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Dr Reddy’s Laboratories gets USFDA approval for Fondaparinux Sodium Injection

13 Jul 2011 Evaluate

Dr Reddy’s Laboratories has received final approval for its Abbreviated New Drug Application (ANDA) Fondaparinux Sodium Injection, a bioequivalent generic version of Arixtra from the United States Food and Drug Administration (USFDA) in collaboration with Alchemia, Brisben, Australia.

The approval covers 2.5mg/ 0.5mg/ 0.4ml, 7.5mg/0.6ml and 10mg/0.8ml doses of the drug in prefilled color-coded, single-dose syringes with automatic needle safety device. The company will manufacture fondaparinux under license using a patented process developed by Alchemia.

The company’s net profit for the fourth quarter declined by 34.48% at Rs 165.87 crore as compared to Rs 253.16 crore for the corresponding quarter previous year. Its total income increased by 7.11% at Rs 1375.77 crore for the quarter under review from Rs 1284.43 crore in the corresponding previous quarter.

Peers
Company Name CMP
Sun Pharma. Inds. 1789.20
Dr. Reddys Labs. 1198.40
Cipla 1333.10
Lupin 2012.10
Zydus Lifesciences 1143.25
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