Status of Registration Certificate (Form 41) of Human Vaccines, Recombinant Products and Veterinary Vaccine issued from 01/01/2015 to 27/02/2015
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1 Status of Registration Certificate (Form 41) of Human Vaccines, Recombinant Products and Veterinary Vaccine issued from 01/01/2015 to 27/02/2015 S. No. Firm Name of Formulation Registration Certificate (RC) No. & Validity HUMAN VACCINES 1. M/s Serum Institute of India Ltd., 212/2, Hadapsar, Pune, India. 2. M/s Sanofi Pasteur India Private Limited,54/A Sir MathuradasVasanji Road, Andheri East, Mumbai , India 3. M/s Abbott India Limited, 2 nd Floor, Unit No. 3, Corporate Park, Bulk Inactivated Trivalent Poliomyelitis Vaccine containing concentrated amounts of inactivated polio virus: 1. Haemophilus type B Conjugate Vaccine. I.P. 2. Typhoid Polysaccharide Vaccine I.P. 3. Inactivated Hepatitis A Vaccine, Adsorbed. I.P. Hepatitis A virus, GBM strain (Inactivated) 80 antigen units 4. Inactivated Hepatitis A Vaccine (Adsorbed) I.P. Hepatitis A virus, GBM strain (Inactivated) 160 antigen units 5. Poliomyelitis Vaccine I.P., Oral (Trivalent) 6. Pneumococcal Polysaccharide Vaccine. I.P. 7. Yellow Fever Vaccine (Live). I.P. 8. Inactivated Influenza Vaccine (Split Virion, inactivated) I.P. (0.5 ml dose) 9. Inactivated Influenza Vaccine (Split Virion, Inactivated.) I.P. (0.25 ml dose) 10. Rabies vaccine, Human IP. 11. Inactivated Poliomyelitis Vaccine 12. Combined vaccine DtacP-IPV-PRP-T Injection 13. Yellow Fever Vaccine (Live) multidose presentation (ten dose vial) along with diluent. 0.5 ml Inactivated Influenza vaccine (surface antigen), I.P., suspension for Injection in prefilled syringes Page 1 of 8 SV-68 Valid upto: 31/01/2018 SV-5 SVH-2 valid up to:30/04/2018
2 Sion-Trombay Road, Chembur, Mumbai , India 4. M/s G. C. ChemiePharmie Ltd., 5/C, Shree Laxmi Ind. Estate, New Link Road, Andheri (West), Mumbai , India 5. M/s Sanofi Pasteur India Private Limited,54/A Sir MathuradasVasanji Road, Andheri East, Mumbai , India 6. M/s. GlaxoSmithKline Pharmaceuticals Ltd., Patiala Road, Nabha (Punjab) 14720, India ml Inactivated Influenza Vaccine (Split Virion) I.P., Suspension for injection in prefilled syringes ml Inactivated Influenza Vaccine (Split Virion) I.P., Suspension for injection in prefilled syringes 1. Haemophilus type B Conjugate Vaccine. I.P. 2. Typhoid Polysaccharide Vaccine I.P. 3. Inactivated Hepatitis A Vaccine, Adsorbed. I.P. Hepatitis A virus, GBM strain (Inactivated) 80 antigen units 4. Inactivated Hepatitis A Vaccine (Adsorbed) I.P. Hepatitis A virus, GBM strain (Inactivated) 160 antigen units 5. Pneumococcal Polysaccharide Vaccine. I.P. 6. Yellow Fever Vaccine (Live). I.P. 7. Inactivated Influenza Vaccine (Split Virion, inactivated) I.P. (0.5 ml dose) 8. Inactivated Influenza Vaccine (Split Virion, Inactivated.) I.P. (0.25 ml dose) 9. Rabies vaccine, Human IP. 10. Inactivated Poliomyelitis Vaccine 11. Adsorbed Diphtheria, Tetanus, Pertussis (Acellular Component), Inactivated Poliomyelitis Vaccine and Haemophilus Type b Conjugate Vaccine. I.P. 12. Adsorbed Diphtheria, Tetanus, Pertussis Acellular component and inactivated Poliomyelitis vaccine. IP 1. Bulk unlabelled vials or PFS of Pneumococcal Polysaccharide Conjugate Vaccine (adsorbed) Ph. Eur. 2. Bulk unlabelled PFS of Diphtheria, Tetanus and Pertusis (Acellular Component) vaccine (adsorbed) Ph. Eur. 3. Bulk unlabelled vials of Hepatitis B Virus Vaccine IP (genetically engineered) SV-101 valid up to: 09/08/2017 SV-1 SV-64 valid up to: 11/12/2016 Page 2 of 8
3 7. M/s.GlaxoSmithKline Pharmaceuticals Ltd., Dr. Annie Besant Road, Mumbai, India 4. Bulk unlabelled vials or PFS of Inactivated Hepatitis A Vaccine (Adsorbed) IP 5. Bulk unlabelled vials of Haemophilus Type b Conjugate Vaccine IP and bulk vial or PFS or Ampoule of diluent 6. Bulk unlabelled vials or PFS of Meningococcal Polysaccharide Vaccine IP and bulk sealed vial or PFS or Ampoule of diluent 7. Bulk unlabelled vials of Measles, Mumps and Rubella Vaccine (live) and bulk sealed vial or PFS or Ampoule of diluent 8. Bulk unlabelled PFS of Hepatitis A (Inactivated) and Hepatitis B (r-dna) Vaccine (Adsorbed) IP 9. Bulk unlabelled PFS of Typhoid Polysaccharide Vaccine IP 10. Bulk unlabelled vials of Varicella Vaccine, Live IP and and bulk sealed vial or PFS or Ampoule of diluent 11. Bulk unlabelled PFS of Diphtheria, Tetanus and Pertussis (Acellular Component) Vaccine (Adsorbed) Ph. Eur. 12. Bulk unlabelled vials of Rotavirus vaccine, (Live Attenuated, oral) IP and bulk sealed PFS of diluent 13. Bulk unlabelled vials or PFS of Human Papillomavirus vaccine Ph. Eur. Live Attenuated Measles, Mumps, Rubella and Varicella vaccine SV-15 RECOMBINANT PRODUCTS 8. M/s Merck Specialities Pvt. Ltd, Plot No. D-116, MIDC., Bldg No. 2, 1 st Floor, Thane Belapure Road, Shir Vane, Navi Mumbai , Maharashtra 1. Chorionic gonadotropin alpha (r-dna Human Chorionic Gonadotropin Hormone) solution for injection 2. r-dna Human Somatropin Hormone Injection 3. r-human Interferon beta 1a solution for injection 4. Recombinant Human Interferon Beta 1a solution for injection in cartridge, 66mcg (18MIU)/1.5 ml & 132mcg (36MIU)/1.5ml, both in multidose cartridges. 5. Follitropin alpha (r-dna human Follicle Stimulating FFR-13 valid up to: 21/04/2018 Page 3 of 8
4 9. M/s Claris Lifesciences Ltd., Claris Corporate Head Quarters, Nr. Parimal Railway Crossing, Ellisbridge, Ahmedabad, India 10. M/s Pfizer Limited, The Capital- A Wing, 1802, 18th Floor, Plot No. C-70, G Block, Bandra (East), Mumbai , India 11. M/s Fulford (India) Limited, Gala No. 1D&2, Bldg. No. B-3, City Link Warehouses Complex,Mumbai Nashik Highway Vadapa, Bhiwandi Dist. Thane , Maharashtra, India 12. M/s Novartis Healthcare Pvt. Ltd., Sandoz House, Dr. Annie Besant Road, Worli, Mumbai , India. 13. M/s. Roche Products (India) Pvt. Ltd., Plot No. 13-A, Paper Box House, Survey No. 78, Hissa No. 1, CTS No. 46/15, Mahakali Road, Andheri (East), Mumbai , India 14. M/s Merck Specialities Pvt. Ltd., 7 th Floor, Shiv Sagar Estate A, Hormone) in lyophilized powder in vials 6. Follitropin alpha (r-dna human Follicle Stimulating Hormone) solution for injection in pre-filledpen 7. Choriogonadotropinalfa 250mcg/0.5ml Cartridge in a Pre-filled Pen & one Injection needle. r-human Erythropoietin alpha (recombinant)-2000 IU/ml& 4000 IU/ml. 1. Etanercept Injection 25 mg /Pre Filled Syringe (Solution, 1ml). 2. Etanercept Solution for Injection 50 mg in Pre Filled Pen. 1. Pegylated Interferon alfa-2b 50mcg, 80mcg, 100mcg, 120mcg &150mcg Powder for Injection in vials. 2. Interferon alfa-2b 18MIU, 30MIU & 60MIU Injection in Multidose Pen. Ranibizumab Solution for Injection 10mg/ml in Pre-filled Syringe (PFS) & in vial. Trastuzumab Emtansine for injection (r-dna origin) r-human Interferon beta-1a (Rebif), 22mcg & 44mcg in 0.5 ml solution for injection in pre-filled Pens Page 4 of 8 FF-224 valid up to: 19/02/2018 FF-86 FF-71 FF-401 valid up to: 31/10/2015 FFR-38 valid up to: 02/02/2018 FFR-13 valid up to: 21/04/2015
5 Dr. Annie Besant Road, Worli, Mumbai , India. 15. M/s. Eli Lilly & Company (India) Pvt. Ltd., Plot no, 92, Sector 32, Gurgaon, , Haryana 16. M/s Merck Specialities Pvt. Ltd, Plot No. D-116, MIDC, Bldg No. 2, 1 st Floor, Thane Belapure Road, Shir Vane, Navi Mumbai , Maharashtra, India 17. M/s. Roche Products (India) Pvt. Ltd., Plot No. 13-A, Paper Box House, Hissa No. 1, Mahakali Road, Andheri (East), Mumbai 18. M/s Roche Products (India) Pvt. Ltd., Plot No. 13-A, Paper Box House, Survey No. 78, Hissa No. 1, Mahakali Road, Andheri (East),Mumbai , India 19. M/s Merck Specialities Pvt. Ltd, Plot No. D-116, MIDC., Bldg No. 2, 1 st Floor, Thane Belapure Road, Abciximab Solution for injection 10 mg/5ml vial 1. Follitropin alpha (r-dna human Follicle Stimulating Hormone) solution for injection in pre-filled pen 2. Chorionic gonadotropin alpha (r-dna Human Chorionic Gonadotropin Hormone) solution for injection 3. r-dna Human Somatotropin Hormone Injection 4. r-hu-lutenising Hormone powder for solution for injection 5. Follitropin alpha (r-dna human Follicle Stimulating Hormone) in lyophilized powder in vials 1. Trastuzumab Powder for Concentrate for solution for Infusion in vials (440mg) 2. Bacteriostatic water for Injection (solvent for Trastuzumab injection 20 ml Vial) 1. Rituximab Concentrate for Solution for Infusion in Vials (500mg/50ml and 100mg/10ml). 2. Peginterferon alfa-2a for solution for Injection in 180mcg/0.5ml & 135 mcg/0.5 ml Pre filled Syringes 3. Pegfilgrastim Solution for injection in 6mg/0.6ml prefilled syringes. 4. Trastuzumab Powder for Concentrate for solution for Infusion in vials (150mg). 5. Bevacizumab Concentrate for Solution for Infusion in vials (100mg/4ml and 400mg/16ml). 6. Bacteriostatic Water for Injection 20ml vial (Solvent for Trastuzumab). Cetuximab Injection. FF-370 valid up to: 31/03/2018 FFR-12 valid up to: 21/04/2018 FFR-37 valid up to: 08/01/2018 FF-1 FF-373 valid up to: 31/03/2018 Page 5 of 8
6 Shir Vane, Navi Mumbai, India 20. M/s Sanofi-Synthelabo(India) Limited, Ground Floor, 54/A, Sir MathuradasVasant Road, Andheri East, Mumbai, India 21. M/s. BoehringerIngelheim India Pvt. Ltd., Bld No.D-5, Gala no:1 to 3, Shree Arihant Compound, RetiBunder Road, Kalher, Tal: Bhiwandi-15(Thane Zone5), India 22. M/s Zoetis India Limited, Prithvi Complex, RetiBunder Road, Kalher, Tah. Bhiwandi, Dist Thane , India 23. M/s Virbac Animal Health India Pvt. Ltd., Western Edge-I, Western Express Highway, Magathane, Borivili (East), Mumbai, India 24. M/s Intervet India Pvt. Ltd.,S.No. 136, Build.-3,3A,+4C ColdRoom Ware House Brihanagar, Pune- Nagar Road Wagholi, Pune, Tal: Wagholi (Pune-Zone1) Maharashtra, India VETERINARY VACCINE Rabies Veterinary Vaccine, Inactivated I.P. Porcine Circovirus Vaccine Type 2, killed Baculovirus vector Mycoplasma Synoviae Vaccine, Live (Strain MS-H) Rabies Veterinary Vaccine, Inactivated (Cell Culture), I.P. Ten dose 1. Combined Infectious Bursal Disease & Newcastle disease Vaccine, Inactivated, Water in oil emulsion. 2. Ranikhet Disease Vaccine, Inactivated, I.P. 3. Combined Avian Infectious Bronchitis Disease & Newcastle disease Vaccine, Inactivated, Water in oil emulsion. 4. Combined Avian Encephalomyelitis and Fowl Pox Vaccine, Live, Freeze dried. 5. Mycoplasma Gallisepticum Vaccine, Live, Freeze dried. 6. Avian Infectious Bronchitis Vaccine, Live, I.P. 7. Reo Virus Vaccine, Inactivated, I.P. 8. Infectious Bursal Disease Vaccine, Live, I.P. 9. Mycoplasma Gallisepticum Vaccine, Inactivated. 10. Ranikhet Disease Vaccine, Inactivated, I.P. SVV-11 valid up to: 26/02/2018 SVV-1 valid up to: 30/09/2017 SV-19 valid up to: 18/02/2016 SV-43 valid up to: 14/03/2017 SV-6 Page 6 of 8
7 25. M/s Panav Bio-Tech, Shop No. 131, 1 st Floor, Vardhman Big V Plaza,Plot No. 12, C-Centre, Road No. 44, Rani Bagh, Pitampura, 11. Combined Avian Infectious Bronchitis Disease, Infectious Bursal Disease, Newcastle Disease and Reo virus Vaccine, Inactivated, Water in oil emulsion. 12. Rabies vaccine (cell cultured, Inactivated) for veterinary use. 13. Infectious Coryza Vaccine, Inactivated, I.P. 14. Combined Canine Distemper, Canine Adenovirus, Canine Parvovirus & canine Parainfluenza Vaccine, Live, Freeze dried. 15. Combined Canine Distemper & Canine Parvovirus Vaccine, Live, Freeze dried. 16. Combined Avian Infectious Bronchitis Disease, Infectious Bursal Disease & Newcastle Disease Vaccine, Inactivated, Water in oil emulsion. 17. Combined Avian Infectious Bronchitis &Ranikhet disease Vaccine, Inactivated, Water in oil emulsion. 18. Salmonella enteritidis& Salmonella typhimurium Vaccine, Inactivated, I.P. 19. Avian colibacillosis Vaccine, Inactivated, Water in Oil Emulsion. 20. Combined Rabies & Canine Leptospirosis Vaccine, Inactivated. 21. Infectious Bursal Disease Vaccine, Live, I.P. 22. Ranikhet disease Vaccine, Live, I.P. 23. Ranikhet disease Vaccine, Live, I.P. 24. NOBILIS CORVAC is an inactivated trivalent poultry vaccine containing serotype A, B and C of Avibacteriumparagallinarum. 25. Live, Freeze-dried vaccine against Bordetellabronchiseptica and Canine parainfluenza virus (Nobivac KC). 26. Canine Leptospirosis Vaccine, Inactivated, I.P. 1. Vaccines against Canine Distemper, Parvovirus, Parainfluenza, Hepatitis, Adenovirus, Corona virus and 5 Leptospirosis. 2. Vaccine against Canine Distemper, Parvovirus, SVV-2 valid up to: 31/03/2018 Page 7 of 8
8 Delhi , India Parainfluenza, Hepatitis, Adenovirus, Corona virus and Leptospirosis. 3. Vaccine against Corona virus in Dogs. 4. Inactivated Vaccines against Canine Distemper, Parvovirus, Parainfluenza, Adenovirus type 2 and Leptospirosis infections. Page 8 of 8
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