Aurobindo Pharma receives USFDA approval for Bivalirudin Injection

30 Jul 2018 Evaluate

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 $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.

Aurobindo Pharma is engaged in manufacturing pharmaceutical products. It offers active pharmaceutical ingredients, intermediates and generic formulations like astemizole, domeperidone and omeprazole; anti-infective, oral and sterile antibiotics, pain management and osteoporosis segments.

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