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 India 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, Mumbai, 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,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 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: Turbhe (Thane-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 Page 1 of 5 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. Page 2 of 5 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 Nashik 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 Maharashtra, India. 4. M/s Cipla Ltd., Peninsula Business Park, Etanercept (r-DNA origin) 25 mg, FFR-28 GanpatraoKadamMarg, Lower Parel,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 Page 3 of 5 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, Worli, 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 Pune-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 Page 4 of 5 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 Page 5 of 5 .