Dr. Reddys Laboratories Ltd.

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.