(Form-46) Permission issued from January 2009 to June 2010
| S.No. | Name of the firm | Date | Name of the molecule approved | Indication | dosage form and Strength |
| 1 | Biocon | 1/21/2009 | Insulin glargin | Tretament of Type Idiabetes Mellitus | 100 IU/ml Vial |
| 2 | Serum institute of india | 1/19/2009 | r-HU-EPO injection | For the treatment of anemia due to chronic renal failure patient on maintenance Hemodialysis | 2000 IU/4000 IU/ 10000IU/1ml vial |
| 3 | Cadila Pharmaceuticals Ltd | 1/7/2009 | r-HU-EPO injection | Treatment of patients with Anaemia due to CRF | Each 0.5/1ml vial/PFS contains EPO 2000 IU |
| 4 | Biocon | 1/21/2009 | Insulin Glargin (bulk) | ||
| 5 | Shashun Chemicals | 5/28/2009 | r-streptokinase injection | Acute myocardial infraction (AMI) | 15,00,000 IU/vial |
| 6 | Shashun Chemicals | 5/1/2009 | r-streptokinase (bulk) | ||
| 7 | Cadila Healthcare Ltd | 6/5/2009 | r-metHu-GCSF | reduction in the duration of neutropenia in bone marrow transplant patients or in those who have received cytotoxic therapy | one vial of 1.0ml injection solution contains 30 million IU of r-metHu-GCSF |
| 8 | Bharat Biotec International Ltd | 7/10/2009 | r-human Epidermal growth factor (Bulk) | ||
| 9 | Cadila healthcare Ltd | 8/18/2009 | peg-r-metHu-GCSF | reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy for malignancy | each vial of 1ml contains 10mg of peg-r-metHu-GCSF(6 mg/0.6ml) |
| 10 | Reliance Life Sciences | 10/12/2009 | Recombinant Plasminogen Activator (Reteplase) | Acute myocardial infraction and ST segment elevation | 18mg/vial |
| 11 | Reliance Life sciences | 11/13/2009 | (R-Tissue Plasminogen Activator)-Bulk | ||
| 12 | Reliance Biopharmaceuticals | 11/13/2009 | r-human interferon alpha 2b (Bulk) | ||
| 13 | Gennova Biopharmaceuticals Ltd. | 1/29/2010 | peg-r-hu-GCSF | For prevention of neutropenia in the patient receiving cancer chemotherapy | 6mg/0.6ml, pre-filled syringes for injection |
| 14 | Gennova Biopharmaceuticals Ltd. | 3/16/2010 | r-hu-GCSF | cancer patients receiving mmyelosuppressive therapy | each 1ml vial contains 300mcg, 1.6 ml vial contains 480mcg, 1ml PFS contains 150mcg, 05ml PFS contains 300 mcg, 0.8ml PFS contains 480 mcg |
| 15 | Dr. Reddy's Laboratories ltd | 3/23/2010 | Darbepoetin alfa | Tretament of anemia associated with chronic renal failure, including patients on dialysis and patients not on dialysis and for the treatment of anemia in patients with non-myeloid malignancies, where anemia is due to the effect of concomitantly administered chemotherapy | Each 1ml single dose vial contains: 25, 40, 60, 100, 200, 300, 500 mcg. Each 0.75 ml SDV contains: 150 mcg. Each 0.3ml SD-PFS contains: 60, 150 mcg. Each 0.4 ml SD-PFS contains: 40, 200 mcg. Each 0.42 ml SD-PFS contains: 25 mcg. Each 0.5 ml SD-PFS contains: 100 mcg. Each 0.6ml SD-PFS contains: 300 mcg. Each 1.0 ml SD-PFS contains: 500 mcg |
| 16 | Cadila Healthcare Ltd | 4/28/2010 | r-Hu-EPO Lyophilized injection | For maintaining hemoglobin level in chronic renal failure | Each vial contains: 1000IU/2000IU/4000IU/ 10000IU and 40000IU |
| 17 | Virchow Biotech Pvt Ltd | 4/28/2010 | rh-PDGF-BB + β-TCP | For the treatment of preidontal defects (Intrabony Peridontal Defect, Peridontal Defect, Gingival Recession) | Each pack contains: (one cup containing 0.5 cc of β-TCP particles (0.25 to 1.0 mm) and one syringe containing a solution of 0.5ml rh-PDGF-BB (0.3 mg/ml) |
| 18 | Reliance Life Sciences | 4/30/2010 | r-Hu-FSH | For the treatment of female infertlity | 750 IU/ml |
| 19 | Reliance Life Sciences | 4/30/2010 | r-Hu-FSH (Bulk) |