Zydus Lifesciences Limited has secured a tentative approval from the United States Food and Drug Administration (USFDA) for its Empagliflozin and Linagliptin Tablets in the 10 mg/5 mg and 25 mg/5 mg strengths. These tablets are the generic equivalent of Glyxambi® and are used as an add-on therapy to diet and exercise for adults with type 2 diabetes mellitus who require treatment with both empagliflozin and linagliptin.
The approved products will be manufactured at the company’s state-of-the-art formulation facility located in the SEZ at Ahmedabad. According to IQVIA data for the twelve months ending September 2025, the combination therapy recorded annual sales of USD 215.8 million in the US market, indicating a strong commercial opportunity once final approval is granted.
With this development, Zydus continues to strengthen its position in the US generics segment. The company now holds 428 approvals and has filed 487 ANDAs since it began its filing journey in FY 2003–04, underscoring its long-term commitment to expanding its global pharmaceutical portfolio.
