Aurobindo Pharma Receives USFDA Approval for Dapagliflozin Tablets, 5 mg and 10 mg
Aurobindo Pharma Limited has announced that it has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Dapagliflozin Tablets, 5 mg and 10 mg. The approved drug is stated to be bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Farxiga Tablets, 5 mg and 10 mg, manufactured by AstraZeneca AB.These products will be manufactured at Unit-IV of APL Healthcare Limited, a wholly owned subsidiary of the Company, and are scheduled for immediate launch.
The market potential for the approved product is significant, with an estimated market size of US$ 10.2 billion for the twelve months ending February 2026, according to IQVIA MAT data.
Aurobindo Pharma has a substantial track record with the USFDA, holding a total of 579 ANDA approvals as of 31 March 2026, comprising 554 final approvals and 25 tentative approvals. The company notes that its status as one of the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification for Dapagliflozin Tablets, 5 mg and 10 mg, makes it eligible for 180 days of shared generic drug exclusivity.
Dapagliflozin Tablets are indicated for use as an adjunct to diet and exercise to improve glycaemic control in adults with type-2 diabetes mellitus.
Aurobindo Pharma Limited is headquartered in Hyderabad, India, and operates as an integrated global pharmaceutical company. The firm develops, manufactures, and commercializes a range of generic pharmaceuticals, branded specialty pharmaceuticals, and active pharmaceutical ingredients across more than 150 countries.
The company maintains a robust presence with over 30 manufacturing and packaging facilities that have received approvals from leading regulatory agencies. The portfolio is spread across seven major therapeutic areas, including CNS, Anti-Retroviral, CVS, Antibiotics, Gastroenterological, Anti-Diabetics, and AntiAllergic.
The operational details regarding the company's USFDA approvals and product reach can be summarized as follows:
| Metric | Detail |
|---|---|
| Total ANDA Approvals (as of 31 March 2026) | 579 |
| Final Approvals | 554 |
| Tentative Approvals | 25 |
| Estimated Market Size (12 months ending Feb 2026) | US$ 10.2 billion |
For further corporate details, Aurobindo Pharma Limited can be reached via its corporate channels.
AUROPHARMA Stock Price Movement
Shares of Aurobindo Pharma Limited slipped today by 0.78% to settle at ₹1330 in post-market trading. The stock saw 1.56 million shares transact, following a session where it previously touched its 52-week high near ₹1359.9.Source:
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