Aurobindo Pharma Gains USFDA Approval for Dapagliflozin Tablets
Filing Summary
Aurobindo Pharma Limited has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Dapagliflozin Tablets in 5 mg and 10 mg doses. These tablets are bioequivalent to AstraZeneca’s Farxiga Tablets. The product will be manufactured at Aurobindo’s Unit-IV facility and launched immediately. The market size for this product is estimated at USD 10.2 billion for the twelve months ending February 2026. Aurobindo holds 579 ANDA approvals from the USFDA, including 554 final and 25 tentative approvals, as of March 31, 2026.
Aurobindo Pharma Limited has announced the receipt of final approval from the US Food & Drug Administration (USFDA) for the manufacture and marketing of Dapagliflozin Tablets in 5 mg and 10 mg doses. These tablets are bioequivalent and therapeutically equivalent to the reference listed drug, Farxiga Tablets, produced by AstraZeneca AB. The approval allows Aurobindo to proceed with the immediate launch of the product.
The approved Dapagliflozin Tablets have an estimated market size of USD 10.2 billion for the twelve months ending February 2026, according to IQVIA MAT. Aurobindo Pharma has accumulated a total of 579 Abbreviated New Drug Application (ANDA) approvals from the USFDA, which includes 554 final approvals and 25 tentative approvals as of March 31, 2026. The company is one of the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification for these tablets, making it eligible for 180 days of shared generic drug exclusivity.
The Dapagliflozin Tablets will be manufactured at Unit-IV of APL Healthcare Limited, a wholly-owned subsidiary of Aurobindo Pharma. The tablets are indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type-2 diabetes mellitus. The immediate launch of this product is planned following the approval.
Aurobindo Pharma’s approval for Dapagliflozin Tablets adds to its extensive portfolio of generic pharmaceuticals. The company operates over 30 manufacturing and packaging facilities, which are approved by leading regulatory agencies, including the USFDA, UK MHRA, EDQM, Japan PMDA, WHO, Health Canada, South Africa MCC, and Brazil ANVISA. Aurobindo’s product portfolio spans seven major therapeutic areas, including CNS, Anti-Retroviral, CVS, Antibiotics, Gastroenterological, Anti-Diabetics, and Anti-Allergic.
The timeline for the product’s market entry is immediate, following the USFDA approval. The manufacturing will take place at Aurobindo’s Unit-IV facility, which is part of APL Healthcare Limited. The company has strategically positioned itself to capitalize on the market potential of Dapagliflozin Tablets through its established manufacturing capabilities and regulatory approvals.
Aurobindo Pharma Limited is a global pharmaceutical company headquartered in Hyderabad, India. It develops, manufactures, and commercializes a wide range of generic pharmaceuticals, branded specialty pharmaceuticals, and active pharmaceutical ingredients. The company operates in over 150 countries and focuses on expanding its product portfolio across various therapeutic areas supported by a strong research and development setup.