Aurobindo Pharma receives USFDA approval for Dapagliflozin and Metformin Hydrochloride XR Tablets
(20:10, 07 Apr 2026)
Aurobindo Pharma announced that the final approval is received from the US Food & Drug Administration (USFDA) to manufacture and market Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets, 5 mg/ 500 mg, 5 mg/1000 mg, 10 mg/500 mg, and 10 mg/1000 mg, which is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Xigduo XR Tablets, 5 mg/ 500 mg, 5 mg/1000 mg, 10 mg/500 mg, and 10 mg/1000 mg, of AstraZeneca AB. These products will be manufactured at Unit-IV of APL Healthcare, a wholly owned subsidiary of the Company and will be launched immediately.