The approved drug is therapeutically equivalent to AstraZeneca’s reference listed drug (RLD), Farxiga. Dapagliflozin is a sodium-glucose cotransporter 2 (SGLT2) inhibitor used to reduce the risk of hospitalization for heart failure in adults with type 2 diabetes and to improve glycaemic control.

Alembic said it was among the first applicants to file a substantially complete ANDA with a paragraph IV certification for the drug, making it eligible for 180 days of shared generic drug exclusivity.

According to IQVIA, the Dapagliflozin tablets market had an estimated size of $10.49 billion for the 12 months ended December 2025.

The company now has a cumulative total of 235 ANDA approvals from the USFDA, including 217 final approvals and 18 tentative approvals.

Alembic Pharmaceuticals, a vertically integrated research and development company, is engaged in the manufacture and marketing of generic pharmaceutical products across global markets. The company’s consolidated net profit fell 3.9% to Rs 132.97 crore despite a 10.8% jump in net sales to Rs 1,876.31 crore in Q3 FY26 over Q3 FY25.