Zydus Lifesciences has received tentative approval from the USFDA for Dapagliflozin Tablets, 5 mg and 10 mg. These tablets, a generic version of Farxiga®, are used to improve glycemic control in adults with type 2 diabetes, alongside diet and exercise. The tablets will be manufactured at the group’s Ahmedabad facility.
USFDA Approval for Diabetes Treatment
Zydus Lifesciences Limited has received tentative approval from the United States Food and Drug Administration (USFDA) for its Dapagliflozin Tablets, in strengths of 5 mg and 10 mg. This approval covers a generic version of Farxiga® tablets.
Dapagliflozin Tablets: Usage and Manufacturing
Dapagliflozin is a sodium-glucose cotransporter 2 (SGLT2) inhibitor. It is prescribed as an adjunct to diet and exercise to improve glycaemic control in adults who have type 2 diabetes mellitus. The manufacturing of these tablets will take place at the group’s formulation manufacturing facility located in Ahmedabad, within a Special Economic Zone (SEZ).
Market Data
As per December 2025 data, Dapagliflozin tablets had annual sales of USD 10,486.9 million in the United States, according to IQVIA MAT data.
Zydus’s ANDA Filings
As of December 31, 2025, the Zydus group has 430 approvals and has filed 505* ANDAs since the commencement of the filing process in Fiscal Year 2003-04.
Source: BSE
