mg tablet (additional strength) 08.06.07 tablet Glimepiride IP 0.5 mg + Metformin Hydrochloride ER 500 mg uncoated 20.01.14 bilayered tablets (additional strength) Glimepiride1mg/2mg+Metformin Hcl I.P.500mg/500mg in SR form tablet 13.11.2002 Glipizide + Metformin 20/03/1998 Glipizide 2.5mg/5mg + Metformin 250mg/500mg tablet 20/03/1998 Glipizide GITS Tabs 5mg/10mg 21-Aug-96 Glipizidex Oct, 1978 Glucagon Injection 1975 to 76 Glucomannan Oct, 1978 Glucomannan Sachets (herbal medicine) ( Each sachets containing 01.09.1993 Glucomannan-0.75gm/1.0.gm/1.3gm) Glucosamine sulphate potassium chloride 500 mg + Ibuprofen IP 200mg film 24.08.1999 coated Tablets Glutaraldehyde 15% + cocobenzyl dimethyl ammonium chloride 10% + dye 14.09.11 <0.1% + perfume 6% + soften water-0.5% per litre Glutathione for Injection 600mg Sep,1971 Glybenclamide Tablet 5 mg 04.11.2002 Glycapyrrolate 500mcg + Neostigmine 2500 mcg per 5 ml injection Dec,1979 Glycopyrrolate Injection 0.2 mg/ml 11.04.2002 Glycopyrrolate-500mcg+ Neostigmine Methyl sulfate-2500mcg per 5 ml 01.04.2014 injection Glycopyrronium bromide inhalation powder hard capsule with inhaler. Each Feb,1976 capsule contains 63mcg Glycopyrronium bromide eq. to Glycopyrronium 50 mcg. Glydiazinamide 05.07.2000 Goserelin Acetate 18.12.2009 Granisetron 24.04.1996 Guaiphenasin Syrup 133mg/5ml 05.07.2000 Guaiphenesin ER Tablet (600mg) 16.05.2009 Guaiphenesin ER Tablet 1200mg 28.08.2008 Gugulipid 31.01.08 Haemodialysis Powder/Liquid Form containing citrate 1985 to 87 Haltrexone Oct., 1996 Halcinonide Dec-94 Halcinonide + Neomycin 1975 to 76 Halcinonide 1mg + Neomycin sulphate eq. to 2.5mg of neomycin base Jul-79 ointment/cream Halobetasol 0.05% + Clotrimazole 1.0% cream 04.01.08 Halobetasol 0.05% + Salicylic acid 6% Ointment (additional Strength) 04.01.08 PHARMADOCX (Pharmaceutical Consultant) Ph 9896133556 Mail [email protected] (Contact for Setting up Pharma, Cosmetics, Medical Devices Plant, WHOGMP) LIST OF NEW DRUGS 1961 – MAY 2017 download from http://www.pharmadocx.com Page - 54

Halobetasol 0.50mg + Fusidic acid 20mg Cream 14.05.08 Halobetasol 0.5mg + Miconazole 20mg per gram Cream 31.01.08 Halobetasol Propionate (0.5mg) + Salicylic Acid 30mg per gm of ointment. 30.01.2008 Halobetasol Scalp Approved 0.05% w/v 01.08.2007 Halobetazol Propionate Cream (0.05%) Jul, 1980 Halofuginone 02.02.2007 Halometasone (as monohydrate ) 0.05% Cream 03.1979 to 07. 1981 Halometasone monohydrate 0.05% w/w + Fusidic acid 2.00% w/w cream 13.09.2008 Halometasone monohydrate 0.05% w/w + Fusidic acid 2.00% w/w cream Feb-90 Haloperidol Deaconate 30/03/2006 Haloperidol Tablet (0.5mg) (addl. Lower strength) Feb-90 Hamycin cream 0.1% 03.03.2006 Hamycin Suspension 26.03.2002 Heparin Sodium 2 units + Sodium Chloride 9mg per ml 16.1.2014 Heparin Sodium Topical Solution 1000 IU/ml (Additional Dosage Form) Jan.87 Hepatitis B Vaccine May-91 Horse antihuman lymphocyte globulin 05.02.1998 HPMC 0.3% +Dextran 0.1% + Glycerin 0.2% May, 1991 HPMC 0.3% +Dextran 0.1% + Glycerin 0.2% Jan-93 eye drop Human Erythropoietin Injection 30/08/06 Human Insulin Sep,1978 Human Insulin (r-DNA) Powder inhaler 1985- 89 Human Placental Extract Injection 30.08.2006 Human Recombinant Granulocyte Colony Stimulating Factor Inj. 5/5/2011 Hyaluronic Acid Pre- filled Syringe 30mg/2ml& 60mg/4ml(Additional 29.06.2001 Strength) Hyaluronic Acid Salt 25mg + Cross-Linked Hyaluronic acid 25mg per ml in 30.01.08 prefilled syringe Hyaluronic Acid Salt 25mg + Cross-Linked Hyaluronic acid 25mg per ml in 30.01.2008 prefilledsyringe Hyaluronic Acid Sodium Salt 0.2 gm + Silver Sulfadiazine 1.0 gm/25 gm tube 31.03.09 Hyaluronic Acid Sodium Salt 50 mg + Silver Sulfadiazine 1.0gm/100gmgauze 31.01.09 pads impregneted with cream. Hyaluronic acid (cross linked) Pre-filled syringe 18mg/0.6ml and 24mg/0.8ml 31.03.09 Hyaluronic Acid Sodium Salt (i) Each 15gm tube contains: HyaluronicAcid 31.03.09 Sodium Salt 0.2gm/ 100gm (ii) Sterile Gauze Pads impregnated with cream: Each gauze pad contains Hyaluronic Acid Sodium Salt 50/100mg Hyaluronic Acid Sodium Salt 0.2 gm + Silver Sulfadiazine 1.0 gm/25 gm Jun-73 tube Hyaluronic Acid Sodium Salt 50 mg + Silver Sulfadiazine 1.0 gm/ 100 gm gauze pads impregneted with cream. Hydrocarticosone acetate 1%w/w + Nitrofurazone 0.2%w/w cream Aug-85 Hydrocortisone Aceponate 0.584 mg/ml Cutaneous Spray Solution (Vet.) Mar-71 Hydrocortisone Butyrate 1969 to 74 Hydrocortisone Butyrate cream/ ointment 0.10 % 1985-87 Hydroflumethiazide + Rauwalfia Mar,1971 PHARMADOCX (Pharmaceutical Consultant) Ph 9896133556 Mail [email protected] (Contact for Setting up Pharma, Cosmetics, Medical Devices Plant, WHOGMP) LIST OF NEW DRUGS 1961 – MAY 2017 download from http://www.pharmadocx.com Page - 55

Hydroflumethiazide 25mg/50mg + Rauwalfia 50mg/50mg Tablets Mar-71 Hydroflumethiazide Tablet 25 mg 31.01.08 Hydroquinone 2% + Tretinoin 0.025% (w/w) Momentasone 0.10% Gel 31.01.08 Hydroquinone 2% + Tretinoin 0.025% (w/w) Momentasone 0.10% Gel 31.01.08 Hydroquinone 2% + Tretinoin 0.05% + Hydrocortisone1% Cream 23.02.09 Hydroquinone 2%+ Tretinoin 0.05% + Hydrocortisone1%Cream 23.02.09 Hydroquinone 20mg + Tretinoin 0.25mg + Fluocinolone Acetonide 0.1mg per 23.02.09 gm Cream Hydroquinone 20mg + Tretinoin 0.25mg + Fluocinolone Acetonide 0.1mg per 31.01.11 gm Cream Hydroquinone USP 2% w/w + Tretinoin USP 0.025% w/w + Allantoin USP 31.01.11 1%w/w Gel Hydroquinone USP 2% w/w + Tretinoin USP 0.025% w/w + Allantoin USP Jun-86 1%w/w Gel Hydrotalcite Jun-86 Hydrotalcite + Smithicone 1985-87 Hydrotalcite 500mg + Smithicone (activated) 125mg Tablet & Hydrotalcite Jun-86 500mg + Smithicone (activated) 125mg per 5ml Suspension Hydroxy ethyl starch 10% Solution for infusion 31.01.08 Hydroxychloroquine 400mg tablets (Additional Strength) 17.10.08 Hydroxychloroquine Sulphate (Additional indication ) 31.01.2008 Hydroxychloroquine Sulphate Tablet 300mg (Additional strength/indication) 17.10.2008 Hydroxychloroquine Sulphate USP 400 mg tablets (Additional Indication) Jun-81 Hydroxyethyltheophylline + Theophylline monohydrate Jan,1971 Hydroxyethyltheophylline 231 mg + Theophylline monohydrate 69 mg SR Jun-81 Tablet Hydroxyurea Jan,1971 HydroxyureaUSPCapsules500mg 1969to74 Hydroxyurea USP Tablet 200 mg 20/08/10 Hydroxyzine Hydrochloride SR Tablets 25/50/75mg 31.03.08 Hylan GF 20 Injection (Synvisc) (Additional Indication) 04.11.10 Hyoscine Butylbromide 20 mg tablet (Additional Strength) 31.03.2008 Hyoscine-N-Butylbromide (10mg) + Paracetamol 500mg Tablet 8/12/2005 Hyoscine-N-Butylbromide (10mg) + Paracetamol 500mg Tablet 08.12.2005 For designing API / Bulk Drug Plant contact Pharmadocx Ibandronic Acid Injection 1mg/ml 3/10/2003 Ibandronic Acid Tablet (150mg) addl. Strength 18.05.2004 Ibopamine HCl 25.05.2006 Ibrutinib Hard gelatin Capsule 140mg 03.10.2003 Ibuprofen Oct-84 Ibuprofen 400mg + Chlorzoxazone 500mg Tablets 1969-74 Ibuprofen 400mg + Chlorzoxazone 500mg Tablets Mar,1971 Ibuprofen 400mg+ Paracetamol 325mg tablet Mar,1971 Ibuprofen BP Tablets, 200 mg Mar-90 Ibuprofen BP Tablets, 50 mg Apr,1979 Ibuprofen CR Tab 600mg 10.06.16

Ibuprofen Suspension 100mg/5ml 8/6/2006 Ibutilide Bulk & Ibutilide Fumarate Injection 0.1mg/m 26-07-2007 Icodextrin 7.5% peritoneal dialysis solution May-91 Idaravone Injection (1.5mg/ml). 08.06.2006 Idarubicin Hydrochloride 26.07.2007 Idebenone May, 1991 Idebenone tablets -30mg 26.09.97 Ifosfamide 05.04.11 Ifosfamide Injection 200mg/500mg/1g/vial Sept. 1978 Ilaprazole Tablets 5mg/10mg 9/9/2014 Iloperidone Tablets 1mg/2mg/4mg/6mg/8mg /10mg/12mg 15/11/2011 IMATINIB mesilate100/400mg tablets and 100 mg capsules (Additional 11/8/2011 indication) Imatinib mesylate 100 mg/400mg Tablets (Additional Indication) 5/4/2010 Imatinib mesylate 100 mg/400mg Tablets and 100mg Capsules (Additional 09.12.2001 Indication) Imatinib Mesylate 100/400mg Tablets (Addl. Indication) 03.10.09 Imatinib Mesylate 23-02-2004 Imidacloprid 10% + Moxidectin 1.0% & 2.5% Topical solution 09.12.2001 (Veterinary) Each pippette contains: (a) 0.4ml, 1.0ml, 2.5ml, 4ml of 10% Imidacloprid and 1.0% moxidectin (b) 0.4ml, 0.8ml of 10% Imidacloprid and 2.5% moxidectin Imidapril 14/07/10 Imipenem (as anhydrous) 250mg/500mg + Cilastatin Sodium eq. Cilastatin 23.02.2004 250mg/500mg per vial Imipenem 50mg + Clistatin 50mg 28.06.12 Imipenem 50mg + Clistatin 50mg Injection 28.06.12 Imipenem IP (Sterile) eq to anhydrous Imipenem 1 g + Cilastatin Sodium IP 25-07-2003 (sterile) eq to Cilastatin 1 g Powder for Injection (Additional strength) Imipenem IP (Sterile) eq.to. anhydrous Imipenem 1 g + Cilastatin Sodium IP Jan,1979 (sterile) eq.to. Cilastatin 1 g Powder for Injection (Additional strength) Imipenem +Cilastatin 28-12-2004 Imipramine Pamoate Capsule 75 mg/ 150 mg 25.07.2003 Imiquimod Cream 5% w/w 4/24/2010 Immucyst Bacillus calmette Gurin vaccine 28.12.2004 Inactivated rabies vaccine (Human Diploid cell) 01/06/1992 Indacaterol ( as Maleate ) Inhalation Powder Hard Capsules ….. 03.1972 to ...150/300mcg 07.1981 Indapamide (SR) 1.5mg/1.5mg + Nebivolol 2.5mg/5mg tablet 08.07.2009 Indapamide (SR) 1.5mg/1.5mg +Nebivolol 2.5mg/5mg tablet Oct, 1978 Indapamide 1.5mg/1.5mg + Ramipril 2.5mg/2.5mg FC Tablet 01.02.2001 Indapamide Hemihydrate 30.4.15 Indapamide Hemihydrate Tablets, 2.5mg Oct, 1978 Indinavir Sulphate March.86 Indomethacin Injection 1mg/vial (add. Dosage form) 01.02.2001 infectious bursal disease vaccine Nov-87 Infectious coryza vaccine 1985 to 87 PHARMADOCX (Pharmaceutical Consultant) Ph 9896133556 Mail [email protected] (Contact for Setting up Pharma, Cosmetics, Medical Devices Plant, WHOGMP) LIST OF NEW DRUGS 1961 – MAY 2017 download from http://www.pharmadocx.com Page - 57

Influenza Vaccine inactivated May-88 Inj. of a mixture of sod. Salt & methyl glucamine salt of 3,5-diacetamido- 1985 to 87 2,4,6-triiodobenzoic acid Interferon alpha injection (recombinant) 11.07.2001 Intralipid 30% 01.05.1988 Intravenous Fat Emulsion with Medium chain triglyceride Solution (10%) : 12.05.2005 Soyabean Oil USP 5gm+ Medium chain triglycries BP 5gm+ Egg lecithin 1.20g+Glyccerol IP 2.50gm+ water for injection q.s. per 100ml solution Intravenous Fat Emulsion with Medium chain triglyceride Solution (20%) : 19.3.13 Soyabean Oil USP 10gm+ Medium chain triglycries BP 10gm + Egg lecithin 1.20gm+Glyccerol IP 2.50gm+ water for injection q.s. per 100ml solution Iobitridol Jun-86 Iobitridol 17.10.2001 Iobitridol Solution for Injection Each 100mg solution contain 65.81 g 05.10.2000 Iobitridolcorressponding mass of Iodine 30gm Iohexol Sterile Sol. Jul-90 Iohexpl Sterile Solution 5/12/2011 Iomeprol 1985 to 87 Ioprimide 05.10.2000 Iopromide 1-Jul-90 Iopromide injection (Equ. To 300 & 370mg of Iodine) (Additional Indication) 03.04.2001 Ioversol Injection Nov-92 Ioversol Injection 160, 240 , 300, 320, 350 Dec-93 Ipratropium Bromide 500mcg + Salbutamol 26.06.2000 sulphate eq. to Salbutamol 2.5mg per 2.5 ml respiratory solution Ipratropium Bromide 31.01.2001 Ipratropium Bromide inhaler 20 mcg Nov. 1992 Irbesartan 31.08.10 Irbesartan 150mg/300mg + Hydrochlothiazide- 12.5mg/ 12.5mg tablet 26.06.2000 Irinotecan HCl Trihydrate 20.08.13 Irinotecan HCl Trihydrate Injection 20 mg/ml (Pack Size 25ml) 23.05.1997 Irinotecan HCl trihydrate solution for IV infusion 20 mg /ml in 2 ml & 5 ml 22.12.11 packsize Iron (III) isomaltoside 1000 solution for injection/infusion 100mg per ml 22.12.11 Iron+B6+B12 Feb,1977 Iron Amino Acid Chelate as Ferrous Bisglycinate (75mg) eq. to Elemental Feb,1977 Iron 15mg + Folic acid IP 0.25mg + Vitamin B 12 IP 3.75mcg +Zinc Picolinate (26mg) eq. to Elemental Zinc 5.5mg Syrup Iron Amino Acid Chelate as Ferrous Bisglycinate (75mg) eq. to Elemental 5/6/2010 Iron 15mg + Folic acid IP 0.25mg + Vitamin B 12 IP 3.75mcg + Zinc Picolinate (26mg) eq. to Elemental Zinc 5.5mg Syrup Iron Polymaltose eq to Elemental Iron Drops 50 mg/ml 26-Dec-97 Irsogladine Maleate Tablet 2mg /4mg 19.03.08 Isepamicin 19.03.08 Isepamicin injection 100mg/250mg per vial 26.02.1997 PHARMADOCX (Pharmaceutical Consultant) Ph 9896133556 Mail [email protected] (Contact for Setting up Pharma, Cosmetics, Medical Devices Plant, WHOGMP) LIST OF NEW DRUGS 1961 – MAY 2017 download from http://www.pharmadocx.com Page - 58

ISMN 30mg SR + Atenolol 50mg tablets (Additional Strength) 02.01.08 ISMN 30mg SR + Atenolol 50mg tablets (Additional Strength) 02.01.08 ISMN 30mg SR + Metoprolol Succinate equivalent to metoprolol tartrate 23.03.07 25mg/ 50mg tablets (Additional Strength) ISMN 30mg SR + Metoprolol Succinate equivalent to metoprolol tartrate 02.01.2008 25mg/50mg tablets (Additional Strength) ISMN 60mg Sr + Atenolol 50mg/100mg 20/07/2006 ISMN 60mg/60mg SR + Atenolol 50mg/100mg film coated tablet 23.03.2007 ISMN SR 30mg + Aspirin 75/150 mg tablet (addl. Strength). 10/8/2006 ISMN SR 30mg/30mg + Aspirin 75/150mg film coated tablet (addl. Strength) 20.07.2006 ISMN SR 60mg + Metoprolol Succinate ER 25/50mg 03.10.09 ISMN SR 60mg/60mg + Metoprolol Succinate ER 25/50mg film coated tablet Jul-90 Isoflupredone Acetate Suspension for Injection (2mg per ml) ( For Veterinary) Jan,1977 Isoflurane 20.01.2000 Isometanidium Chloride Jul-90 Isoniazid 300mg+Ethambutol 800mg+Vitamin B6 10mg tablet Jan. 1977 Isopropyl Unoprostone Sep,1974 Isopropylthioimidazolidione Tablet 5 mg 25.11.2003 Isoptin Hydrochloride Injection 5 mg/ 2ml 18.09.2009 Isosorbibe 20 mg + Hydralazine 37.5 mg tablets May-91 Isosorbibe 20mg + Hydralazine 37.5 mg tablets Aug-85 Isosorbide mononitrate 16.07.2002 Isosorbide mononitrate SR tab. 50mg 1985 to 87 Isosorbide Mononitrate tablet 20/40/60 mg 08.06.07 Isosorbid-mononitrate (SR pellets) 60mg+Aspirin 75mg Capsule 11/10/2004 Isotretinoin Gel (0.05%) 08.06.07 Isotretinoin 0.05% + Erythromycin 2% gel 11.10.2004 Isotretinoin Soft Gel Cap. 08.06.2007 Isoxuprine Hydrochloride Sustained Release Tablet 40 mg 21.06.2002 Isphghula 3.5gm + Lactitol 10gm per 15gm Sachet 22/05/2006 Itopiride Capsules 20-Jul-93 Itopride 150 mg capsule (S.R) 09.05.2002 Itraconazole capsules -100mg 22.05.2006 Itrolan Isovist 7/1/1993 Ivabradine (Hcl.) 5mg/7.5mg Tablets Oct., 1992 Ivabradine Hcl Tablets 5/7.5mg (Additional Indication) 03.07.08 Ivabradine HCL Tablets 5mg/7.5mg (Additional indication) Oct-85 Ivabradine Tablets 5mg/7.5mg (Additional Indication) 09.10.08 Ivermectin 13.09.08 Ivermectin IP 10 mg+ Clorsulon USP 100 mg (veterinary product): Each ml of 1985 to 87 injection contains Ivermectin solution 10 % w/v and 1% w/v injection 14.10.14 Ixabepilone lyophilized powder (additional Indication) Aug,1971 Ixabepilone lyophilized powder inj. 15mg/45mg per vial 09.10.2008 For setting up Cosmetics Unit Contact Pharmadocx Ketamine 13.09.2008

Ketamine Hydrochloride 1969 to 74 Ketoconazole Oct-86 Ketoconazole 2% + Zinc Pyrithone 1% Lotion 1985 to 87 Ketoconazole 2% w/v + Prepared Coal Tar 2% w/v (I.P. 1966) Solution Oct-86 Ketoconazole IP 1.0 %w/w + Chlorhexidine Gluconate Solution IP Eq. to 23.02.09 Chlorhexidine Gluconate 2.1 % w/w shampoo for topical use. (veterinary product) Ketoconazole tablet 200 mg and Ketoconazole suspension 20mg/ml 09.12.03 ketoconazole vaccine(Killed) 09.02.09 Ketoconazole 2% + Zinc Pyrithone 1% Lotion Jul-89 Ketoconazole 2% w/v + Prepared Coal Tar 2% w/v (I.P. 1966) Solution 11.12.2009 Ketoprofen 18.4.12 Ketoprofen CT Tab. 100mg 03/1979 To 07.1981 Ketoprofen plaster 30 mg (7cm X 10 cm) 09.03.11 Ketoprofen Plaster 30mg (7cm X 10cm) Apr, 1981 Ketoprofen Plaster 30mg (7cm X 10cm) 29.4.15 Ketoprofen Tablets/Capsule 50mg 1-Mar-96 Ketorolac ODS 10mg(Add. Dosage form) 20-09-2005 Ketorolac Sterile Ophthalmic solution 0.5% 21.09.10 Ketorolac Tromethamine 21.09.10 Ketorolac Tromethamine 0.4% Eye drops (addl. Strength) Apr-92 Ketorolac Tromethamine 0.4% w/v + Moxifloxacin 0.5% w/v Opthalmic 24.07.08 solution (Additional strength) Ketorolac Tromethamine 0.4% w/v +Moxifloxacin 0.5% w/v Opthalmic 24.07.08 solution Ketorolac Tromethamine 4mg + Gatifloxacin 3mg Eye Drops 12/07/2005 Ketorolac Tromethamine 5mg + Moxifloxacin 5mg/ml Opthalmic Solution 24.07.2008 Ketorolac Tromethamine 5mg + Ofloxacin 3mg per ml Eye drops 11.07.2007 Ketorolac Tromethamine 5mg + Ofloxacin 3mg/ml Eye drops 21.11.11 Ketorolac Tromethamine injection 30 mg/ ampoule 21.11.11 Ketorolac Tromethamine IP 4.00mg + Olopatadine Hcl eq. to Olopatadine 10/2/2010 1.00mg + Benzalkonium Chloride IP 0.05mg Ophthalmic solution Ketorolac Tromethamine IP 4.00mg + Olopatadine Hcl eq. to Olopatadine Apr-92 1.00mg + Benzalkonium Chloride IP 0.05mg Ophthalmic solution Ketorolac Tromethamine Ophthalmic Solution 0.45% 31.03.09 Ketorolac Tromethamine tablet 10 mg Mar-89 Ketorolac Tromethamine Gel 2%w/w May-91 KFD Vaccine May-92 Kitotifen Jun-90 Korsolex concentrated May, 1991 MEDICAL DEVICES MANUFACTURING FACILITY 1 CRORE L- Carnitine May, 1992 L- Lysine Hcl Ointment (150mg/gm) Jan.87 Labetalol Hydrochloride 08.08.2006 Labetalol Hydrochloride tablet 50 mg/ 100mg/ 200 mg 1985 to 87 Lacidipine tabs 2mg/4mg 19.10.12 PHARMADOCX (Pharmaceutical Consultant) Ph 9896133556 Mail [email protected] (Contact for Setting up Pharma, Cosmetics, Medical Devices Plant, WHOGMP) LIST OF NEW DRUGS 1961 – MAY 2017 download from http://www.pharmadocx.com Page - 60

Lacosamide film coated tablet 50mg /100mg /150mg /200mg 06.05.1997 Lacosamide Injection 10mg/ml 06.11.1995 Lacosamide Syrup15mg/ml(Additional Dosage Form) 14.05.07 Lactic acid + Lactoserum 21-11-2005 Lactic acid 1.0% w/v + Lactoserum 0.9% w/v (for topical use) 06.11.1995 Lactitol monohydrate Syrup 66.67/100ml 9/8/2014 Lactitol Sachet (10gm/20gm) 14.05.2007 Lactobacillus brevis CD2 Lozenges 100mg (corresponding to not less than 1 21.11.2005 billion) of live, lyophilised, lactic acid bacteria, Lactobacillus brevis CD2. (Additional indication) Lactobacillus Rhammnosus 1 billion cells + Saccharomyces Boulardi 125 mg Oct,1971 + Zinc Enriched yeast 20 mg sachets & capsules Lactobacillus Rhammnosus 1 billion cells + Saccharomyces Boulardi 125mg 28/03/2006 + Zinc Enriched yeast 20 mg sachets & capsules Lactobacillus Sporengenes Tablet, 50/100 million 11.11.2009 Lactulose Enema (20%) 06.08.2005 Lafutidine Tablets ....5mg/10mg. 28.03.2006 Lamivudine 04/08/2005 Lamivudine 150mg + Zidovudine 300mg + Efavirenz 600mg Combipack 27.03.1998 Lamivudine (40mg) + Nevirapine (70mg + Stavudine (10mg) per 5ml powder 1/28/2005 for suspension Lamivudine (40mg) + Stavudine (10mg) per 5ml reconstituted solution 28.01.2005 Lamivudine (40mg) +Nevirapine (70mg +Stavudine (10mg) (in 5ml) powder 08.04.2005 for suspension Lamivudine (40mg) +Stavudine (10mg/5ml) reconstituted solution 26.11.1999 Lamivudine + Zidovudine 11/8/2006 Lamivudine 150mg + Stavudine 40mg + Efavirenz 600mg Combi kit Tablet 26.11.1999 Lamivudine 150mg + Zidovudine 300 + Ebacavir 300 mg tablets 08.06.2005 Lamivudine 150mg + Zidovudine 300 + Efavirenz 600mg Combi kit Tablet 30.09.2003 Lamivudine 150mg + Zidovudine 300 tablets 08.06.2005 Lamivudine 20mg + Nevirapine 35mg + Stavudine 5mg tablet 01.04.08 Lamivudine 20mg + Stavudine 5mg dispersible tablets (Additional Sgtrength) 11.08.2006 Lamivudine 30/60mg + Stavudine 6mg/12mg + Nevirapine 50mg/100mg 01.04.2008 dispersible tablet Lamivudine 300mg + Abacavir 600mg Tablets 14.06.2005 Lamivudine 30mg + Zidovudine 60mg +Nevirapine 50mg Oral Suspension 12/7/2006 (Tablets for oral Suspension) Lamivudine 40mg + Stavudine 10mg dispersible tablet. 23.02.09 Lamivudine 30mg + Zidovudine 60mg +Nevirapine 50mg Oral Suspension 12.07.2006 (Tablets for oral Suspension) Lamivudine150mg+ Zidovudine 300mg + Abacavir as sulphate 300mg tablet 8/6/2006 Lamivudine300 mg ER+ Zidovudine 600mg ER tablet 5/4/2010 Lamivudine300 mg ER+ Zidovudine 600mg ER+ Nevirapine 400 mg tablet 09.03.2004 Lamotrigin 15.07.2004 Lamotrigin 200mg tablet (addl. Strength) dispersible tablet 14.05.1998 (5mg/50mg/100mg/200mg) Lamotrigine 25mg Modified Release Tablet (Addl. Strength) 08.06.2006 PHARMADOCX (Pharmaceutical Consultant) Ph 9896133556 Mail [email protected] (Contact for Setting up Pharma, Cosmetics, Medical Devices Plant, WHOGMP) LIST OF NEW DRUGS 1961 – MAY 2017 download from http://www.pharmadocx.com Page - 61

Lamotrigine ER Tablet 25mg/50mg/ 100mg/200mg 17.12.08 Lamotrigine MR Tablets 150mg (Addl. Strength) 20/03/2010 Lamotrigine MR Tablets 50/100mg 26-08-2004 Lamotrigine Orodispersible Tablet 12.5 mg(additional strength) 17.12.2008 Lamotrigine S.R. tablet 50 mg/100 mg/200 mg 16.12.94 Lamotrigine tab -25mg 26.08.2004 Lanine Diacemper killed, canine Hepatitis Leptospira Parovirous Vaccine 9/11/2005 Lansoprazole capsules 1985 to 87 Lansoprazole capsules 15 mg/30 mg 12/1/1994 Lansoprazole for injection 30mg/vial 24-07-2007 Lanthanum Carbonate Chewable tablet (250mg/500mg) 10/5/2010 Lapatinib (as Ditosylate) (250mg) Tablet 09.11.2005 Lapatinib Ditosylate Tablets 250mg (addl. Indication) 24.07.2007 L-Asparginase 02.08.2002 Latanoprost 1969 to 74 Latanoprost 0.005% W/v + Timolol maleate 0.5% W/v (Presevative free) 12.05.1998 Opthalamic Solution (Additional Dosage Form) Latanoprost 50mcg + Timolol maleate eq.to. Timolol 50mg each ml eye drops May,1971 Latanoprost 50mcg/ml Ophtalamic Solution (Additional Indication) 02.08.2002 L-Carnitine 08.12.2015 L-dihydroxyphenylalanine Jun-90 L-dihydroxyphenylalanine Tablet/Capsule 500 mg 1969 to 74 Lecithin Liquid (each 5 ml contains lecithin 500mg equivalent to essential 08.12.2015 phospholipids 250mg Ledipasvir (90mg)+ Sofosbuvir (400mg) Tablet 14.05.2008 Ledipasvir Bulk 16.05.07 Leflunomide 22.04.08 Lenalidomide 01.10.2001 Lenalidomide capsule (5mg/10mg/15mg/25mg) 01.10.2001 Lenalidomide Capsule 5mg/10mg/15mg/25mg (Additional Indication) 16.05.2007 Lenvatinib 4mg/10mg Hard Gelatin Capsules (Lenvatinib Mesylate) 22.04.2008 Lercanidine HCl 10.04.07 Lercanidipine 10mg + Atenolol 50mg Tablet 07.05.2002 Letrozole 2 17.10.2003 Letrozole 2.5mg tablet (for additional indication) 12.03.1998 Leuprolide acetate depot injection Jul,1980 Leuprolide acetate depot injection 3.75mg per vial 10.12.1997 Levamisole + Mebendazole Jul,1980 Levamisole 50 mg+Mebendazole 200mg tablet 28.09.1993 Levamisole HCl IP 1.5 g eq to levamisole 1.27 g + Oxyclozanide IP 2.0 g + 29.09.1993 Anhydrous Copper Sulphate BP eq to elemental copper 18.75 mg + Zinc sulphate monohydrate USP eq to elemental Zinc 6.0 mg + Cobalt sulphate eq to elemental cobalt 2.25 mg (veterinary product) Each Bolus (Tablet) contains:

Levamisole HCl IP 112.5 mg eq to levamisole 95.45 mg + Oxyclozanide IP 11.03.16 150 mg + Anhydrous Copper Sulphate BP eq to elemental copper 1.25 mg + Zinc sulphate monohydrate USP eq to elemental Zinc 0.4 mg + Cobalt sulphate eq to elemental cobalt 0.15 mg (veterinary product): Each 5 ml of the suspension contains Levamisole HCl IP 2.0gm + Oxyclozanide IP 4.0gm (veterinary product) 17.12.14 (Additional strength) Each Bolus contains: Levamisole Hydrochloride Injection 15% & 30% w/v 08.03.16 Levamisole hydrochloride IP 15.0% w/w Eq. to Levamisole 12.7% w/w + 4/4/2005 Anhydrous Copper Sulphate BP Eq. to elemental Copper 0.16% w/w + Zinc Sulphate Monohydrate USP Eq. to elemental Zinc 0.05% w/w + Cobalt Sulphate Eq. to elemental Cobalt 0.02% w/w soluble powder for oral use. (veterinary product) Levamisole Injection 18.2% w/v 30.01.08 Levamisole-1.5%+Oxyclozanide-3.0% Suspension 22-09-2005 Levetiracetam (250mg,500mg,750mg) Tablets 24/02/2006 Levetiracetam Oral Solution (100mg/ml) 5/5/2011 Levetiracetam Oral Solution (100mg/ml). 9/10/2007 Levetiracetam Oral Solution 100mg/ml (Additional Indication) 2.05.2009 Levetiracetam Tablet (addl. indication) 16/01/2010 Levetiracetam SR Tablet 500/750/1000mg 09.10.2007 Levobetaxolol HCl Opthalmic Suspension 0.5% 08.05.07 Levobunolol Hydrochloride 13.01.2010 Levobunolol Hydrochloride ophthalmic solution 2.5MG/5.0MG 16.05.1996 Levocetirizem 2Hcl. Dispersible tablet (2.5mg) 25-07-2007 Levocetirizine 2.5mg + Montelukast 4mg Dispersible Tablet & Syrup 08.05.2007 Levocetirizine Di-HCl mouth dissolving tablets (5mg) (new dosage form) 5/5/2011 Levocetirizine Di-HCl syrup (2.5mg/5ml) (for use in children 2 years and 25.07.2007 above). Levocetirizine Di-HCl Syrup 2.5mg/5ml (Additional Indication) 13.10.10 Levocetirizine Dihydrochloride 2.5mg + Montelukast 5mg dispersible tablet 29.01.2004 Levocetirizine dihydrochloride 2.5mg +Montelukast 5mg dispersible tablet 14.1.15 Levocetirizine Dihydrochloride IP 2.5mg/2.5mg/5mg + Montelukast Sodium 13-01-2005 IP Eq. to Montelukast 4mg/5mg/10mg orally disintegrating strip. (Additional dosage form) Levocetirizine HCl 2.5mg/5mg + Pseudoephodrine HCl SR 120mg/180mg 13.12.99 tablet Levocetirizine ODS 2.5/5mg (Additional dosage form) 29.01.2004 Levocetirizine Syrup (2.5mg/5ml) 20/07/2006 Levocetrizine 13.01.2005 Levocetrizine 2.5/5mg + Ambroxol 30mg/5ml of Syrup 12.12.2002 Levocetrizine 5mg + Ambroxol Hydrochloride SR (75mg) Capsule 20.07.2006 Levocetrizine 5mg + Ambroxol Hydrochloride SR (75mg) tablet 29.07.2005 Levocetrizine Di HCl Dispersible tablet 5mg/10mg (New Dosage form) 24.05.2006 Levocitirizine 2 Hcl 5mg+ Ambroxol Hcl SR 75mg + Pseudoephedrine Hcl 28.01.2008 120mg SR Capsules

Levocloperastine ( as Fendizoate) Suspension eq. to Levocloperastine 09.08.2006 Hcl 20mg / 5ml. Levodopa (50mg/100mg/150mg) + Carbidopa (12.5mg/25mg/37.5mg + 04.03.09 Entacapone (200mg) FC tablet Levodopa + Benserazide 25.07.2005 Levodopa 100/100/250 + Carbidopa10/25/25mg mouth dissolving tablet Nov-85 Levodopa 100/100/250 + Carbidopa10/25/25mg mouth dissolving tablet 02.09.1988 Levodopa 100mg/200mg + Benserazide 25mg/50mg each capsule 08.01.2008 Levodopa 100mg/250mg + Carbidopa 10mg/25mg Tablet/Capsules 08.01.08 Levodopa 200mg + Carbidopa 50mg C.R. tablet Dec-83 Levodopa+Carbidopa 08.01.2008 Levodropropizine Eur. Ph. 30mg + Chlorpheniramine maleate IP 2mg per 5 Dec-83 ml Syrup Levodropropizine Eur. Ph. 30mg + Chlorpheniramine maleate IP 2mg per 5 11/7/2007 ml Syrup Levodropropizine oral suspension (30mg/5ml) 11/7/2007 Levofloxacin 25.02.2005 Levofloxacin (15mg) + Prednisolone Acetate 10mg per ml eye drops. Jul-99 levofloxacin (250mg/500mg) + ambroxol SR 75mg tablet 16.07.2007 Levofloxacin 0.5% Ear drops 08.02.2007 Levofloxacin Oph. Solu. (1.5%) 15mg/ml. (Addl. Strength). 27.06.2006 Levofloxacin Ophthalmic Solution (0.5%) 16.12.2005 Levofloxacin Oral Solution (each 240ml bottle contains Levofloxacin 04.03.2005 125mg/5ml.) Levofloxacin tablet (250mg /500mg) & Infusion 5mg/ml (For additional 07.03.2007 indication) Levonorgesterel 26.09.2006 Levonorgesterel + Ethniyl estradiol 17.01.2002 Levonorgesterel 100mcg +Ethniyl estradiol IP 20mcg tablet 07.06.2001 Levonorgestrel 0.03mg tablet 07.02.07 Levonorgestrel 0.25mg + Ethinyl Estradiol 0.05mg tablets 23.03.2007 Levonorgestrel 1.5mg tablets 20-10-2004 Levosalbutamol MDI (50mcg/actuation) & Dry Powder inhaler 07.02.2007 (100mcg/capsule) (New Dosage Form) Levosalbutamol rotacaps (100 mcg/capsule) & inhaler (50 mcg /actuation) 16.03.2007 Levosalbutamol Tablet 1 mg/2mg & Syrup 1 mg/5 ml. 20.10.2004 Levosimendan Injection 2.5mg / ml 16.07.2004 Levosulpiride Inj. 25mg/2ml (additional Strength) 12.6.07 Levosulpiride Inj. 25mg/ml, 2ml 17.12.2008 Levosulpiride tablet (25mg) 26.09.2008 Levosulpiride Tablet (50mg/100mg) (addl. strength for addl. indication). 10.05.2007 Levosulpride (SR) 75mg + Rabeprazole sodium IP (EC Pellets) 20mg 12.06.2007 Capsule Levosulpride (SR) 75mg + Rabeprazole sodium IP (EC Pellets) 20mg Capsule 17.12.08 Levosulpride ER Tablet 100/150/200mg 28.11.1997 Levosulpride Injection 25mg/2ml (Additional Strength) Oct-88 Levovist May, 1999 PHARMADOCX (Pharmaceutical Consultant) Ph 9896133556 Mail [email protected] (Contact for Setting up Pharma, Cosmetics, Medical Devices Plant, WHOGMP) LIST OF NEW DRUGS 1961 – MAY 2017 download from http://www.pharmadocx.com Page - 64

Levovist 4gm & 2.5gm granules per 20 ml vial(1gm granules contains 28.11.1997 Galactose 999mg + Palmetic acid 1 mg) Licomycin 50mg + Spectinomycin 100mg for vetarnary use 26/03/2010 Lidocaine +Prilocaine 26/03/2010 Lidocaine 2%+Prilocaine 2.5% w/w cream 13.05.1999 Lidocaine 2.5% w/w+Prilocaine 2.5% w/w Gel 30/07/10 Lidocaine 2.5% w/w+Prilocaine 2.5% w/w Gel (additional strength) 15/07/10 Lidocaine HCl Ophthalmic Sterile Gel 35 mg/ml 26.02.09 Lidocaine Lozenges 100mg (Additional Strength) 19.08.2009 Lidocaine Lozenges 200/300mg 17/06/2010 Lidocaine Lozenges 200/300mg (Addl. Indication) 26.03.09 Lidocaine Patch 350mg (Additional Pack Size) 03/12/2010 Lidocaine Patch 700mg in aqueous base. (50 mg per gram adhesive) 12/3/2010 Lidocaine7.5mg + Prilocaine 2.5mg per acutation spray May,1974 Lidocaine7.5mg + Prilocaine2.5mg per acutation spray Sep-78 Lidoflazine Tablets 18.06.1996 Lidoflazine Tablets, 60mg 1969 to 74 Lignocaine + Aluminium Hydroxide + Magnesium hydroxide + Activated 26.07.13 dimethicone Lignocaine 50mg + Aluminium Hydroxide 300mg + Magnesium hydroxide Sept., 1978 100mg + Activated dimethicone 20NF 50mg Tablet & 5 ml suspension Lignocaine(base) 2% + Silver Sulphadiazine 1% + Chlorhexidine Glulonate 23.01.12 02% cream Linagliptin 2.5mg/2.5mg/2.5mg + Metformin 500mg/850mg/1000mg Film Mar-89 coated Tablets Linagliptin film coated Tablet 5mg Dec,1972 Lincomycin 300mg + ethyl Prednisolone Jun,1973 Lincomycin 300mg + Neomycin 200mg + Methyl Prednisolone 5mg per 10ml Mar-89 Infusion Solution Lincomycin Hydrochloride Capsule 500 mg 04.10.2001 Lincomycin Syrup 250 mg/5ml 30-05-2004 Linezolid 01.04.2002 Linezolid (600 mg) Tablet 04.10.2001 Linezolid 2mg+Dextrose-5% per ml injection 30.05.2004 Lipid Based Amphotericin-B Gel 0.1% 02.08.2016 Lipoproteins extracted from human placenta lotion 50% 29.01.09 Liposomal Amphotericin B Injection 50mg/vial (Additional Dosage Form) 29/04/2010 Liquid Paraffin1.25ml + Milk of Magnesia 3.75ml + Sodium Picosulphate 29/04/2010 3.33mg per 5ml Liquid paraffin 6% + White soft paraffin 15%w/v Cream 29.01.09 Liquid paraffin 6% + White soft paraffin 15%w/v Cream Nov-91 Liquid Paraffin1.25ml + Milk of Magnesia 3.75ml + 23.11.1995 Sodium Picosulphate3.33mg per 5ml Lisinopril 23.04.2002 Lisinopril 10mg/20mg/5mg+Hydrochlorothiazide 12.5mg/25mg/12.5mg 01.11.1991 uncoated tablet

L-Isoleucine 0.335gm + L-Lencine 0.500gm + L-Valine 0.380gm + L-Lysine Nov,1972 0.550gm + L-Methionine 0.120gm + L-Pnenylalanine 0.210gm + L- Threomine 0.185gm + L-Tryptophan 0.100 + L-Ariginine 0.420gm+ L- Histidine 0.190gm + L-Alanine 0.400gm + L-aspartic acid 0.300gm + L- Lystine 0.095gm + L-Glutanic acid 0.500gm + Amino acetic acid IP 0.200gm + L-proline 0.150gm+L- serine 0.200gm + L-Tyrosine 0.45gm + L- ornithine Hcl 0.144gm + Taurine 0.030gm per 100 ml injection L-Isoleucine 9.20mg + L-Leucine HCL 9.45mg+L- Methionine 0.395mg + L- 28-06-2004 Phenylalanine 0.44mg + L-Threonine0.30 mg + L-Tryptophen 2.14mg + L- Valine 0.70mg + L-Alanine 8.90mg + L-Arginine 8.40mg + L- Aspartic Acid 15.37mg + L histadine 0.20mg + L- Proline 3.10mg + L-Serine 5.30mg + L- tyrosine 2.60mg + Glycine 0.40mg + WFI per 100ml Lithium Carbonate 10.04.08 Lithium Carbonate Capsule 250 mg 1969 to 74 Lithium Carbonate ER (450mg) tablet 21.05.07 Live freeze-dried lactic acid bacteria and bifidobacteria capsules 28.06.2004 Livetiracetam conc. for infusion 100mg/ml (new dosage form) 10.04.2008 Lixisenatide pre-filled solution for injection 10µg/20 µg 21.05.2007 Lofepramine 20-May-94 Lomefloxacin Jan-90 Lomefloxacin eye drops 3mg/ml 20.05.1994 LomefloxacinTablet 400mg Jun-86 LomustineCapsule10mg,40mg&100mg Dec,1976 Lopamidol Sterile Sol 16.10.2001 Loperamide 06/08/2006 Loperamide + Simethicone 08.09.08 Loperamide Hcl 2mg + Simethicone 125mg tablet 16.10.2001 Lopinavir 200mg + Ritonavir 50mg Tablet (addl. Strength) 08.09.08 Lopinavir + Ritonavir (100 + 25mg) Tablets (additional strength) 08.06.2006 Lopinavir 200mg + Ritonavir 50mg Tablet (addl. Strength) 18.01.2001 Lopinavir 80mg + Ritonavir 20mg per 5 ml oral solution, Lopinavir 133.3mg 17.09.1999 + Ritonavir 33.3 mg Capsule Lopinavir+Ritonavir Jun-92 Loratadine 21.08.1996 Loratadine 10mg + Psendoephedrine sulphate in ER form 180mg film coated Jun-92 Tablet Loratadine tablet 10 mg Sep,1973 Loratidine + Pseudoephedrine 29.05.15 Loratidine 5mg + Pseudoephedrine 120mg (ER) tablets 21.08.1996 Lorazepam Dec,1973 Lorazepam Orodispersible Tablet 1mg/2mg(add. Dosage form) 1969 to 74 Lorazepam Tablet 1mg, 2 mg 13.09.10 Lornoxicam 4mg + Eperisone 50mg tablet 05.02.09 Lornoxicam 4mg + Paracetamol 500mg film coated tablets 02/12/2010 Lornoxicam 4mg/4mg + Thiocolchicoside 4mg/8mg tablets 12.11.07 Lornoxicam 8mg /2ml inj. 14.05.2009 Lornoxicam 8mg + Paracetamol 500mg Tablet 23/03/2010 PHARMADOCX (Pharmaceutical Consultant) Ph 9896133556 Mail [email protected] (Contact for Setting up Pharma, Cosmetics, Medical Devices Plant, WHOGMP) LIST OF NEW DRUGS 1961 – MAY 2017 download from http://www.pharmadocx.com Page - 66

Lornoxicam 8mg/8mg + Thiocolchicoside 4mg/8mg Tablets (additional 11.12.2009 strength) Lornoxicam 8mg/8mg + Thiocolchicoside 4mg/8mg Tablets 21.05.07 Lornoxicam ER Tablet 8 mg (Additional Strength) 26.6.2009 Lornoxicam tablet 4mg/ 8mg 05.02.09 Lornoxicam 12 mg SR (additional strength) 25.04.2009 Lornoxicam 4mg + Paracetamol 500mg film coated tablets 15.09.08 Lornoxicam SR 16mg Tabs 15.09.08 Losartan + Chlorthalidone (25/25/50/50mg + 6.25/12.5/6.25/12.5mg) Tablets 10.11.08 Losartan + Chlorthalidone (25/25/50/50mg + 6.25/12.5/6.25/12.5mg) Tablets 10.11.08 Losartan + HCTZ (100 mg + 25 mg) Tablets 16.03.09 Losartan 100mg+ HCTZ 25 mg tablet 10.11.2008 Losartan 25/25/50/50mg + Chlorthalidone 6.25/12.5/6.25/12.5mg FC Tablet 14.05.08 Losartan50mg+Atenolol50mg 14.05.08 Losartan Potassium 25mcg + Amlodipine (as besylate) 5mg tablets. 08.06.1999 (Additional Strength) Losartan Potassium 50mg + Hydrochlorothiazide 12.5mg film coated Tablet 14.05.2008 Losartan Potassium tablets -25mg/50mg/100mg 10.09.2003 Losartan 100mg+ HCTZ 25 mg tablet 12/7/2007 Losarten 50mg/50mg + Ramipril 2.5mg/5.0mg tabs 12/7/2007 Loteprednol Etabonate (0.5%) + Levofloxacin (1.5%) Eye drops. 1.12.2009 Loteprednol etabonate 0.5% w/v + Moxifloxacin 0.5% w/v opthalmic 14.02.07 Suspension Loteprednol etabonate 0.5% w/v + Moxifloxacin 0.5% w/v opthalmic 14.02.07 Suspension Loteprednol Etabonate 5mg + Tobramycine 3mg per ml ophthalmic solution 15.03.2002 Loteprednol Etabonate 5mg + Tobramycine 3mg per ml ophthalmic solution 31.01.09 Loteprednol Etabonate Ophtalmic Sol. 5-Oct-95 Loteprednol Etabonate Nasal spray 0.1% w/v 24.12.2004 Lovastatin 10mg/20mg/40mg Sep-90 Lovastatin 20mg + Niacin 500mg ER form film coated Tablets Apr, 1977 Loxapine 14.08.08 Loxitalmic Acid 16.10.10 Loxoprofen Sodium tablet (60mg) 19-12-11 Lubiprostone Soft Gelatin Capsules ..…8mcg /24mcg 3.06.2009 Luliconazole lotion 1 % W/V (new Dosage Form) 1/8/2006 Luliconazole Cream 1% Jun-86 Lumiracoxib Tablet (100/200/400mg). 18.07.16 Luprostiol Jul-69 Lurasidone Hydrochloride Bulk & Lurasidone Hydrochloride Tablets Sep,1973 40mg/80mg Lutin 0.1gm + Vit 0.1gm + Vit K1 2.5mg + Dicalcium Phosphate 0.1gm + Apr-79 Carlozochrome Salicylate 1mg tablet Lyndiol Injection Sep-73 Lynestrenal 0.75mg + Ethinylestradiol 37.5mcg tablet Mar,1975 Lynestrenal 1mg + Ethinylestradiol 50mcg tablet Sep-70 lynestrenol BP Tablet 2.5 mg Apr-67 PHARMADOCX (Pharmaceutical Consultant) Ph 9896133556 Mail [email protected] (Contact for Setting up Pharma, Cosmetics, Medical Devices Plant, WHOGMP) LIST OF NEW DRUGS 1961 – MAY 2017 download from http://www.pharmadocx.com Page - 67

Lynestronol 2.5mg + Ethinyloestradiol 50mcg 7-Jul-93 Lynestronol 2.5mg + Mestranol 0.075mg Tablet Nov-82 For Setting up Medical Devices Implant Factory Contact Website : Pharmadocx 9896133556 www.pharmadoc x.com Maduramicin 1% w/w premix Vet 26/03/2010 Magaldrate tab 400 mg 4.06.2009 Magnesium Hydroxide IP 98 mg Added as Magnesium Hydroxide paste 04.12.08 Aluminium Hydroxide 0.291 g (Added as Aluminium Hydroxide Paste) Eq to 0.380g of Dried Aluminium Hydroxide gel IP Oxetacaine BP 10 mg Liquid orals Each 5 ml (one teaspoonful) contains Magnesium Valproate CR Tablet 200/ 300/400/ 500 mg (additonal strength) 13.02.15 Magnesium Valporate Prolonged release tablet 600mg Dec,1973 Magnesuim Valproate Tablet 200mg/400mg Sep, 1975 Malathion dusting powder 1% 25.11.2009 Malathion lotion 0.5 % Sep,1972 Maraviroc Tablets 150mg/300mg. Feb-83 Marcaine 0.25 %/0.5% with or without adranaline Dec-87 Measles Mumps Rubella Vaccine Dec,1978 Measles, mumps and rubella vaccine Nov,1974 Mebendazole 12/12/2006 Mebendazole Suspension 100 mg/5ml 1969 to 74 Mebendazole Tablets, 100mg 12/12/2006 Mebeverine Hcl 6/7/2006 Mebeverine Hcl 135mg + Chlordiazepoxide 5mg tablet 1969 to 74 Mebeverine HCl 135mg + Isabgula husk 3.5gm sachet. 12.12.2006 Mebeverine HCl 135mg + Isabgula husk 3.5gm sachet. Oct,1971 Mebeverine HCl prolonged release capsule (200mg). 10.03.2008 Mebeverine Hydrochloride Tablet 100 mg 03.07.08 Mecobalamin 0.5mg + Alpha Lipoic Acid 100mg + Benfotiamin 100mg + 03.07.08 Pyridoxine 50mg fim coated tablet Mecobalamin 0.5mg + Alpha Lipoic Acid 100mg + Benfotiamin100mg + 19.03.08 Pyridoxine 50mg tablets Mecobalamin 0.5mg+ Alpha Lipoic Acid 100mg + Benfotiamin100mg + 19.03.08 Pyridoxine 50mg tablets Mecobalamin 1000mcg + Alpha Lipoic Acid 200mg + vitamin B6 3mg + 01.03.2008 Folic Acid 1.5mg + Inositol 100mg + Benfotiamine 100mg capsule Mecobalamin 1000mcg + Alpha Lipoic Acid 200mg + vitamin B6 3mg + 06.09.2008 Folic Acid 1.5mg + Inositol 100mg + Benfotiamine 100mg capsule Mecobalamin 1000mcg + Vit B1 10mg + Vit B6 3mg + Folic Acid 1mg + 03.07.2008 Calcium Pantothenate 50mg + Niacinamide 45mg tablets Mecobalamin 1500mcg + Alpha lipoic acid 100mg + Vit B6 3mg + Folic 25.02.2008 acid 1.5mg + Zinc 15mg + Chromium 60mcg + Selenium 65mcg + Biotin 100mcg + Inositol 2mg Tablet Mecobalamin 1500mcg + Alpha Lipoic Acid 100mg + B1 10mg + B6 3mg + 13.11.2007 Folic Acid 1.5mg capsules

Mecobalamin 1500mcg + Alpha lipoic acid 100mg + Inositol 100mg + Vit.A 03.07.2008 5000IU + Vit B1 10mg + Pyridoxine 1.5mg + Vit E 25IU + Calcium Pantothenate 10mg + Folic Acid 1500mcg + Chromium 200mcg + Selenium 163.6mcg tablet Mecobalamin 1500mcg + Alpha lipoic acid 100mg + Inositol 100mg + Vit.A 29.11.2007 5000IU + Vit B1 10mg + Pyridoxine 1.5mg + Vit E 25IU + Calcium Pantothenate 10mg + Folic Acid 1500mcg + Chromium 200mcg + Selenium 163.6mcg tablet Mecobalamin 500mcg + Alpha Lipoic Acid 100mg + Folic acid 1.5mg + 30.01.2008 Benfotiamine 50mg Soft gelatin Capsules Mecobalamin 500mcg + Vit A 5000IU + Vit D3 400IU + Vit E 25IU + Vit B1 16/03/2010 10mg +Riboflavin 10mg + B6 3mg + Niacinamide 50mg + Calcium Pantothenate 12.5mg + Vit C 100mg + Folic acid 1500mcg + Biotin 60mcg + L-Glutamic acid 100mg + Dl-Methionine 25mg + Magnesium oxide 30mg + Manganese 2.5mg + Copper 2.5mg + Zinc 22.5mg + Chromium 100mcg + Selenium 60mcg tablets Mecobalamin 500mcg + Zinc Sulphate 61.8mg + Calcium Patothenate 10mg 16/03/2010 + Pyridoxine 3mg + Folic Acid 1.5mg + Niacinamide 50mg + Chromium 50mcg Tablets Mecobalamin 750 mcg + Pyridoxine 1.5mg + Nicotinamide 45 27.10.2009 mg+Benfotiamine 150mg Tablets Mecobalamin 750 mcg+Pyridoxine 1.5mg+Nicotinamide 45 mg + 27.10.2009 Benfotiamine 150mg Tablets Mecobalamin 750 mg + Pyridoxine Hydrochloride1.5 mg + Nicotinamide 45 29.11.07 mg tablets Mecobalamin 750mg + Pyridoxine Hydrochloride1.5 mg + Nicotinamide 45 29.11.07 mg tablets Mecobalamin0.5mg + Pyridoxine 50mg + Benfotiamine100mg capsule 30.01.08 Mecobalamin0.5mg + Pyridoxine 50mg + Benfotiamine100mg capsule 30.01.08 Mecobalamin1500mcg + Alpha Lipoic Acid100mg + Benfothiamine15mg + 30.01.08 B63mg + Calcium Pantothenate 25mg + Folic Acid 1.5mg + Zinc oxide 22.5mg + Chromium picolinate 65mcg + Inositol10mcg+Lutein5mg capsule Mecobalamin1500mcg +Alpha Lipoic 30.01.08 Acid100mg+Benfothiamine15mg+B63mg+Calcium Pantothenate25mg+Folic Acid 1.5mg+Zinc oxide22.5mg+Chromium picolinate65mcg+Inositol10mcg+Lutein5mg capsule Mecobalamin500mcg + Alpha Lipoic Acid200mg + Benfotiamin 10mg + 12.07.2007 Pyridoxine3mg + Biotin5mg + Folic acid 1.5mg capsule Mecobalamin500mcg + Alpha Lipoic Acid200mg + Benfotiamin 10mg + 12.07.2007 Pyridoxine3mg + Biotin5mg + Folic acid 1.5mg capsule Mecobalamine 500mcg + Alpha Lipoic Acid 100mg + Inositol 100mg + Folic 29.11.2007 Acid 0.5mg + Chromium Polynicotinate 65mcg + Selenium Dioxide 18mcg Capsules Mecobalamine 1500mcg + Alpha Lipoic Acid 200mg + Inositol 100mg + 12/07/2007 Folic Acid 1.5mg + Chromium Polynicotinate 200mcg + Seleno Methionine 55mcg + Zinc Monomethionine 25mg Capsule PHARMADOCX (Pharmaceutical Consultant) Ph 9896133556 Mail [email protected] (Contact for Setting up Pharma, Cosmetics, Medical Devices Plant, WHOGMP) LIST OF NEW DRUGS 1961 – MAY 2017 download from http://www.pharmadocx.com Page - 69

Mecobalamine 1500mcg + Alphalipoic Acid 100mg + Thiamine mononitrate 39275 10mg + Pyridoxine 3mg + Folic Acid 1.5mg Capsule Mecobalamine 500/1500mcg + Alpha Lipoic Acid 100mg + Inositol 100mg + 02.04.07 Folic Acid 0.5/1.5mg + Chromium Polynicotinate 65mcg/200mcg + Selenium Dioxide18/55mcg + Benfotiamine 50/150mg capsule Mecobalamine 500/1500mcg + Alpha Lipoic Acid 100mg + Inositol 100mg + 02.04.07 Folic Acid 0.5/1.5mg + Chromium Polynicotinate 65mcg/200mcg+ Selenium Dioxide18/55mcg + Benfotiamine 50/150mg capsule Mecobalamine 500mcg + Alpha Lipoic acid 100mg soft gelatin capsule 19-07-2005 Mecobalamine 500mcg + Alpha Lipoic acid 100mg soft gelatin capsule 12.08.2016 Mecobalamine E.R. tablet (1500mcg) 23.02.1999 Medoxyprogesterone Acetate Suspension for Injection 104mg/0.65ml Jun-86 Subcutaneous Route. (Additional Indication) Medronic acid 10 mg + Stannous chloride 2H2O-1mg per vial injection Jul,1980 Medroxy progesterone acetate Tablet Jan,1976 Medrysone Ophthalmic Suspension 1.0% 12.07.2002 Mefenamic acid 3-Mar-97 Mefenamic acid 500mg + Tizanidine 2mg Nov-82 Mefloquine Hcl tabs 250mg Nov-82 Megaldrate 400mg + Simethicone 60 mg chewable tablet 5.12.12 Megaldrate 400mg + Simethicone 60 mg per 5ml Suspension Feb,1974 Megestrol Acetate Oral Suspension 400mg per 10ml (10 & 20mg Sachet) 16.10.2002 Meglumine Locarbate 16.08.2001 Meglumine gadoteric May-88 Meglunine Ioxaglate sodium + Sodium Ioxaglate injection 12-Mar-98 Melagenina Lotion 16.02.99 Melatonin tab -3mg 23.2.15 Melitracen + Flupenthixol 02.04.2002 Melitracen Hcl 28.10.98 Meloxicam 28.10.98 Meloxicam ODT 7.5/15 mg(Additional dosage form) 31.01.08 Meloxicam Inj. (Vet) 31.01.08 Memantine 5mg /10mg + Donepezil 5mg Tablets 17.12.2010 Memantine 5mg/10mg + Donepezil 5mg Tablets 06.09.10 Memantine ER Tablet 7mg/14mg/21mg. (Additional Strength) 19-07-2004 Memantine HCl ER Tablet 28mg 28-May-93 Memantine HCl tablet 5 mg/10 mg. 20/05/2011 Menesin Sodium 15.03.11 Meparticin 1985 to 87 Mepartricin tablets 50000 Units May-93 Merckezyme 15.03.11 Meropenem Injection IP 500mg/1.0g (Additional Indication) May-77 Meropenem IP 1000mg + Sulbactam sodium USP 500mg injection 08.01.2002 Meropenem IP 1000mg + Sulbactam sodium USP 500mg injection 30.03.09 Meropenem Inj. 04.04.2002 Mesalamine PR Tablets 1.2gm 04.04.2002 Mesalazine SR 29.11.07 PHARMADOCX (Pharmaceutical Consultant) Ph 9896133556 Mail [email protected] (Contact for Setting up Pharma, Cosmetics, Medical Devices Plant, WHOGMP) LIST OF NEW DRUGS 1961 – MAY 2017 download from http://www.pharmadocx.com Page - 70

Me-salicylate 30% + Menthol 10% + camphor 4% Cream Jul,1974 Me-salicylate 30% + Menthol 10% + camphor 4% Cream Mar,1981 mesterolone May-67 Mesterolone Tablet 10 mg 2.05.2014 Mesterolone Tablet 25 mg 24-10-2003 Mestranol 4mg + Ethinyloestradial 0.05mg Tablet 08.10.2002 Metadoxine 22-02-2005 Metaxalone 24.10.2003 Metaxalone (400mg) + Diclofenac Potassium (50mg) tablet 08.10.2002 Metclopramide 22.02.2005 Metformin (ER) 1000mg/500mg + Saxagliptin 2.5 mg/5mg Tablets 20/08/10 Metformin 500/500mg + Repaglinide 1/2mg Tablet 08/02/2010 Metformin 500/500mg + Repaglinide 1/2mg 2/8/2010 Metformin 500/850/1000mg + Sitagliptin Phosphate 50/50/50mg Tablet 17.12.2003 (Additional Indication) Metformin 500/850/1000mg+Sitagliptin Phosphate 50/50/50mg (Additional 25.9.14 Indication) Metformin 500mg CR + Glipizide 5mg CR Tablet 22.10.13 Metformin ER tablet 750mg (Additional strength) 17.12.2003 Metformin Hcl 500mg/850mg/1000mg + Vildagliptin50mg/50mg/50mg Film 25.01.08 coated Tablet ( additional indication) Metformin Hcl 850mg + Sitagliptin Phosphate 50mg Tablet 25.01.08 Metformin HCl ER 500mg + Fenofibrate 80mg/160mg tablet 05.01.11 Metformin HCl ER 500mg + Fenofibrate 80mg/160mg tablet 25.01.2008 Metformin HCl IP 500mg + Alpha Lipoic Acid USP 200mg Tablet 4/3/2005 Metformin HCl IP 500mg + Alpha Lipoic Acid USP 200mg Tablet 28/05/2010 Metformin Oral Solution (100mg/ml) 28/05/2010 Metformin SR 500mg/500mg + Gliclazide SR 60mg/30mg + Pioglitazone 04.03.2005 15mg/15mg tablets Metformin SR 500mg/500mg + GliclazideSR 60mg/30mg + Pioglitazone 10.05.2016 15mg/15mg tablets Methadone Hydrochloride 5mg/10mg per ml syrup; 5mg/ 10mg/ 20mg / 10.05.2016 40mg tablet Methadone Hydrochloride Oral Syrup 5mg/10mg per ml (in 150 ml pack) Apr-70 (additional indication) Methadone Hydrochloride tablet 5mg/10mg (additional indication) Jul, 1980 Methandienone BP 25mg + Benzyl alcohol in sterile solution 9% w/v/ml 22-12-2005 Methicillin Sodium 25-11-2005 Methimazole Tablet ( 5mg/10mg) 07.03.08 Methotrexate Topical gel (1%) Addl. Strength 22.12.2005 Methoxsalen USP-20mg Tablet 25.11.2005 Methyl Cobalamin 07.03.2008 Methyl cobalamine 500mcg + folic acid 1.5mg + B6-3mg,+ Zn.sulphate 31.10.07 61.8mg + Ca. Pantothenate 10mg+ Niacinamide- 50mg + chrimium-50mcg capsule

Methyl cobalamine 500mcg + folic acid1.5mg + B5-5mg,+ Zn.sulphate 25mg 29.11.07 + Cr.Polynicotinate 200mcg + selenium-65mcg + inositol-1.5mg + alpha lipoic acid–100mg capsule Methyl cobalamine 500mcg + folic acid1.5mg+B5-5mg,+Zn.sulphate Mar,1978 25mg+Cr.Polynicotinate 200mcg+selenium-65mcg+inositol-1.5mg + alpha lipoic acid –100mg capsule Methyl cobalamine 500mcg+folic acid1.5mg+B6-3mg,+Zn.sulphate 15/06/2006 61.8mg+Ca.Pantothenate 10mg+ Niacinamide-50mg +chrimium-50mcg capsule Methyl predinsolone 19.11.07 Methyl predinsolone 10 mg + Clotrimazole 1mg per gram cream 19.11.07 Methyl Prednisolone Aceponate Cream (0.1%) 12.07.2007 Methyl Prednisolone Aceponate Topical Solution (0.1%) 04.04.2007 Methyl prednisolone aceponate-1mg + Mupirocin 20 mg Cream 06.06.1997 Methyl prednisolone aceponate-1mg + salicylic acid-50mg ointment 21.11.2007 Methyl prednisolone aceponate-1mg + salicylic 10.07.2009 acid-50mg ointment Methyl valerate 100mg + Quinine Anhydrous 15mg + Camphor 10mg + Oil 11.01.11 of eucalyptus 10mg capsule Methyl Phenidate ER Tablet 10/20/30mg 01.03.2008 Methylcobalamin 500mcg + Folic Acid IP 1.5mg + Zinc Sulphate IP 31-07-2007. 25mg + Chromium Polynicotinate 200mcg + Selenium as Sodium Selenite USP 65 mcg + Inositol 100mg + Alpha Lipoic Acid 50mg + Streptococcus faecalis 30 Millions (30 lakh) + Clostridium butyricum 2 Million (20 lakh) + Bacillus mesentericus 1 Million (10 lakh) + Lactic acid bacillus 50 Million (500lakh) Capsule Methylcobalamin 500mcg + Vit A 5000IU + Vit E25IU + Ascorbic Acid 31-07-2007. 100mg + Vit B1 10mg + Riboflavin 10mg + Pyridoxine 3mg + Niacinamide 500mcg + Folic Acid 50mg + Calcium Pantothenate 1mg + Zinc Oxide 12.5mg + Cupric Oxide 15mg + Sodium Selenate 2.5mg + Manganese Chloride 60mg+ Manganese 1.4mg + Chromium 65mcg tablets Methylcobalamin (500mcg) + Alpha Lipoic Acid (100mg) + Pyridoxine 31.03.08 (3mg) + Folic acid (1.5mg) Soft Gelatin Capsule. Methylcobalamin (500mcg) + Alpha Lipoic Acid (100mg) + Pyridoxine 31.03.08 (3mg) + Folic acid (1.5mg) Soft Gelatin Capsule. Methylcobalamin 1000 mcg + Pyridoxine HCl IP 100 mg + Nicotinamide IP 4.11.2009 100 mg + Depanthenole IP 50 mg per 2ml of Injection Methylcobalamin 1000mcg + Pyridoxine Hcl IP 100mg + Nicotinamide IP 31.07.2007 100mg + D-Panthenol IP 50mg per 2 ml of injection Methylcobalamin 1000mcg + Pyridoxine Hcl IP 100mg + Nicotinamide IP 4.11.2009 100mg + D-Panthenol IP 50mg per 2 ml of injection Methylcobalamin 1500 mcg + Gabapentin SR 600 mg film coated tablets 19.09.2005 Methylcobalamin 1500 mcg + Gabapentin SR 600 mg film coated tablets 03.07.2008 (additional strength) Methylcobalamin 1500 mcg ER + Pyridoxine (20 mg) + Folic Acid 5 mg 03.07.2008 Tablet Methylcobalamin 1500mcg (ER) + Pyridoxine 20mg IR + Folic Acid 5mg 16.09.2005 tablets PHARMADOCX (Pharmaceutical Consultant) Ph 9896133556 Mail [email protected] (Contact for Setting up Pharma, Cosmetics, Medical Devices Plant, WHOGMP) LIST OF NEW DRUGS 1961 – MAY 2017 download from http://www.pharmadocx.com Page - 72

Methylcobalamin 1500mcg + Alpha Lipoic Acid 100mg + Folic Acid 1.5mg + 04.07.08 Selenium Dioxide 163.6mg + Calcium Pantothenate 10mg + Vit B1 10mg + Vit B6 1.5mg + Vit E 25IU + Vit A 5000IU + Inositol 100mg + Chromium polynicotinate 200mcg soft gelatin capsules Methylcobalamin 1500mcg + Alpha lipoic acid 200mcg + Folic acid 1.5mg + 04.07.08 Biotin 30mcg + Pyridoxine 3mg capsules Methylcobalamin 1500mcg + Alpha Lipoic Acid 200mg + Benfotiamine 14.10.2008 50mg + Vit B6 3mg + Biotin 5mg + Folic Acid 1.5mg capsule Methylcobalamin 1500mcg + Alpha Lipoic Acid 200mg + Benfotiamine 14.01.09 50mg + Vit B6 3mg + Biotin 5mg + Folic Acid 1.5mg capsule Methylcobalamin 1500mcg + Alpha Lipoic Acid 300mg Capsule 23/06/2010 Methylcobalamin 1500mcg + Calcium 200mg + Calcitriol 0.25mcg + Folic 03.07.2008 Acid 1.5mg + Pyridoxine 3mg Capsules Methylcobalamin 1500mcg + Folic acid 0.7mg + Niacinamide 12mg injection 23/06/2010 Methylcobalamin 1500mcg + Pyridoxine 1.5mg + Folic acid 5mg capsules 23/06/2010 Methylcobalamin 1500mcg + Pyridoxine 100mg + Nicotinamide 100mg 23/06/2010 injection Methylcobalamin 1500mcg + Pyridoxine 100mg + Nicotinamide 100mg 05.09.2008 injection Methylcobalamin 1500mcg +Folic acid 0.7mg +Niacinamide 12mg injection 26.09.2007 Methylcobalamin 150mg + Pyridoxine 12.5mg + Alpha Lipoic Acid + Inositol 04.07.2008 + Folic Acid Methylcobalamin 500 mcg + Alpha lipoic Acid 100mg + Pyridoxine Hcl 1.5 19.02.2008 mg + Thiamine 2 mg + Calcium Picolinate 200mg Tablet Methylcobalamin 500 mcg + Alpha lipoic Acid 100mg Soft Gelatin Capsule 16.10.2007 Methylcobalamin 500 mcg + Beta Carotene 10.33mg + Alpha Lipoic Acid 05.04.2007 100mg +B6 1.5 mg + B1 2 mg & Cr. Polynicotinate Methylcobalamin 500 mcg + gaba pentin 300 mg FC tablet 18.10.2007 Methylcobalamin 500 mcg +Alpha Lipoic Acid 100mg + Pyridoxine (3 mg) + 05.08.2005 Folic Acid 1.5 mg Soft Gelatin Capsule Methylcobalamin 500 mcg +Folic Acid 1.5 mg + Alpha Lipoic Acid 100mg + 31.07.2007 B6 3mg + Thiamine 10 mg Capsule Methylcobalamin 500 mcg +Folic Acid 1.5 mg + Alpha Lipoic Acid 300mg + 29.11.2007 Benfetiamin 50mg Capsule Methylcobalamin 500/750/1500mcg + Alpha Lipoic Acid 100/200 + 13.11.2007 Pyridoxine 1.0/1.5/3mg + Folic Acid 0.5/0.75/1.5mg Soft Gelatin Capsules Methylcobalamin 500mcg + Alpha lipoic acid 100mg + Beta Carotene 25.02.2008 5.17mcg +VitB1 2mg+ Vit B2 2mg+VitB6 1.5mg+ Vit C50mg+ Vit D3 200IU + Vit E 10IU + Niacinamide 25mg + Folic Acid 50mg + Calcium Patothenate 5mg + Chromium Picolinate 2.5mg + Selenium Di oxide 1.4mg + Zinc Oxide 65mcg + Copper Sulphate 15mg + Manganese Sulphate 60mcg + Lutein 1mg tablet

Methylcobalamin 500mcg + Alpha lipoic acid 100mg + Beta Carotene 14.05.2008 5.17mcg + Vit B1 2mg +VitB22mg+VitB61.5mg+VitC50mg+Vit D3 200IU + Vit E 10IU + Niacinamide 25mg + Folic Acid 50mg + Calcium Patothenate 5mg + Chromium Picolinate 2.5mg + Selenium Di oxide 1.4mg + Zinc Oxide 65mcg + Copper Sulphate 15mg + Manganese Sulphate 60mcg + Lutein 1mg table Methylcobalamin 500mcg + Alpha Lipoic Acid 100mg + Pyridoxine 1.5mg + 31.07.2007 Folic Acid 3mg Soft Gelatin Capsule Methylcobalamin 500mcg + Alpha Lipoic Acid 50mg + Folic Acid 1.5mg + 01.03.2008 Selenium Dioxide 163.6mcg + Calcium Pantothenate 10mg + Vit B1 10mg + Vit B6 1.5mg + Vit E 25IU + Beta Carotene 20.66mg tablet Methylcobalamin 500mcg + Ascorbic acid 100mg + Niacinamide 50mg + Vit 18-10-2007. E 25mg + Calcium Pantothenate 12.5mg+Vit B1 10mg + Riboflavin 10mg + Vit B6 3mg + Vit A 5000IU + Folic Acid 1mg + Zinc Oxide 15mg + Copper Gluconate 2.5mg +Manganese 1.4mg + Chromium 65mcg + Selenium 60mcg tablets Methylcobalamin 500mcg + Beta Carotene 20.66mg + Vit A 5000IU + Alpha 28.12.2007 Lipoic Acid 50mg + Folic Acid 1.5mg + Selenium 163.6mcg + Calcium Pantothenate 10mg + Vit B1 1.5mg + Vit B6 + Vit E 25IU tablets Methylcobalamin 500mcg + beta carotine-10.33mg+alpha lipoic acid 31.10.2007 100mg+B6 1.5mg+B1 2mg & Chromium Polynicotinate soft gelatin capsule Methylcobalamin 500mcg + Calcium 250mg + Calcitriol 0.25mcg + Folic 11.01.11 Acid 1.5mg + Pyridoxine 3mg + Zinc 7.5mg Capsules Methylcobalamin 500mcg + Folic acid 1.5mg + B5 - 5gm + Zinc Sulphate 14.10.2008 25mg + Chromium Polynicotinate 200mcg + selenium 65mcg + B6 1.5mg + inositol 100mg + Alpha lipoic acid 50mcg Capsules (Each inner capsule contains - Streptococcus Faccalis T-110 JPC 30 Million; Clostridium butyricum TO-A 2 Million;Bacillusmesentericus TO-A JPC 1 Million;Lactic acid bacillus 50 Million) Methylcobalamin 500mcg + Folic Acid IP 1.5mg + Zinc Sulphate IP 25mg + 04.07.2008 Chromium Polynicotinate 200mcg + Selenium as Sodium Selenite USP 65 mcg + Inositol 100mg + Alpha Lipoic Acid 50mg + Streptococcus faecalis 30 Millions (30 lakh) + Clostridium butyricum 2 Million (20 lakh) + Bacillus mesentericus 1 Million (10 lakh) + Lactic acid bacillus 50 Million (500lakh) Capsule Methylcobalamin 500mcg + L-Arginine 13.28mg + L- Histidine 3.71mg + L- 28.12.2007 Isoleucine 5.9mg + L- Leucine 18.3mg + L- Lysine 25mg + DL Methiononie 18.4mg + L- Phenylalanine 5mg + L- Threonine 4.2mg + L- Tryptophan 5mg + L- Valine 6.7mg + 5-Hydroxy Anthranilic acid 0.2mg + Vit A 2500IU + Cholecalciferol 200IU + Tocopherol Acetate 7.5IU + Vit B1 5mg + Riboflavin 1.5mg + Nicotinamide 40mg + Calcium Patothenate 30mcg + Vit b6 0.75mg + Vit C 4mg + Biotin 20.5mg + Folic Acid 7.43mg + Copper sulphate 1.4mg + Ferrous sulphate 0.1mg + Magnesium sulphate 10mcg + Potassium iodide15mg + Sodium selenite200mcg + Zinc sulphate + Chromium polynicotinate

Methylcobalamin 500mcg + Pyridoxine 3mg + Folic acid 1.5mg + 28.03.2008 Eicosahexanoic acid 90mg + Docosahexanoic acid 60mg + Vit E 25 IU + Vit C 100mg + Zinc 15mg + Selenium 60mcg Capsule Methylcobalamin 500mcg + Vit C 75mg + Vit B6 10mg + Folic Acid 5mg + 19.02.2008 Carbonyl Iron 100mg capsules Methylcobalamin 500mcg + VitA 5000IU + Vit D3 400IU + Vit E 25mg + 18-10-2007. Calcium Pantothenate 50mg + L- Glutamic Acid 50mg +Vit B1 10mg + Riboflavin 10mg + Vit B6 3mg + Niacinamide 50mg + Vit C 75mg+ Biotin 260mcg + Folic Acid 1mg + Zinc Sulphate 60mg + Chromium Picolinate 150mcg + Selenium 100mcg + Manganese Sulphate 200mcg + Magnesium Hydroxide 10mg + Copper Sulphate 200mcg Tablet Methylcobalamin 500mcg + VitA 5000IU + Vit E 25mg + Vit C 75mg + Vit 30.01.2008 D3 400IU + Folic Acid 1.5mg + Biotin 150mcg + Vit B1 5mg + Riboflavin 5mg + Vit B6 1.5mg + Niacinamide 50mg + Calcium Pantothenate 10mg + L- Glutamic acid 50mg + Chromium Picolinate 250mcg + Selenium 70mcg + Zinc Sulphate 55mg + Copper Sulphate 2mg + Manganese sulphate 5mg + Sodium Molybdate 25mcg + Manganesium Oxide 10mg sugar coated tablets Methylcobalamin 500mcg + VitA 5000IU + Vit E 25mg + Vit C 75mg + Vit 31.01.2008 D3 400IU + Folic Acid 1.5mg + Biotin 150mcg + Vit B1 5mg + Riboflavin 5mg + Vit B6 1.5mg + Niacinamide 50mg + Calcium Pantothenate 10mg + L- Glutamic acid 50mg + Chromium Picolinate 250mcg + Selenium 70mcg + Zinc Sulphate 55mg + Copper Sulphate 2mg + Manganese sulphate 5mg + Sodium Molybdate 25mcg + Manganesium Oxide 10mg sugar coated tablets Methylcobalamin 500mcg+beta carotine-10.33mg+alpha lipoic acid 14.01.09 100mg+B6 1.5mg+B1 2mg & Cr.polynicotinate. Methylcobalamin 750mcg + Alpha Lipoic Acid 100mg + Folic Acid 300mcg 03/05/2010 capsules Methylcobalamin1500mcg + Calcium 200mg + Calcitriol 0.25mcg + Folic 5/3/2010 Acid1.5mg + Pyridoxine3mg Capsules Methylcobalamin750mcg + Pregabalin75/150mg + Vitamin B6 1.5mg + Folic 16-10-2007. acid 0.75mg + Benfothiamine7.5mg capsules Methylcobalamin750mcg + Pregabalin75/150mg + Vitamin B61.5mg + Folic 16-10-2007. acid0.75mg + Benfothiamine7.5mg capsules Methylcobalamine (500mcg) + Alpha Lipoic acid (100mg) + Pyridoxine HCl 13.11.07 (1.5mg) +Thiamine (2mg) + Calcium Picolinate (200mg) tablet. Methylcobalamine (500mcg) + Alpha Lipoic acid (100mg) + Pyridoxine HCl 29.11.07 (1.5mg)+Thiamine (2mg) + Calcium Picolinate (200mg) tablet. Methylcobalamine 500mcg + folic acid 1.5mg + alpha lipoic acid–300mg + 29.11.07 Benfothiamine- 50mg. capsule Methylcobalamine 500mcg+folic acid 1.5mg + alpha lipoic acid –100mg 13.11.07 +B6-3mg+Thiamine 10mg capsule Methylcobalamine 500mcg+folic acid 1.5mg+ alpha lipoic acid –100mg +B6- 30.01.2008 3mg+Thiamine 10mg capsule Methylcobalamine 500mcg+folic acid1.5mg+ alpha lipoic acid –300mg 30.01.08 +Benfothiamine-50mg. capsule Methylcobalamine 750mcg + Adenosylcobalamin 500mcg + Folic Acid 30.01.08 1.5mg + Elemental Iron 100mg capsules PHARMADOCX (Pharmaceutical Consultant) Ph 9896133556 Mail [email protected] (Contact for Setting up Pharma, Cosmetics, Medical Devices Plant, WHOGMP) LIST OF NEW DRUGS 1961 – MAY 2017 download from http://www.pharmadocx.com Page - 75

Methylcobalamine 750mcg + Alphalipoic acid 100mg + Benfothiamine 7.5mg Feb-69 + B6 1.5mg + Calcium pantothenate25mg + Nicotinamide 50mg + Folic acid 0.75mg capsule Methylcobalamine 750mcg + Alphalipoic acid 100mg + Benfothiamine 7.5mg 07/06/2010 + B6 1.5mg + Calcium pantothenate25mg + Nicotinamide 50mg + Folic acid0.75mg capsule Methyldopa 250mg + HCTZ 15mg Tablet 6/7/2010 Methyloglucamine Salt & Sodium Salt Mixture 8/12/2004 Methylparaben 0.15%w/w + Propyl paraben 0.05%w/w + Glycerin 20%w/w 1975 to 76 +CMC 1.74%w/w +Allantoin 0.5%w/w +Benzyl alcohol 0.5%w/w. GEL Methylparaben 0.15%w/w +Propyl paraben 0.05%w/w+Glycerin 20%w/w 21.11.07 +CMC 1.74%w/w +Allantoin 0.5%w/w +Benzyl alcohol 0.5%w/w. Methylphenidate HCl (18, 36, 54 mg) E.R. tablet 21.11.07 Methylprednisolone 04.04.07 Methylprednisolone aceponate-1mg + Mupirocin-20mg. Cream Mar-78 Methylprednisolone aceponate-1mg + Mupirocin-20mg. cream 09.09.09 Methylprednisolone aceponate-1mg + Salicyclic Acid 50mg Ointment Aug-85 Methylprednisolone Acrponate Cream 0.1% 19.11.2007 Methylprednisolone Acrponate topical solution 0.1% 15.06.2006 Metoclopramide Apr-92 Metoclopramide + Dimethyl polysiloxane 1975 to 76 Metoclopramide (as HCl) 200mg / 400mg per ml Intranasal Solution Aug. 85 Metoclopramide 5mg + Dimethyl polysiloxane 250 mg tablet 23.04.2003 Metoclopramide CR Tab. 15mg 25.08.08 Metolazone 25.08.2008 Metolazone + Spironolactone FC Tablets (2.5/5mg + 50mg) 23.04.2003 Metolazone 2.5/5mg + Spironolactone 50mg/50mg FC Tablet 25.08.2008 Metolazone 2.5mg + Losartan Potassium 25mg/50mg tablets 28.05.08 Metolazone 2.5mg + Ramipril 2.5mg/5mg 28.05.2008 Metoprolol succinate ER 25 mg + Telmisartan 40mg Tablet 28.05.2008 Metoprolol (As succinate) 25mg + Amlodipine (As besylate) 5mg (additional 20.02.07 strength) Metoprolol (As succinate) 50mg/25mg ER) + Amlodipine 5mg/2.5mg tablet 10.04.2007 (For additional indication) Metoprolol (As succinate) ER 25mg/50mg + Ramipril 2.5mg/5mg 20.02.2007 Metoprolol (As succinate) ER 25mg/50mg + Ramipril 2.5mg/5mg tablets 26.02.2007 Metoprolol 050/50/25 mg + Atorvastatin 20/10/10 mg + Ramipril 10/5/2.5 mg 1.07.2009 capsules Metoprolol 25mg/50mg + Chlorthalidone 12.5/ 12.5 mg film coated bilayered Jun-89 Tablet Metoprolol 25mg/50mg + Chlorthalidone 6.25mg /12.5mg film coated 16.07.08 bilayred tablet (additional strength) Metoprolol 50/50/25 mg + Atorvastatin20/10/10 mg + Ramipril 10/5/2.5 mg 16.07.08 capsules Metoprolol 50mg + HCTZ 12.5mg Tablet Aug-85 Metoprolol ER + Amlodipine tablets (Additional Indication) 30/11/06 Metoprolol inj. 1 mg/ml 02/07/2006 PHARMADOCX (Pharmaceutical Consultant) Ph 9896133556 Mail [email protected] (Contact for Setting up Pharma, Cosmetics, Medical Devices Plant, WHOGMP) LIST OF NEW DRUGS 1961 – MAY 2017 download from http://www.pharmadocx.com Page - 76

Metoprolol succinate 25mg /50mg ER + HCTZ 12.5mg tablets 7/2/2006 Metoprolol succinate 25mg /50mg ER + HCTZ 12.5mg 28.01.08 Metoprolol Succinate equiv. to Metoprolol Tartrate 50mg + Amlodipine (as 28.01.08 besylate) 5mg Metoprolol Succinate Equivalent to Metoprolol Tartrate [ER 25/50mg] + 16/07/10 Atorvastatin (As calcium ) 10mg tablets Metoprolol succinate ER 25/50 mg + Telmisartan 20/40mg Tablet 19/07/10 Metoprolol succinate ER 25/50 mg+Telmisartan 20/40mg Oct-82 Metoprolol succinate ER 25mg + 50mg + Olmesartan 20/20mg Tablet 3.10.2009 Metoprolol succinate ER 25mg+50mg + Olmesartan 20/20mg Mar-82 Metoprolol tartarate 100 mg + Hydroclorothiazide 12.5 mg 14.01.09 Metoprolol Tartrate Oct., 1982 Metoprolol Tartrate ER Tablet 75mg (additional strength) Mar-82 Metoprolol Tartrate tablet 50 mg/100mg 1.09.2003 Metoprolol tartrate tablets 50 mg (Addl. Indication) 19-Jul-93 Metrinidazole + Spiramycin 09.11.2003 Metrinidazole 10 mg + Benzoc+A2571aine 200 mg gel 15.03.1994 Metrinidazole 10 mg + Benzocaine 200 mg gel 11.09.2003 Metrinidazole CR Tablet 600 mg 11.09.2003 Metrizamide 26-08-2004 Metromidazile (as benzoate) 10mg + Benzocaine 200mg per gram topical gel 21.02.08 Metronidazole (skin ointment) gel 1 % W/W Nov,1978 Metronidazole 10mg + Benzocaine 200mg Gel Apr,1976 Metronidazole CR tablet 600mg Aug,1976 Metronidazole Injection IV 2mg/ml Mar-79 Metronidazole Suspension 125 mg/5ml Oct-77 Metronidazole Suspension 200 mg/5ml Metronodazole 100mg + Furazolidone 30mg + Kaolin & Pectin per 5ml Aug-85 suspension Metronodazole 40mg + Furazolidone 30mg + Kaolin 1gm + Pectin 20mg per Aug-85 5ml suspension Mexiletine Capsules 50/150 mg 1969 to 74 Mexiletine HCL 5/12/2011 Mexiletine inj. 250 mg/ 10 ml 1985 to 87 Mianserin HCl 31.01.09 Mianserin HCl tablet 10/20/30 mg 1985 to 87 Micafungin sodium for injection 100mg/vial (Additional Strength) Oct,1974 Micafungin sodium for Injection 10mg per vial/50mg per vial (Additional Dec,1974 Indication) Micafungin ( as sodium) Powder for solution for infusion 50mg / vial Jul-89 Miconazole Aug,1975 Miconazole Cream 2% 1969 to 74 Miconazole Eye drops 1% Jun,1978 Miconazole Nitrate IP 2% w/w+ Fluocinolone Acetonide IP 0.01% w/w 28.11.13 Cream Miconazole Nitrate IP 2%w/w + Flucinolone Acetonide IP 0.01%w/w cream 30.04.15 Miconazole Nitrate Powder 20 mg/gm 10.03.95 PHARMADOCX (Pharmaceutical Consultant) Ph 9896133556 Mail [email protected] (Contact for Setting up Pharma, Cosmetics, Medical Devices Plant, WHOGMP) LIST OF NEW DRUGS 1961 – MAY 2017 download from http://www.pharmadocx.com Page - 77

Miconazole Nitrate Solution 2% 28.11.13 Miconazole Nitrate Vaginal Passary 100 mg 10/5/2006 Micronised Purified Flavonoid 1000mg (MPFF). "Each film coated tablet 18.12.2009 contains diosmin 900mg and flavonoids expressed as Hesperidine 100 mg of Micronised Purified Flavonoid fraction of Rutaceae 1000mg (MPFF)" Micronised Purified Flavonoid Fraction of Rutacea 1000 mg (MPFF) Each 15-Apr-97 film coated tablet contains “Diosmin 900mg and Flavonoids expressed as Hesperidine 100mg of Micronised Purified Flavonoid Fraction of Rutaceae 1000mg (MPFF) (Additional strength) Midazolam 5/7/2005 Midazolam (as maleate) 7.5mg/15mg tablet 15.04.1997 Midazolam Hcl Syrup 2mg/ml 10.05.2006 Midazolam injection BP 1mg/ml & 5mg/ml 13.02.2002 Midazolam Maleate Bulk 16.12.08 Midodrine Hydrochloride 2.5 mg Tablet 05.07.2005 Mifepristone 31-10-2007 Mifepristone + Misoprostol (1 tab of mifepristone 200mg and 4 tab of 13.02.2002 misoprostol 200mcg) Combipack Miglitol (50mg) + Metformin HCl SR (500mg) tablet. 16.12.2008 Miglitol 25 mg + Metformin 500mg tablets 31.10.2007 Miglitol 25 mg + Metformin 500mg tablets 22.05.08 Miglitol Tablet 25 mg/50 mg/100 mg 16.7.2009 Milnacipran Hcl 12.5mg (Addl. Strength) 18.08.2004 Milnacipran Hcl. 25mg/50mg equivalent to Milnacipran free base 21.77 or 17.05.99 43.55 mg. tablet. Milnacipran 100mg (additional Strength) 22.05.2008 Milnacipran 25/50mg Caps (Addl. Indication) 15.03.2002 Milrinone Lactate Inj. May-88 Miltefosin Capsule 10mg/50mg (Additional Indication) 17.05.1999 Miltefosine 16.04.2008 Minocycline 15.03.2002 Minocycline Hydrochloride Extended Release Tablets 45mg/65mg May-88 (Additional Strength) Minoxidil 26.08.08 Mirtazapine 4/1/1988 Misoprostol 14.02.2001 Misoprostol 50Mcg tablet (Additional Strength) 21.06.2001 Misoprostol tablet 25mcg/100mcg/200mcg (additional strength indication 26.08.2008 Misoprostol Tablet 600mcg 08.12.2006 Mitomycin C Injection 2 mg 15.03.2002 Mitoxantrone HCl 28.07.2000 Mitoxantrone HCl injection 2 mg Mar-89 Mixture of sodium Salt + Methyl glucamine salt of 35 diacetamido- 2,4,6- 15-12-2003 triodobenzoic acid Mizolastine 25.04.09 Mizolastine Tablets Oct-90 Moclobemide 15.03.2002 PHARMADOCX (Pharmaceutical Consultant) Ph 9896133556 Mail [email protected] (Contact for Setting up Pharma, Cosmetics, Medical Devices Plant, WHOGMP) LIST OF NEW DRUGS 1961 – MAY 2017 download from http://www.pharmadocx.com Page - 78

Modafinil 16.01.2002 Mometasone 0.1 % + Fusidic acid 2% cream/ointment 30.04.2015 Mometasone Furoate 21.05.2014 Mometasone furoate 0.1% w/w + Terbinafine Hcl 1% w/w Cream Oct-90 Mometasone Furoate Monohydrateequivalent to Mometasone Furoate aqueous 16.01.2002 Nasal Spray 50mcg/actuation (Additional Indication) Mometasone furoate nasal spray 50 mcg/actuation (Additional Indication) 14.12.1995 Mometasone 0.1 % + Fusidic acid 2% cream/ointment 31.08.2000 Monensin Sodium premix 12/6/2010 Mono ammonium glycyrrhizinate 4mg (as Glycyrrhizin) + Amino acetic acid 10.11.08 40mg + L- Cyptein HCl 2mg per 2 ml Inj. Mono basic Sodium Phosphate Monohydrate 276mg + Dibasic sodium 10.11.08 Phosphate Heptahydrate 268mg per ml injection Monteleukast Sodium Tablet 10mg; Monteleukast Sodium 4/5mg Chewable 31.01.08 Tablet;Monteleukast Sodium Oral granule(Additional Indication) Montelucast + Desloratidine(10mg + 5mg) FC Tablets 31.01.08 Montelucast + Desloratidine(10mg + 5mg) FC Tablets 03.03.2009 Montelucast 10mg + Levocetirizine 5mg film coated tablets 19.03.09 Montelucast 10mg + Levocetirizine 5mg film coated tablets 07.07.2011 Montelucast 4 mg+ Levocetrizine 2.5 mg tablet 17-05-2005 Montelucast 4 mg+ Levocetrizine 2.5 mg tablet 29.05.15 Montelukast 10mg + Fexofenadine 120mg Chewable Tablets (Additional 04.06.2003 dosage form) Montelukast Granules (4mg/pack) 10.04.2003 Montelukast Orally Disintegrating Strips 4mg/5mg/10mg (add. Dosage form) 11.09.10 Montelukast Sod. Eq.to. Montelukast 5mg/10mg+ Bambuterol HCl BP 26.02.2002 10mg/20mg film coated tablet Montelukast Sod. Eq.to. Montelukast 5mg/5mg+ Bambuterol HCl BP 06.03.2003 5mg/10mg film coated tablet Montelukast Sodium 10 mg Tablet, Montelukast Sodium 4/5 mg Chewable 16.12.11 Tablet and Montelukast Sodium Oral Granules (Additional Indication). Montelukast sodium chewable tablet 4mg/5mg and Montelukast sodium film 16.09.08 coated tablet 10mg. Montelukast Sodium IP eq.to Montelukast 10mg + Olopatadine Hcl 5mg 13.02.2002 Tablets Montelukast Sodium IP eq.to Montelukast 10mg +Olopatadine Hcl 5mg Aug,1973 Tablets Montelukast Suspension 5mg/5ml 12.03.2001 Montelukast Sodium 16.09.2008 Montelukast Sodium Tablets 16-Jan-97 Morantel tartrate 13.02.2002 Mosapride 26.06.2001 Mosapride Citrate dihydrate eq. to Mosapride cotrate-5mg+MPS (Methyl 12.03.2001 Polysiloxane 125mg chewable tablets Moxidectin inj (vet) 1% w/v 15.03.1994 Moxifloxacin 6/2/2006 Moxifloxacin (0.5%) + Dexamethasone Phosphate (0.1%) Eye drops 11/7/2007 PHARMADOCX (Pharmaceutical Consultant) Ph 9896133556 Mail [email protected] (Contact for Setting up Pharma, Cosmetics, Medical Devices Plant, WHOGMP) LIST OF NEW DRUGS 1961 – MAY 2017 download from http://www.pharmadocx.com Page - 79

Moxifloxacin Eye drops (0.5%) 16-10-2007 Moxifloxacin Eye Ointment (5mg/gm) 16-10-2007 Moxifloxacin HCL (0.5%) + Ketorolac Tromethamine 0.5% Ophthalmic 05.01.11 Solution. Moxifloxacin HCL (0.5%) + Ketorolac Tromethamine 0.5% Ophthalmic 05.01.11 Solution. Moxifloxacin HCl (5mg) + Prednisolone Acetate (10mg)per ml. (eye drops) 27.02.07 Moxifloxacin HCl (5mg) + Prednisolone Acetate (10mg)per ml. (eye drops) 07.03.12 Moxifloxacin HCl BP 0.5% w/v + Bromfenac Sodium 0.09% w/v Eye drop 31.01.2001 Moxifloxacin HCl BP 0.5% w/v + Bromfenac Sodium 0.09% w/v Eye drop 31-10-2007 Moxonidine tablet 0.2mg/0.3mg/0.4mg 31-10-2007 Mucotrol Concentrated Oral Gel Wafer. 23.01.08 Multi Organ Preservative Solution Component A: (1000ml/2000ml/4000ml) 29.10.2009 Each 100ml contains : Glucose anhydrous 3.57gms component B: (20ml/40ml/80ml) Supplementary Electrolyte Solution: Potassium. Dihydrogen Phosphate 10.76gm+ Pot. Mono Hydrogen Phosphate 37.74gm + KCL-5.7 gm +Sodium Bicarbonate IP 4.3 g + Hydrochloric acid ( to adjust pH) Mupirocin 07.02.99 Mupirocin (2%) + Methylprednisolone Aceponate (0.1%) Cream. 91.09.01 Mycophenolate Mofetil Capsule 250mg, 500mg & Oral suspension 200mg/ml 31.10.2007 (Additional Indication) Mycophenolate Sodium Enteric coated tablet 540 mg (Additional Strength) 23.12.2004 Mycophenolate Mofetil 18.05.99 Mycophenolate mofetil Capsules 250mg, Tablets 500mg, Oral suspension 23.07.2007 200mg/ml (addl. Indication) Mycophenolate Mofetil Tablets 750mg Additional Strength 22.04.1996 Nabivolol Hcl eq. Nabivolol 5 mg + HCTZ 12.5mg Tablets 6/6/2006 Nabumetone 06/06/2006 NaCl 0.52g + KCl 0.3g + Sod. Citrate 0.58g+Dextrose Anh. 2.7g per 200ml 17/08/06 ORS in Liquid form NaCl-0.125gm + KCl 0.150gm+NaHCO3-0.250gm+Citric acid (anhydrous)- 17/08/06 0.577gm + Dextrose (anhydrous) 2.650gm ORS Tablets Nadifloxacin (1%) + Miconazole Nitrate (2%) + Mometasone Furoate (0.1%) 06.10.2003 Cream Nadifloxacin (1%) + Miconazole Nitrate (2%) + Mometasone Furoate (0.1%) 09.3.2003 Cream Nadifloxacin (10mg/gm) + Mometasone Furoate (1mg/gm) cream 10/5/2006 Nadifloxacin (10mg/gm) + Mometasone Furoate (1mg/gm) cream 28.03.2002 Nadifloxacin 10mg + Clobetasol propionate 500mcg each gram gel & cream Sep-85 Nadifloxacin 10mg + Miconazole 20mg cream 20/08/10 Nadifloxacin Gel 1% 17.03.99 Nadifloxacin Cream 10.05.2006 Nadolol 28.03.2002 Nadolol tablet USP 20/40/80 mg 1985 to 87 Nafarelin Acetate 11-Oct-96 Naftopidil Tablets 25/50/75mg 17.03.1999 PHARMADOCX (Pharmaceutical Consultant) Ph 9896133556 Mail [email protected] (Contact for Setting up Pharma, Cosmetics, Medical Devices Plant, WHOGMP) LIST OF NEW DRUGS 1961 – MAY 2017 download from http://www.pharmadocx.com Page - 80

Nalbuphine injection 10mg/20mg per ml. 28.04.08 Nalidixic Acid Feb-90 Naloxone HCL 1969 to 74 Naltrexone Hcl tabs 50mg Jul-92 Nanocrystalline Silver Gel 0.002% 18.7.2009 Naproxen Suspension 125mg/5ml 04.01.2008 Naproxen Tablets 28.04.2008 Naproxen Tablets 250 mg 01.05.2002 Naratriptan (as HCl) Tablets 1/ 2.5mg 01.8.2004 Natamycin 08.01.2004 Natamycin cream 2% 3/1979 to 7/1981 Natamycin Vaginal Tablets 25 mg Nov-72 Nateglinide 17/01/2006 Nateglinide 60/120 mg + Metformin 500mg/500mg SR Tablet 17/01/2006 Nateglinide Tablet 08.01.2004 Natiglinide 60mg/120mg + Metformin HCl 500mg/500mg (SR) tablet 01.05.2002 N-butanol 0.52gm + Citric Acid 0.0025gm + Physiological sodium chloride 12.07.2002 add to 5ml per 5 ml N-butyl -2-cyno crylate Apr-91 Nebivolol (as HCl) 5mg + Valsartan 80mg 19.06.1996 Nebivolol 5mg + Amlodipine 10mg FC Tablet 17.01.2006 Nebivolol 5mg + HCTZ 12.5mg tablets 09.06.2006 Nebivolol Tablets 22.12.2004 Nebivolol HCl 12.07.2002 Nefopam 22-04-2004 Nelfinavir 625mg tablet (addl.strength) Apr-91 Nelfinavir Mesylate Aug-85 Neomycin + Bacitracin + Polymix B Sulphate ointment Sep-87 Neomycin Sulphate + Polymyxin B Sulphate + Zinc bacitracin Sep-87 Neomycin Sulphate 910mg + Polymyxin B Sulphate 300000 units + Zinc 01/03/1977 bacitracin 25000units + Propellent to maba 210gm aerosol pouch of 210gm Neotame 24/05/2006 Nepafenac Opthalmic suspension (1mg/ml) 22.04.2004 Netilmicin sulphate 06.03.2000 Netilmicin sulphate inj. 10 mg/ 25 mg/ 100 mg per ml 1985 to 87 Neutral insulin and Insulin Zinc suspension 31.03.2008 Neutral insulin and Insulin Zinc suspension 18.7.2009 Nevibolol (as HCl) 5mg + Amlodipine (as besylate) 5mg/10mg film coated 31.03.2010 tablets Nevibolol (as HCl) 5mg + Amlodipine (as besylate) 5mg/10mg 29-Oct-93 Nevirapine 07.04.08 Nevirapine Extented release tablet 400mg (Additional Strength) 9-Oct-96 Nevirapine tablet 50 mg for oral suspension mg Oct-85 Niacin 1000mg ER + Laropiprant 20mg Tablet 24/04/2006 Nicardipine capsules 20mg/30mg 23-Mar-99 Nicardipine Hcl. 10-Jan-97 Nicardipine Hcl. Injection 2.5mg/ml Oct-93 PHARMADOCX (Pharmaceutical Consultant) Ph 9896133556 Mail [email protected] (Contact for Setting up Pharma, Cosmetics, Medical Devices Plant, WHOGMP) LIST OF NEW DRUGS 1961 – MAY 2017 download from http://www.pharmadocx.com Page - 81

Nicardipine retard caps. 40mg/30mg 07.04.2008 Nicergoline 03.02.09 Nicergoline sugar coated tablet,5 mg/ 30 mg 1985 to 87 Nicorandil E.R Tablet (10mg/20mg) 26/03/2010 Nicorandil injection 2mg/12mg/48mg 18.1.13 Nicorandil tabs 5mg/10mg/20mg Nov-89 Nicorandil Transdermal Therapeuctics 26.02.09 Nicotine (as Polacrilex) Lozenges 2mg & 4mg 17.05.1995 Nicotine Polacrilex Gum 2mg & 4mg (Addl. Indication) 26.02.09 Nicotinic Acid and Laropiprant Modified Release Tablets:Nicotinic Dec-84 Acid..1000 mg Laropiprant ....20mg Nicoumalone Tablets 0.5mg/5mg/6mg 24.03.08 Nifedipine Sustained Release tablets 20 mg Feb,1975 Nifedipine + Atenolol May,1979 Nifedipine 0.3% + Lidocaine1.5% cream 1/1/1990 Nifedipine 0.3% + Lidocaine1.5% cream 29/09/10 Nifedipine capsules 5 mg/ 10 mg 10/7/2010 Nifedipine SR Tablets 10mg/20mg Oct-91 Niflumic acid Approved for more than 4 years Niflumic acid Capsule 250 mg 1975 to 76 Nilotinib Capsules 150 mg. 28.03.08 Nilotinib Capsules 200mg 16-09-2005 Nilutamide 16-09-2005 Nilutamide Tablets Oct-91 Nimesulide 17.11.2009 Nimesulide 1.0% w/w + Ethanol 31% w/w topical solution 13.01.1995 Nimesulide 100mg ER + Levocetirizine HCl 5mg Tablets 8/10/2004 Nimesulide 1% + Methyl Salicylate 5%. Aerosol 28-06-2004 Nimesulide 1% + Methyl Salicylate 5%. 13-Jan-95 Nimesulide 1.0% w/w + Ethanol 31% w/w topical solution 16.05.2009 Nimesulide 100mg + Paracetamol 500mg Tablets Aug-92 Nimesulide 100mg ER + Levocetirizine HCl 5mg Tablets 28.03.08 Nimesulide Injection (100 mg/ml) (Veterinary) Sep, 1977 Nimesulide Injection 75mg/ml. Oct, 1977 Nimesulide tablets 100 mg 2.Nimesulide suspension-50mg/ 5ml 3. Aug-85 Nimesulide Transdermal Gel-1% Nimesulide ER 200mg ( Additional Indication) 01.04.16 Nimodipine tab 30 mg, inj.10mg/50 ml 11.03.16 Nimorazole 17-03-2004 Nimorazole Tablet 250 mg 30-06-2005 Nimustine HCl 30-06-2005 Nimustine HCl inj. 25 mg/ 50 mg per vial 1985 to 87 Nintedanib Soft Gelatin Capsule 100/150mg (Nintedanib ethanesulfonate) Jun, 1973 Nintedanib soft Gelatin Capsule 100/150mg (Nintedanib ethanesulfonate) Sep,1973 Nintedanib soft Gelatin Capsule 100/150mg (Nintedanib ethanesulfonate) 1969 to 74 PHARMADOCX (Pharmaceutical Consultant) Ph 9896133556 Mail [email protected] (Contact for Setting up Pharma, Cosmetics, Medical Devices Plant, WHOGMP) LIST OF NEW DRUGS 1961 – MAY 2017 download from http://www.pharmadocx.com Page - 82

Nitazoxanide 19.09.1995 Nitazoxanide (500mg) + Ofloxacin (200mg) Tablet May-91 Nitrazepam 30.06.2005 Nitrazepam Tablet 5 mg 1969 to 74 Nitrendipine Jun-86 Nitrendipine +Atenolol May-91 Nitrendipine 10mg/20mg+Atenolol 30mg/30mg tablets 19.09.1995 Nitrendipine tablet 10/ 20 mg Jan-82 Nitrofurantoin BP sensitivity disk 100 mcg/200 mcg 3-Jun-93 Nitrofurantoin SR Tab. 100mg Mar,1975 Nitrofurazane + urea 02.04.2002 Nitrofurazane 0.06gm + urea 6.21gm bolus Aug-73 Nitroglycerin injection 19-Feb-96 Nitroglycerin ointment 1985 to 87 Nitroglycerin patch 25/50 mg Jan-82 Nitroglycerine Sustained Release tablet 2.6 mg 26.07.1995 Nitroglycerine-10/20/40mg + Dextrose Hydrous 5gm Injection May-67 Nitroscanate tablets (VET) 100mg/500mg Jun-77 Nitroxazepine Hydrochloride Injection 25 mg/2ml May-67 Nitroxazepine HydrochlorideTablet 25 mg May,1977 Nonoxynol 2% w/v + Chlorometoxylenol 0.5%w/v Feb-90 Norethisterane acetate + ethinyl estradiol 12-Mar-97 Norethisterone 1mg + Ethinyl estradiol 30mcg Tablet Nov-87 Norethisterone 2mg and Mestranol 0.1mg 29.06.1993 Norethisterone BP Tablet 0.35 mg Aug-68 Norethisterone Enanthate Inj. Apr-86 Norfloxacin 1985 to 87 Norfloxacin + Tinidazole 1985 to 87 Norfloxacin eye drops 0.3% 09.05.95 Norfloxacin powder (vet) 10% Jun-67 Norfloxacin tablet 400 mg/ 800 mg and ODT 100 mg Aug-87 Norgestimate 180µgm/215µgm/250µgm + Ethinyl oestradiol Apr,1978 35µgm/35µgm/35µgm Tablets (Triphasic oral contraceptive tablets) Norgestrel + Ethinyloestradiol Tablet 19.03.2009 Noristerat injection 23.02.2009 Northynodrel 2.5mg + Mestranol 0.1mg 19.03.09 Nova-T 23.02.09 N-phenylethylanthranilic acid Capsule 300 mg 1985 to 87 For Setting up of Orthopaedic Implant Factory contact [email protected] Pharmadocx 9896133556 Octinoxate 7.5% + Avobenzone 2% + Oxybenzone 3% + Zinc Oxide 2% 23.02.09 Lotion Octinoxate 7.5% + Avobenzone 2%+Oxybenzone 3%+Octocrylene 3% + Zinc Feb-90 Oxide 2% lotion Octinoxate 7.5% + Avobenzone 3% + Oxybenzone 3% + Titanium dioxide 20-01-2005 2% lotion

Octy.lonium Bromide 17.08.2009 Ofloxacin Dec-91 Ofloxacin (200mg) + Ornidazole (500mg) feb. 1990 Ofloxacin 2mg + Ornidazole 5 mg per ml Infusion 20.01.2005 Ofloxacin 2mg + Ornidazole 5 mg per ml Infusion 14.10.14 Ofloxacin eye drops 3mg/ml 11/8/2006 Ofloxacin Infusion 2mg/ml 27.10.2009 Olanzapine 27.10.2009 Olanzapine 5mg/10mg+ Fluoxetine HCl eq. to Fluoxetine 20mg/20mg tablet 27.01.2000 Olanzapine pamoate Prolonged release powder for suspension for I.M 15.09.08 injection (combi pack) Each combipack contains a. Vial of Olanzapine pamoate Prolonged release powder for suspension. Each vial contains: Olanzapine pamoate monohydrate eq to Olanzapine..... 210mg/300mg/405mg. After reconstituton each mL of suspension contains 150mg. b. Vial of vehicle: 3mL clear, colourless to slight yellow solution contains: Manitol IP.... 5.070%w/v Sodium carboxymethyl cellulose IP.... 0.770% w/v Polysorbate 80 IP..... 0.025%w/v HCL IP....q.s. NAOH IP....q.s Water for injection....q.s. to 100% Olanzapine powder For oral suspensian (10mg/5ml) 15.09.08 Olmesartan (20/40mg )+ Atorvastatin 5/10/20mg film coated tablets 9/8/2010 Olmesartan (as Medoxomil) 10mg (addl. Strength) 28/06/2006 Olmesartan (as Medoxomil)-20mg + Ramipril - 5 mg tablet 28.05.2006 Olmesartan + Ramipril (40mg + 5mg) tablets (Additional Strength) 12.06.2007 Olmesartan + Ramipril (40mg + 5mg) tablets (Additional Strength) 19.08.2008 Olmesartan 40mg + Amlodipine 5mg (Additional Strength) 12.6.07 Olmesartan 40mg + Amlodipine 5mg Tablet (Additional Strength) 12.6.07 Olmesartan 40mg + HCTZ 25mg tablet (addl. Strength) 15-10-2007 Olmesartan 40mg + Ramipril 5mg Tablet 28.06.2006 Olmesartan medoximil-20mg + Ramipril-5mg Tablet 24.04.07 Olmesartan medoximil-20mg + Ramipril-5mg. tablet 10/2/2010 Olmesartan Medoxomil (20mg) + Amlodipine Besylate (5mg) Tablet. 26.02.07 Olmesartan Medoxomil (20mg) + Amlodipine Besylate (5mg) Tablet. 05.08.08 Olmesartan Medoxomil (5mg/20mg/40mg) Tablet 8/6/2006 Olopatadime Ophthalmic solution (0.2%) (additional Strength) 03/05/2010 Olopatadine Hcl Nasal Spray 0.6% w/w (Additional Indication) 24.04.2007 Olopatadine Hcl. Tablet 2.5mg/5mg 05.08.2008 Olopatadine Nasal Spray (0.6%) 26.02.07 Olopatadine Ophthalmic solution( 0.1%) 03/10/2005 Olopatadine5mg + Ambroxol30mg tablets 08.06.2006 Olopatadine5mg + Ambroxol30mg tablets 08/01/2007 Omega-3 acid ethyl esters (90%) 1000mg comprising (Eicosapentaenoic acid 1/8/2007 (EPA) ethyl ester 460mg + Docosahexaenoic acid (DHA) ethyl ester 380mg) capsules (Additional Strength) Omeprazole 18-6-2007. Omeprazole (20mg) Enteric coated + Domperidone (30mg) (S.R.) capsule Apr-99 Omeprazole (20mg) Enteric coated + Domperidone (30mg) (S.R.) capsule 19.03.09 PHARMADOCX (Pharmaceutical Consultant) Ph 9896133556 Mail [email protected] (Contact for Setting up Pharma, Cosmetics, Medical Devices Plant, WHOGMP) LIST OF NEW DRUGS 1961 – MAY 2017 download from http://www.pharmadocx.com Page - 84

Omeprazole (20mg/40mg) + Sod. Bicarbonate- 600mg+ Mg.Hydroxide- 07.05.2005 700mg .chew tab. Omeprazole (20mg/40mg)+Sod. Bicarbonate-600mg+ Mg.Hydroxide-700mg 15.06.07 .chew tab. Omeprazole (E.coated) 40mg + Sodium Bicarbonate 1100mg capsule. 15.06.07 Omeprazole + Amoxycillin + Tinidazole 15.10.2007 Omeprazole + Clarithromycin + Tinidazole 09.09.1997 Omeprazole 20/40mg + Sodium Bicarbonate 600mg+ Magnesium Hydroxide 09.09.1997 700mg sachet Omeprazole 20mg (EC) + Domperidone 10mg Capsule 16.02.2016 Omeprazole 20mg/40mg + Sodium Bicarbonate 1100mg capsules 30-11-2005 Omeprazole 20mg/40mg + Sodium bicarbonate 1680mg per sachet powder for 19.03.09 oral suspension Omeprazole Magnesium Delayed Release Granules for oral Suspension 10mg 15-10-2007 Omeprazole Powder for suspension (20mg/Sachet) 22/11/2011 Omeprazole 20/40mg + Sodium Bicarbonate 600mg+ Magnesium Hydroxide 30.11.2005 700mg sachet Omeprazole(20mg) + Sodium bicarbonate (1100mg) tablet (addl. strength). 8.11.12 Omeprazole(20mg) + Sodium bicarbonate (1100mg) tablet (addl. strength). 28-09-2007 Ondansetron tablet: 4 mg /8 mg and injection: 4mg 2 ml & 8 mg/4 ml 16.11.10 Ondansetron Fast Dissolving Strips 4mg/8mg (New dosage form) 04/05/2010 Ondansetron Hydrochloride Injection 5/4/2010 Ondansetron Hydrochloride Mouth Melting Strips 4mg 16.02.1994 Ondansetron Hydrochloride Oral Spray 2mg (Each spray delivers 13.11.10. ondansetron-2mg) Ondansetron orally disintegrating tablet (4mg/8mg) (additional dosage form) May-92 Ondansetron Rapid Film Oral Strip 4/8 mg 27-10-2004 one strip of 3 uncoated tablets of artesunate 150mg & one strip of 2 uncoated 03.01.12 tablets of FDC of Sulphadoxine IP 500mg + Pyrimethamine IP 25mg one strip of 3 uncoated tablets of artesunate 150mg & one strip of 2 uncoated 03.01.12 tablets of FDC of Sulphadoxine IP 500mg + Pyrimethamine IP 25mg Opipramol dihydrochloride Tablet 50mg/100mg. 13-Jan-97 Oral Polio vaccine Nov-77 Orlistat (120 mg) Capsule May-92 Ornidazole 27.10.2004 Ornidazole IP 1 % w/w + Povidone Iodine IP (0.5% w/w available Iodine) 5% w/w Ointment

Ornidazole IP 1 % w/w + Povidone Iodine IP (0.5% w/w available Iodine) 5% 28.01.08 w/w Ointment Ornidazole tablet and infusion [Each tab contains, Ornidazole-500mg,/ 24/04/2006 Ornidazole infusion-5mg/ml (100ml infusion bottle)] Orphenadrine citrate 35mg + Paracetamol 450mg tablet 19/06/2010 Orphenedrine Citrate Injection 60mg/2ml 25-10-2005 Orthoclone Sterile 26-Oct-98 Oseltamivir 30mg & 45mg Capsules (Additional Strength) 4/8/2006 Oseltamivir formulation (additional indication) 30-10-2007 Oseltamivir Phosphate (Additional indication) 30.10.2001 PHARMADOCX (Pharmaceutical Consultant) Ph 9896133556 Mail [email protected] (Contact for Setting up Pharma, Cosmetics, Medical Devices Plant, WHOGMP) LIST OF NEW DRUGS 1961 – MAY 2017 download from http://www.pharmadocx.com Page - 85

Oseltamivir (as phosphate) Capsule (75mg) & oral suspension (12mg/ml) 13.08.2009 Otained from streptomyces virginies (Virginiamycin) 19/05/2006 Oxaliplatin Freeze dried powder for IV injection 50mg/100mg per vial 1975 to 76 Oxaliplatin injection 8/9/2005 Oxandrolone Tablet (2.5/10mg) 26.10.1998 Oxaprozine Tablet (600mg) 26.11.2009 Oxcarbazepine May, 1976 Oxcarbazepine 150/300/600mg Tablet (Addl. Indication 17.01.2000 Oxcarbazepine S.R 450mg/900mg (addl. Strength). Sep, 1974 Oxcarbazepine S.R. (150mg/300mg/600mg) Tablet Jun,1973 Oxcarbazepine Tablets (Additional Indication)150/300/600 mg 3-Sep-98 Oxibendazole premix 1.33% w/w 04.11.10 Oxiconazole 5/5/2004 Oxolinic acid Nov,1972 Oxprenolol Hydrochloride Apr,1973 Oxybutynin chloride Tab/Syrup [ 1. Each uncoated tab contains Oxybutynin Jul,1973 chloride-2.5mg/ 5mg 2. Each 5ml syrup contains Oxybutynin chloride-2.5mg] Oxybutynin Gel 100 mg Jul,1973 Oxybutynine E.R. tablets Apr,1979 Oxyclozamide 05.05.2004 Oxyfedrine Oct,1978 Oxyfedrine Injection 2 mg/ml 1969 to 74 Oxyfedrine Solution 10 mg Jun,1973 Oxyfedrine Tablet 24 mg 5.07.1993 Oxyfedrine Tablet 8 mg May-90 Oxymetazoline Hydrochloride + Nacl 28.01.08 Oxymetazoline Hydrochloride 0.25% (Paediatric) 12.10.2001 Oxymetazoline Hydrochloride Nasal Spray50mcg/0.05%w/w Dec-87 Oxyprenolol Hydrochloride Dec-87 Oxytetracycline HCL-500mg + Furazolidone-500mg+Clioquinol-500mg per 24.02.11 100 gm syringe Oxytetracycline injection200mg/ml 11-10-2007. Ozagrel Hcl. Tablets 100mg/200mg 11-10-2007. Ozothine 28.01.2008 Ozothine syrup 60 mg /5 ml 1985 to 87 Ozothine tablet 60 mg 25-Aug-94 For Setting up Surgical Devices Factory contact Pharmadocx

Paclitaxel Injection 22.01.14 Paclitaxel Injection 30mg/100 mg/300 mg (additional Indication) Aug-94 Paclitaxel (protein bound particle) for injectable suspension (paclitaxel 08.11.2008 (100mg) + Albumin Human 900mg per 20ml injection Paclitaxel inj.30/100/300mg vial (Addl. Indication) 11.10.2007 Paclitaxel injection [5ml single dose vial contains-Paclitaxel-30mg] 11.08.2016 Paclitaxel Injection Concentrate for Nanodispersion 100mg and 300mg 14.11.2009 (Additional Dosage Form) PHARMADOCX (Pharmaceutical Consultant) Ph 9896133556 Mail [email protected] (Contact for Setting up Pharma, Cosmetics, Medical Devices Plant, WHOGMP) LIST OF NEW DRUGS 1961 – MAY 2017 download from http://www.pharmadocx.com Page - 86

Paclitaxel Lipid Suspension for Injection 30mg/vial and 60mg/vial (Additional 26.09.08 Dosage Form) Paclitaxel nanoparticle Inj. (20mg/ml) 04.03.09 Paclitaxel Nanoparticle Solution for Injection 20mg/ml (Additional indication) 23.08.06 Palbociclib Capsules 75mg/100mg/125 mg 19.3.13 Paliperidone ER tablet 12 mg (Additional Strength) 25.04.2009 Paliperidone ER Tablet 3mg / 6mg / 9mg Apr,1971 Paliperidone ER Tablets 1.5mg 26.09.2008 Palonesetron Injection 0.25mg/5ml (Additional Indication) 07.02.07 Palonosetron Melt in Mouth Tablets 0.5mg 07.02.07 Palonosetron Hcl 0.075mg IV Inj (Addl. Strength) 04/08/2006 Panchromium Bromide 17/03/2010 Panchromium Bromide Injection, 4mg/ml 1969 to 74 Panobinostat Hard Gelatin Capsules 10mg/15mg/20mg (Panobinostat lactate) 23-12-2004 Pantaprazole sodium 20mg/40mg Tablet (with sodium bicarbonate As buffer) 8/4/2006 Pantoprazole (as Sodium) (E.C) 40mg + Itopride (150mg) S.R 07.02.2007 Pantoprazole 40mg + Cinitapride (ER) 3mg Capsules 18.05.2005 Pantoprazole (40mg) + Domperidone (20mg) ( 10mg IR + 10mg SR) 30/03/2010 Pantoprazole (as Sodium) (E.C) 40mg + Itopride (150mg) S.R 23.12.2004 Pantoprazole + Amoxycillin + Tinidazole 28.4.2008 Pantoprazole 20mg EC + Domperidone 10mg Capsules 15.10.1999 Pantoprazole 40mg + Cinitapride (ER) 3mg Capsules 28.04.08 Pantoprazole 40mg EC + Domperidone 30mg SR Capsules 27.01.14 Pantoprazole Mouth Dissolving Tablet 20/40 mg 24.12.2004 Pantoprazole sod. Tab 20 / 40mg Oct,1971 Pantoprazole Sodium (with Sodium Bicarbonate as Buffer) 30.09.08 Pantoprazole Sodium (With Sodium bicarbonate as buffer) 20mg/40mg tablets 30.09.08 Pantoprazole Sodium IP Eq to Pantoprazole 40 mg (As Enteric coated pellets) 24.12.08 + Levosulpiride 75 mg (as sustained release tablets) Capsules Pantoprazole Sodium sesquihydrate eq.to. Pantoprazole 40 mg/40mg + 24.12.08 Domperidone 20mg/ 20mg (10 mg IR+ 10mg SR) Capsule Pantoprazole Tablets May-76 Papain > 521700 units + Urea 100 mg ointment 09.12.1998 Para-aminomethylbenzoic acid Injection 50 mg 15.07.2005 Paracetamol + Meloxicam + Benzyl Alcohol + Lignocaine (5mg/ml + Dec-72 150mg/ml + 1% + 1% ) Injection Paracetamol + Phenylephrine Hydrochloride (Each 6gm Sachet contains: 21.06.11 500mg + 10mg) Sachet Paracetamol 120mg + Diphenylpyralime HCl 1.5mg + Phenylpropanolamine 24.12.2008 HCl 10mg per 5ml expectorant Paracetamol 300 mg + Dextropropoxyphene 25 mg Mar-76 Paracetamol 300mg + D-propoxyphene HCl 25mg per tablet Dec-72 Paracetamol 325mg + Tramadol Hydrochloride 37.5 mg Tablets 11.4.12 Paracetamol 325mg + Tramadol Hydrochloride 37.5 mg Tablets 05.01.11 Paracetamol 450 mg + Chlormexanone 100 mg tablet 10.02.11 Paracetamol 500mg/500mg + Thioclchicoside 4mg/8mg tablet Oct-82 Paracetamol Bilayer Tablet 1000mg 07.12.11 PHARMADOCX (Pharmaceutical Consultant) Ph 9896133556 Mail [email protected] (Contact for Setting up Pharma, Cosmetics, Medical Devices Plant, WHOGMP) LIST OF NEW DRUGS 1961 – MAY 2017 download from http://www.pharmadocx.com Page - 87

Paracetamol Chewable Tablet 500 mg. (Additional Dosage Form) 13.10.10 Paracetamol Fast Release Tablet 500mg (Additional Dosage Form) 10/2/2010 Paracetamol IP 325mg + Pamabrom USP 25mg Tablets 23.12.08 Paracetamol IP 325mg + Pamabrom USP 25mg Tablets 24/05/2010 Paracetamol IP 500mg + Phenylephrine HCL IP 5mg +Caffeine (anhydrous) Feb,1973 IP 30mg + Diphenhydramine HCL IP 25mg tablet. Paracetamol IP 500mg + Phenylephrine HCL IP 5mg+ Caffeine (anhydrous) Jun-73 IP 30mg + Diphenhydramine HCL IP 25mg tablet. Paracetamol Solution for Infusion (10mg/ml) in 50ml (Additional Packsize) 01.11.2002 Paracetamol solution for infusion 10mg/ml 30/08/06 Paracetamol SR 1000mg Bilayered tablet 04.10.2000 Parbendazole Mar-89 Parbendazole 4%w/w + Ethixygin 0.125% w/w + Extracted soya flour 18.03.2015 added to 100% suspension Parecoxib Inj. May-93 Paromomycin Inj. 375mg/ml 16.10.10 Paroxetine Hydrochloride 23.2.15 Parvovirus vaccine 09.07.08 Pasireotide solution for injection 0.3mg/0.6mg/0.9mg May-91 Paspat injection 29.08.2016 Pazopanib (as Hydrochloride) film coated Tablets…200mg / 400mg 6/2/2006 Pazopanib Tablet 200/400mg (additional indication) 07 03 2014 Pazufloxacin Mesylate i.v. infusion 300mg/100ml & 500mg/100ml 30.10.12 Pefloxacin Mesylate Dihydrate 04.12.08 PEG L-Asparaginase (Pegaspargase) Injection 750IU/mL, iv/im (Pack size 16/01/2010 5mL/vial) Pegaptinib Sodium Injection (0.3mg). 08.10.08 Pegasperagase 3,750 IU/5 mL Mar-88 Pemetrexed Disodium 500mg/100mg Powder for Injection Oct,1977 Pemetrexed disodium 500mg / 100mg powder for sol. (Addl. Indication) 08.10.2008 Pemetrexed Disodium 500mg/100mg Powder for Injection (additional 11/5/2010 indication) Pemetrexed disodium500mg / 100mg powder for sol. (Addl.indication ) Sep,1975 Penfluridol Nov, 1975 Penfluridol tablet 20 mg Mar-88 Pentazocine Lactate Injection 30 mg/ml March.86 Pentazocine Tablet 50 mg Nov, 1975 Pentosan polysulfate Sodium Cpasules 100mg Mar-90 Pentoxifylline 01.09.2004 Pentoxifylline Dragee 100 mg 1975 to 76 Pentoxifylline dragees 400 mg 31/05/2006 Pentoxifylline Injection 100mg/5ml Sep-91 Pentoxyphylline SR 24.03.1998 Peplomycin Inj. Jul-69 Peracetic Acid (NLT 4.5%) + Hydrogen Peroxide (NLT 24%) Disinfectant 16.05.09 liquid for livestock species. Perampanel 2mg/4mg/6mg/8mg/10mg/12mg Tablets 6-Mar-95 PHARMADOCX (Pharmaceutical Consultant) Ph 9896133556 Mail [email protected] (Contact for Setting up Pharma, Cosmetics, Medical Devices Plant, WHOGMP) LIST OF NEW DRUGS 1961 – MAY 2017 download from http://www.pharmadocx.com Page - 88

Perflutren liquid microsphere injectable suspension Nov,1971 Perindopril 31.05.2006 Perindopril 2mg/4mg+Indepamide 0.625mg/1.25mg tablet 24.03.1998 Perindopril +Indepamide Sep-71 Perindopril arginine 2.5mg/5mg/10mg film coated tablet Feb-80 Permethrin 2/12/2005 Permethrin cream 5% 06.03.1995 Pheiramine Maleate Tablet 31.01.08 Phenyl dimethyl isopropyl pyrazolone 150mg + Diethyl dioxotetrahydro 31.01.08 pyridine 50mg + Paracetamol 250mg + Caffeine (Anhydrous) 46.75mg Phenyl propalamine HCl 50mg + Isoprapamide 2.5mg + Diphenyl pyralline 31.01.2008 HCl 5mg capsule Phenylbutazone 125mg + Propyphenazone 125 mg tablets Jul-69 Phenylephrine 2.5% Eye drops 1985 to 87 Phenylephrine 5mg + Chlorpheniramine maleate 0.5mg + Paracetamol 125mg 14.11.08 + sodium citrate 60mg + Menthol 1mg (per 5ml) Syrup Phenylephrine 5mg + Chlorpheniramine maleate 0.5mg + Paracetamol 125mg 5/8/2005 + sodium citrate 60mg + Menthol 1mg (per 5ml) Syrup Phenylmethylamine-amino benzene Sulphate 1.5% w/w + Sep-71 Phenylmethylamine Hcl 1.5% w/w ointment Phenylmethylamine-amino benzene Sulphate 15mg + Phenylmethylamine 6/7/2007 Hcl 10mg tablet Phenylpropanolamine + Isopropanamide + Diphenyl Pyrallin HCL 14-6-2007. Phenyramidol HCl tablet 400mg 12.09.2016 Phenytoin Sodium (300mg) tablet 11.02.11 Phenytoin Sodium E.R (300mg) 05.08.2005 Phenytoin sodium ER capsules (300mg) (New dosage form) 14.06.2007 Pholcodiene Syrup (4mg/5ml). Dec,1974 Phospholipids Fraction from Bovine Lung (surfactant) 50 mg/vial 06.07.2007 Picrolimus 10 mg/gm cream 07.07.1995 Pidotimod Tablet 400 mg/800 mg & Oral Solution 400 mg/800 mg per 7ml Sep,1973 Pimcrolimus 10 mg/gm cream Nov, 1973 Pimozide Sep-91 Pimozide Tablet 1mg, 4 mg 1969 to 74 Pinaverium Bromide 23.01.07 Pindolol 23.01.07 Pindolol Tablet 5 mg 1969 to 74 Pinene + camphene + Cineol + Menthone + Menthol + Borneol + Olive oil 13.03.2003 Pinene 7mg + camphene 5mg + Cineol 2mg + Menthone 6mg + Menthol 01.09.1991 32mg + Borneol 5mg + Olive oil 33mg capsule Pioglitazone 15mg + Metformin 500mg (O.D.) tablets 25.02.2005 Pioglitazone 15mg/30mg + Metformin ER 1000mg tablet (additional strength) 17.10.2000 Pioglitazone 15mg/30mg + Metformin ER 1000mg tablet (additional strength) 26.04.2004 Pioglitazone HCl eq.to. Pioglitazone 15mg/15mg+ Glimepiride 1mg/2mg Nov-92 tablet Pioglitazone HCl eq.to. Pioglitazone 30mg/30mg+ Glimepiride 1mg/2mg Aug-89 uncoated tablet (additional strength) PHARMADOCX (Pharmaceutical Consultant) Ph 9896133556 Mail [email protected] (Contact for Setting up Pharma, Cosmetics, Medical Devices Plant, WHOGMP) LIST OF NEW DRUGS 1961 – MAY 2017 download from http://www.pharmadocx.com Page - 89

Pioglitazone Hydrochloride Eq.to. Pioglitazone 15mg/30mg + Metformin HCl 13.08.1999 IP 500mg (ER) tablets Pioglitazone Hydrochloride 13.08.99 Pioglotazone 15mg/30mg + Metformin500mg/500mg ER Tablet 17.10.200 Pipecuronium Bromide 14.09.10 Piperacillin Sodium 27-Sep-93 Piperacillin sodium eq.to. piperacillin 4gm/2gm + Tazobactum sodium 19/01/2010 500mg/250mg per vial injection Piperacillin - Tazobactam Inj. 19/01/2010 Piperaquine tetraphosphate as Piperaquine Tetraphosphate Tetrahydrate (QP) 25-Mar-96 320 mg + Dihydroartemisinin (DHA) 40 mg Each Film coated tablet contains Piracetam 23.10.12 Pirarubicin HCl Injection 02.01.15 Pirfenidone film coated tablet ...200mg Apr-90 Piribedil Mar,1981 Piribedil S.R. Tablets 50mg Aug-91 Piroxicam Sep-93 Piroxicam 20mg tab& Paracetamol 500mg tab combikit 27-12-2011 Piroxicam 20mg tab& Paracetamol 500mg tab combikit Aug-86 Piroxicam Betacyclodextrin tabs 20 mg 14-01-2005 Piroxicam Gel dec. 1977 Piroxicam inj. 20mg/ml 1985 to 87 Piroxicam Sublingual Tablet 20 mg (Additional Dosage Form) 1985 to 87 Piroxicam tablet 10 mg 5-May-95 Pitavastatin (1mg/2mg) Tablet 23.07.2004 Pitavastatin Tablet 4mg Mar-87 Plantago Ovata (Isapgol) seed husk (I.P) 20.03.07 Plerixafor Injection 20mg/ml Jul-86 Podophyllotoxin Topical solution [Each 3-5ml contains, Podophyllotoxin- 13.09.11 0.5%] Policresulen 50mg + Cinchocaine 10mg per gram ointment 13.09.11 Polidocanol Injection 18-9-2007. Pollidacanol Inj. 31.01.12 Polonosetron (As Hcl.) For Injection 0.25mg/5ml 18-9-2007. Polyestradiol Phosphate injection May,1973 Polyethylene glycol 0.4% w/v + Propylene Glycol 0.3% w/v Eye Drops 30-Apr-97 Polyethylene glycol 0.4% w/v + Propylene Glycol 0.3% w/v Eye Drops 16.05.1996 Polyethylin Glycol 400 (0.4%) + Propylene Glycol (0.3%). 11.01.1996 Polyglycalic acid sutures 18.09.2007 Polyglycolic Acid 20-12-2011 Polysaccharide Pneumococcal Pneumia Vaccine 1969 to 74 Polyvidone eye drops 5% Jul-96 Polyvinyl Alcohol 14mg/30mg + Benzalkonium chloride-8.05mg per ml 18.7.2009 Opthalmic solution Polyvinyl Alochol + Povidone + Chlorbutanol eye drops Nov,1972 Polyvinyl Alochol 14mg + Povidone 6mg + Chlorbutanol 5mg per ml eye 05.04.1990 drops PHARMADOCX (Pharmaceutical Consultant) Ph 9896133556 Mail [email protected] (Contact for Setting up Pharma, Cosmetics, Medical Devices Plant, WHOGMP) LIST OF NEW DRUGS 1961 – MAY 2017 download from http://www.pharmadocx.com Page - 90

Polyvinyl Alochol with Povidone and chlorbutanol eye drops 11.01.1996 Ponderax SR tab.60 mg 11.01.1996 Poractant 15.06.2016 Posaconazole oral suspension 40 mg/ ml (additional Indication) 24.12.2002 Posaconazole Oral Suspension 40mg/ml Nov,1972 Potassium Clavulanic Eq. to Clavulanic Acid 125mg + Amoxycillin Sep, 1978 Trihydrate Eq. to Amoxycillin 250mg tablet Povidone Iodine Gargle 0.5 % Sep, 1978 Povidone Iodine Ointment USP 10% w/w (available Iodine 1%w/w) Water Sep, 1978 soluble ointment Povidone Iodine Sachet (containing Effervescent Granules) Each 2gm Sachet 22-Nov-96 contains: 175mg (available iodine 17.5mg) Povidone Iodine Solution 10 % 13/03/2010 Povidone Iodine USP Ointment 5% 25-07-2005 Povidone Iodine USP Scrub 4% 13/04/2010 Povidone Iodine USP Solution 5% 15.01.14 Povidone-Iodine sterile ophthalmic prep solution 5.0% w/v 20.12.2000 Pramipexole Di HCl monohydrate ER Tablet 0.375/0.75/1.5/3/4.5 mg 10/8/2006 Pramipexole Di-hydrochloride Tablet (0.125mg/0.25mg/0.5mg/1mg/1.5mg). 25.11.13 Prasugrel (as Hydrochloride) film coated tablet ....5 mg / 10mg. Feb-86 Prasugrel Hydrochloride IP 10 mg (as film coated tablet) + Aspirin IP(as Aug-85 enteric coated tablets) 75 mg hard gelatine capsule Pravastatin 30/03/2010 Pravastatin 40mg tablet (Additional strength) 30/03/2010 Praziquantal 20mg + Pyrantel embonate 230mg Tablet ( Veterinary product) Jun-90 Praziquantel tablet 6-Aug-97 Praziquantel tablet 600 mg Jul-86 Praziquntel 175mg + Pyrantel 504mg + Febental 525mg Tablets Dec,1971 Praziquntel 175mg + Pyrantel 504mg + Febental 525mg Tablets 26.11.2009 Prazosin Hydrochloride 04.07.2003 Prednicarbate Cream [Each gm of cream contains, Prednicarbate-2.5mg] 05.08.2008 Prednimustine tablet 12.10.10 Prednisolone I.P Tablets 10 mg 12.10.10 Prednisolone Sodium Phosphate Orally Disintegrating Tablet 10/15/30mg 1969 to 74 Prednisolone Steroglycolate 08.05.08 Prednisolone10mg + Ofloxacin 3mg per ml eye drop 25-11-2005 Pregabalin 75mg/150mg + Methylcobalamin 750mcg capsules (Additional 19/05/2006 Strength) Pregabalin 150mg/75mg + Methylcobalamin 750mcg + Alpha lipoic acid 29.04.08 100mg + Pyridoxine 3mg + Folic acid 1.5mg capsule Pregabalin capsule (75/150/300mg) 02/09/2010 Pregabalin Capsule 25/50/100/200mg (addl. Strength) 16.05.2009 Pregabalin capsules (Addl. Indication) 19.05.2006 Pregabalin SR 75/150/300mg + Methylcobalamin 1500mcg tablets 12.10.07 Pregabalin SR 75/150/300mg + Methylcobalamin 1500mcg tablets 21/08/06 Pregabalin SR Tablet 75mg (Additional Strength) 12.03.08 Pregabalin SR Tablet 150/300mg Jul-90 PHARMADOCX (Pharmaceutical Consultant) Ph 9896133556 Mail [email protected] (Contact for Setting up Pharma, Cosmetics, Medical Devices Plant, WHOGMP) LIST OF NEW DRUGS 1961 – MAY 2017 download from http://www.pharmadocx.com Page - 91

Pregabalin-75mg/150mg + Methylcobalamine 500mcg cap Jun,1973 Pregabalin-75mg/150mg +Methylcobalamine 500mcg cap 5/5/2011 Premetrexed(Disodium) powder For solution For Inj. 500mg/vial 09.06.11 Premetrxed disodium injection 100mg/vial (Additional Strength) 09.06.11 Prenoxdiazine HCl Apr, 1981 Prenylamine lactate Tablet 60 mg 23-Sep-96 Primaquine Tablet 45mg(Additional Strength) Nov-86 PROBIO : Each sachet (1g) contains: Total Probiotic.... Not less than 1.25 18/01/2010 Billion CFU (Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium longum, Saccharomyces boulardii) 2. PROBIO & PREBIO (F)s Each sachet (1g) contains: Probio (CMP 5) Total Probiotic...Not less than 1.25 Billion CFU (Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium longum, Saccharomyces boulardii) Fructo Oligo Saccharides …. 100mg 3. PROBIO & PREBIO (D) Each sachet (1.3g) contains: Probio (CMP 5) CFU (Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium longum, Saccharomyces boulardii) Fructo Oligo Saccharides...1000mg PROBIO : Each sachet (1g) contains: Total Probiotic.... Not less than 1.25 18/01/2010 Billion CFU (Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium longum, Saccharomyces boulardii) PROBIO & PREBIO (F)s Each sachet (1g) contains: Probio (CMP 5) Total Probiotic...Not less than 1.25 Billion CFU (Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium longum, Saccharomyces boulardii); Fructo Oligo Saccharides …. 100mg PROBIO & PREBIO (D); Each sachet (1.3g) contains: Probio (CMP 5); Total probiotic... not less than 1.25 billion CFU (Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium longum, Saccharomyces boulardii); Fructo Oligo Saccharides...1000mg

Procarbazine 19.11.07 Promegestone tabs 0.125mg/0.250mg/0.500mg 19.11.07 Prooanidid Nov-88 Propafenone Hydrochloride 19.11.07 Propanol 1-ol 18gm + Ethanol 100% 19.11.07 45gm/100ml solution Propanol 1-ol 18gm + Ethanol 100% 45gm/100ml solution 22/03/2006 Propanol 50gm+povidone iodine-1gm in 100ml solution Jan.87 Propanol 50gm+povidone iodine-1gm in 100ml Jan.87 solution Propanol-18 gm+Ethenol(100%)-45gm in 100ml solution 5.11.2009 Propanol-18gm + Ethenol (100%)-45gm in 100ml solution 27.10.2009 Propionyl-L-Carnitine HCl Tablet (500mg) & injection 300mg/vial 04.04.07 Propofenonen injection 70 mg/ 20 ml ampoule 04.04.07 Propofenonen tablets 150 mg/ 300 mg 27.10.2009 Propofol 1% for injection (Additional Indication) 27/02/2010 Propofol 10 mg+ Lignocaine 2.5 mg per ml injection 18-May-98 PHARMADOCX (Pharmaceutical Consultant) Ph 9896133556 Mail [email protected] (Contact for Setting up Pharma, Cosmetics, Medical Devices Plant, WHOGMP) LIST OF NEW DRUGS 1961 – MAY 2017 download from http://www.pharmadocx.com Page - 92

Propofol 10mg + Lignocaem 1mg per ml injection 03.02.1997 Propofol 10mg + Lignocaem 1mg per ml injection Nov-78 Propofol 10mg + Lignocaine 2.5mg per ml injection (addditional Strength) 16/03/2010 Propofol 2% w/v Injection (additionalStrength) 16/03/2010 Propofol injection 10mg per ml Feb-80 Propoxur 1gm + Flomethrion 0.225gm per 10mg of collor for veternary use Oct-82 Propoxyphene Napasylate100mg + Paracetamol 650mg Capsule Oct-82 Propranolol 40mg (SR Pellets) + Fluarizine 5mg/10mg capsules Dec.87 Propranolol 40mg (SR Pellets) + Fluarizine 5mg/10mg capsules Sep-85 Propranolol 40mg + Hydrallazime 25mg tablet Oct,1972 Propranolol HCl 40 mg+HCTZ 25 mg tablets Nov,1971 Propranolol Hcl 80 mg + Bendrafluazide 2.5 mg capsule Nov,1971 Propranolol HCL SR capsules 80 mg Jun-86 Propranolol HCl SR tablets 80/160 mg Jun,1972 Propranolol Hydrochloride 30-10-2007 Propranolol Hydrochloride Injection 1 mg/ml 28.09.1992 Propranolol Hydrochloride Tablet 10 mg Oct-71 Prosolvine inj. 7.5 mg/ ml Nov-85 Prothionamide B.P. 1969 to 74 Prulifloxacin (600mg) Tablet. Dec-89 Pseudoehedrine HCl 30mg + Ibuprofen 200mg tablet Sep-77 Psoralen + Copper Sulphate 23.04.2001 Psoralen 10mg + Copper Sulphate 2mg Tablet 30.07.2002 Purified chick Embryo 01.10.1971 Purified chick Embryo Cell vaccine Jul,1972 PVP/VA resin 5% + Benzalkonium chloride 0.10% + Lignocaine HCl 0.25% 1985 to 87 + D-panthanol DAB -7DDR 2% aerosol pack of 85gm Pygenum Africum May-92 Pyrantel embonate 14.4mg + Febental 15mg per ml suspension for Veternary 23.12.2010 use Pyrantel Pamoate U.S.P. 23.12.2010 Pyrazinamide dispersible tabs -250mg 5/4/2011 Pyridine 3-carboxylic acid hydroxy methylamide 0.125gm + Choline 05.03.07 Bitartrate Tablet Pyridoxine HCl CR tab.100mg 21.02.08 Pyridoxine HCL IP 3mg + Nicotinamide IP 100mg + Cyanocobalamin IP 1/8/2006 15mcg + Folic acid IP 500mcg + Chromium Picolinate USP 250mcg Tablet Pyridoxine HCL IP 3mg + Nicotinamide IP 100mg + Cyanocobalamin IP 10.04.07 15mcg + Folic acid IP 500mcg + Chromium Picolinate USP 250mcg Tablet Quetiapen fumarate Sustained Release Tablets 50mg and 100mg (Additional 31.05.2002 Strength) Quetiapine (As fumarate) SR 400mg tablet (additional strength) 19.09.2002 Quetiapine fumarate SR tablets 26.02.09 Quetiapine S.R tablet 200/300mg. 10.02.2003 Quetiapine SR Tablets 50mg ( additional strength) 26.02.09 Quetiapine Fumerate Jul,1971 Quinapril Aug,1980 PHARMADOCX (Pharmaceutical Consultant) Ph 9896133556 Mail [email protected] (Contact for Setting up Pharma, Cosmetics, Medical Devices Plant, WHOGMP) LIST OF NEW DRUGS 1961 – MAY 2017 download from http://www.pharmadocx.com Page - 93

Quinapril 20mg + HCTZ 25mg film coated tablet Aug,1980 Quinapril HCl eq.to Quinapril 10mg/20mg, Hydrochorothiazide 24-05-2005 12.5mg/12.5mg film coated tablet Quinapril 20mg + HCTZ 25mg film coated tablet 15-04-2005 Quinapyramine Sulphate B vet C 1.5 g + Quinapyramine Chloride B vet C May-91 1.0g Injectable dosing Form (veterinary product) Each vial contains: Quinestral Tablets, 25mcg 1969 to 74 Quinestrol 19.03.15 Quinpramine Chloride 27.12.2001 Quinpramine Sulphate 28/11/06 For WHO GMP certification of your plant contact Pharmadocx. 9896133556

R (-) Ondansetron oral Solution (1mg/5ml) 28/11/06 R(-) Ondansetron (2mg/4mg) tablet 10.08.2004 Rabbit Anti Human Thymocyte immunoglobulin 27.07.2004 Rabeprazole 28.04.2008 Rabeprazole 20mg (EC) + Itopride SR 150mg 28.04.08 Rabeprazole 20mg (EC) + Itopride SR 150mg capsule 26.02.07 Rabeprazole 20mg+Mosapride 15mg SR tablet 26.02.07 Rabeprazole Sodium ( with Sodium bicarbonate as buffer) 21-05-2004 Rabeprazole Sodium (20 mg) + Domperidone (30 mg) S.R. Capsule 03.12.2010 Rabeprazole Sodium (With Sodium bicarbonate as buffer) 10mg/20mg tablets 04.10.2004 Rabeprazole Sodium 20mg/10mg with sodium bicarbonate As buffer 28.04.2008 Rabeprazole sodium Enteric coated pellets 15.4% w/w (20mg/129.83mg) 26.02.2007 Rabeprazole Sodium Injection 20 mg/vial 15/12/06 Rabeprazole Sodium Powder oral suspension (sachet of 20 mg) (Additional 04.05.2001 dasage form) Rabies vaccine (inactivated) 27/01/2010 Rabies Veterinary Vaccine (inactive) 1985 to 81 Racecadotril Aug-91 Racecadotril dispersible tablet (10mg/30mg) (new dosage Form) 05/11/2005 Racecadotril Sachet (10mg/30mg) 11/5/2005 Raloxifene HCl 18.05.2004 Raltegravir (as Potassium) film coated Tablets 400mg 24/05/2010 Ramelteon film coated tablets 8mg 20.02.07 Ramipril 20.02.07 Ramipril (5mg) + Telmisartan (40mg) tablet 26.08.1996 Ramipril 1.25/ 2.5/5/10 mg(Additional Indication) 11.05.2005 Ramipril 10mg + HCTZ 12.5mg tablet (additional strength) 20.02.08 Ramipril 2.5mg/5mg + Hydrochlorothiazide 12.5mg/25mg tablet 11.12.2007 Ramipril 2.5mg/5mg + Losartan Potassium 50mg/50mg tablet 01.08.2003 Ramipril 2.5mg+S(-) Amlodipine Besylate eq. to S(-) Amlodipine 2.5mg 3/7/2010 tablet and capsule Ramipril 5mg + HCTZ 12.5mg tablets (Additional Strength) 30.7.2009 Ramipril BP 2.5mg/5mg + Telmisartan 40mg uncoated tablet 20.02.2008 PHARMADOCX (Pharmaceutical Consultant) Ph 9896133556 Mail [email protected] (Contact for Setting up Pharma, Cosmetics, Medical Devices Plant, WHOGMP) LIST OF NEW DRUGS 1961 – MAY 2017 download from http://www.pharmadocx.com Page - 94

Ramipril BP 2.5mg/5mg+Candesartan cilexatil eq. to candesartan 8mg/8mg Feb.86 bilayer tablet Ramipril MR Capsules 2.5/5 mg (Additional Strength) Feb-90 Ramipril MR capsule 10mg Aug-85 Ramosetron Dispersible Tablet 0.1 mg 11/8/2011 Ramosetron Hydrochloride Tablets 2.5mcg, 5mcg, 0.1mg & Injecton 0.3mg 24/04/2010 /2ml Ranitidine 31.01.09 ranitidine injection 50 mg /2 ml 31.01.09 Ranitidine syrup 150 mg/10 ml 1985 to 87 Ranitidine tablet 150 mg 11.08.2003 Ranolazine ER Tablet 375mg/750mg (Additional Strength) 28-07-2004 Ranolazine ER Tablets 750mg (Additional Strength) 31.12.2002 Ranolazine 1000mg ER Tabs (Additional Strength) Apr-86 Rasagiline (as mesylate ) Tablet 0.5mg/1mg Jul-89 Raubasine 10mg+ Almitrine 30mg film coated tablet 01 07 14 Rebamipide 100 mg tablet 11.08.2003 Reboxetine 23.03.2000 Receptal injection Jan.87 Recombinant Human Tissue Type plasminogen activator Jan.87 Regorafenib film coated tablet 40 mg Sep-86 Renolazine Extend ReleAse tablet (500mg) Jan-72 Repaglinide 25-09-2007 Repreterol syrup 10mg/ 5 ml 14-May-97 Repreterol tablet 20mg 4/4/2006 Reproterol Hydrochloride 3-Apr-97 Reserpine 0.1mg + Clopamide 5mg + Dihydroergocristine 0.5mg Tablet 25.04.2009 Resperidone E.R. (long-acting) injection (12.5mg/vial) (addl. strength). Nov-90 Resperidone Liquid 1 mg / ml 24.12.2009 Resperidone Tablet & Syrup (addl. Ind ) 9.12.1993 Resperidone tabs 1mg/2mg/3mg/4mg 16-07-2007 Retapamulin Ointment 1% 21.02.1995 Retinoin 11.12.08 Retrodrine Hcl 1969 to 74 Ribavirin 11.12.08 Ribavirin Capsules 200mg (Addl. Strength) 11.12.08 Rice based ORS citrate containing each sachet: Nacl 3.5g+KCl 11.12.08 1.5g+Sodium Citrate 2.9gm+Extruded Rice 50.0gm. (II) Rice based ORS electrolytes containing each sachet: Nacl 1.25gm+ KCl 1.50gm+Sodium Citrate 2.90gm+ Extruded Rice 50.0gm Rifampicin 75mg Isoniazid 50mg dispersible tablet (additional strength) Jun-83 Rifabutin Capsule (150mg). 08.08.2016 Rifampicin Jun,1971 Rifampicin - 75mg Isoniazid -50mg Pyrazinamide -150 mg dispersible tablet 1969 to 74 (additional strength) Rifampicin + INH + Piperine (200mg + 300mg + 10mg ) Capsules 16.06.2016 Rifampicin + INH + Piperine (200mg + 300mg + 10mg ) Capsules Jun-83 PHARMADOCX (Pharmaceutical Consultant) Ph 9896133556 Mail [email protected] (Contact for Setting up Pharma, Cosmetics, Medical Devices Plant, WHOGMP) LIST OF NEW DRUGS 1961 – MAY 2017 download from http://www.pharmadocx.com Page - 95

Rifampicin + Piperine (200mg + 10mg) Capsules 26.11.2009 Rifampicin +Piperine (200mg + 10mg ) Capsules 9/6/2011 Rifampicin syrup 18/08/2011 Rifampicin USP Tablets, 450mg 18.7.2009 Rifampicin300mg/450mg/600mg+INH 200mg/300mg/300mg 28/08/06 Rifaximin Dispersible Tablet 200mg 21-Feb-95 Rifaximin Oral Suspension 100mg/5ml (New Dosage Form) 11.05.07 Rifaximin Tablet 550 mg (Additional strength and Additional Indication) 16.09.08 Rifaximin 400mg (additional Indication) 8/10/2007 Rifaximine 200mg tab. 17-10-2003 Rilmenidine Dihydrogen Phosphate tab. 1 mg 17.10.1997 Riluzole Tablets 29.08.2009 Rimonabant tablet 20mg 26-08-2004 Risedronate Sodium 150mg Tablet (Additional Strength) 19.12.13 Risedronate Sodium tablet (35mg) (additional indication) 21-Feb-95 Risedronate Sodium 8-Sep-97 Risperidone 18.01.2001 Risperidone long acting injection (Addl. Indication) Risperidone long-acting suspension for injection 25 mg/37.5 mg/50 mg per 18.01.2001 vial Risperidone prolonged release suspension for injection (Deep Intramuscular 10.07.2000 Deltoid route using appropriate safety needle) (Additional route of administration) Ritodrine HCL tablet and injection [Each tablet contains, Ritodrine HCL- 30/01/2010 10mg, Ritodrine HCL Injection each ml contains-Ritodrine HCL-USP 10mg] Ritonavir 100mg 2.9.14 Ritonavir 33.3mg + Lopenavir 133.3mg soft gelatin capsule 08.09.1997 Ritonavir 20mg + Lopenavir 80 per ml oral solution 31-Jul-98 Ritonavir Capsule 13.7.15 Rituximab 28.01.08 Rivaroxaban Caps 27.02.2003 Rivaroxaban film coated Tablets 10mg 10.07.200 Rivaroxaban tablet 15/20mg (Additional strength/indication) 31.07.1998 Rivaroxaban tablet 2.5mg Rivaroxaban tablet 2.5mg (add. strength) 24/05/2010 Rivastigmine capsules 0.5mg/1.0mg/1.5mg/3mg/4mg/5mg/6mg 26.06.2000 Rivastigmine transdermal patch (each patch of 5m2, 10m2,15m2 & 17 07 14 20m2 contain Rivastigmine base 9/18/27/36mg respectively Rivastigmine transdermal patch. EachTranstermal patch of 15cm2 contains 12.01.07 Rivastigmine 27mg (Additional indication) Rizatriptan 03.12.2001 Rizatriptan Benzoate orally disintegrating tablet 10 mg(Additional Dosage 6/2/2010 Form) Rocuromiem Bromide Inj. 21.08.2003 Rofecoxib 04.01.11 Rofecoxib 25 mg + Paracetamol 500 mg tablet 3.12.2009 Rofecoxib 50 mg + Tizanidine SR 6 mg tablet 15.10.2003 Roflumilast Tab 500 mcg 18.06.1996 PHARMADOCX (Pharmaceutical Consultant) Ph 9896133556 Mail [email protected] (Contact for Setting up Pharma, Cosmetics, Medical Devices Plant, WHOGMP) LIST OF NEW DRUGS 1961 – MAY 2017 download from http://www.pharmadocx.com Page - 96

R-Ondansetron (As Hcl. Dihydrate) (1mg/ml) injection 19.03.09 Ropinirole 14.07.2000 Ropinirole 6mg ER Tablets (Addl. Strength) 21.02.2002 Ropinirole ER Tablet 1 mg. (Additional Strength) 08/08/2006 Ropinirole ER tablet 2/4/8mg 8/8/2006 Ropivacaine HCl Inj.2/5/7.5/10mg 08.02.07 Rosiglitazone 08.02.07 Rosiglitazone 4mg+Metformin 500mg tablet 20.05.2003 Rosiglitazone (as maleate)2mg + Glibenclamide 5mg + MetFormin 500mg 14.11.2002 tablet Rosiglitazone (as maleate)2mg + Glibenclamide 5mg + MetFormin 500mg 11.10.2001 tablet Rosiglitazone 1mg + Metformin Hcl 500mg tablet (additional strength) 11.09.2002 Rosiglitazone 1mg + Metofmin Hcl 500mg tablet (additional strength) 28.06.2000 Rosiglitazone 2mg/4mg + Metformin SR 1000mg/1000mg tablet Jul-82 Rosiglitazone maleate 2mg+ Metformin 500mg + Gliclazide 4./80 mg FC 23/08/10 Tablet Rosiglitazone maleate eq. to Rosiglitazone 2mg + Glimepiride 1mg tablet 12-09-2003 Rosiglitazone maleate eq.to Rosiglitazone 2 mg+Metformin IP 500mg tablet 14.11.2002 Rosiglitazone maleate eq.to Rosiglitazone- 2mg/4mg+ Metformin HCl (SR) 11.09.2002 500mg /500mg Tablet Rosiglitazone Maleate 22.08.2006 Rosoxacin 23/08/10 Rosoxacin Capsules 150 mg Jul-82 Rosuvastatin 23.08.10 Rosuvastatin calcium eq. to Rosuvastatin 10mg + Ezetimibe 10mg tablets 19.02.2011 Rosuvastatin 5/10/20mg + Fenofibrate 67/145/160mg Tablet 24.08.11 Rosuvastatin 5/10/20mg+Fenofibrate 67/145/160mg 29.12.2010 Rosuvastatin 5/10mg + Fenofibrate 145/67 mg Tablet 29.12.2010 Rosuvastatin 5/5/5/10/10/10/20mg + Fenofibrate 05.12.11 67.5/145/160/67.5/145/160/160mg Tablet Rosuvastatin Calcium Eq. to Rosuvastatin (as film coated tablet) 20mg/20mg 24/05/2010 Aspirin (as enteric coated tablet) 75mg/150mg (Additional strength) Each Hard Gelatin Capsules contains: Rosuvastatin Calcium eq. to Rosuvastatin 20mg/20mg + Fenofibrate BP 11.03.16 67.5mg/145mg Tablets Rosuvastatin Calcium eq.to. Rosuvastatin 20mg/20mg + Fenofibrate BP 08.11.08 67.5mg/145mg Tablets Rosuvastatin Calcium IP 5mg/10mg + Fenofibrate BP 160mg/160mg tablet 5/4/2011 Rosuvastatin Calcium IP eq to Rosuvastatin 5mg + Ezetimibe 10mg. Mar-92 (Additional Strength) Rosuvastatin calcium IP Eq. to Rosuvastatin (as film coated immediate release 26-09-2007 tablet) 5mg/10mg Choline Fenofibrate IP Eq. to Fenofibric acid (as delayed release tablets) 135mg/135mg Each Hard gelatin capsule contains: Rosuvastatin Calcium Tablet(Additional Indication) 17.01.17 Rosuvastatin Calcium tablets 5/10/20/40mg (Addl. Indication) 5/4/2005 Rosuvastatin Calcium Tablets 5/10/20mg (Additional Indication) 10.11.2009 PHARMADOCX (Pharmaceutical Consultant) Ph 9896133556 Mail [email protected] (Contact for Setting up Pharma, Cosmetics, Medical Devices Plant, WHOGMP) LIST OF NEW DRUGS 1961 – MAY 2017 download from http://www.pharmadocx.com Page - 97

Rowachol 25.11.2009 Roxatidine Acetate HCl 10.11.2009 Roxithromycin 29.05.15 R-Sibutramine Capsule (2.5mg/5mg) 23.2.15 Rupatadine (10mg) tablet 28.01.2013 Rupatadine 10 mg + Montelukast 10 mg Tablets 25.03.2003 Rupatadine 10 mg + Montelukast 10 mg Tablets 15.04.2004 Ruxolitinib 10mg(add. Strength) 16.08.2002 Ruxolitinib Tablet 5/15/20mg (Additional indication) Sep-91 Ruxolitinib Tablet 5mg/15mg/20mg 25.11.2009 S (-) Amlodipine 2.5mg/5mg + Atenolol 50mg/50mg tablet 05.01.11 S (-) Amlodipine besilate Eq. to S(-) Amlodipine 2.5mg/5mg + HCTZ 05.01.11 12.5mg/12.5mg tablet S (-) Amlodipine Besylate 22.09.11 S (+) Etodolac 150/200/300mg + Paracetamol 500/500/500mg Tablets 07.10.10 S (+) Etodolac 150/200/300mg + Paracetamol 500/500/500mg Tablets 30/08/06 S (+) Etodolac 300mg +Thiocolchicoside 8mg Tablet 16.01.2004 S (+) Etodolac 300mg +Thiocolchicoside 8mg Tablet 09.7.2003 S(-) Metoprolol Succinate ER Eq. to S (-) Metoprolol tartarate 25mg/50mg + 10.02.2004 Clopidogrel (IR) 75mg/75mg tablet S(-) pantoprazole (as sodium) 20mg (E.C.) + Domperidome SR 30mg tablet 17.04.2003 S(-) Alenolol 25mg+Hydrochlorthiazide 12.5mg tablets 09.07.2003 S(-) Amlodipine 2.5mg/5mg + Atenolol 8mg/8mg Tablet 18.10.13 S(-) Amlodipine 2.5mg/5mg + Atrovastin 10 mg Tablet 10.03.2003 S(-) Amlodipine 2.5mg/5mg + Clopidogrel 75mg/75mg Tablets 22.09.11 S(-) Amlodipine 2.5mg/5mg + Clopidogrel 75mg/75mg Tablets 10.02.2004 S(-) Amlodipine 2.5mg+Lisinopril 5mg tablet 17.10.2002 S(-) Amlodipine 5.0mg + Losartan Potasium 50mg tablet 17.10.2002 S(-) Amlodipine 5mg+Atenolol 50mg tablet 16.05.07 S(-) Amlodipine besilate IP Eq to S(-) Amlodipine 5mg /2.5mg + 16.05.07 Hydrochlorothiazide IP 25mg/12.5mg + Olmesartan Medoxomil 40 mg /40 mg Tablet S(-) Amlodipine Besylate eq. to S(-) Amlodipine-2.5mg + Atorvastatin cal 11.11.2005 eq.to Atorvastatin 10mg tablet S(-) Amlodipine-2.5mg/2.5mg + Atenolol 25/50mg tablet 07.10.10 S(-) Amlodipine-2.5mg/2.5mg + Losartan Potasium 25mg/50mg tablet 15-04-2005 S(-) Metoprolol (As succinate) 25mg + S(-) Amlodipine (As besylate 2.5/5mg 15-04-2005 S(-) Metoprolol 25/50mg (ER) + HCTZ 12.5mg/12.5mg (IR) Tablets 30/08/06 S(-) Metoprolol Succinate ER Eq. to S (-) Metoprolol tartarate 25mg/50mg + 13.09.2004 Clopidogrel (IR) 75mg/75mg tablet S(-) Metoprolol Succinate S.R. tablets (equivalent to S(-) Metoprolol Tartrate 02.10.2003 12.5mg /25mg / 50mg) S(-) pantoprazole (as sodium) 20mg (E.C.) + Domperidome SR 30mg tablet 01/04/2010 S(-) Pantoprazole (as Sodium) Inj. 20mg/vial 20-05-2005 S(-)Amlodipine 2.5mg + Nebivolol 5mg Tablets 08/05/2010 S(-)Amlodipine 2.5mg + Ramipril 2.5mg Tablet 5/8/2010 S(-)Metoprolol 25mg/50mg (ER) + Atorvastatin (IR)10mg tablets 02.06.08 PHARMADOCX (Pharmaceutical Consultant) Ph 9896133556 Mail [email protected] (Contact for Setting up Pharma, Cosmetics, Medical Devices Plant, WHOGMP) LIST OF NEW DRUGS 1961 – MAY 2017 download from http://www.pharmadocx.com Page - 98

S(-)Metoprolol 25mg/50mg (ER) + Atorvastatin (IR)10mg tablets 18-Dec-97 S(-)Pantoprazole (10mg/20mg) tablet 14.07.2016 S(+) Etodolac 5/10%w/w + Camphor 4%w/w + Menthol 10%w/w + Methyl Nov-90 salicylate 5%w/w + Linseed oil 3%w/w gel S(+) Etodolac 5/10%w/w + Camphor 4%w/w + Menthol 10%w/w + Methyl Oct,1971 salicylate 5%w/w + Linseed oil 3%w/w S(+) Etodolac ER tablets 200mg/300mg Feb,1973 Saccharomyces boulardi Oct,1974 Saccharomyces boulardii (caps/sachets)[Each capsule/sachets contains 18.12.1997 Saecharomyces boulardii 282.5mg] Sacubutril+ Valsartan film coated tablets 50mg/100 mg/200mg 06.03.2000 Salazopyrin Tab.ER 500mg Jan,1979 Salbutamol Sulphate Mar,1980 Salbutamol Sulphate BP 1969 to 74 Salbutamol Sulphate BP Tablet 4 mg Jul, 1978 Salbutamol Sulphate Elixir 2mg/5ml 18.12.08 Salbutamol sulphate eq. to Salbutamol 100mg + Ipratropium Bromide BP 18.12.08 200mcg inhaler Salbutamol Sulphate Injection 50mg/5ml 17.11.08 Salbutamol Sulphate Sustained Release Tablet 8 mg 17.11.08 Salcalcitonin 17.11.08 Salfametopyrazine 10.4.12 Salicylic Acid + Cetyl Alcohol + Stearyl Alcohol (2% + 2.65% + 0.26%) 17.11.08 Lotion Salicylic Acid + Cetyl Alcohol + Stearyl Alcohol (2% + 2.65% + 0.26%) 28.01.08 Lotion Salicylic Acid + Coal Tar (3% + 1%) Solution Jan.89 Salicylic Acid + Coal Tar + Precipitated Sulphur (3% + 1% + 3%) Ointment 17.11.2008 Salicylic Acid + Coal Tar + Precipitated Sulphur (3% + 1% + 3%) Ointment 1-Dec-93 Salicylic acid 10mg/20mg (Foaming facewash solution) 09.11.2000 Salinomycin 3-Aug-95 Salinomycin premix 6% 20/03/2006 Salmeterol (as Xinofoate) 25mcg/25mcg/25mcg+Fluticasone Propionate BP 25-07-2005 50mcg/ 125mcg / 250mcg per actuation Inhaler Salmeterol Inhaler/Salmeterol Rotacap. (Each actuation delivers-Salmeterol Jun,1972 Xinafoate-25mcg Each Rotacaps contains Salmeterol xinafoate eql to Salmeterol-50mcg) Salmeterol Xinafoate eq.to. Salmeterol 25mcg + Fluticasone propionate 25.2.13 50mcg/125mcg/250mcg per actuation Salmon Calcitonin Injection [1. Each ampoule contains- Salmon Calcitonin- 16/01/2010 100 IU/ml 2. Each vial contains-Salmon Calcitonin 400 IU/2ml.] Samduramycin Sodium 28.04.11 Saquinavir (500mg) tablet (addl. Strength) 11/9/2003 Saquinavir (as mesylate) 500mg Tablet 18-10-2007 Sarcolysin I.P. 18-10-2007 Saroglitazar 2mg/4mg Tablets Nov-85 Sarpogrelate Hydrochloride film coated Tablets 100mg 24.10.09 PHARMADOCX (Pharmaceutical Consultant) Ph 9896133556 Mail [email protected] (Contact for Setting up Pharma, Cosmetics, Medical Devices Plant, WHOGMP) LIST OF NEW DRUGS 1961 – MAY 2017 download from http://www.pharmadocx.com Page - 99

S-Atenolol 04.03.1998 Satranidazole (300mg) + Ofloxacin (200mg) Tablet. Aug-86 Satranidazole (300mg) + Ofloxacin (200mg) Tablet. 13-May-93 Satranidazole tablet 150 mg 09.01.09 Saxagliptin (as HCl) 2.5mg/ 5mg Tablets Aug-91 Saxagliptin Hydrochloride eq. to Saxagliptin 5 mg Metformin Hydrochloride Jan-85 IP 1000mg (Extended Release Tablet) (Additional strength) Each film coated tablet contains: S-Bupivacaine Hydrochloride Injection 2.5mg/5mg/7.5mg per ml 05.03.15 Secadrex tablet 30.11.12 SecnidazoleTablet and oral suspension (1. Each tab 500 mg/ 1000 mg ) and (2. 12-Sep-97 Each 15ml suspension contains Secnidazole-500mg, Selamectin Tropical solution (forverterinary use.) 60mg/120mg per ml Sep-85 Selegiline HCl 5/3/2010 Septopal Beads and Chains 03/05/2010 Seratrodast Tablets 40mg/80mg 31.01.08 Serenoa-Repens cap[Each soft gelatin caps contains 160mg lipid extract to 09.10.08 serenoa repons] Serratio peptidase tablet 5 mg 02.05.2009 Sertaconazole 2% w/v+ Zinc Pyrithione 1% w/v Shampoo 29.11.07 Sertaconazole 2% w/v+ Zinc Pyrithione 1% w/v Shampoo 29.11.07 Sertaconazole Nitrate Cream 2%, 9-Jun-98 Sertaconazole Nitrate Vaginal Tab.500mg 9-Jun-98 Sertaconazole Nitrate Powder 2% w/w & Lotion 2% w/v 20-05-2005 Sertanidazole-300mg+ Ofloxacin-200mg tablet 26.11.2009 Sertanidazole-300mg+ Ofloxacin-200mg tablet 28.04.08 Sertoparin Sodium Injection 08.01.2001 Sertraline Hcl 5.12.12 Sertraline tab 25mg 23.12.99 Sertraline tab 50mg/100mg 23.01.07 Sevelamer (400mg/800mg) tablet 09.06.1998 Sevelamer Carbonate (Additional Indication) 05.07.2013 Sevelamer Carbonate 400mg/800mg tablets & sachet 400mg/800mg 01.10.1999 Sevoflurene 23.06.11 Sibutramine Hydrochloride Jul-96 Sildenafil Citrate 20mg Tablet Jun-78 Sildenafil Citrate Injection 0.8mg/ml Sep, 1979 Sildenafil Citrate Orally Disintegrating Strips. 25mg/50mg (Additional Apr-88 Dosage Form) Sildenafil Citrate 16.04.08 Silodosin Capsules2mg/4mg/8mg 22-Jun-95 Silodosin Tablets 4mg 14.11.2010 Silver Sulphadiazine 11/5/2005 Silver sulphadiazine eye ointment. 1% 3/1979 to 7/1981 Silver Wound Dressing 21.7.2009 Silymarin 22.01.08 Silymarin tablet -70mg 25-Sep-97 PHARMADOCX (Pharmaceutical Consultant) Ph 9896133556 Mail [email protected] (Contact for Setting up Pharma, Cosmetics, Medical Devices Plant, WHOGMP) LIST OF NEW DRUGS 1961 – MAY 2017 download from http://www.pharmadocx.com Page - 100

Simethicone Orally disintegrating strip 62.5mg 21.7.2009 Simvastatin 22.06.1995 Simvastatin (10/20mg) + Ezetimibe (10mg) Tab 15.07.2002 Simvastatin (10/20mg) + Ezetimibe (10mg/10mg) Tablets Apr, 1981 Simvastatin 20 mg + Ramipril 5mg + Atenolol 50 mg + HCTZ 12.5 mg + 28.04.08 Aspirin 100 mg (EC Pellets) Capsules Simvastatin tab 5mg/10mg/20mg/40mg 28.04.08 Simvastatin 20 mg + Ramipril 5mg + Atenolol 50 mg + HCTZ 12.5 mg + 3/7/2010 Aspirin 100 mg (EC Pellets) Capsules Sirolimus 30-10-2007 Sisomicin Sulphate 25.09.1997 Sitagliptin ( As Phosphate) 50mg + Metformin Hcl. 500mg/1000mg Film 22.01.08 coated tablets Sitagliptin ( As Phosphate) 50mg + Metformin Hcl. 500mg/1000mg Film 19.08.08 coated tablets Sitagliptin Phosphate 25/50/100 mg Tablet (Additional Indication) Nov-78 Sitagliptin Tablet (25mg/50mg/100mg). Nov-78 Smatriptan (as succinate ) 50mg + Naproxen sodium 550mg tablets May-73 Smatriptan (as succinate ) 50mg + Naproxen sodium 550mg tablets Oct,1975 S-Metoprolol Succinate Oral Solution (Each Ml contains: S-Metoprolol 11/2/2010 Succinate 9.5mg equal to S-Metoprolol Tartrate 10mg) Sod. Chloride 20.475mg + Pot. Chloride 0.783gm + Mag. Chloride 02/11/2010 0.534gm + Cal. Chloride 0.972gm + Sod. Acetate 19.054gm per 100ml Dialysis fluid Sod. Chloride 20.047mg + Pot. Chloride 0.522gm + Mag. Chloride 0.366gm + 14.05.08 Cal. Chloride 0.859gm + Sod. Acetate 19.047gm per 100ml Dialysis fluid Sod. Chloride 558mg + Pot. Chloride 14.9 mg + Mag. Chloride 10.16mg + 14.05.08 Cal. Chloride dihydrate 21.9mg + 20/6 Molar Sod. Lactate 1.34 ml + Dextrase Anhydrous 1.5gm per 100ml Sodium Chloride 20% Hypertonic saline for Intra-amniotic use 25.08.08 Sodium chloride 6.80gm + Potassium chloride 0.30 gm + Calcium chloride 25.08.08 dihydrate 0.37gm + Magnesium chloride hexahydrate 0.20gm + Sodium acetate trihydrate 3.27gm + L-malic acid 0.67gm in 1000ml solution for infusion Sodium chloride 6.80gm + Potassium chloride 0.30gm + Calcium chloride Nov,1972 dihydrate 0.37gm + Magnesium chloride hexahydrate 0.20gm + Sodium acetate trihydrate 3.27gm + L-malic acid 0.67gm in 1000ml solution for infusion Sodium Chondroitin sulfate 40mg + sodium Hyaluronate 30mg per ml Mar-92 Intraocular Injection (additional strength) Sodium Chondroitin sulfate 40mg + sodium Hyaluronate 30mg per ml 05.09.2002 Intraocular Injection (additional strength) Sodium Chondroitin Sulphate + Sodium Hyaluronate injection (40mg + not Aug,1975 more than 17mg per ml) Sodium Chondroitin Sulphate + Sodium Hyaluronate injection (40mg + not May,1974 more than 17mg per ml) Sodium chromoglycate 10/11/2005

Sodium Enoxaparin 04.04.2000 Sodium Ferric Gluconate complex with sucrose eq. to elemental iron 6.25mg 16/03/2006 (12.5mg/ml) Sodium Fluaride BP Tablet 20 mg 03.06.08 Sodium Fusidate Ointment, 20mg/gm 6/2/2010 Sodium Hyaluronate 0.1% eye drops (addl. Strength) 26/07/2006 Sodium Hyaluronate 30mg + Chodroitin Sulfate 40mg each ml opthalmic 23.4.12 solution Sodium Hyaluronate Cream 0.2% Jun-89 Sodium Hyaluronate injectable gel (each 0.6ml. 1ml pre filled syringe Jul,1979 contains, sodium Hyaluronate 20mg/ml, 22.5mg/ml Sodium Hyaluronate Injectable Gel 14mg/ml, 18mg/ml, 25.5mg/ml 09.11.2001 (Additional Strength) Sodium Hyaluronate Injection (1%). 11-Feb-97 Sodium Hyaluronate Injection 8mg/vial (6ml Pre-filled syringe for Intra 15.04.2002 Articular use only) Sodium Hyaluronate sol. Sep-77 Sodium Hydroxy oxopyrido phrnoxazine Carboxylate Oct,1981 Sodium meglumin Lothalamate 24.01.08 Sodium Nitroprusside USP Injection 50mg/vial 1975 to 76 Sodium Picosulphate 26-08-2005 Sodium Picosulphate 5mg + liquid Paraffin 4.8ml liquid paraffin per 15ml 11.02.1997 solution Sodium Picosulphate Tab/Syrup [1. Each uncoated tab contains, Sodium 23.08.99 Picosulphate-5mg/10mg 2. Each 5ml syrup contains, Sodium Picosulphate- 5mg] Sodium Pyrolidone Carboxylic acid 2.5% w/w + Sodium Lactate solu. Eq. to 24.01.08 Sodium Lactate 2.5% w/w+Vit. E 1% w/w+ Olive Oil 3% w/w cream Sodium Salicylate IP (Eq. to Salicylic acid IP 0.86% w/w) 1.0% w/w + Zinc 24.01.08 Gluconate BP 0.5 % w/w + Pyridoxine HCl IP 0.5% w/w (Shampoo) (veterinary product) Sodium salt of loxitalamic acid 5.13gm + Meglumine salt of loxitalamic acid 17.02.16 10.26gm per 20ml Inj. Sodium Valporate 24.01.08 Sodium Valproate (750mg/1000mg) C.R. Tablet 1969 to 74 Sodium valproate 333mg/133.5mg + Valproic acid 145mg/58.0mg Dec,1981 corresponding to Sodium Valproate 500mg/200mg Film coated CR Tablets Sodium Valproate 499.5mg + Valproic acid 217.5mg equivalent as sodium 02.06.08 valproate- 750mg CR tablet (Additional Strength) Sodium Valproate 499.5mg + Valproic acid 217.5mg equivalent as sodium 13.01.2015 valproate- 750mg CR tablet (Additional Strength) Sodium Valproate 666mg + valproic acid 290mg equivalent as sodium 6/7/2006 valproate 1000mg C.R. tablet (Additional Strength) Sodium Valproate 666mg + valproic acid 290mg equivalent as sodium 23.12.2010 valproate 1000mg C.R. tablet (Additional Strength) Sodium-2-mercepto-ethane sulphonate 23.12.2010

Sofalcone Capsule (100mg/50mg) 31-07-2007 Sofosbuvir Tablet 400 mg 22.01.08 Solifenacin Succinate Tablet (5mg/10mg). 25.9.14 Solution for haemofiltration and haemodialysis (Each unit contains two Aug, 1978 compartments A & B. Before reconstitution: • 1000ml of electrolyte solution in Compartment A contains Calcium Chloride. 2H2O .....5.145gm, Magnesium Chloride. 2H2O....2.033gm, Lactic Acid....5.4gm, • 1000ml of buffer solution in Compartment B contains: Sodium Chloride.... 6.45gm, Sodium Bicarbonate....3.090gm) Solution for haemofiltration and haemodialysis (Each unit contains two 28.08.2000 compartments A & B. Before reconstitution: • 1000ml of electrolyte solution in Compartment A contains: Calcium Chloride. 2H2O .....5.145gm Magnesium Chloride. 2H2O.... 2.033gm Lactic Acid....5.4gm • 1000ml of buffer solution in Compartment B contains: Sodium Chloride....6.45gm Sodium Bicarbonate....3.090gm ) Solution of Solic Benzoic & Salicy acid in aqueous propylene alcohol, malic 06.05.1994 acid Somatostin IV Infusion 1969 to 74 Somatropine (r DNA) inj. 24.04.1995 Sorafenib (as Tosylate) (200mg) Tablet. Jun,1978 Sorafenib tablets 200mg (Additional Indication) 19/01/2010 Sorafenib tosylate tablet 200mg (Additional indication) 19/01/2010 Sorbister Capsule 26.07.2001 Sotalol 11-Nov-96 Soyabean oil USP 10.0gm + Egg Lecithin 0.60gm + Glycerol IP 2.5gm per Sep-85 100ml Intravenous solution Soyabean Protein 33.2 g/150 g 8/1/2010 Soybean oil 60gm + Triglycerides (medium chain) 50gm + olive oil purified 15.03.1994 fish oil 30gm + dl-alpha-tocopherol 163-225mg + glycerol (anhydrous) 25gm + Egg lecithin 12gm + sodium hydroxide (to approx pH 8) + sodium pleate 0.3mg emulsion for infusion in 100ml. Soybean oil 60gm + Triglycerides (medium chain) 50gm + olive oil purified Nov,1971 fish oil 30gm + dl-alpha-tocopherol 163-225mg + glycerol (anhydrous) 25gm + Egg lecithin 12gm + sodium hydroxide (to approx pH 8) + sodium pleate 0.3mg emulsion for infusion in 100ml. Sparfloxacin tabs. 100mg/200mg, 400mg 03/05/2010 Spectinomycin hydrochloride 5/3/2010 Spenglersan 3.12.12 Sphaeranthus Indicus Extract Tablets 700mg 05.01.11 Spiramycin 0.75MIU/1.50MIU+Metronidazole 1.25mg/250mg film coated 05.01.11 Tablets Spiramycin Injection Sep.87 Spironolactone 25mg + Furosemide 20mg tablets Mar,1973 Spironolactone 25mg + Furosemide 20mg tablets 11/11/2005 Spironolactone IP 25mg + Furosemide IP 40mg Tablet 11.11.2005 Spironolactone IP 25mg + Furosemide IP 40mg Tablet 11/11/2005

Stanozolol injection 50 mg/ ml 01.09.1993 Stanozolol Tablet 2 mg 08.05.2005 Stavudine 10mg + Lamivudine 40mg + Nevirapine 70mg dispersible tablet 12-Jul-97 Stavudine 10mg+Lamivudine 40mg+ Nevirapine 70mg dispersible tablet 26.07.01 Stavudine 30mg/40mg + Lamivudine 150 mg /150mg+ Neviramine 21.06.1996 200mg/200mg tablet Stavudine 6mg/12mg + Lamivudine 30mg/60mg Dispersible Tablet 26.12.2003 Stavudine caps 15MG/20MG/30MG/40MG Feb-80 Stavudine powder for suspension 18.04.12 Stavudine SR 100mg tablet 18.04.12 Stavudine` 02.06.1997 Sterile Amoxycillin Sodium eq. to Amoxycillin 500gm/1gm+Sterile May-92 Sulbactam Sodium eq. to Sulbactam 250mg/500mg (each vial) inj. (IM/IV) Sterile Cefotaxime sodium USP eq.to. Cefotaxime 500mg/1000mg+Sterile 15.03.2010 Sulbactam 250mg/500mg per vial injection Sterile Morepenam IP eq. to Anhydrous Meropenam 1000mg +Sterile Sodium 15-03-2010 Carbonate IP Eq. to Sodium 90.2 mg +Sterile Sulbactum Sodium USP eq. to Sulbactum 500 mg injection (veterinary product) Each Vial contains Sterile powder of colistin sulphomethate sodium eq. to 1000000 Units + 19.03.15 Dilucame HCl 2mg per vial Inj. Sterile Solution for Peritoneal Dialysis: Each 1000 ml contains: 15-03-2010 Calcium chloride dihydrate 0.184 g/l + Glycine 0.51 g/l + L- Alanine 0.951 g/l + L- Arginine 1.071 g/l + L- Isoleucine 0.85 g/l + L- Histidine 0.714 g/l + L- Leucine 1.02 g/l + L- Lysine (as Hcl) 0.955 g/l + L-Methionine 0.85 g/l + L- Phenylalanine 0.57 g/l + L-Proline 0.595 g/l + L- Serine 0.51 g/l + L- Threonine 0.646 g/l + L-Tryptophan 0.27 g/l + L- Tyrosine 0.3 g/l + L-Valine 1.393 g/l + Magnesium chloride hexahydrate 0.051 g/l + Sodium chloride 5.38 g/l + Sodium lactate 4.48 g/l Sterile Solution for Peritoneal Dialysis Each 1000 ml contains: Calcium 01.08.2007 chloride dihydrate 0.184 g/l + Glycine 0.51 g/l + L- Alanine 0.951 g/l + L- Arginine 1.071 g/l + L- Isoleucine 0.85 g/l + L- Histidine 0.714 g/l + L- Leucine 1.02 g/l + L- Lysine (as Hcl) 0.955 g/l + L-Methionine 0.85 g/l + L- Phenylalanine 0.57 g/l + L-Proline 0.595 g/l + L- Serine 0.51 g/l + L- Threonine 0.646 g/l + L-Tryptophan 0.27 g/l + L-Tyrosine 0.3 g/l + L-Valine 1.393 g/l + Magnesium chloride hexahydrate 0.051 g/l + Sodium chloride 5.38 g/l + Sodium lactate 4.48 g/l Sterillium rub in disinfectant for hands 31.01.2008 Streptococcus faecalis 30million + Clostridium butyricum 2million + Bacillus 14-06-2005 mesentericus 1million+ Lactic acid bacillus 50million (lactobacillus sporogenes) Capsules Streptococcus faecalis T-110 JPC 30 million + Clostridium butyricum TO-A 2 18-08-2005 million + Bacillus mesentericus TO-A JPC 1 million + Lactic acid bacillus (lactobacillus sporogenes) 50 million Capsules

Streptococcus faecalis T-110 JPC 30 million + Clostridium butyricum TO- 18-08-2005 A 2 million + Bacillus mesentericus TO-A JPC 1 million + Lactic acid bacillus (lactobacillus sporogenes) 50 million Capsules Streptococcus thermophilus 45% + Bifidobacteria (B.longum, 14.12.1995 B.infantis,B.breve) 45% + Lactobacillus acidophillus 3% + Lactobacillus casei 2% + Lactobacillus delbruecki susp. 3% Bulgaris 2% + Lactobacillus plantarum Streptococcus thermophilus 45% w/w + Bifidobacteria (B.longum, 9/10/2007 B.infantis,B.breve) 45% w/w + Lactobacillus acidophillus 3% w/w + Lactobacillus casei 2% w/w + Lactobacillus delbruecki susp. Bulgaris 3% w/w + Lactobacillus plantarum 2% w/w capsules Stronger Neominophagen-C 09-10-2007. Strontium Ranelate Granules (2gm/Sachet) 23.08.2004 Sucralfate (7%) + Povidone Iodine (5%) Ointment 29.04.2002 Sucralfate (7%) + Povidone Iodine (5%) Ointment Nov-86 Sucralfate (70mg ) + Metronidazole (10mg) + Povidone Iodine (50mg) per 09.05.2009 gram of Ointment. Sucralfate (70mg ) + Metronidazole (10mg) + Povidone Iodine (50mg) per 17-12-2003 gram of Ointment. Sucralfate 0.07gm + Metronidazole 0.01gm +Lignocaine 0.04gm per gram 04.04.2000 cream Sucralfate 0.07gm + Metronidazole 0.01gm cream 16.03.2000 Sucralfate tablet 1 gm. 23-Mar-96 Sucralfote May-78 Sucralose 1985 to 87 Sufentanil Citrate Sep,1977 Sulbactam Sod. Eq. Sulbactam 1000mg + Cefoperazone sodium Eq. Sep,1977 Cefoperazone 1000mg each vial injection (IV/IM) (Additional Strength) Sulbutiamine tabs -200mg 06.03.2000 Sulfametopyrazine 500mg + Pyrimethamine 25mg tablet Jan-87 Sulfinpyrazone Capsule 200 mg Apr, 1981 Sulfinpyrazone Tablet 100 mg Jun, 1978 Sulperazone (Sulbactam Sodium) + Cefoperazone Sodium 28-09-2007 Sulpha Chloropyrazine Sodium Nov-62 Sulphadiazine 200mg + Trimethoprim 40mg suspension 26.10.99 Sulphadiazine 400mg + Trimethoprim 80mg tablet Jan-86 Sulphadoxine Feb.87 Sulphamethoxazole 500 mg + pyrimethamine 25 mg 6-May-94 Sulphametopyrazine 1-May-78 Sulphur Hexafluoride Powder and solvent for dispersion for injection 04.02.1998 (45mcg/ml). Sulpiride 24.11.08 Sulprostone injection 24.11.08 Sulprostone injection 500 mcg/ ampoule 3.08.2009 Sultamicillin Tab [Each film coated tablet contains: Sultamicillin( as- 3.08.2009 Tosylate)-375mg equl to sulbactam 147mg and Ampicillin 220mg)]

Sultamicillin(as Tosylate) 375mg eq. Sulbactam 147.0 mg +Ampicillin 6-Feb-96 220mg Film coated tablets. Sumatriptan + Naproxen (50mg + 275mg) Tablets 5/5/2011 Sumatriptan + Naproxen (50mg + 275mg) Tablets (additional strength) 10.04.07 Sumatriptan 85 mg + Naproxen 500 mg Tablets 12/6/2006 Sumatriptan 85 mg + Naproxen 500 mg Tablets Sep, 1977 Sumatriptan tablets and injection [Each film coated tabs contains, 1. 26.03.09 Sumatriptan (as succinate)-100mg/50mg/25mg 2. Sumatriptan injection contains Sumatriptan as succinate 6mg-per 0.5ml] Sunitinib malate Capsules 12.5mg/25mg (Additional Indication) Nov-93 Sunitinib Maleate Capsules 12.5mg/25mg/50mg Dec-62 Super Oxidized Solution (containing Water 99.9% with salts like sodium 26.09.11 hypochlorite, hypochlorous acid, hydrogen peroxide ozone, chlorine chloride, sodium hydroxide, sodium carbonate and sodium chloride) Suramin Inj. 14-Feb-96 Surgical Sealant 21.07.1997 Tablets of Norethisterone acetate + Ethinyl oestradiol 11/8/2011 Tablets of Norethynodrel and Ethinyl Estradiol 3-methyl ether 24/04/2010 Tacalcitol ointment 4mcg 26.11.2009 Tacrine Hydrochloride 24/05/2010 Tacrine Hydrochloride caps 10mg/20mg/30mg/40mg 06.02.1996 Tacrolimus Capsules 0.25mg 10/3/2003 Tacrolimus Capsules 0.5mg/1mg/5mg (Additional Indication) 11/9/2003 Tacrolimus Capsules 3mg (Additional Strength) 30.07.2014 Tacrolimus Granules for oral suspension 0.2/1 mg per sachet 27.2.13 Tacrolimus PR Caps 0.5/1/5 mg 14.11.2009 Tacrolimus Ointment 21.10.11 Tadalafil Jun,1980 Tadalafil Orally Disintegrating Strip 10mg & 20mg (Additional dosage form) Apr,1981 Tadalafil Tablet 2.5mg/5mg 08.10.2008 Tadalafil tablet 20 mg (Additional Indication) 17.11.08 Tafluprost Eye Drops 0.0015% w/v 17.11.08 Tamoxifen Citrate 17.03.2004 Tamoxifen Citrate Capsule 10 mg 06.02.2006 Tamsulosin Hydrochloride 0.4mg + Tolterodine tartrate 2mg ER 6/2/2006 capsule Tamsulosin (0.4mg MR Pellets + Tolterodine 2mg/4mg ER Pellets) Capsules 04.04.2002 Tamsulosin + Tolterodine (0.4mg MR Pellets + 2mg/4mg ER Pellets) 9.12.13 Capsules Tamsulosin 0.4mg + Finastride 5mg MR Capsule 12.11.13 Tamsulosin HCl (MR) 0.4mg + Dutasteride 0.5mg tablet 18.04.11 Tamsulosin HCl (MR) 0.4mg + Dutasteride 0.5mg tablet 13.01.1994 Tamsulosin HCl 13.01.1994 Tapentadol Extended release tablet 100/150/200mg (Additional strength) 12.09.2003 Tapentadol Extended release Tablet 50mg (Additional Strength) 24.05.2005 Tapentadol Hydrochloride Tablets 50mg/75mg/100mg 24-05-2005 Taurolidine 2 % or 0.5 % 1/4/2005 PHARMADOCX (Pharmaceutical Consultant) Ph 9896133556 Mail [email protected] (Contact for Setting up Pharma, Cosmetics, Medical Devices Plant, WHOGMP) LIST OF NEW DRUGS 1961 – MAY 2017 download from http://www.pharmadocx.com Page - 106

Taurolidine 2.5g + Povidone 6.25g per 500ml Taurolidine 2g + Povidone 5g per 100ml 04/01/2005 Tazarotene 22-08-2007 Tazarotene (0.05%) + Mometasone Furoate (0.1%) Cream (addl.strength) 22-08-2007 Tazarotene (0.05%) + Mometasone Furoate (0.1%) Cream (addl.strength) 01.11.2002 Tazarotene (1mg) +Mometasone Furoate (1mg) per gram cream 19-Feb-97 Tazarotene (1mg) +Mometasone Furoate (1mg) per gram cream 30/08/06 Tegafur (100mg) + Uracil (224mg) capsule. 25.11.2002 Tegafur (100mg) + Uracil (224mg) capsule. 03.01.2013 Tegaserod Maleate 28-01-2005 Teicoplanin For IM/IV Injection 100mg/200mg/400mg per vial 15.09.08 Telbivudine 600mg tablet 15.09.08 Telmisartan 03.01.2013 telmisartan 20mg + Amlodipine Besylate Eq. to Amlodipine 2.5mg + 22.05.08 Hydrochlorothizide 6.25mg Tablets (Additional Strength) Telmisartan + Ramipril (40mg + 2.5mg ) Tablets (Additional Strength) 04/05/2010 Telmisartan 20mg + Amlodipine Besylate Eq.to Amlodipine 2.5mg + 5/4/2010 Hydrochlorothizide 6.25mg Tablets (Additional Strength) Telmisartan 40 mg + Atorvastatin (as calcium) 10 mg Tablets 30/08/06 Telmisartan 40 mg + Atorvastatin (as calcium) 10 mg Tablets 29.08.2003 Telmisartan 40/80 mg+ Indapamide SR 1.5/1.5 mg tablet 31.03.09 Telmisartan 40mg + Amlodipine (as Besylate) 5mg tablet 14/05/2010 Telmisartan 40mg + Amlodipine (as Besylate) 5mg tablet 31.03.09 Telmisartan 40mg/80mg + Hydrochlorthiazide 12.5mg/12.5mg tablet 08.07.08 Telmisartan 80mg + Amlodipine 5mg tablet (Additional strength) 31.03.08 Telmisartan IP 80mg + Hydrochlorothiazide IP 25mg uncoated bilayered 17.01.2000 tablet (Additional Strength) Telmisartan tablet 20/40/80 mg(Additional indication) 24/05/2010 Telmisartan 80mg + Amlodipine 5mg tablet 11.12.2010 Temoporfin 1mg/ml Injection (Additional Strength) 18.05.2015 Temozolamide capsules 140mg/180mg (Addl. Strength) 23/02/2006 Temozolomide 23/02/2006 Temozolomide lyophilised powder 100mg / vial 07.01.08 Temsirolimus Concentrate for Infusion for Injection 25mg/ml 07.01.08 Tene ligliptin Hydrobromide Hydrate Eq. to Teneligliptin 20mg Metformin- 17-08-2005 500mg/1000mg (ER) Tablets Teneligliptin Tablet 20mg 30.03.16 Tenofovir Disoproxil Fumarate (300mg) + Emtricitabine (200mg) tablet 08/01/2006 Tenofovir Disoproxil Fumarate (300mg) + Emtricitabine (200mg) tablet 1/8/2006 Tenofovir disoproxil fumarate 300mg + Lamivudine 300mg tablet 23.07.2008 Tenofovir disoproxil fumarate 300mg + Lamivudine 300mg tablet 23.07.08 Tenofovir Disoproxil Fumarate Tablet (300mg) 23.07.08 Tenofovir Disoproxil Fumarate300mg + Emtricitabin 200mg + Efavirenz 19.6.2009 600mg tablet Tenofovir Fumarate 300mg + Lamivudine 300mg + Efavirenz 600mg FC 29-Apr-93 Tablet Tenofovir Fumarate 300mg + Lamivudine 300mg + Efavirenz 600mg Tablets 29-Mar-95 PHARMADOCX (Pharmaceutical Consultant) Ph 9896133556 Mail [email protected] (Contact for Setting up Pharma, Cosmetics, Medical Devices Plant, WHOGMP) LIST OF NEW DRUGS 1961 – MAY 2017 download from http://www.pharmadocx.com Page - 107

Tenofovir Disoproxil Fumerate 300mg Oct-82 Tenoxicam Jul,1980 Tenoxicam tablet 20 mg Apr-93 Teratolo Hydrochloride Nov,1979 Terazosin Hcl tablet 1mg/2mg/5mg Jun-88 Terbanarine Nov,1979 Terbinafine Tab. 250mg / cream 1% 29.03.1995 Terbutaline Nebulising Solution Nov, 1979 Terbutaline sulphate 1.5mg + Guaphenesine 66.5 mg per 5ml syrup Nov, 1979 Terbutaline Sulphate Injection 0.5 mg/ml 19-Jul-94 Terbutaline Sulphate Syrup 0.3mg/ml 24.03.1995 Terbutaline Sulphate Tablet 2.5 mg & 5 mg Sep-90 Terbutamine Sulphate Syrup 0.3 mg/ml 4/9/2003 Terbutamine Sulphate Tablet 5 mg Jun, 1981 Terconazole 22-Jul-95 Terconazole Vaginal ovule/vaginal cream [1. Each ovule contains: Jul-94 Terconazole- 80mg 2. Terconazole vaginal cream contains-Terconazole- 0.8%.] Terfenadine 60mg + Pseudoephedrine HCL 120mg as E.R. tablets Jun-88 Terfinadine Nov,1971 Terfinadine + Pseudoephedrine Mar,1975 Teriparatide 24.03.1995 Terizidone Mar,1972 Terlipressin Acetate Injection I.V. 08.02.07 Terlipressin Acetate Injection I.V. -1mg. 08.02.07 Tertatolol Hydrochloride 27.07.1995 Testolactone Jan-64 Testolactone Injection 100 mg/ml 12/7/2005 Testolactone Tablets 50 mg 29-11-2005 Testosterone cypionate (100mg/200mg) + Cotton seed oil 736/566mg per ml 15/02/2006 injection Testosterone cypionate (100mg/200mg) + Cotton seed oil 736/566mg per ml 22.07.08 injection Testosterone decanoate + Isocaproate Sep-85 Testosterone Gel 1%. 10.03.99 Testosterone Spray (25mg) Nov-92 Testosterone Transdermal Spray (12.5mg/spray) (addl. Lower strength) Nov-92 Testosterone Undecanoate Aug,1979 Testosterone Undecanoate 250mg/ml Injection Jan-69 Testosterone Undecanoate capsules 40 mg 1985 to 87 Tetrabenazine Jul,1973 Tetrachlorodecaoxide Dec,1971 Tetrachlorodecaoxide oxoferin Dec,1976 Tetrachlorodecaoxide Sol. 1.037 mg/100ml Nov-92 Tetracycline HCl 250mg + Broxyquinoline 200mg + Brobenzoxadine 40mg 12.08.2002 Tetracycline Sustained Release Capsule 250 mg 31.03.09 Tetramisole Hydrochloride 30% w/w Mar-73 PHARMADOCX (Pharmaceutical Consultant) Ph 9896133556 Mail [email protected] (Contact for Setting up Pharma, Cosmetics, Medical Devices Plant, WHOGMP) LIST OF NEW DRUGS 1961 – MAY 2017 download from http://www.pharmadocx.com Page - 108

Tetramisole Hydrochloride Syrup 50mg/5ml Mar-73 Tetranicolinoyl Fructose Tablets 250 mg 26.02.2009 Tetranicotinoyl Fructose 26.02.2009 Thalidomide 31/04/2010 Theophylline + Ephedrine + Diazepam + Prednisolone 31.03.09 Theophylline 400mg SR + Montelukast10mg Tablet 17.11.08 Theophylline 400mg SR + Montelukast10mg Tablet 17.11.08 Theophylline anhydrous 100mg + Ephedrine HCl 10mg + Diazepam1mg + 11.10.10 Prednisolone 1.5mg tablet Thiamine Mononitrate IP 10.0mg + Riboflavin IP 10.0mg + Pyridoxine HCl 11.10.10 IP 3.0mg + Vit. B12 IP 15.0mcg + Niacinamide IP 100.0mg + Calcium Pantothenate USP 50mg + Folic Acid IP 1.5mg + Biotin USP 100.0mcg + Ascorbic Acid IP 150.0mg capsule Thiamine Mononitrate IP 10mg + Riboflavin IP 10mg + Pyridoxine HCl IP 06.11.2008 3mg+ Vit. B12 IP15mcg + Niacinamide IP 100mg + Calcium Pantothenate IP 50mg + Folic Acid IP 1.5mg + Biotin USP 100mcg + Ascorbic Acid IP 150mg + Zinc Sulphate monohydrate USP 41.4mg (eq. to 15mg elemental Zinc) capsule Thiocholchicoside SR Tablet 16 mg 11.06.08 Thiocolchicoside 12.02.2002 Thiocolchicoside + Etoricoxib (4mg + 60 mg) FC Tablets 11.06.08 Thiocolchicoside + Etoricoxib(4mg + 60 mg) FC Tablets 25.04.09 Thiocolchicoside 0.25% + Methyl salicylate IP 100mg + Menthol IP 50mg 25-Mar-96 +Absolute alchol IP 50mg per gm gel Thiocolchicoside 0.25% +Methyl salicylate IP 100mg +Menthol IP 50mg 25.04.09 +Absolute alchol IP 50mg per gm gel Thiocolchicoside 4/8mg + Ketoprofen 50/100mg FC Tablet Dec,1973 Thiocolchicoside 4mg/8mg + Ketoprofen 50mg/100mg tablets 25.03.1996 Thiocolchicoside 8mg + Etoricoxib 60 mg tablets (additional strength) Jul-86 Thiocolchicoside tablet -4 MG 17.4.15 Thiocolchicoside 8 mg + Etoricoxib 60 mg tablets Aug-86 Thiophanate 23.06.11 THV (Turkey Herpex Virus) Inn. 16-Oct-96 Thymogen Inj. Aug-86 Thymosin Alfa-1 Inj. Dec.86 Tiagabine HCL Tablet (2/4/12/16 mg) 1969 to 74 Tiamulin Hydrogen Fumarate 19-Feb-97 Tiamulin hydrogen fumarate solution for injection 162 mg/ml (add. Dosage 1985 to 87 form) Tiamulin Hydrogen Fumrate 14.05.2004 Tiamulin soluble granules 03.05.12 Tiapride Hydrochloride Tablets 25mg/50mg/100mg 30.10.1996 Tiaprofenic Acid 11.02.93 Tiaprofenic Acid tablet 200 mg and 300 mg 28/08/06 Tiaprost Trometamol inj (vet) 150mg 25.01.2000 Tibolone tablet 2.5mg 14/05/2010 Ticagrelor Tablet 90mg Jul-85 PHARMADOCX (Pharmaceutical Consultant) Ph 9896133556 Mail [email protected] (Contact for Setting up Pharma, Cosmetics, Medical Devices Plant, WHOGMP) LIST OF NEW DRUGS 1961 – MAY 2017 download from http://www.pharmadocx.com Page - 109

Ticarcilin 3gm + Clavulanic Acid 100mg (per vial) injection 08.11.08 Ticarcilin + Clavulanic Acid Sep-84 Ticlopidine 30.10.1996 Ticlopidine HCL 250 mg tablet Feburary 1993 Tigecycline powder For Inj. 50mg/vial 09.05.1995 Timolol + Maleate 25.01.2000 Timolol + Pilocarpine Dec-83 Timolol maleate 5mg (as based) + Pilocarpine Hcl 20mg per ml opthalmic Mar-90 solution Timolol Maleate Long Acting Ophthalamic Solution 5mg/ml Timolol Maleate oph. Solution 2.5 mg/ml Feb,1974 Timolol Maleate SR Eye Drops 5.0mg / ml 22.03.11 Tinazolin eulk 24.12.2004 Tinidazole 1985 to 85 Tinidazole + Diloxanide Furoate 1969 to 74 Tinidazole 150mg + Diloxonide Furoate 250mg tablet 31.01.08 Tinidazole 600mg+Norfloxacin 400mg tablets 31.01.08 Tinidazole Infusion 2mg/ml in 400 ml, 2mg/ml in 800ml 22.04.2004 Tinidazole suspension 75 mg/5 ml 26.04.2004 Tinidazole Tablets, 150 mg 31.01.2008 Tioconazole Vaginal Gel 65mg per gm 22.11.2004 Tiotropium (as Tiotropium Bromide Monohydrate) 18mcg + Formoterol 16.04.2003 Fumarate Dihydro. 12mcg + Ciclesomide 400mcg per capsules Tiotropium (as Tiotropium Bromide Monohydrate) 18mcg + Formoterol 9/3/2005 Fumarate Dihydro. 12mcg + Ciclesomide 400mcg per capsules Tiotropium (as titropium Bromide Monohydrate) 18 mcg + Fometrol Fumrate 01.09.1984 Dihydro. 12 mcg + Ciclesomide 400 mcg per Capsule Tiotropium Br 18mcg + Formoterol 12mcg Rotacap 12.08.2003 Tiotropium Br 9mcg + Femoterol 12mcg Inhaler 22/08/06 Tiotropium Bromide monohydrate Eq. to Tiotropium 9mcg + Formoterol 06.02.2002 Fumarate dehydrate eq. to Formoterol Fumarate 6mcg meter dose inhaler Tiotropium Bromide Monohydrate Eq.to Tiotropium 18mcg+Formoterol 22/03/2006 Fumarate 12mcg dry powder inhaler Tiotropium Bromide Sep-85 Tirofiban (0.25mg/ml injection) (additional strength) April.87 Tirofiban HCl I.V 12.09.2002 Tiropramide Hcl (100mg) tablet 01.04.16 Tizanidine SR 13/04/2010 Tobramycin 07.12.11 Tobramycin 0.3 % + Flurometalone 0.1 % Eye Drops 1985 to 87 Tobramycin Inhalation solution (300mg/5ml) 4-Mar-98 Tobramycin inj. 10/40 mg per ml Feb-77 Tobramycin ophthalmic solution 0.03% per vial 21.10.10 Tobramycin sulphate eq. to Tobramycin 3mg+ Flurometholone 1mg per 07.12.11 ml Opthalmic suspension Tofacitinib Tablets 5 mg(Tofacitinib Citrate) 21.10.10 Tofisopam uncoated tablet JP... 50/100mg 12.04.2013 PHARMADOCX (Pharmaceutical Consultant) Ph 9896133556 Mail [email protected] (Contact for Setting up Pharma, Cosmetics, Medical Devices Plant, WHOGMP) LIST OF NEW DRUGS 1961 – MAY 2017 download from http://www.pharmadocx.com Page - 110

Tolfenamic acid 04.11.10 Tolfenamic acid caps 200mg 12.09.2002 Tolnaytate + Nystatin 04.03.1998 Tolnaytate 10mg + Nystatin 100,000 Units per gm cream Feb-77 Tolperisone HCL 150mg + Paracetamol IP 500mg tablet 30/03/2010 Tolperisone Hcl IP 150mg + Diclofenac IP 50mg Tablets 26.09.08 Tolperisone HCL 150mg + Paracetamol IP 500mg tablet 15-06-2007 Tolperisone HCl 450mg + Diclofenac Sodium IP100mg SR tablets 15-06-2007 (Additional Strength) Tolperisone Hcl IP 150mg + Diclofenac IP 50mg Tablets 15.06.07 Tolperisone HCl Mouth Dissolving tablet 50/100 mg (Additional Dosage 15.06.07 Form) Tolperisone Hcl SR 450mg Tablets 31.01.14 Tolperisone HCl Tablet 50 / 100 / 150mg 13.09.2001 Tolterodine Tartrate 4mg (ER) + Tamsulosin HCL 0.4mg Capsule. 06.09.2012 Tolterodine Tartrate 4mg (ER) + Tamsulosin HCL 0.4mg Capsule. Aug-85 Tolterodine tartrate ER 4mg + Tamsulocin Hcl. ER 0.4mg tablet 23.08.99 Tolterodine tartrate ER 4mg + Tamsulocin Hcl. ER 0.4mg tablet 28/11/2011 Tolterodine Tartrate Extended release tablets 2mg/4mg (Additional Dosage 15.06.99 Form) Tolterodine-L-Tartrate 09.06.2003 Tolvaptan Tablets 15/30mg 17.01.07 TonazolineHClnasaldrop0.08%sol. 20/03/2010 Topiramate 30.03.09 Topotecan Hydrochloride capsules 0.25/1mg (New dosage form) 09.01.2003 Topotecan Hydrochloride 12.09.13 Torsamide 21.11.11 Torsemide10mg+Amiloride5mgtablets 21.11.11 Totrazuril 06.03.2002 Trabectedin powder for Conc. solution for infusion (Additional Indication) 27.01.93 Trabectedin powder for concentrate for solution for infusion 1 mg/ vial 23/11/06 Tramadol HCl 37.5mg+Paracetamol 325mg tablet 23/11/06 Tramadol HCL 200mg Controlled Release tablet (Additional Dosage Form) 3/10/2003 Tramadol Hcl IP (As Immediate Release Layer) 50mg + Diclofenac Sodium 13.01.2005 IP (As Sustained Release Layer) 75mg Tablets Tramadol Hcl IP (As Immediate Release Layer)50mg + Diclofenac Sodium IP 22-02-2005 (As Sustained Release Layer) 75mg Tablets Tramadol Hydrochloride Injection 50 mg per 1 ml and 100 mg per 2 ml 22-02-2005 ampoule Trametinib 0.5 mg/2mg Tablets (Trametinib dimethyl sulfoxide) Tramodol 30.04.1998 Trandalopril 1mg/2mg/4mg/2mg + Verapamil (ER) 29.12.2004 240mg/240mg/240mg/180mg Trandalopril 1mg/2mg/4mg/2mg + Verapamil (ER) 15.6.2007. 240mg/240mg/240mg/180mg tablet Trandolapril 15.06.07 Tranexamic Acid 25mg/50mg + Ethamsylate 12.5mg/12.5mg Tablet 06.03.2002 PHARMADOCX (Pharmaceutical Consultant) Ph 9896133556 Mail [email protected] (Contact for Setting up Pharma, Cosmetics, Medical Devices Plant, WHOGMP) LIST OF NEW DRUGS 1961 – MAY 2017 download from http://www.pharmadocx.com Page - 111

Tranexamic Acid Jan-93 Tranexamic Acid (500mg) + Mefenamic acid (250mg) tablet 20.02.09 Tranexamic Acid (500mg) + Mefenamic acid (250mg) tablet 11.05.2000 Tranexamic Acid 250mg + Ethamsylate 250mg film coated Tablet 10.07.2000 Tranexamic acid Mouth Wash (50mg/ml) 28.01.08 Tranexamic acid mouthwash (50mg/ml) 28.01.08 Tranexamic Acid 8/12/2005 Tranexamic Acid Tab SR 750mg 22.07.2016 Trapidil Mar-87 Trastuzumab Jul-87 Travoprost 40mcg + Timolol (as Maleate) 5mg per ml of eye drops Jul, 1974 Travoprost 40mcg + Timolol (as Maleate) 5mg per ml of eye drops Jul, 1974 Travoprost Eye drops (40mcg/ml) Jul, 1974 Travoprost Eye Drops 30mcg/ml with polyquaternium-1 10mcg/ml 26.08.08 (Additional Strength) Trazadone 14.10.08 Trazodone tablet 25 mg/ 50 mg/ 100 mg Jan-89 Tretinoin 0.05% lotion Oct-75 Tretinoin 0.05% sewab Dec,1978 Tretinoin 0.05% Vanishing cream Sep-88 Tretinoin Microsphere Gel (0.1% W/V) 01/07/1992 Tretinoine Gel as Micro Sphere 0.04% % 0.1% Feb,1973 Tri Potassium Dicitrate Bisulphate May,1973 Triamterene 50mg + HCTZ 25mg tablet May,1973 Trichlormethiazide Tablets, 2mg May,1973 Triclabendazole 08.12.11 Triclabendazole + Levamisole 17.01.2001 Triclabendazole 5gm/12gm+Levamisole 3.75gm/7.5gm per 100ml Suspension Jul-92 for Veternary use Trifluperidal Hydrochloride 10/10/2005 Trifluperidal Hydrochloride Injection 1 mg/ml Jun, 1980 Trifluperidal Hydrochloride Oral liquid, 5mg/5ml Sep-73 Trifluperidal Hydrochloride Tablet 0.25mg/0.5mg Jan-79 Trifluperidol Hcl Oct-76 Trifluridine Eye Drops 1% w/v Jul-74 Triflusal Jun-74 Trimebutine Maleate May-90 Trimetazidine Dihydrochloride Tablet 3 mg Jun-83 Trimethoprim & Sulphadoxine Sep-75 Trimethoprim + Sulphadoxime Jun-87 Trimethoprim + Sulphaolazine 1969 to 74 Trimethoprim 160mg + Sulphamethoxazole 800mg per 3 ml Inj. Jul-70 Trimethoprim 4%w/v + Sulphadoxime 20%w/v Jul-70 Trimethoprim 80mg + Sulphamethoxazole 400mg per 5ml infusion 11.06.13 Trimethoprim powder 100gm 16.11.12 Trimethoprim tablet 100 mg 25.09.2001

Trimethoprim+sulfamoxole Mar-89 Trimethoprin 40mg + sulphamethoxazole 200mg/5ml suspension 10.05.2016 Trimethoprin 80mg/20mg + sulphamethoxazole 400mg/100mg tablet 14.11.2009 Trimethoxysilyl Quaternary Ammonium Chloride 0.40% hand protectant and Nov, 1975 sanitizer Trimethoxysilyl Quaternary Ammonium Chloride solution for spray inanimate 1975 to 76 surfaces for disinfection 0.71%. Triple Chamber bags for peritoneal dialysis solution :Compartment A)[ 61 20-03-2004 ml] Dextrose IP eq. to dextrose anhydrous 453.0gm+Nacl IP 5.67gm water for injection q.s. each 1000ml Compartment B) [104 ml]Dextrose IP eq. to dextrose anhydrous 453.0gm+Nacl IP 5.67gm water for injection q.s. Compartment C) [1969ml] Nacl IP 5.67gm+CaCl 2 IP 0.279gm+MgCl2 IP 0.165gm+Sodium lactate solution BP eq. to sodium lactate 4.259 gm water for injection, each 1000 ml water for injection q.s. Tripotassium Dicitrate Bisulphate 23-Feb-95 Triptorelin embonate equivalent to Triptorelin 22.5mg Injection (Lyophilized Mar-90 power for suspension for injection, Intramuscular Route) Additional Strength Triticum Vulgare Topical Cream Each 100gm of cream contains: Aqueous 04.09.2009 extract of Triticum Vulgare (dry residue 200mg / 100ml) ..... 15gm 2- phenoxyethanol Eur. Ph.....1gm 2) Triticum Vulgare Vaginal Pessary Each 3.5gm of vaginal pessary contains: Aqueous extract of Triticum Vulgare (dry residue 200mg/ 100ml) .....0.60gm 2-phenoxyethanol Eur. Ph.....0.04gm Trofosfamide Aug, 1976 Trofosfamide 28.05.09 Trofosfamide Tablet 50 mg 20/05/2010 Trolamine Cream (0.67%) 24 04 14 Tromantadine HCl oinment 1 gm Ointment May, 1980 Tropic amide Sterile Ophthalmic Solution 08.10.08 TrospiumChlorideERCapsules60mg 15.09.11 Trospium Chloride film coated tablet 20mg 03.04.12 Troxipide film coated Tablets 50mg /100mg 19.09.14 Tulobuterol Transdermal Patch 0.5 mg/ 1.0 mg /2.0 mg Aug,1975 Tylvalosin Tartarate May-82 Tylvalosin tartrate oral soluble granules Sachet 62.5% w/w (Veterinary) 20-07-2005 Udenafil Tablet 100mg/200mg 08.12.08 Ulinastatin for Injection 50000 IU / 100000 IU 1/12/2004 Ulinastatin Injection 11.02.11 Urea 30 % solution for Intra-amniotic use 30.01.08 Urokinase for Injection 25.09.2002 Urovision Inj. 10.12.2001 Ursodeoxycholic Acid (500mg) S.R Tablet 01.08.2002 Ursodeoxycholic Acid 300/600 SR Tablets (Additional Strength) 20.09.2004 Ursodeoxycholic acid S.R. Capsule (450mg) Nov,1976 Ursodeoxycholic Acid Suspension 125mg/5ml and 250 mg /5ml. 9.10.2009 Ursodeoxycholic acid tablets 600mg 20-11-2003 Vacuranium Bromide Inj. Dec-78 Valacyclovir 28.03.1994 PHARMADOCX (Pharmaceutical Consultant) Ph 9896133556 Mail [email protected] (Contact for Setting up Pharma, Cosmetics, Medical Devices Plant, WHOGMP) LIST OF NEW DRUGS 1961 – MAY 2017 download from http://www.pharmadocx.com Page - 113

Valdecoxib 18.03.2003 Valdecoxib 20mg + Paracetamol 500mg Tablet 01.11.2003 Valethamate bromide 29.05.07 Valganciclovir Powder for Oral Solution 50mg/ml Jun-86 Valgancyclovir 19.10.12 Valsartan 18.09.2000 Valsartan 80mg/160mg/160mg+HCTZ 12.5mg/12.5mg/25mg tablet Apr-86 Valsarten 80mg + S(-) Amlodipine (as besylate) 2.5mg capsule 19.08.15 Vancomycin Hcl Injection 1985 to 87 Varenicline (As tartrate) 0.5mg/1mg tablets 21.07.2008 Vecuronium Bromide 21.07.08 Vemurafenib Tablet 240mg 18.01.08 Venlafaxine Hdrochloride 13.05.2002 Venoprin injection 28-Oct-98 Vilazodone Hydrochloride 20mg/40mg and Bulk 17.01.2001 Vildagliptin 50/50/50mg + Metformin 500/850/1000mg Tablet 01.08.2003 Vildagliptin 50mg/50mg/50mg + Metformin Hcl 500mg +850mg +1000mg Feb,1975 tablets Vildagliptin Tablets 50mg/100mg Jul,1975 Vimpocetine Jul-69 Vindesine Sulphate Injection 23/06/2010 Vindesine Sulphate Injection 1mg/5mg per vial 28.10.1998 Vinorelbin Tartrate Inj. 23/06/2010 Vinpocetin Jul-69 Virginiamycin 07/12/2006 Virginiamycin 2% premix 12/7/2006 Vit K 1 5mg + Calcium Lactolionate 100 m g+ Carlozocrome Salicylate 42278 2.5mg + Phenol 0.5% + Lignocaine Hcl 1% injection Vitamin A (oily form) as palmiate 2000IU + Vitamin B1 1mg + Vitamin B2 08/06/2010 1mg + Vitamin B6 1.34mg + Vitamin B12 1mcg + Ascorbic acid 33.3mg + Vitamin D3 200IU + Folic acid 0.3mg + Calcium pantothenate 1mg + Niacinamide 15mg + Dibasic calcium phosphate 100mg + Phosphorus 77mg+ Ferrous fumarate 50mg + Copper 0.01mg+ Potassium iodide 0.0015mg + Heavy magnesium oxide 1mg + Manganse sulphate 0.01mg + Potassium sulphate 1mg + Zinc sulphate 0.15mg Capsule Vitamin A (oily form) as palmiate 2000IU + Vitamin B1 1mg + Vitamin B2 17-11-2005 1mg + Vitamin B6 1.34mg + Vitamin B12 1mcg + Ascorbic acid 33.3mg + Vitamin D3 200IU + Folic acid 0.3mg + Calcium pantothenate 1mg + Niacinamide 15mg + Dibasic calcium phosphate 100mg + Phosphorus 77mg+ Ferrous fumarate 50mg + Copper 0.01mg+ Potassium iodide 0.0015mg + Heavy magnesium oxide 1mg + Manganse sulphate 0.01mg + Potassium sulphate 1mg + Zinc sulphate 0.15mg Capsule Vitamin A,D & E 13.07.2009 Vitamin C 500mcg + Zinc Citrate 2.2mg + Selenium 60mcg tablet. 28.12.07 Vitamin C 500mcg + Zinc Citrate 2.2mg + Selenium 60mcg tablet. 20.11.07 Vitamin D3 (Cholecalciferol) Orally disintegrating strips 2000 IU (additional 13.7.2009 Dosage form) PHARMADOCX (Pharmaceutical Consultant) Ph 9896133556 Mail [email protected] (Contact for Setting up Pharma, Cosmetics, Medical Devices Plant, WHOGMP) LIST OF NEW DRUGS 1961 – MAY 2017 download from http://www.pharmadocx.com Page - 114

Voglibose 0.3mg + Metformin (SR) 500mg Tablet 6/8/2010 Voglibose (0.2mg/0.3mg) Tablet 21/02/2006 Voglibose 0.2 mg + Metformin 500mg Tablets 9/9/2004 Voglibose 0.2mg/0.3mg tablet (Mouth dissolving) 31.01.08 Voglibose disp.tab.0.2mg/0.3mg 31-07-2007 Voglibose 0.2 mg + Metformin 500mg Tablets Feb,1973 Voglibose0.3 + Metformin (SR) 500mg Jul, 1980 Voriconazole Powder for oral soluion (40mg/ml) Nov-90 Voriconazole Tablet (50 mg/200 mg) Infusion (200 mg/vial) 23.12.2009 VSL # (Combination of lactic acid bacteria (VSL # 3) 23.12.2009 VSL # 3 (Probiotic Blend) sachet Oct,1971 Why to order printer to print 10 registers when you can get 1 from Pharmadocx. Stop wastage of Stationary. Call us. We deliver on door all pharma stationary. Xantinol Nicotinate Tablet 500 mg Nov-71 Xipamid Tablet 40 mg 3.06.2009 Xylazine HCl 03.12.2001 Xylometazoline 0.5 mg + Ipratropium 0.6 mg Nasal spray 26-Jul-93 Xylometazoline 0.5 mg + Ipratropium 0.6 mg Nasal spray 17.01.2002 Yeast Tannic Acid Compound 31.10.10 Yeast tannic acid compound 250mg + lodochlorohydroxyquinoline 150mg + 13/02/2006 Benzalconium chloride 10mg Tablet Yttrium-90 Microspheres Injection (Yttrium-90...3GBq (at the time of 22.01.08 calibration) per vial) Zafirlukast 01.03.2004 Zalcitabine Film Coated Tablets 0.375mg/0.750mg 18-Dec-98 Zaleplon Apr-88 Zaltoprofen film coated tablet …80mg JP 30.09.10 Zanamavir inhalation powder 12.12.1995 Zanamavir inhalation powder 5mg/blister (Additional Indication) 13.02.06 Zidovudine 600mg ER + Lamivudine 300mg ER Sep,1978 Zidovudine (300mg) tabs 3/9/2004 Zidovudine Capsules 18.03.2002 Zidovudine Capsules + Injection 08.10.1994 Zileuton uncoated bilayered extended release tablet ...600mg Apr-88 Zinc Gluconate 87.1% mg (eq. to elemental Zinc 12.5mg) Ascorbic acid Jan-75 100mg + Sodium Ascorbate 170mg (eq. to 150 mg of Acorbic acid) chewable tablet Zinc (Gluconate) oral solution (20mg/5ml) 27-12-2011 Zinc + Vitamin C 23.09.14 Zinc Sulphate IP Capsule 220 mg 6-12-2007. Ziprasidone Hydrochloride 12.12.1995 Ziprasidone powder for injection(after reconstitution 20 mg/ml) 1.08.2009 Ziprasidone HCl 07.01.09

ZnSO4 0.660mg (heptahydrate eq. to elemental Zinc 0.15mg)+CuSO4 05.11.2001 0.236mg (Pentahydrate eq. to elmetnal copper 0.06mg)+Chromic chloride 1.83mg (anhydrous eq. to elemental chromium 0.6mg)+MnSO40.047mg(monohydrate eq. to elemental maganies 0.025mg+Benzyl alchol 1% (preservative)Trace metal additive infusion (TMA Infusion) Zoalene25%+Ethoxygim0.125%premix 29.05.09 Zoledronic Acid 4 mg/100 ml ready to use (RTU) solution for I.V Infusion 28.05.99 (Additional Dosage Form) Zoledronic acid 5mg/100ml solution for infusion (addl. indication). 42289 Zoledronic Acid Solution for Infusion Addl. Indication 10/7/2006 Zoledronic Acid Injection 5mg/100ml (Addl. Indication) 21-12-2005 Zolendronic Acid 25/05/2006 Zolmitriptan...5.0% w/v Benzalkonium Chloride NF ... 0.01% w/v Nasal 16-Aug-96 spray Zolpidem 15/04/2010 Zolpidem Tartarate Orally disintegrating Tablet 5mg/10mg (Additional 29.07.99 dosage form) Zolpidem Tartrate E.R tablet (6.25mg/12.5mg). 10.10.2001 Zonisamide (100mg) capsule 07.08.14 Zonisamide capsule 25/50mg (addl. Strength) 07.08.14 Zopiclone 18.09.14 Zopiclone 7.5MG tablet 07.08.14 Zotepine tablet ....25/50/100mg Aug-96 Zuclopenthixol Acetate 15.03.2002 α-Ketoisoleucine Calcium salt 67.0mg + α- Ketoleucine Calcium Salt 29.07.1999 101.0mg + α- Ketophenylalanine Calcium Salt 68.0mg + α- Ketovaline Calcium Salt 86.0mg + α-Hydroxymethionine Calcium Salt 59.0mg + Lycine acetate 105.0mg (=75mg lysine) + Threonine 53.0mg + Tryptophan 23.0mg + Histidine 38.0mg + Tyrosine 30.0mg Film coated tablets β-Carotene (30% dispension) 15mg (eq. to vit. A 7500 I.U)+ Vit. E acetate- 14.10.14 25mg+Vit. C- 100mg +Pyridoxine HCL (Vit. B6) 1.5mg+ Cyanocobalamin (vit. B12) 5mcg+ Folic acid- 400mcg+Zinc as Zno-15mg+Selenium as SeO2 100mg+copper (element) as CuSO4 1mg Capsule

LIST OF CLIENTS API PLANTS SETUP/ FDA PHARMA PLANTS SETUP/ FDA Alpspure Lifesciences Pvt. Ltd. Sonipat Aarge Healthcraft, Parwanoo Excellent Pharma Care (India), Sonipat Alps Life Sciences Pvt. Ltd., Sonipat Glide Chem Pvt. Ltd., Sonipat Amree Pharmaceuticals, Karnal Kunal Calcium Ltd., Yamuna Nagar Emcross Pharmachem, Rookee Times Pharma & Chemicals, Gurgaon Banson Pharma, Patiala Clevus Lifesciences, Parwanoo AYURVEDIC PLANT SETUP Devbhoomi Pharma, Haridwar Ramkripa Agro Una Eshumin Biotech Bhatinda, Punjab. Daffodil Healthcare, Delhi Jackson Labs. Pvt. Ltd., Amritsar Hitkary Pharmacy (I) Pvt. Ltd., Sonipat Magnus Biotech Pvt. Ltd., Karnal Jagat Pharma, Bareilly Mcneil& Argus Pharma Ltd., Ambala RP Pharmaceuticals, Karnal MBC Industries Kala Amb Neutec Healthcare Pvt. Ltd. Narela Delhi COSMETICS PLANTS SETUP/ Opal Healthcare, Karnal FDA Asmi Int. Pvt. Ltd., Sonipat Oshin Labs Kundli Bionature Personal Care, Panipat Quest Labs Pvt. Ltd., Indore Bharat Enterprises, Sonipat Rachil Remedies, kangra Erma Care Pvt. Ltd., Karnal Real Care Lifesciences, Parwanoo, HP. Fine & Shine Cosmetics Pvt. Ltd., Revive Pharma Karnal Sonipat Goodrich Agrochem Pvt. Ltd., Karnal Sia Pharma Pvt. Ltd., Sonipat Indica Oragnics, Sonipat Senate Laboratories, Rookee Maharishi Herbal Cosmetics, Kundli Sceptere Medical India Pvt. Ltd., Sonipat Madia Impex Pvt. Ltd., Panipat Shreeganesh Biotech, Roorke. Omega Remedies Pvt. Ltd., Karnal Uttam Lifesciences, Karnal VNS International, Sonipat Varav Biogenesis Pvt. Ltd., Kala Amb Yaxon Biocare Pvt. Ltd., Sonipat DIAGNOSTIC KITS PELLETS Alpine Biomedicals Pvt. Ltd. Biogenetics Pharma, Patiala Kute Wellness Inc. Multani, Kala Amb

HAEMODIALYSIS SOLUTION SOFT GELATIN CAPSULE Hindustan Biomedical,Sonipat Broad Injectables, Una Real Care Life Science, Parwanoo MEDICAL DEVICES SETUP/ FDA SURGICAL DRESSING PLANT SET UP / FDA Ashish & Company, Rai, Sonipat. Arya Surgical Industry, Jind Auxein Medical Pvt. Ltd., Sonipat Divine India, Sonipat Bone Life Surgicals, Ghaziabad Eiffer, Ghaziabad BD Surgical Industries, Bahadurgarh Florance Surgicals Jind Capital Orthopedics, Ghaziabad KS Surgical Pvt. Ltd., Modi Nagar Dostan Surgical Engg. Works, M-Pex Surgical Industries, Safidon Ghaziabad DCL Dencare Pvt. Ltd., Gurgaon WHO GMP CERTIFICATION G.R. Bioure Surgicals Pvt. Ltd., Hapur Alps Life Sciences Pvt. Ltd., Sonipat HospilineEquipments Pvt. Ltd., Hapur Affy Parenteral, Badhi JS Medimax Pvt. Ltd., Sonipat Glide Chem Pvt. Ltd., Sonipat Narula Exports, New Delhi Klintoz Pharma Pvt. Ltd., Roorkee Narang Medical Ltd., Ghaziabad Magnus Biotech Pvt. Ltd., Karnal OSCO, Ghaziabad Mcneil& Argus Pharm. Ltd., Ambala Prymax Healthcare LLP, Faridabad Solitaire Pharmacia Pvt. Ltd., Chandigarh Ribbel Int. Ltd., Sonipat ( Foley Systochem Laboratories Ltd., Catheter) Ghaziabad Siora Surgicals Pvt. Ltd.( Ortho STERISIATION Implants), Sonipat Shagun Cares Inc., Ghaziabad MicrotrolSterilisation Pvt. Ltd. Rewari for ETO Sunshine Orthopedics, Sonipat Alligned Industries, Rewari. For GAMMA STER Shakti Orthopedics MEDICAL GRADE OXYGEN Supercardio Devices Pvt. Ltd., Arun Oxygen Ltd., Yamuna Nagar Bahadurgarh Trans Global Surgicals, Sonipat ( Ortho Air Liquide North (I) Pvt. Ltd., Panipat Implants) XLO Orthopedics, Sohna Kaveri Industrial Gases, Yamuna Nagar Laxmi Carbide, Ambala PHARMADOCX (Pharmaceutical Consultant) Ph 9896133556 Mail [email protected] (Contact for Setting up Pharma, Cosmetics, Medical Devices Plant, WHOGMP) LIST OF NEW DRUGS 1961 – MAY 2017 download from http://www.pharmadocx.com Page - 118 PHARMACEUTICAL STATIONARY

1. Building Maintenance Record 2. Chemical Stock Register 3. Control/ Retain Sample Register 4. Daily pH Meter Standardisation Register 5. Equipment operation & cleaning log book Register 6. Finished Goods Stock Register 7. Packing Material Stock Register 8. Potable/ Purified Water Tank Cleaning Record Register 9. Production Register 10.RLAF Log Book Register 11.RM/ PM/FG Entry Register in Lab 12.Raw Material Stock Register ( As per Schedule U for Drugs) 13.Raw Material Stock Register ( As per Schedule U1 for Cosmetics) 14.Raw Material Sampling Register 15.Service Record of Machine 16.Temperature / Humidity Record Register PHARMADOCX PHARMA CONSULTANT OLD DC ROAD, SONIPAT 131001 [email protected] www.pharmadocx.com Ph.:- 0130-2200630, 9896133556 Blog:- pharmadocx.wordpress.com Please refer CDSCO Website for accurate & uptodate information on New Drugs.

PHARMADOCX (Pharmaceutical Consultant) Ph 9896133556 Mail [email protected] (Contact for Setting up Pharma, Cosmetics, Medical Devices Plant, WHOGMP)