Alembic Pharmaceuticals has received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Dapagliflozin Tablets in 5 mg and 10 mg strengths, strengthening its US generics portfolio in the high-value diabetes and cardiovascular therapy segment.

The approved product is the generic equivalent of AstraZeneca’s Farxiga, a widely prescribed SGLT2 inhibitor used to improve glycemic control in adults with type 2 diabetes and reduce the risk of hospitalization for heart failure in patients with established cardiovascular risk factors.

Alembic said it was among the first applicants to file a substantially complete ANDA with a Paragraph IV certification, making the company eligible for 180 days of shared generic drug exclusivity following the approval. The exclusivity window is expected to provide a strategic early-entry advantage in the US market.

According to IQVIA data, Dapagliflozin tablets posted estimated US sales of $10.49 billion for the 12 months ended December 2025, making it one of the most significant recent approvals in Alembic’s US pipeline from a market-value perspective.

With this approval, Alembic’s cumulative USFDA tally has reached 235 ANDA approvals, including 217 final approvals and 18 tentative approvals, underscoring the company’s sustained momentum in regulated markets and complex generics filings.