Aurobindo Pharma receives USFDA Approval for Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets

Aurobindo Pharma Limited is pleased to announce 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 Limited, a wholly owned subsidiary of the Company and will be launched immediately.

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.

Aurobindo Pharma Limited, being one of the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification 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, is thus eligible for 180 days of shared generic drug exclusivity.

Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets are indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type-2 diabetes mellitus when treatment with both dapagliflozin and metformin is appropriate.

Shares of Aurobindo Pharma Limited was last trading in BSE at Rs. 1329.60 as compared to the previous close of Rs. 1339.80. The total number of shares traded during the day was 37775 in over 3596 trades.

The stock hit an intraday high of Rs. 1357.00 and intraday low of 1316.10. The net turnover during the day was Rs. 50609577.00.

Source : Equity Bulls

Keywords

AurobindoPharma INE406A01037 Pharmaceuticals USFDA Approval Dapagliflozin MetforminHydrochloride ExtendedRelease Tablets