Status of Import License (Form 10) of Human Vaccines, Recombinant Products and Veterinary Vaccine issued from 01/01/2015 to 27/02/2015

Size: px

Start display at page:

Download "Status of Import License (Form 10) of Human Vaccines, Recombinant Products and Veterinary Vaccine issued from 01/01/2015 to 27/02/2015"

Grant Berry
6 years ago
Views:

1 Status of Import License (Form 10) of Human Vaccines, Recombinant Products and Veterinary Vaccine issued from 01/01/2015 to 27/02/2015 S. No. Firm Name of Formulation Import LicenseNo. & Validity HUMAN VACCINES 1. M/s.GlaxoSmithKline Pharmaceuticals Ltd., Dr. Annie Besant Road, Mumbai, India 2. M/s.GlaxoSmithKline Pharmaceuticals Ltd., Dr. Annie Besant Road, Mumbai, India 3. M/s Sanofi Pasteur India Private Limited, 54/A Sir MathuradasVasanji Road, Andheri East, Mumbai , India 1. Diphtheria, Tetanus and Pertussis (Acellular Component) Vaccine (Adsorbed) Ph. Eur. Composition: Each 0.5ml vaccine contains 2 IU (2.5 Lf) of diphtheria toxoid, 20 IU (5 Lf) of tetanus toxoid, 8µg of Pertussis toxoid (PT), 8µg of Filamentous Haemagglutinin (FHA) and 2.5µg of Pertactin (PRN) adsorbed on aluminium hydroxide (Total 0.3 mg Al3+) and aluminum phosphate (Total 0.2 mg Al3+) 2. Diphtheria, Tetanus and Pertussis (Acellular Component) Vaccine (Adsorbed) Ph. Eur. Composition: Each 0.5ml vaccine contains Not less than 30 IU of diphtheria toxoid (DT), Not less than 40 IU of tetanus toxoid (TT), 25µg of de-toxified Pertussis toxin (PT), 25µg of formalin-treated filamentous haemagglutinin (FHA) and 8µg of formalin-treated Pertactin adsorbed on 0.5 mg of aluminium as aluminium hydroxide 1. Live Attenuated Measles, Mumps, Rubella and Varicella Vaccine 1. Haemophilus type B Conjugate Vaccine. I.P. vial with Diluent 2. Typhoid Polysaccharide Vaccine I.P. 3. Inactivated Hepatitis A Vaccine, Adsorbed. I.P. Hepatitis A virus, GBM strain (Inactivated) 80 Page 1 of 12 SV-15-3 SV-15-3 valid up to 31/12/2017 SV-5-42

2 4. M/s. GlaxoSmithKline Pharmaceuticals Ltd., Patiala Road, Nabha (Punjab) 14720, India 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. 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) 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 Page 2 of 12 SV Valid up to 11/12/2016

3 5. M/s G. C. ChemiePharmie Ltd., 5/C, Shree Laxmi Ind. Estate, New Link Road, Andheri (West), Mumbai , India 6. M/s Sanofi Pasteur India Private Limited, 54/A Sir MathuradasVasanji Road, Andheri East, Mumbai , India 7. M/s Serum Institute of India Ltd., 212/2, Hadapsar, Pune, India 8. M/s.GlaxoSmithKline Pharmaceuticals Ltd., Dr. Annie Besant Road, Mumbai, India 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 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. Combination Vaccine of Diphtheria Toxoid and Acellular Pertussis suspension for suspension for single use(0.5ml) 2. Combination vaccine of Diphtheria Toxoid, Tetanus Toxoid And Acellular Pertussis suspension for single use (0.5ml) 1. Bulk Inactivated Trivalent Poliomyelitis Vaccine containing concentrated amounts of inactivated polio virus. 1. Hepatitis B Virus Vaccine IP 2. Inactivated Hepatitis A Vaccine (Adsorbed) IP 3. Pneumococcal polysaccharide and Non-Typeable Haemophilus influenza(nthi) protein D conjugate vaccine, adsorbed 4. Hepatitis A (Inactivated) and Hepatitis B (r-dna) Vaccine (Adsorbed) IP 5. Varicella vaccine, Live IP SV valid up to 09/08/2017 SV valid up to 31/12/2017 SV valid up to: 31/01/2018 SV Page 3 of 12

4 9. M/s. GlaxoSmithKline Pharmaceuticals Ltd., Patiala Road, Nabha (Punjab), India 10. M/s. GlaxoSmithKline Pharmaceuticals Ltd., Patiala Road, Nabha (Punjab), India 11. M/s. GlaxoSmithKline Pharmaceuticals Ltd., Patiala Road, Nabha (Punjab) 14720, India 12. M/s. GlaxoSmithKline Pharmaceuticals Ltd., Patiala Road, Nabha (Punjab), India 13. M/s Abbott India Limited, Corporate Park, Sion-Trombay Road, Chembur, Mumbai, India 14. M/s. Shantha Biotechnics Ltd. Survey No. 274, Athvelli village, 1. Diphtheria, Tetanus and Pertussis (Acellular Component) vaccine (Adsorbed)Ph.Eur Composition: Each 0.5ml vaccine contains Not less than 30 IU of diphtheria toxoid (DT), Not less than 40 IU of tetanus toxoid (TT), 25 µg of de-toxified Pertussis toxin (PT), 25 µg of formalin-treated filamentous haemagglutinin& 8 µg of formalin-treated Pertactin adsorbed on 0.5 mg of aluminium as aluminium hydroxide 1. Diphtheria, Tetanus and Pertussis (Acellular Component) vaccine (Adsorbed)Ph.Eur Composition: Each 0.5ml vaccine contains 2 IU (2.5 Lf) of diphtheria toxoid, 20 IU (5 Lf) of tetanus toxoid, 8 µg of Pertussis toxoid (PT), 8µg of Filamentous Haemagglutinin (FHA) and 2.5µg of Pertactin (PRN) adsorbed on aluminium hydroxide (Total 0.3 mg Al3+) and aluminum phosphate (Total 0.2 mg Al3+) 1. Hepatitis B Virus Vaccine IP 2. Inactivated Hepatitis A Vaccine (Adsorbed) IP 3. Hepatitis A (Inactivated) and Hepatitis B (r-dna) Vaccine (adsorbed) IP 4. Varicella Vaccine, Live IP 1. Haemophilus Type b conjugate vaccine IP 2. Measeles Mumps Rubella Vaccine(Live) IP 3. Typhoid Polysaccharide vaccine IP 4. Meningococcal Polysaccharide vaccine IP ml Inactivated Influenza vaccine (surface antigen), I.P., suspension for Injection in prefilled syringes 1. Inactivated Vero Trivalent Polio Vaccine Bulk (concentrated trivalent) Page 4 of 12 SV SV SV Sv SVH valid up to: 30/04/2018 SVH valid up to: 31/07/2017

5 Medchal Mandal, Rangareddy Dist.Andhra Pradesh, India. 15. 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 16. M/s. Sandor Medicaids Pvt Ltd, /5, Road No.3, Banjara Hills, Hyderabad , India. 17. M/s Roche Products (India) Pvt. Ltd., Plot No. 13-A, Paper Box (East),Mumbai , India 18. M/s Roche Products (India) Pvt. Ltd., Plot No. 13-A, Paper Box (East),Mumbai , India 19. M/s. Boehringer Ingelheim India Pvt. Ltd., Bld No.D-5, Gala no:1 to 3, Shree Arihant Compound, Ground Floor, RetiBunder Road, Kalher, Bhiwandi, Tal: Bhiwandi 15 (Thane Zone 5) Pin: , Maharashtra, India RECOMBINANT PRODUCTS 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. Agalsidase beta powder for concenterate for solution for infusion FFR valid up to: 21/04/2018 FF valid up to: 30/09/ Trastuzumab Emtansine for injection (r-dna origin) FFR valid up to: 02/02/ Trastuzumab Powder for Concentrate for solution for Infusion in vials (440mg) 2. Bacteriostatic water for Injection (solvent for Trastuzumab for injection 20 ml Vial) 1. Alteplase for injection(ph.eur) (rt-pa- Recombinant Human Tissue Type Plasminogen Activator Inj. 20mg & 50 mg vials with Sterilised water for injection (Ph.Eur) 20ml and 50ml. 2. Tenecteplase (TNK-tPA) Injection Intravenous bolus Injection Each vial contains: Tenecteplase-40 mg: 8000 Units with Sterilised water for injection (Ph.Eur) 8 ml Tenecteplase-50 mg: Units with Sterilised water for FFR valid up to: 08/01/2018 FF-88-6 valid up to: 28/02/2018 Page 5 of 12

6 20. 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 21. M/s. Pfizer Ltd, The Capital-A Wing, 1802, 18 th Floor, Plt No. C- 70, G block, Bandra (East), Mumbai , India 22. M/s. Merck Specialities Pvt Ltd., Shiv Sagar Estate A Dr. Annie Besant Road, Worli, Mumbai. 23. M/s. Eli Lilly & Company (India) Pvt Ltd. Plot No.92, Sector 32, Gurgaon , Haryana, India. 24. M/s. Roche Products (India) Pvt. 25. M/s. Eli Lilly & Company (India) Pvt Ltd., Plot No.92, Sector-32, Gurgaon, , Haryana, India. injection (Ph.Eur) 10ml 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. 1. Etanercept Injection 25 mg /Pre Filled Syringe (Solution, 1ml). 2. Etanercept Solution for Injection 50 mg in Pre Filled Pen. FF FF Cetuximab Injection. FF valid up to: 31/03/ Abciximab Solution for injection 10mg/5ml vial. FFR valid up to: 31/03/ Trastuzumab Powder for Concentrate for solution for Infusion in vials (150mg). 2. Bevacizumab Concentrate for Solution for Infusion in vials (100mg/4ml and 400mg/16ml). 3. Bacteriostatic Water for Injection 20ml vial (Solvent for Trastuzumab). 1. Insulin Human (r-dna origin -100 IU/ml 3ml Cartridges ofhuminsulin R (Regular) (Insulin Human Injection). 2. Insulin Human (r-dna origin -100 IU/ml 3ml Cartridges of Huminsulin N (NPH) (Isophane Insulin Human Suspension). 3. Insulin Human (r-dna origin -100 IU/ml 3ml Cartridges of Huminsulin 30/70 (30% Neutral Insulin Solution & 70% FF-1-33 FF valid up to 31/12/2017 Page 6 of 12

7 26. M/s. NovoNordisk India Pvt Ltd., Plot No. 32, 47-50, EPIP Area, Whitefield, Bangalore , India. Isophane Suspension Human) % Insulin Lispro& 75% Insulin Lispro Protamine Suspension (r-dna origin) Mix IU/ml (3ml Cartridges) 5. 50% Insulin Lispro& 50% Insulin Lispro Protamine Suspension (r-dna origin) Mix IU/ml ( 3 ml Cartridges) 6. Somatropin- 18 IU (6mg)/36 IU (12 mg), (Somatropin for injection (r-dna origin)- Cartridges with Sterile Diluent syringe with a needle for injection) 7. Teriparatide injection (r-dna origin (Teriparatide), 600 mcg/2.4 ml. 1. Soluble Insulin Injection I.P.( Insulin Human Biosynthetic, r- DNA origin ) 2. Isophane Insulin Injection I.P. (Insulin Human Biosynthetic, r- DNA origin ) 3. Biphasic Isophane Insulin Injection I.P.(Insulin Human Biosynthetic, r-dna origin) 4. Pre-Mixed Human Insulin Analogue Injection (Biosynthetic, Monocomponent r-dna origin) 5. Human Growth Hormone Injection (Somatropin) (Biosynthetic, r-dna origin) 6. Eptacog Alfa-Activated, human Coagulation VII Activated (Biosynthetic, r-dna origin) 7. Human Insulin Analogue Injection-Insulin Detemir (Biosynthetic, Monocomponent r-dna origin) 8. Liraglutide, Glucagon-Like Peptide-1 analogue 9. Insulin degludec (r-dna origin) solution for subcutaneous injection. 10. Soluble Insulin Injection I.P. (Human Insulin, Biosynthetic, Page 7 of 12 FF valid up to 31/12/2017

8 27. M/s. Roche Products (India) Pvt 28. M/s. Roche Products (India) Pvt (East), Mumbai, India. 29. M/s.GlaxoSmithKline Pharmaceuticals Ltd., Dr. Annie Besant Road, Mumbai, India 30. M/s. Eli Lilly & Company (India) Pvt Ltd.,Plot No.92, Sector 32, Gurgaon, , Haryana, India 31. M/s. Novartis India Ltd., Bld No.27, Gala No.1-4 Bld No. 28, Arihant Compound, PurnaBhiwandi (Thane-Zone5), India. Monocomponent, r-dna origin) 40IU/ml in 10ml vials. 11. Isophane Insulin Injection I.P. (Human Insulin, Biosynthetic, Monocomponent, r-dna origin) 40IU/ml in 10ml vials. 12. Biphasic Isophane Insulin Injection I.P. (Human Insulin, Biosynthetic, Monocomponent, r-dna origin) (30% Soluble + 70% Isophane Insulin) 40IU/ml in 10ml vials. 13. Insulin degludec/ Insulin Aspart (r-dna origin) solution for Subcutaneous injection. 1. Trastuzumab Powder for concentrate for solution for infusion in vials(440mg) 2. Rituximab Concentrate for solution for infusion in Vials (500mg/50ml and 100mg/10ml) 1. Bevacizumab Concentrate for Solution for Infusion in vials (100mg/4ml and 400mg/16ml). 1. Ofatumumab Concentrate for solution for Infusion (r-dna Origin) 1. Insulin Lispro (r-dna origin) 100IU/ml Solution for injection, 3ml cartridge % Insulin Lispro and 75% Insulin Lispro Protamine (r- DNA origin) Suspenion for injection 100IU/ml, 3ml cartridges. 1. Basiliximab Injection/ I.V. infusion 2. Omalizumab Injection FF FF FFR valid up to 31/12/2017 FFR Valid up to 31/01/2018 FF-52-7 Page 8 of 12

9 32. M/s. Reliance Life Science Pvt Ltd. Of DhirubhaiAmbani Life Science Centre (DALC), Thane- Belapur Road, Mumbai, India. 33. M/s. Roche Products (India) Pvt. 34. M/s. Roche Products (India) Pvt. 35. M/s. Roche Products (India) Pvt. 36. M/s. Roche Products (India) Pvt. 37. M/s. Roche Products (India) Pvt. 38. M/s. Roche Products (India) Pvt. 39. M/s. Roche Products (India) Pvt. 1. Recombinant Human Erythropoetin Alfa Concentrate Solution (Bulk) 1. Methoxy Polyethylene glycol-epoetin beta solution for Injection in PFS 30µg, 40µg, 60µg, 120µg in 0.3ml Prefilled Syringes and 360µg in 0.6 ml Prefilled Syringes. 1. Methoxy Polyethylene glycol-epoetin beta Solution for Injection in 50µg, 75µg, 100µg, 150µg, 200µg, 250µg in 0.3ml PFS. 1. Rituximab Concentration for solution for Infusion in vial 100mg/10ml & 500mg/50ml. 1. Trastuzumab Powder for Concentrate for Solution for Infusion in 150 mg vials. 2. Peginterferon alfa-2a solution for Injection in 180mcg/0.5ml & 135mcg/0.5ml PFS. 1. Epoetin beta Solution for Injection in 2000IU, 3000IU, 4000IU, 5000IU, 10,000IU and 30,000IU Pre-Filled Syringes. 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 1. Bevacizumab Concentrate for Solution for Infusion 100mg/4ml & 400mg/16ml. Page 9 of 12 FFR Valid up to FF-3-46 valid up to 31/12/2017 FF-3-12 FF-3-85 FF-3-31 FF FF FF-3-70

10 40. 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 VACCINES 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. 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 SV Page 10 of 12

11 41. M/s Zoetis India Limited, RetiBunder Road, Kalher, Tah. Bhiwandi, Dist Thane, India 42. 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, Delhi , India 43. M/s Virbac Animal Health India Pvt. Ltd., Western Edge-I, 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, Inact. 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. Mycoplasma Synoviae Vaccine, Live (Strain MS-H) SV valid up to: 18/02/ Vaccines against Canine Distemper, Parvovirus, Parainfluenza, Hepatitis, Adenovirus, Corona virus and 5 Leptospirosis. 2. Vaccine against Canine Distemper, Parvovirus, Parainfluenza, Hepatitis, Adenovirus, Corona virus and Leptospirosis. 3. Vaccine against Corona virus in Dogs. 4. Vaccines against Canine Distemper, Parvovirus, Parainfluenza, Adenovirus type 2 and Leptospirosis infections in dogs, 1ml vial along with 1 ml vial of diluent. 1. Rabies Veterinary Vaccine, Inactivated (Cell Culture), I.P. Ten dose SVV-2-03 valid up to: 31/03/2018 SV valid up to: 14/03/2017 Page 11 of 12

12 Western Express Highway, Magathane, Borivili, Mumbai. Page 12 of 12

Status of Registration Certificate (Form 41) of Human Vaccines, Recombinant Products and Veterinary Vaccine issued from 01/01/2015 to 27/02/2015

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