Aurobindo Pharma has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Bivalirudin injection, 250 mg/vial.

The approved ANDA is a generic equivalent to the reference listed drug (RLD) product Angiomax Injection of The Medicines Company.

The estimated market size of Bivalirudin injection is USD 101 million for the twelve months ended May 2018 according to IQVIA. The product will be launched in September 2018.

This is the 53rd ANDA (including 1 tentative approval) to be approved out of Unit IV formulation facility in Hyderabad, India used for manufacturing general injectable & ophthalmic products. Aurobindo now has a total of 381 ANDA approvals (348 Final approvals including 17 from Aurolife Pharma LLC and 33 tentative approvals) from USFDA.

Shares of the company gained Rs 12.5, or 2.11%, to trade at Rs 603.70. The total volume of shares traded was 57,127 at the BSE (11.36 a.m., Monday).