Aurobindo Pharma received final USFDA approval to manufacture and market Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets.
The approved product has an estimated market size of US$514 million for the twelve months ending February 2026.
The company is eligible for 180 days of shared generic drug exclusivity as a first ANDA applicant.
Products will be manufactured at Unit-IV of APL Healthcare Limited and launched immediately.