Aurobindo Pharma has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Dapagliflozin Tablets, 5 mg and 10 mg, which is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Farxiga Tablets, 5 mg and 10 mg, of AstraZeneca AB.  Dapagliflozin Tablets are indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type-2 diabetes mellitus. These products will be manufactured at Unit-IV of APL Healthcare, a wholly owned subsidiary of the company and will be launched immediately.

The approved product has an estimated market size of $10.2 billion for the twelve months ending February 2026, according to IQVIA MAT. Aurobindo Pharma has a total of 579 ANDA approvals (554 final approvals and 25 tentative approvals) from USFDA as of 31 March 2026. Aurobindo Pharma being 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, is thus eligible for 180 days of shared generic drug exclusivity. 

Aurobindo Pharma is engaged in manufacturing pharmaceutical products. It offers active pharmaceutical ingredients, intermediates and generic formulations like astemizole, domeperidone and omeprazole; anti-infective, oral and sterile antibiotics, pain management and osteoporosis segments.