Zydus Lifesciences Secures USFDA Approval for Glyxambi Generic

Zydus Lifesciences has obtained a provisional license from the U.S. Food and Drug Administration on Empagliflozin and Linagliptin pills.

This is a milestone in the U.S. expanding portfolio of the company. It reports about the generic Glyxambi tablets, a popular medication to treat type 2 diabetes.

This clearance gives Zydus an upper hand in the competitive diabetes care market, whereby there is an increasing demand of trustworthy and cost-effective therapies.

Also Read: Creating a patient-centric healthcare ecosystem for all

The combination therapy is indicated in the form of an addition to diet and exercise to allow adults with type 2 diabetes to achieve a better glycaemic control. Zydus will produce the tablets at its formulation plant in the SEZ in Ahmedabad, which will strengthen India as a major supplier of generic drugs in the world. These tablets have been reported to have USD 215.8 million sales on the U.S. market alone every year and are of significance in the commercial world, as shown by IQVIA MAT September 2025.

This action has now seen Zydus Lifesciences having a total of 428 approvals and having already filed 487 ANDAs since it embarked on the process of filing approvals in FY 2003-04. The firm is still directed toward its mission of offering high-quality and affordable healthcare solutions. Supported by more than 27,000 employees, the group has a high level of innovation in its operations worldwide.

To the momentum, the company has reported a consolidated net profit growth of 38.12 percent and consolidated net profit stood at Rs 1258.60 crore in Q2 FY26, as compared to 911.2 crore in the same period at the end of last year. The operations revenue also increased by 18.07 per cent year-on-year to Rs 6,037.9 crore, which highlights its continuous growth in major markets.