Aurobindo Pharma today said it has received approval from the US health regulator to manufacture and market Bivalirudin injection, an anticoagulant medication, in the American market.
The company has received final approval from the US Food and Drug Administration (USFDA) for its product which is a generic version of The Medicines Company's Angiomax injection, the Hyderabad-based firm said in a statement.
The product will be launched in September 2018, it added.
According to IQVIA, the estimated market size for Bivalirudin injection stood at USD 101 million for the 12 months ending May 2018.
Aurobindo now has a total of 381 abbreviated new drug application (ANDA) approvals from the USFDA.
Shares of the company were trading 2.25 per cent higher at Rs 604.50 on the BSE.
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