Aurobindo Pharma Limited has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets in various strengths. This approval allows the company to produce tablets that are bioequivalent and therapeutically equivalent to the reference drug Xigduo XR, developed by AstraZeneca AB.
The approved tablets, which will be manufactured at Unit-IV of APL Healthcare Limited, a wholly owned subsidiary of Aurobindo Pharma, are set to be launched immediately. The product targets a significant market, with an estimated size of $514 million for the twelve months ending February 2026, according to IQVIA MAT.
Aurobindo Pharma has now secured a total of 579 Abbreviated New Drug Application (ANDA) approvals from the USFDA, comprising 554 final approvals and 25 tentative approvals as of 31 March 2026. The company is one of the first ANDA applicants to submit a substantially complete application with a paragraph IV certification for the Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets, making it eligible for 180 days of shared generic drug exclusivity.
The 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 Limited is a global pharmaceutical company headquartered in Hyderabad, India, with a presence in over 150 countries. The company develops, manufactures, and commercialises a wide range of generic pharmaceuticals and active pharmaceutical ingredients. It operates more than 30 manufacturing and packaging facilities approved by leading regulatory agencies worldwide.
Disclaimer: This article is based on a regulatory filing submitted to the National Stock Exchange of India (NSE).