Wedoany.com Report-Dec.1, Zydus Lifesciences has received tentative approval from the United States Food and Drug Administration (US FDA) for Empagliflozin and Linagliptin Tablets.

The approved abbreviated new drug application (ANDA) is the generic equivalent of Glyxambi Tablets, the reference listed drug in the United States. The combination medication is indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus when treatment with both empagliflozin and linagliptin is appropriate.

The product will be manufactured at the company's formulation facility located in the Special Economic Zone (SEZ) at Ahmedabad, India.

According to IQVIA data (MAT September 2025), Empagliflozin and Linagliptin Tablets recorded annual sales of USD 215.8 million in the United States market.

With this approval, Zydus has now secured 428 ANDA approvals from the US FDA. Since starting the filing process in FY 2003-04, the group has submitted a total of 487 ANDAs.

Zydus Lifesciences continues to expand its portfolio of affordable generic medications for diabetes management and other therapeutic areas, supporting broader access to essential treatments.

In its latest financial performance, the company reported strong growth for the second quarter of FY26. Consolidated net profit rose 38.12% year-on-year to Rs 1,258.60 crore, compared with Rs 911.2 crore in the same quarter of the previous year. Revenue from operations increased 18.07% to Rs 6,037.9 crore during the period.

The results reflect sustained demand for the company's pharmaceutical products across domestic and international markets, as well as operational efficiency in manufacturing and supply chain management.

Zydus remains committed to its mission of delivering quality healthcare solutions that enable people to lead healthier lives. The company employs more than 27,000 people globally and focuses on innovation across the entire value chain—from research and development to manufacturing and marketing of a wide range of therapies.

The tentative approval for Empagliflozin and Linagliptin Tablets marks another step in Zydus Lifesciences' strategy to strengthen its presence in the large and growing U.S. generics market, particularly in chronic disease segments such as diabetes care. Final approval will allow commercial launch of the product, offering patients a cost-effective treatment option.