Zydus Life gets US FDA nod for generic version of antidiabetic combination drug Glyxambi

Zydus Lifesciences said that it has received tentative approval from the United States Food and Drug Administration (US FDA) for Empagliflozin and Linagliptin Tablets.

The approved ANDA is a generic version of the US reference listed drug Glyxambi Tablets.

Empagliflozin and Linagliptin Tablets, in a combination, are indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both empagliflozin and linagliptin is appropriate.

Empagliflozin and Linagliptin Tablets will be produced at the groups formulation manufacturing facility at SEZ, Ahmedabad.

Empagliflozin and Linagliptin Tablets had annual sales of USD 215.8 mn in the United States (IQVIA MAT Sept-2025).

The group now has 428 approvals and has so far filed 487 ANDAs since the commencement of the filing process in FY 2003-04.

The Zydus Group with an overarching purpose of empowering people with freedom to live healthier and more fulfilled lives, is an innovative, global life-sciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The group employs over 27000 people worldwide and is driven by its mission to unlock new possibilities in lifesciences through quality healthcare solutions that impact lives.

Zydus Lifesciences reported a 38.12% jump in consolidated net profit to Rs 1,258.60 crore in Q2 FY26, compared with Rs 911.2 crore posted in Q2 FY25. Revenue from operations increased 18.07% year on year (YoY) to Rs 6,037.9 crore in Q2 FY26.

The scrip rose 0.54% to currently trade at Rs 942.35 on the BSE.

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