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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Mariah Ray
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1 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, Opp. Koper Bus Stop, Purna-Bhi, Tal: Bhiwandi-14 (Thane-Zone5) Maharashtra , India 3. M/s Sanofi Synthelabo (India) Private Limited, Citylink Warehousing Complex, Village Vadpe, Tal: Bhiwandi , Thane Z5, India RECOMBINANT PRODUCT Recombinant Insulin Glargine 100IU/ml FFR Valid upto 18/03/2019 Insulin Lispro I.P. (r-dna origin) in Pre-Filled Pen 100IU/ml, 3ml Solution for Injection. Insulin Lispro Biphasic Injection I.P. [50% Insulin Lispro Protamine Suspension and 50% Insulin Lispro Injection (r-dna origin)], 100IU/ml in Pre-Filled Pen 3ml. Insulin Lispro Biphasic Injection I.P. [(75% Insulin Lispro Protamine Suspension and 25% Insulin Lispro Injection (r-dna origin)] 100IU/ml in Pre-Filled Pen 3ml. Insulin Human I.P. (r-dna origin); 100IU/ml, 3ml cartridge. Isophane Insulin Human Suspension I.P. (r-dna origin); 100IU/ml, 3ml cartridge. Biphasic Insulin Injection I.P. (r-dna origin)- 30% Solution Insulin & 70% Isophane Suspension Human, 100IU/ml, 3ml cartridge. Aflibercept solution for infusion (r-dna origin) Solution for infusion Each single use vial contains Aflibercept...100mg/200mg Strength...25mg/ml Page 1 of 5 FFR Valid upto 31/01/2018 FFR Valid upto 09/02/2019

2 4. M/s Lupin Limited, Shree Arihant Recombinant Insulin Glargine Injection 100 FFR Compound, Gala No.1 to 9, Bldg. No. Z1, 1 st IU/mL Valid upto 18/03/2019 Fl., Kalher Pipeline, Kalher, Bhiwandi, Tal: Bhiwandi (Thane-Zone5), Pin: , India 5. M/s UCB India Pvt. Ltd., 503/504, Peninsula Towers, G.K. Marg, Lower Parel, Mumbai , India. 6. M/s Ferring Pharmaceuticals Pvt. Ltd., Sunshine Tower, 24 th Floor, Senapati Bapat Marg, Dadar (West), Mumbai , India 7. M/s LG Life Sciences India Pvt. Ltd.,Basement Commercial SCO No. 321, Sector-29, Gurgaon, India Natalizumab 300mg concentrate for solution for infusion (r-dna origin) Interferon beta-1a 30µg (6 million IU)/0.5 ml (r- DNA origin) in Prefilled Pen and Prefilled Syringe Somatropin (Recombinant Human Growth Hormone) Bacteriostatic sodium chloride injection USP. Recombinant Human Growth Hormone (Somatropin)... 4 IU Recombinant Human Erythropoietin Injection IU/ 1.0 ml, IU/ 2.0 ml Sustained Release Recombinant Human Growth Hormone (Somatropin) contains.. 24 mg Recombinant Human Follicle Stimulating Page 2 of 5 FFR Valid upto 31/10/2018 *(Import License No. FFR is now transferred from M/s Biogen Idec Biotech India Pvt. Ltd. to M/s UCB India Pvt. Ltd.) FFR Valid upto 30/04/2019 SV Valid upto 31/03/2019

3 Hormone Injection Injection (Powder for solution) 8. M/s. Bioviz Technologies Pvt. Ltd. D.No /S/103/1, I & II Floors, Sagar Co-OP, Housing Society Road No. 2, Banjara Hills, MCH Circle -5 Mandal, Hyderabad Dist Each vial Contains: r- Human Follitropin IU/ 150 IU and Sterile Diluent (0.01% Polysorbate 20 in Saline) ml Recombinant Human Follicle Stimulating Hormone Solution for injection 75IU/0.15ml, 150IU/0.3ml, 225IU/0.45ml and 300IU/0.6ml in pre-filled Syringes. Recombinant Human Erythropoietin- (Bulk- Ready to fill) (2000IU/ml and 4000IU/ml) FFR Valid upto 18/01/ M/s. Novo Nordisk India Pvt. Ltd., Plot No. 32, 47-50, EPIP Area, Whitefield, Bangalore , India 10. M/s Bristol Myers Squibb India Pvt. Ltd., City Link Ware Houses Complex, Mumbai Nashik Highway, Taluka: Bhiwandi-16, District: Thane Z-5, Pin: , India. 11. M/s Merck Specialities Pvt. Ltd, Plot No. D- 116, MIDC., Bldg No. 2, 1 st Floor, Thane Belapure Road, Shir Vane, Navi Mumbai Insulin degludec/liraglutide (Xultophy ) (r-dna origin) Additional route of administration of Abatacept 125mg/ml solution for subcutaneous injection Follitropin alpha (Recombinant Follicle Stimulating Hormone) lyophilized powder in vials. Human Somatropin hormone Injection as Saizen Page 3 of 5 FF FF valid up to 30/09/2017 FFR Valid upto 21/04/2018

4 400706, Maharashtra, India 5.83mg/ml (1 cartridge of 1.03ml containing 6mg of somatropin) Human Somatropin hormone Injection as Saizen 8mg/ml (1 Cartridge of 1.5ml containing 12mg of Somatropin) Human Somatropin hormone Injection as Saizen 8mg/ml (1 Cartridge of 2.5ml containing 20mg of Somatropin) r-6hgh solution for injection. HUMAN VACCINE 1. M/s MSD Pharmaceuticals Pvt Ltd., City link, Ware Houses Complex, Mumbai- Nashik Highway, S.No , Village Vadapa, Tal-Bhiwandi, Dist-Thane, Maharashtra (Rotavirus Vaccine, Live, Oral, Pentavalent) oral solution Single dose of 2ml contains- Name of Active Ingredients G1 Reassortant G2 Reassortant G3 Reassortant G4 Reassortant P1 Reassortant Quantity IU/dose IU/dose IU/dose IU/dose IU/dose FFR valid up to 31/05/ M/s. Sanofi Pasteur India Private Limited, Inactivated Purified Vero cells Rabies vaccine (Powder in vial and diluent in Prefillled syringe) SV-1-32 Page 4 of 5

5 3. M/s. Sanofi Pasteur India Private Limited, Inactivated Purified Vero cells Rabies vaccine (Powder SV-5-42 in vial and Diluent in Prefillled syringe) 4. M/s. Sanofi Pasteur India Private Limited, 5. M/s. Sanofi Pasteur India Private Limited, Multidose presentation (10 doses, 10 vials) of Inactivated Influenza vaccine (Split Virion) Multidose presentation (10 doses, 10 vials) of Inactivated Influenza vaccine (Split Virion) SV-1-32 SV-5-42 VETERINARY VACCINE Nil Page 5 of 5

Status of Registration Certificate (Form 41) of Human Vaccines issued from 01/03/2015 to 29/05/2015. Human vaccines

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