Alembic Pharmaceuticals Gains USFDA Approval for Dapagliflozin Tablets

Alembic Pharmaceuticals Limited has announced the receipt of final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Dapagliflozin Tablets, 5 mg and 10 mg. The approval confirms that these tablets are therapeutically equivalent to the reference listed drug product, Farxiga Tablets, 5 mg and 10 mg, of AstraZeneca AB.

The Dapagliflozin Tablets are 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. Additionally, they are used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Alembic was among the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification for these tablets, making it eligible for 180 days of shared generic drug exclusivity.

The estimated market size for Dapagliflozin tablets is approximately USD 10,487 million for the twelve months ending December 2025, according to IQVIA. This approval adds to Alembic’s cumulative total of 235 ANDA approvals from the USFDA, which includes 217 final approvals and 18 tentative approvals.

Alembic Pharmaceuticals Limited is a vertically integrated research and development pharmaceutical company engaged in the manufacture and marketing of generic pharmaceutical products globally. The company has been a leader in healthcare since 1907 and is recognized for its branded generics in India. Alembic’s research and manufacturing facilities are approved by regulatory authorities in many developed countries, including the USFDA.