Zydus Lifesciences Limited, along with its subsidiaries and affiliates, has received tentative approval from the United States Food and Drug Administration (USFDA) for Dapagliflozin Tablets in 5 mg and 10 mg strengths. The reference listed drug for this approval is Farxiga® Tablets, a widely prescribed therapy in the United States for the management of type 2 diabetes.
Dapagliflozin belongs to the SGLT2 inhibitor class of medicines and is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus. The drug has also gained strong physician acceptance due to its additional benefits in diabetes-related cardiovascular and renal outcomes, making it a key product in the US anti-diabetic market.
The approved Dapagliflozin tablets will be manufactured at Zydus’ formulation manufacturing facility located at SEZ, Ahmedabad, reinforcing the group’s strong manufacturing and regulatory compliance capabilities for regulated markets such as the United States.
From a market opportunity perspective, Dapagliflozin is a high-value product. As per IQVIA MAT December 2025, the drug recorded annual sales of USD 10,486.9 million in the United States, highlighting the significant revenue potential once final approval and commercialisation are achieved.
With this latest development, Zydus continues to scale its US generics business. The group now has 430 USFDA approvals and has filed a cumulative 505 ANDAs since the commencement of its ANDA filing process in FY 2003–04, underscoring its long-term focus on the US generics and specialty pharmaceuticals market.
