Alembic Pharmaceuticals has secured final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Dapagliflozin Tablets, 5 mg and 10 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Farxiga Tablets, 5 mg and 10 mg, of AstraZeneca AB (AstraZeneca). Dapagliflozin tablet is a sodium-glucose cotransporter 2 (SGLT2) inhibitor indicated to reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established cardiovascular disease or multiple cardiovascular risk factors. It is also indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

The company was one of the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification for Dapagliflozin Tablets, 5 mg and 10 mg. Therefore, with this approval, the company is eligible for 180 days of shared generic drug exclusivity. The company has a cumulative total of 235 ANDA approvals (217 final approvals and 18 tentative approvals) from USFDA.

Alembic Pharmaceuticals is involved in manufacturing and marketing of India Formulations, International Generics, and Active Pharmaceutical Ingredients with vertical integration capabilities.