Status of Registration Certificate (Form 41) of Human Vaccines, Recombinant Products and Veterinary Vaccine issued from 30/04/2016 to 20/12/2016

S. Firm Name of Formulation Registration No. Certificate No. & Validity HUMAN VACCINE 1. M/s. Prosper Channel Life Science Pvt.  Diphtheria, Tetanus and Acellular Pertussis SVH-16 Ltd.,B-244, Sector- 7, PalamExtn., New Delhi- Combined Vaccine, adsorbed Valid up to 110045, India. 23/06/2019 2. M/s. GlaxoSmithKline Pharmaceuticals Ltd.,  Measles, Mumps and Rubella Vaccine (live) SVH-7 Dr. Annie Besant Road, , India IP in Vial Valid up to 25/12/2019 3. M/s Sanofi Pasteur India Pvt. Ltd.,Sanofi  Diphtheria, Tetanus, Pertussis (acellular SV-1 House, CT Survey No. 117-B,L&T Business Component), Hepatitis B (r-DNA), Valid up to Park, Saki Vihar Road,, Mumbai- Poliomyelitis (Inactivated) and Haemophilus 31/12/2017 400072, India. Influenzae type b conjugate vaccine (adsorbed).Suspension for Injection by Intramuscular route.Presentation:Single dose Pre-filled syringe&Single dose vial 4. M/s Sanofi Pasteur India Pvt. Ltd.,Sanofi  Diphtheria, Tetanus, Pertussis (acellular SV-5 House, CT Survey No. 117-B,L&T Business Component), Hepatitis B (r-DNA), Valid up to Park, Saki Vihar Road,Powai, Mumbai- Poliomyelitis (Inactivated) and Haemophilus 31/12/2017 400072, India. Influenzae type b conjugate vaccine (adsorbed).Suspension for Injection by Intramuscular route.Presentation:Single dose Pre-filled syringe&Single dose vial 5. M/s Pusan Bioresearch Enterprizes,Unit 007,  Rabies Vaccine, Human I.P. (Vero cell), Freeze SV-52 Chamber No. 06, Cabin No. 2, A.A. Cold Dried, 0.5mL/Vial; including sterile water for Valid up to Storage, Fifth Floor, D/395, M.I.D.C. T.T.C. injection I.P. 0.5mL in ampoule. 10/03/2019 IND.EST., KukshetTurbhe, TAL: (-Zone 7), Pin: 700705, India. 6. M/s GlaxoSmithKline Asia Private  Live Attenuated Measles, Mumps, Rubella and SV-64 Limited,Patiala Road, Nabha,Punjab- 147201, Varicella Vaccine. Valid up to India. 11/12/2016

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7. M/s GlaxoSmithKline Asia Private  Live Attenuated Measles, Mumps, Rubella and SV-64 Limited,Patiala Road, Nabha,Punjab- 147201, Varicella Vaccine. Valid up to India.  Bulk unlabelled vials or PFS of Pneumococcal 11/12/2019 Polysaccharide Conjugate Vaccine (adsorbed) Ph. Eur.  Bulk unlabelled PFS of Diphtheria, Tetanus and Pertusis (Acellular Component) vaccine (adsorbed) Ph. Eur.  Bulk unlabelled vials or PFS of Inactivated Hepatitis A Vaccine (Adsorbed) IP (1440 & 720)  Bulk unlabelled vials of Haemophilus Type b Conjugate Vaccine IP and bulk vial or PFS or Ampoule of diluent  Bulk unlabelled vials of Measles, Mumps and Rubella Vaccine (live) IP and bulk PFS or Ampoule of diluent  Bulk unlabelled PFS of Hepatitis A (Inactivated) and Hepatitis B (r-DNA) Vaccine (Adsorbed) IP  Bulk unlabelled vials of Varicella Vaccine, Live IP and bulk PFS or Ampoule of diluent  Bulk unlabelled PFS of Diphtheria, Tetanus and Pertussis (Acellular Component) Vaccine (Adsorbed) Ph. Eur.  Bulk unlabelled vials of Rotavirus vaccine, (Live Attenuated, Oral) IP and bulk sealed PFS of diluent  Bulk unlabelled vials or PFS of Human Papillomavirus vaccine Ph. Eur.  Bulk unlabelled vials of Measles, Mumps and Rubella and Varicella Vaccine (live) Ph. Eur. and bulk sealed vial or PFS or Ampoule of diluent.

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 Rotavirus vaccine, (Live Attenuated, Oral) IP  Human Papillomavirus vaccine Ph. Eur. RECOMBINANT PRODUCTS 1. M/s. Johnson & Johnson Private  Siltuximab powder for concentrate for FF-101 Limited,Gala No. 3, Bldg. No. B-2, City Link solution for infusion 100mg and 400mg (r- Valid up to Warehousing Complex, Sr. no. 120-121 DNA Origin) 01/07/2018 Mumbai Highway, Village-Vadape, Tal: Bhiwandi-16 (Thane-Z5), Pin: 421302, India 2. M/s UCB India Pvt. Ltd.,Bldg No. P.3 Unit No.  Peginterferon beta-1a, (63 mcg, 94mcg, 125 FFR-43 101 to 103,1st Floor, Prithvi Complex, mcg/0.5 ml) (r-DNA Origin) pre filled Valid up to KalherPiperline,KalherBhiwandi – 421302, syringes and pre filled pen 25/05/2019 India. 3. M/s Fulford (India) Ltd.,of Gala No. 1D&2,  Pegylated Interferon alfa-2b50 mcg, 100 FF-71 Building No. B-3,City Link Warehouses mcg, 120mcg, & 150 mcg powder for Valid up to Complex,Mumbai-Nashik Highway Vadapa, injection in vials 31/12/2017 Bhiwandi,Dist-Thane 421302 , India. 4. M/s Cipla Ltd., Peninsula Business Park,  Etanercept (r-DNA origin) 25 mg, FFR-28 GanpatraoKadamMarg, Lower ,Mumbai Lyophilized powder for solution for Valid up to 400013, India. subcutaneous injection in vials 29/05/2019 5. M/s GlaxosmithKline Pharmaceuticals Ltd.,Dr.  Albiglutide Powder and Solvent for solution FFR-36 Annie Besant Road,WorliMumbai - 400030, for injection (r-DNA origin) 30mg & 50 mg. Valid up to India. 11/12/2017 6. M/s Eli Lilly and Company (India) Pvt. Ltd.,  Ramucirumab Concentrate for Solution for FF-522 Bldg No. 14, Gala No. 1-4, 1st Floor, Arihant Infusion 10 mg/ml (100 mg/ 10 ml vial and Valid up to Comm. Complex,Opp. Koper Bus Stop, 500 mg/50 ml vial) 31/08/2018 Purna,Bhiwandi, Maharashtra. 7. M/s MSD Pharmaceuticals Pvt. Ltd., S.No.  Pembrolizumab injection 100 mg/4 ml FFR-45 120-121, Gala No. 1B, Bldg No.B-3, City Link, (25 mg/ml in a single vial) Valid up to Ware Houses Complex, Mumbai-Nashik 24/07/2019 Highway, Vadape Tal.Bhiwandi-13, Thane zone 5-421302, Maharashtra, India. 8. M/s Bristol Myers Squibb India Pvt. Ltd.,Bldg.  Nivolumab 10mg/ml concentrate for FF-481 B4, Gala No. 3, 4, 5A & 6A, City LinkWare solution for infusion (r-DNA Origin) Valid up to

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Houses Complex, Mumbai Nashik Highway, 30/09/2017 Vadape Village, Taluka: Bhiwandi-16, District: Thane Z-5,Pin: 421302, India. 9. M/s LG Life Sciences India Pvt Ltd., LG House,  Recombinant Hepatitis-B Vaccine IP SV-13 lot No.11, Sector 44, Gurgaon-122001, India. Valid up to 31/03/2019 10. M/s Novartis Healthcare Private  Ofatumumab concentrate for solution for FFR-44 Limited,Sanodz House, Shivsagar Estate, Dr. infusion 20mg r-DNA Origin Valid up to Annie Beasant Road, , Mumbai- 400 018, 12/07/2019 India. 11 M/s. Hindustan Biosciences Ltd, D.No., 8-2-  Recombinant Human Erythropoietin FFR-1 269/S, Plot No. 31, Sagar Society, Road No. 2, Injection, Each Vial of 1ml contains.... 2000 Valid up to Banjara Hills, Hyderabad, 500034, India. IU, 3000IU, 4000IU 26/04/2019  Recombinant Human Erythropoietin 2000 IU, 3000IU, 4000IU in Pre-filled Syringe and 6000IU/ml & 10,000IU/ml in multi dose vials VETERINARY VACCINE 1. M/s Sanofi-Synthelabo (India) Private imited,  Rabies Veterinary Vaccine, Inactivated, IP SVV-11 Citylink Warehousing Complex, BldgNo . A-  Infectious Coryza Vaccine, Inactivated, I.P. Valid up to 4, Gala No. 6&7, S.No 120, 121, Mumbai 26/02/2018 Nasik Highway, Vadape Village- 421302, Tal: Bhiwandi-16, Dist: Thane Z5, India. 2. M/s Intervet India Pvt Ltd.,Briahnagar, Off  Avian Infectious Bronchitis Vaccine, SV-6 -Nagar Road,Wagholi-412207, Dist- Inactivated, I.P., Water in Oil Emulsion. Valid up to Pune, India.  Avian Infectious Bronchitis Vaccine, 31/12/2017 Inactivated, I.P., 3. M/s. Hipra India Pvt. Ltd., M.No. 1/0361, 1st  Avian Salmonella Vaccine, Inactivated, I.P. SVV-13 Floor, Gut No. 1337/1, Old Gut No. 2323/1,  Combined Ranikhet Disease and Avian Valid up to Wagholi 412 207, Tal. Haveli, Dist Pune, Infectious Bronchitis Vaccine, Live 27/03/2019 India.  Ranikhet Disease Vaccine, Live, IP 4. M/s. Sanofi-Synthelabo (India) Private  Combined Inactivated Salmonella SVV-14 Limited.,Citylink Warehousing Complex, Bldg Enteritidis and Salmonella Typhimurium Valid up to No. A-4,Gala No. 6 & 7, S.No. 120-121, Vaccine. 05/05/2019 Mumbai Nashik Highway,Vadape Village-  Mycoplasma Gallisepticum Inactivated

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421302, Tal: Bhiwandi-16, Dist: Thane-Zone bacterin 5, India. 5. M/s. Zoetis India Limited,Godown No. 1&2,  Canine Distemper- Adenovirus Type-2- SVV-4 Bldg. No. 12B,Prithvi Complex, RetiBunder Parainfluenza-Parvovirus vaccine, Valid up to Road,Kalher, Tah. Bhiwandi, Dist. Thane Modified live virus, Leptospira Bacterin. 18/02/2019 421302, India. 6. M/s. Lal Pet Products,Plot No. 24, IDC, MG  Combined Canine Distemper, Infectious SV-25 Road Sec-14, Gurgaon, India. Hepatitis, Infectious Laryngotracheitis, Valid up to Parvovirus &Parainfluenza Vaccine, Live, 02/05/2019 Freeze dried.  Canine Leptospirosis Vaccine, Inactivated, I.P.  Rabies Vaccine, Inactivated, I.P.  Canine Corona Virus, Inactivated, I.P 7. M/s Zoetis India Ltd., 31st & 32nd, 3rd Floor,  Infectious Coryza Vaccine IP, Inactivated SVV-8 Kalpataru Synergy, Opp. Grand Hyatt, (Mineral oil emulsion) Valid up to: Santacruz (E), Mumbai 400055, India. 02/01/2020

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