Receipt of USFDA approval for Dapagliflozin and Metformin Hydrochloride - Aurobindo Pharma Ltd

Code BSE: 524804 NSE:

The Company in connection receipt of USFDA approval for Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets, 5 mg/ 500 mg, 5 mg/1000 mg, 10 mg/500 mg, and 10 mg/1000 mg. The approved product has an estimated market size of US$ 514 Million 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.