Aurobindo Pharma 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. These tablets are bioequivalent and therapeutically equivalent to the reference listed drug, Farxiga Tablets, 5 mg and 10 mg, produced by AstraZeneca AB.
The Dapagliflozin Tablets will be produced at Unit-IV of APL Healthcare Limited, a wholly owned subsidiary of Aurobindo Pharma. The company plans to launch the product immediately. According to IQVIA MAT, the approved product has an estimated market size of US$ 10.2 billion for the twelve months ending February 2026.
Aurobindo Pharma has a robust portfolio with a total of 579 ANDA approvals from the USFDA as of 31 March 2026, comprising 554 final approvals and 25 tentative approvals. The company is one of the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification for Dapagliflozin Tablets, making it eligible for 180 days of shared generic drug exclusivity.
Dapagliflozin Tablets are indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type-2 diabetes mellitus.
Aurobindo Pharma Limited is a global pharmaceutical company headquartered in Hyderabad, India, with operations in over 150 countries. The company develops, manufactures, and commercialises a wide range of generic pharmaceuticals, branded specialty pharmaceuticals, and active pharmaceutical ingredients.
Disclaimer: This article is based on a regulatory filing submitted to the National Stock Exchange of India (NSE).