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Aurobindo Pharma gets final nod for Dapagliflozin, Metformin Hydrochloride Extended-Release Tablets

08 Apr 2026 Evaluate

Aurobindo Pharma has received final approval from 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. 

The approved product has an estimated market size of $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 March 31, 2026.

Aurobindo Pharma, 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.

Aurobindo Pharma is engaged in manufacturing pharmaceutical products. It offers active pharmaceutical ingredients, intermediates and generic formulations like astemizole, domeperidone and omeprazole; anti-infective, oral and sterile antibiotics, pain management and osteoporosis segments.

Aurobindo Pharma Share Price

1385.65 -0.45 (-0.03%)
17-Apr-2026 16:59 View Price Chart
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