(Form-45) Import 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 Taksal 1/7/2009 Tocilizumab Rheumatoid Arthritis 4, 10, 20 ml/vial
2 Sandor medicadis 3/4/2009 Fabrazyme (Agalsidase beta) Treatment of long term enzyme therapy in patients with a confirmed diagnisis of Fabry disease (Alpha-galactosidase A deficiency) 37.0mg/vial
3 Merck 4/22/2009 R-hu-INF beta-1a (Rebif) treatment of  relapsing multiple seleresis 0.5ml pre-filled syringe
4 Baxter 4/1/2009 anti Haemophilic factor    
5 Merck Specialiteis Pvt Ltd 4/22/2009 r-DNA Hu-Somatropin Hormone Growth deficiency associated with proven insufficient secretion of endogenous growth hormone 1.33mg/3.33mg
6 Merck Specilities 4/1/2009 Follitropin alfa (r-hu-FSH) treatment of female infertility 300IU/0.5ml, 450IU/0.75ml, 900IU/1.5ml
7 Merck Specilities 4/22/2009 Hu-somatropin hormone Growth deficiency associated with proven insufficient secretion of endogenous growth hormoe 1.33mg and 3.33mg
8 Merck Specilities 4/1/2009 r-hu-chorionic gonadotropin hormone (ovitrelle)    
9 Claris 5/29/2009 GCSF Increase neutrophilic count after bonemarrow transplantation, neutro-philic granulocytopenia reduced by chemotherpay of cancers inducing maligna-nt lymphoma, embryonic cell tumor, neuroblastoma. Each PFS contains 300mcg/0.9ml
10 Gufic lifesciences 5/29/2009 GCSF Increase neutrophilic count after bonemarrow transplantation, neutro-philic granulocytopenia reduced by chemotherpay of cancers inducing maligna-nt lymphoma, embryonic cell tumor, neuroblastoma. Each PFS contains 300mcg/0.9ml
11 Eli Lilly 5/20/2009 Insulin lispro diabeteic Mellitus  
12 Novo Nordisk 5/14/2009 Soluble Insulin Injection I.P. for the treatment of patients with diabeteic Mellitus each 3ml cartridges contains 100 IU/ ml
13 Novo Nordisk 5/14/2009 Biphasic Isophane Insulin Injection for the treatment of patients with diabeteic Mellitus each 3ml cartridges contains 100 IU/ ml
14 Novo Nordisk 5/14/2009 Isophane Insulin Injection for the treatment of patients with diabeteic Mellitus each 3ml cartridges contains 100 IU/ ml
15 Novo Nordisk 5/14/2009 Insulin Aspart for the treatment of patients with diabeteic Mellitus each 3ml cartridges contains 100 IU/ ml
16 Sandor Medicaids 6/1/2009 Cerezyme Long-term enzyme replacement therapy in patients with non-neurological gaucher disease 200, 400 units/vial
17 Chandra Bhagat pharma Ltd 7/21/2009 R-Hu-GCSF Injection Increase of neutrophilic count after bonemarrow transplantation, neutro-philic granulocytopenia reduced by chemotherpay of cancers inducing maligna-nt lymphoma, embryonic cell tumor, neuroblastoma. Each PFS contains 300mcg/0.9ml
18 KSR phramacy 7/10/2009 GCSF Increase neutrophilic count after bonemarrow transplantation, neutro-philic granulocytopenia reduced by chemotherpay of cancers inducing maligna-nt lymphoma, embryonic cell tumor, neuroblastoma. Each PFS contains 300mcg/0.9ml
19 VHB life sciences 8/4/2009 R-Hu-GCSF Injection Increase oneutrophilic count after bonemarrow transplantation, neutro-philic granulocytopenia reduced by chemotherpay of cancers inducing maligna-nt lymphoma, embryonic cell tumor, neuroblastoma. Each PFS contains 300mcg/0.9ml
20 USV Ltd 9/2/2009 R-Hu-GCSF Injection Increase oneutrophilic count after bonemarrow transplantation, neutro-philic granulocytopenia reduced by chemotherpay of cancers inducing maligna-nt lymphoma, embryonic cell tumor, neuroblastoma. 75mcg/0.30ml, 150mcgmcg/0.60ml & 300mcg/0.90ml
21 Trigenesis Life Sciences 9/8/2009 R-Hu-GCSF Injection Increase neutrophilic count after bonemarrow transplantation, neutro-philic granulocytopenia reduced by chemotherpay of cancers inducing maligna-nt lymphoma, embryonic cell tumor, neuroblastoma. 75mcg/0.30ml, 150mcgmcg/0.60ml & 300mcg/0.90ml
22 Sanofi Synthelabo Ltd 12/22/2009 Rasburicase  Treatment and prophylaxis of acute hyperuricaemia, in order to prevent acute renal failure in patients with haematological malignancy with a tumor burden and at a risk of a rapid tumor lysis or shrinkage at initiation of chemotherapy 1.5mg/ml, 7.5mg/ml powder and solvent for solution for infusion
23 Novo Nordisk India Pvt Ltd 2/8/2010 Liraglutide Treatment of type-II Diabetes Mellitus Each PFS contains 18mg/3ml
24 VHB Medisciences Ltd 3/4/2010 r-hu-GCSF-injection Increase of neutrophilic count after bonemarrow transplantation, neutro-philic granulocytopenia reduced by chemotherpay of cancers inducing maligna-nt lymphoma, embryonic cell tumor, neuroblastoma. 300mcg/0.9ml
25 Ferring Pharmaceuticals 4/4/2010 r-Hu-Growth Hormone (Somatropin) Long term treatment of children who have growth failure due to inadequate secretion of growth hormone and for the long-term treatment of growth retardation due to Turner's syndrome Each vial contains 4 mg (12 IU)
26 Sandor Medicaids Pvt Ltd 5/13/2010 Aldurazyme (Laronidase) Patients with Hurler and Hurler-Scheie forms of Mucopolysaccharidosis I (MPS) and for Patients with Scheie form who have moderate to severe symptoms Laronidase-----2.9 mg
27 Biogen Idec Biotech India Pvt Ltd 5/28/2010 Natalizumab For the treatment of relapsing forms of Multiple Scheloris (MS) Each vial of 15 ml contains: natalizumab--300mg
28 Bioviz technologies Pvt Ltd 6/14/2010 r-hu-GCSF-injection For decreasing severity of chemotherapy induced neutropenia. Cancer patients receiving Myelosuppresice chemotherapy Each PFS contains:   r-Hu- GCSF-75mcg/0.3ml, 150mcg/0.6ml and 300mcg/0.9ml
29 Bioviz Technologies Pvt Ltd 6/14/2010 r-Hu-EPO For the treatment of anemia due to chronic renal failure. Each pre-filled syringe of 1ml contains: r-Hu-EPO-2,000 /4,000 IU
30 Scigen Biopharma Pvt Ltd 6/18/2010 R-Hu-Growth Hormone  Injection Long-term treatment of children who have growth failure associated due to endogenous growth hormone and for treatment of short stature in children with Turner's syndrome confirmed by chromosomal analysis Powder for injection. Each vial after reconstitution contains 5.8 mg (17.41 IU); solution for injection. Each cartridge of 1.5ml contains 5mg (15 IU) and 10 mg (30 IU)
31 Bioviz Technologies Pvt Ltd 6/14/2010 r-hu-EPO (Bulk)