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

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

Aurobindo Pharma Limited announced the receipt of final approval from the US Food & Drug Administration (USFDA) for the manufacture and marketing of Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets. The approved strengths are 5 mg/ 500 mg, 5 mg/1000 mg, 10 mg/500 mg, and 10 mg/1000 mg.

These products are reported to be bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Xigduo XR Tablets, with strengths 5 mg/ 500 mg, 5 mg/1000 mg, 10 mg/500 mg, and 10 mg/1000 mg, manufactured by AstraZeneca AB.

The company stated that the approved drugs will be manufactured at Unit-IV of APL Healthcare Limited, a wholly owned subsidiary of Aurobindo Pharma Limited, and will be launched immediately.

The approved product category has an estimated market size of US$ 514 Million for the twelve months ending February 2026, according to IQVIA MAT.

Aurobindo Pharma Limited, which was one of the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification for these specific tablets, is consequently 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.

As of 31 March 2026, Aurobindo Pharma reported having a total of 579 ANDA approvals, comprising 554 final approvals and 25 tentative approvals, from the USFDA.

Aurobindo Pharma Limited is an integrated global pharmaceutical company headquartered in Hyderabad, India. The company develops, manufactures, and commercializes a range of generic pharmaceuticals, branded specialty pharmaceuticals, and active pharmaceutical ingredients globally in over 150 countries.

The company operates over 30 manufacturing and packaging facilities that have received approvals from major regulatory agencies, including USFDA, UK MHRA, EDQM, Japan PMDA, WHO, Health Canada, South Africa MCC, and Brazil ANVISA. Aurobindo Pharma’s product portfolio spans seven therapeutic areas: CNS, Anti-Retroviral, CVS, Antibiotics, Gastroenterological, Anti-Diabetics, and AntiAllergic, supported by its R&D capabilities.

For reference, Aurobindo Pharma is listed on the NSE under the code AUROPHARMA and on the BSE under the code 524804.

AUROPHARMA Stock Price Movement​

Shares of Aurobindo Pharma Limited slipped by 0.78% today, settling at ₹1330 in post-market trading. The stock traded on a volume of 1.56 million shares, following a run that saw the equity touch its 52-week high of ₹1359.9.

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