Aurobindo Pharma Limited has informed the Exchange regarding a press release dated April 07, 2026, titled "Aurobindo Pharma receives USFDA approval for Dapagliflozin Tablets, 5 mg and 10 mg".
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Aurobindo Pharma has received final USFDA approval to manufacture and market Dapagliflozin Tablets in two strengths (5 mg and 10 mg). The product is bioequivalent and therapeutically equivalent to AstraZeneca's Farxiga. The approved product addresses a market estimated at US$ 10.2 billion (IQVIA MAT for 12 months ending February 2026). Production will be handled by APL Healthcare Limited, the company's wholly owned subsidiary, and the product will be launched immediately. As one of the first ANDA applicants with a paragraph IV certification, Aurobindo is eligible for 180 days of shared generic drug exclusivity. This adds to the company's portfolio of 579 ANDA approvals (554 final and 25 tentative) from USFDA as of March 31, 2026.
The approval opens access to a large US$ 10.2 billion market and the 180-day exclusivity period provides a competitive window to capture generic market share before other generics enter. Immediate launch signals positive revenue contribution potential.