Status of Import License (Form 10) of Recombinant Products, Human and Veterinary Vaccines issued from 30/04/2016 to 20/12/2016
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1 Status of Import License (Form 10) of Recombinant Products, Human and Veterinary Vaccines issued from 30/04/2016 to 20/12/2016 RECOMBINANT PRODUCTS S. No. Firm Name of Formulation Import License No. & Validity 1. M/s LG Life Sciences India Pvt. Ltd., LG House, Plot No. 11, Sector - 44, Gurgaon , India. Recombinant Hepatitis-B Vaccine IP SV /03/ M/s. Novartis Healthcare Pvt Ltd, Sandoz house, Dr. Annie Besant Road, Mumbai , India. 3. M/s. Cipla Ltd., Bldg No. L7 & L8, Ground, First, Second Floor, Rajlaxmi Hitech Textile Park, Mumbai Nashik Highway, Village Sonale.Bhiwandi Dist Thane, Tal: Bhiwandi 14 (Thane Z5). 4. M/s Sandoz Private Limited, Sandoz House, Shivsagar Estate, Dr. Annie Besant Road, Worli, Mumbai M/s Sandoz Private Limited, Sandoz House, Shivsagar Estate, Dr. Annie Besant Road, Worli, Mumbai India 6. M/s. Eli Lilly and Company (India) Pvt Ltd., Bldg No. 14, Gala No. 1-4, 1 st Floor, Arihant Comm. Complex, Opp. Koper Bus Stop, Purna, Bhiwandi, Maharashtra. Ofatumumab concentrate for solution for infusion 20mg r-dna Origin Etanercept (r-dna origin) 25 mg, Lyophilized powder for solution for subcutaneous injection in vials. Omalizumab Injection Each vial contains:- Omalizumab mg /150 mg (With adequate solvent solution in ampoules) Omalizumab Injection Each vial contains:- Omalizumab mg /150 mg (With adequate solvent solution in ampoules) Ramucirumab Concentrate for Solution for Infusion 10 mg/ml (100 mg/ 10 ml vial and 500 mg/50 ml vial) FFR /07/2019 FFR /05/2019 FFR /12/2018 FF /10/2018 FF /08/2018 Page 1 of 7
2 7. M/s Bristol Myers Squibb India Pvt. Ltd., Bldg. B4, Gala No. 3, 4, 5A & 6A City Link Ware Houses Complex, Mumbai Nashik Highway, Vadpe Village Tal: Bhiwandi-16 (Thane Zone 5) 8. M/s. MSD Pharmaceuticals Pvt Ltd., S. No , Gala No.1B, Bldg No. B- 3, City Link, Ware Houses Complex, Mumabi-Nashik Highway, Vadape, Tal: Bhiwandi-13, Thane Zone , Maharashtra, India. 9. M/s Hindustan Biosciences Ltd, D.No /S, Plot No. 31, Sagar Society, Road No: 2, Banjara Hills, Hyderabad. 10. M/s GlaxosmithKline Pharmaceuticals Ltd., Dr. Annie Besant Road,Worli Mumbai , India. 11. M/s. UCB India Pvt. Ltd., Bldg No. P.3 Unit No. 101 to 103, 1st Floor, Prithavi Complex, Kalher Piprline, Kalher Bhiwandi , India. 12. M/s. Sanofi-Synthelabo (India) Private Limited., Citylink Warehousing Complex, Bldg No. A-4, Gala No. 6 & 7, S.No , Mumbai Nashik Highway, Vadape Village , Tal: Bhiwandi-16, Dist: Thane-Zone 5, India. Nivolumab 10 mg/ml concentrate for solution for infusion, (r-dna origin) Pembrolizumab Injection 100mg/4ml (25mg/ml in a single vial) Recombinant Human Erythropoietin Injection, Each Vial of 1ml contains IU, 3000IU, 4000IU Recombinant Human Erythropoietin 2000 IU, 3000IU, 4000IU in Pre-filled Syringe and 6000IU/ml & 10,000IU/ml in multi dose vials Albiglutide Powder and Solvent for solution for injection (r-dna origin) Peg-interferon beta-1a injection 63 mcg, 94mcg and 125mcg/0.5mL, (r-dna origin) Prefilled Syringes and Prefilled Pen Rasburicase (recombinant urate-oxidase enzyme produced by genetically modified Saccharomyces cerevisiae) Injection (Lyophilized powder for solution in vial) FF Dated 30/09/2017 FFR valid up to: 24/07/2019. FFR /04/2019 FFR Valid up to; 11/12/2017 FFR /05/2019 FFR /02/2019 Page 2 of 7
3 13. M/s Fulford (India) Limited, of Gala No. 1D&2, Builidng No. B-3, City Link Warehouses Complex, Mumbai Nashik Highway Vadapa, Bhiwandi, Dist- Thane , Maharashtra, India. Pegylated Interferon alfa-2a 50mcg, 80mcg, 100mcg, 120mcg & 150mcg Powder for injection in vials. FF /12/2017. HUMAN VACCINES S. No. Firm Name of Formulation Import License No. & Validity 1. M/s GlaxoSmithKline Asia Private Bulk unlabelled vials or PFS of SV Limited, Patiala Road, Nabha Punjab, Pneumococcal Polysaccharide Conjugate valid up to: , India. 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 Page 3 of 7
4 2. M/s Novartis Healthcare Pvt Ltd., Vaccine Division, 501, Shre Amba Shanti Chambers, Andheri Kurla Road, Andheri East, Mumbai , India. 3. M/s GlaxoSmithKline Asia Private Limited, Patiala Road, Nabha Punjab, , India. 4. M/s. Sanofi Pasteur India Private Limited, Sanofi House, CT Survey No. 117-B, L&T Business Park, Saki Vihar Road, Powai, Mumbai , India. 5. M/s. Sanofi Pasteur India Private Limited, Sanofi House, CT Survey No. 117-B, L&T Business Park, Saki Vihar Road, Powai, Mumbai , India. 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. Meningococcal Groups A, C, W-135 and Y conjugate Vaccine. Bulk Unlabelled vials of Measles, Rubella AND Varicella Vaccine (Live) Ph. Eur. And bulk unlabelled Ampoules or PFS of diluents Diphtheria, Tetanus, Pertussis (acellular Component), Hepatitis B (r- DNA), Poliomyelitis (Inactivated) and Haemophilus Influenzae type b conjugate vaccine (adsorbed) Diphtheria, Tetanus, Pertussis (acellular Component), Hepatitis B (r-dna), Poliomyelitis (Inactivated) and Haemophilus Influenzae type b conjugate vaccine (adsorbed) SVH valid up to: 28/08/2016 SV valid up to: 11/12/2016 SV /12/2017. SV /12/ M/s Man Mil Chemicals Pvt Ltd., Gala No. 20, Bldg. No. 03, First Floor, Manish Compound, Anjur Phata, Rahnal Village, Tal: Bhiwandi (Thane- Zone-5), Pin: , India. 7. M/s Panacea Biotec Ltd., Vill Malpur, P.O. Bhud, Baddi, District: Solan, H.P , India. Inactivated Influenza Vaccine (Split Virion) SV /08/2017 Inactivated Poliomyelitis Trivalent (Bulk) SV /01/2019 Page 4 of 7
5 8. M/s Biomed Private Limited, C-96, Site No.1, Bulandshahr Road, Industrial Area, Ghaziabad (U.P.), India. 9. M/s Prosper Channel Life Sceinces India Pvt. Ltd., B-244, Sector-7, Palam Extn., New Delhi , India. 10. M/s Wockhardt Ltd, Wockhardt Towers, Bandra Kurla Complex, Bandra (East), Mumbai , India. Purified Tetanus Toxoid Bulk SV /05/2018 Diphtheria, Tetanus and Acellular Pertussis Combined Vaccine, adsorbed. Freeze-dried Live attenuated Hepatitis A Vaccine. SVH Valid up to 23/06/2019. SVH /05/2019 VETERINARY VACCINES S. No. Firm Name of Formulation Import License No. & Validity 1. M/s Zoetis India Ltd., 31st & 32nd, 3rd Floor, Kalpataru Synergy, Opp. Grand Hyatt, Santacruz (E), Mumbai , India. Infectious Coryza Vaccine IP, Inactivated (Mineral oil emulsion) SVV /01/ M/s. Hipra India Pvt Ltd., M No.1/0361, First Floor, C/O Reality Ware Housing Pvt Ltd.Gut No.1337/1, old gut no. 2323/1 Wagholi , Tal.Haveli. Dist Pune, India 3. M/s Sanofi-Synthelabo (India) Private Limited, Citylink Warehousing Complex, Bldg No. A-4, Gala No. 6&7, S. No 120, 121, Mumbai Nasik Highway, Vadape Village, Tal: Bhiwandi-16, Dist: Thane-Zone 5, India. Avian Salmonella Vaccine, Inactivated, Combined Ranikhet Disease and Avian Infectious Bronchitis Ranikhet Disease Vaccine, Live Avian Infectious Coryza Inactivated vaccine Rabies Veterinary Vaccine, Inactivated, SVV /03/2019 SVV /02/2018 Page 5 of 7
6 4. M/s Intervet India Pvt Ltd., Briahnagar, Off Pune-Nagar Road, Wagholi , Dist- Pune, India. Avian Infectious Bronchitis Vaccine, Live, Avian Infectious Bronchitis Vaccine, Inactivated,, Water in Oil Emulsion SV /12/ M/s. Sanofi-Synthelabo (India) Private Limited., Citylink Warehousing Complex, Bldg No. A-4, Gala No. 6 & 7, S.No , Mumbai Nashik Highway, Vadape Village , Tal: Bhiwandi-16, Dist: Thane-Zone 5, India. 6. M/s. Intas Pharmaceuticals Ltd., Plot No. 457 & 458, Sarkhej- Bavla Road, Vill. Matoda , Tal: Sanand, Dist: Ahmedabad, India. Combined Inactivated Salmonella Enteritidis and Salmonella Typhimurium Vaccine Mycoplasma Gallisepticum Inactivated bacterin Rabies Veterinary Vaccine, Inactivated Canine Corona Virus Vaccine, Inactivated Live Canine Distemper Virus, Canine Adenovirus type-2, Canine 4.Parvovirus and Canine Parainfluenza Virus Combined Freeze Dried Vaccine Live, Canine Parvovirus and Canine Coronavirus combined, Freeze dried Vaccine. SVV /05/2019 SVV /03/ M/s. Lal Pet Products, Plot No. 24, IDC, MG Road Sec-14, Gurgaon, India Combined Canine Distemper, Infectious Hepatitis, Infectious Laryngotracheitis, Parvovirus & Parainfluenza Vaccine, Live, Freeze dried Canine Leptospirosis Vaccine, Inactivated, Rabies Vaccine, Inactivated, Canine Corona Virus, Inactivated, I.P SV /05/20191 Page 6 of 7
7 8. M/s. Zoetis India Limited, Godown No. 1& 2, Bldg. No. 12B, Prithvi Complex, Reti Bunder Road, Kalher, Tah. Bhiwandi, Dist. Thane , India. Rabies Veterinary Vaccine, Inactivated (Cell culture) Combined Bovine Rota Virus, Coronavirus Vaccine, Killed Virus, Escherichia Coli Bacterin. Vaccine against Leptospirosis infections in cattle caused by L. hardjo servovar bovis. Canine Distemper-Adenovirus Type 2- Coronavirus-Parainfluenza-Parvovirus Vaccine, Modified Live and Killed Virus, Leptospira Canicola-Icterohaemorrhagiae Bacterin. SVV /02/2019 Page 7 of 7
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. M/s LG Life Sciences India Pvt. Ltd.,Basement Commercial SCO No. 321, Sector-29, Gurgaon, India 2. M/s Eli Lilly and Co (I) Pvt. Ltd., Bldg. No. 14, Gala No. 1 to 4, 1 st Fl, Arihant Comm. Complex,
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Status of Import License (Form 10) of Human Vaccines, Recombinant Products and Veterinary Vaccine issued from 01/01/2015 to 27/02/2015
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