Aurobindo Pharma gets USFDA nod for Amlodipine, Benazepril Capsules

Aurobindo Pharma has received final approvals from the US Food & Drug Administration (USFDA) to manufacture and market Amlodipine Besylate and Benazepril Hydrochloride Capsules 2.5mg/10mg, 5mg/20mg, 5mg/40mg, 10mg/20mg, and 10mg/40mg (ANDA 202239). The products are ready for launch.

Amlodipine Besylate and Benazepril Hydrochloride Capsules are the generic bioequivalent to the reference listed drug Lotrel Capsules of Norvatis Pharmaceutical Corp. According to IMS, the annual sales of Amlodipine Besylate and Benazepril Hydrochloride Capsules is about $500 million for the twelve months ending March 2012.

The products have been approved out of Unit VII (SEZ) formulations facility in Hyderabad, India. The company now has a total of 158 ANDA approvals - 133 final approvals including 1 from Aurolife Pharma LLC and 25 tentative approvals from USFDA.

Aurobindo Pharma has a product presence in key therapeutic segments like SSPs, cephalosporins, antivirals, CNS, cardio-vascular, gastroenterology, etc. The company is the market leader in semi-synthetic penicillin drugs.