Status of Registration Certificate (Form 41) of Human Vaccines issued from 01/03/2015 to 29/05/2015. Human vaccines
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1 Status of Registration Certificate (Form 41) of Human Vaccines issued from 01/03/2015 to 29/05/2015 S. No. Firm Name of Formulation Registration Certificate No. & Validity 1. M/s. Nirlac Chemicals,14 th Floor, Nirmal Building,241/242, Nariman Point,Mumbai , 2. M/s Panacea Biotec Ltd.,B-1, Extension A-27, Mohan Co- Operative, Industrial Estate, Mathura Road, New Delhi , 3. M/s HLL Lifecare Limited, P.B No. 2, Peroorkada,Thiruvananthapuram, 4. M/s Pfizer Limited, The Capital-A Wing, 1802, 18 th Floor, Plot No. C- 70, G Block, Bandra Kurla Human vaccines a) Monovalent Bulk of Poliomyelitis- Sabin Strain type 1 b) Monovalent Bulk of Poliomyelitis- Sabin Strain type 2 c) Monovalent Bulk of Poliomyelitis- Sabin Strain type 3 d) Purified Diphtheria Toxoid Bulk- Antigenic Purity 1500 Lf/mgPN e) Purified Tetanus Toxoid Bulk- Antigenic Purity 1000 Lf/mgPN f) Bulk of Pertussis- Opacity 192 OU/ml Monovalent Bulk of Poliomyelitis-Sabin Strain type I Monovalent Bulk of Poliomyelitis-Sabin Strain type II Monovalent Bulk of Poliomyelitis-Sabin Strain type III Purified Diphtheria Toxoid bulk concentrate ( Lf/ml) in polypropylene bottle. Purified Tetanus Toxoid bulk concentrate ( Lf/ml) in polypropylene bottle. Inactivated whole cell B. Pertussis bulk (192 OU/ml) in polypropylene bottle. Japanese Encephalitis Vaccine (Human) I.P. Pneumococcal Saccharide conjugate vaccine adsorbed 13-valent suspension for injection Page 1 of 5 SV-23 Valid up to 31/05/2018 SV-26 Valid up to 30/06/2018 SVH-3 Valid up to 31/05/2018 SV-50 valid up to 25/03/2018
2 Complex, Bandra (East), Mumbai , 5. M/s GlaxoSmithKline Pharmaceuticals Ltd., Southern Portion of Ground and First floor, No. 144, Poonamallee High Road,Vellappanchavadi, Chennai , 6. M/s. Sanofi Pasteur India Private Limited, 54/A Sir Mathuradas Vasanji Road, Andheri (E), Mumbai , 7. M/s Biological E. Limited, Plot No. 1, S.P. Biotechnology Park, Phase- II, Kolthur (Village), Shameerpet (Mandal),Rangareddy(Dist.),Andhr a Pradesh , India 1. M/s. Eli Lilly & Company (India) Pvt. Ltd., Plot no, 92, Sector 32, Gurgaon , Haryana, India 2. M/s Novo Nordisk India Pvt. Ltd., Plot No. 32, 47-50, EPIP Area, Whitefield, Bangalore , India Each 0.5 ml dose of Inactivated Influenza vaccine (Split Virion), I.P., suspension for Injection in prefilled syringe Inactivated Poliomyelitis Vaccine- multidose presentation (10 dose vial) Measles Bulk (CAM 70), Bulk Suspension Recombinant Products Insulin Lispro I.P. (r-dna Origin) in Prefilled Pen 100 IU/ml, 3ml Solution for Injection (Humalog Kwikpen). Biphasic Insulin Lispro I.P. [50% Insulin Lispro Protamine Suspension and 50% Insulin Lispro Injection (rdna Origin) 100IU/ml in Prefilled pen 3ml] (Humalog Mix 50 Kwikpen). Biphasic Insulin Lispro I.P. [75% Insulin Lispro Protamine Suspension and 25% Insulin Lispro Injection (r-dna Origin) 100IU/ml in Prefilled pen 3ml] (Humalog Mix 25 Kwikpen). Dulaglutide (r-dna origin) (Brand Name: Trulicity) Soluble Insulin Injection I.P. ( Insulin Human Biosynthetic, r- DNA origin Isophane Insulin Injection I.P. (Insulin Human Biosynthetic, r-dna origin ) Page 2 of 5 SV-29 valid up to SV-5 valid up to SVH-10 valid up to 12/03/2018 FFR-16 valid up to: FFR-14 valid up to
3 3. M/s. Roche Products (India) Pvt. Andheri (East), Mumbai , 4. M/s. Roche Products (India) Pvt. 5. M/s. Biocon Limited, Biocon Special Economic Zone, Plot No. 2-4, Phase IV, Bommasandra- Jigani Link Road, Bommasandra Post, Bangalore , India 6. M/s Eli Lilly & Company (India) Pvt. Ltd., Plot no. 92, Sector 32, Gurgaon, , Haryana, India Biphasic Isophane Insulin Injection I.P. (Insulin Human Biosynthetic, r-dna origin ) Human Insulin Analogue Injection (Biosynthetic, Monocomponent r-dna origin) Biphasic Insulin aspart (r-dna origin)[premixed Human Insulin analogue injection] Human Insulin Analogue Injection (Biosynthetic, Monocomponent r-dna origin) Bacteriostatic Water for injection 20 ml vial (Solvent for Trastuzumab) Interferon alfa-2a Injection (r-dna origin) Peginterferon alfa-2a for solution for Injection in 180mcg/0.5ml & 135 mcg/0.5 ml Pre filled Syringes Nimotuzumab Bulk Recombinant Human Erythropoietin Alpha Bulk IU, 4000 IU and IU Recombinant Human Erythropoietin Alpha Concentrate Bulk (> 40,000 IU/ml). r-human-erythropoietin Injection. Humanised Anti-EGFR Monoclonal Antibody (Nimotuzumab Injection) Human Insulin Injection (Biphasic Isophane Insulin Injection I.P.) 100 IU/mL, 3mL in Pre-filled disposable pen. Human Insulin Injection (Soluble Insulin Injection I.P.) 100 IU/mL, 3mL in Pre-filled disposable pen. Page 3 of 5 FFR-35 valid up to 16/11/2017 FFR-35 valid up to 16/11/2017 FF-389 valid up to 30/06/2018 FF-17
4 7. M/s. Roche Products (India) Pvt. 8. M/s. Bayer Pharmaceuticals Pvt. Ltd., Shree Arihant Complex Bldg. D-9, Gala No. 1 to 6, Reti Bunder Road, Kalher village, Dist. Thane,Bhiwandi , Maharashtra, India 9. M/s Merck Specialities Pvt. Ltd., 7 th Floor, Shiv Sagar Estate A, Dr. Annie Besant Road, Worli, Mumbai , 10. M/s Sandor Medicaids Pvt. Ltd., D.No /5, Ground Floor, Road No.3, Banjara Hills, MCH Circle-10 Mandal, Hyderabad , 11. M/s GlaxoSmithKline Pharmaceuticals Ltd., Dr. Annie Besant Road, Worli, Mumbai , 12. M/s Novo Nordisk India Pvt. Ltd., Plot No. 32, 47-50, EPIP Area, White field, Bangalore , 13. M/s. Roche Products (India) Pvt. Human Insulin Icnjection (Isophane Insulin Injection I.P.) 100 IU/mL, 3mL in Pre-filled disposable pen. Obinutuzumab Injection (r-dna origin) Aflibercept (r-dna origin) r-human Interferon beta-1a, 22mcg/0.5ml & 44 mcg/0.5 ml solution for injection in Pre-filled Pens Imiglucerase for injection Denosumab injection (r-dna origin) Insulin crystals HM (GE) Biosynthetic, r-dna origin (Bulk drug substance) Pertuzumab Concentrate for solution for infusion in Vial [420 mg/14 ml] FF-3 FF-621 valid upto 31/01/2018 FFR-13 valid up to FF-495 Valid up to 31/01/2018 FFR-27 valid up to FF-15 Valid up to 31/12/2017 FF-3 Page 4 of 5
5 India 14. M/s.Eli Lilly & Company (India) Pvt. Ltd., Plot no, 92, Sector 32, Gurgaon , Haryana, 1. M/s Intervet India Pvt. Ltd., Off Pune- Nagar Road, Wagholi , Dist. Pune, 2. 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 , 3. 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 , Zinc Insulin Crystals Human: Proinsulin Derived (Recombinant DNA Origin)(Bulk Drug Substance) Veterinary Vaccine Marek s disease New Castle disease vaccine, serotype 2 & 3, live virus, live Marek s disease vector (Live Recombinant Vaccine for Poultry) Inactivated vaccine against Rabies Combined Feline Panleukopenia, Calicivirus and Rhinotracheitis vaccine for cat BD-99 Valid up to 31/12/2017 SVV-3 Valid up to 30/04/2018 SVV-2 Valid up to 31/03/2018 SVV-2 Valid up to 31/03/2018 Page 5 of 5
Status of Import License (Form 10) of Recombinant Products, Human and Veterinary Vaccines issued from 01/03/2016 to 29/04/2016
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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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Status of Import License (Form 10) of Human Vaccines, Recombinant Products and Veterinary Vaccine issued from 01/01/2015 to 27/02/2015
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
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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