Aurobindo Pharma has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Dapagliflozin tablets in 5 mg and 10 mg strengths. This medication, used as an adjunct to diet and exercise for type-2 diabetes mellitus, targets an estimated market size of US$ 10.2 billion. The product will be manufactured at the company’s Unit-IV facility and is set for immediate commercial launch.
Strategic Product Approval
Aurobindo Pharma Limited has secured a significant regulatory milestone with the final USFDA approval for Dapagliflozin tablets (5 mg and 10 mg). These tablets serve as a bioequivalent and therapeutically equivalent alternative to the reference listed drug, Farxiga, developed by AstraZeneca AB. This approval marks an important expansion for the company’s portfolio in the anti-diabetic therapeutic category.
Market Opportunity and Manufacturing
The approved product addresses a substantial market opportunity, with an estimated size of US$ 10.2 billion for the twelve months ending February 2026. Manufacturing of the tablets will take place at Unit-IV of APL Healthcare Limited, a wholly-owned subsidiary of the company. Aurobindo has confirmed that the product will be launched in the market immediately following this approval.
Exclusivity and Portfolio Strength
As one of the first applicants to submit a substantially complete Abbreviated New Drug Application (ANDA) with a Paragraph IV certification, Aurobindo Pharma is eligible for 180 days of shared generic drug exclusivity. This achievement adds to the company’s strong regulatory track record, which reached a total of 579 ANDA approvals as of March 31, 2026, further solidifying its presence in global pharmaceutical markets.
Source: BSE
