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Lupin launches generic Dapagliflozin tablets in US after FDA nod

13-Apr-2026 | 10:11
Lupin announced the launch of Dapagliflozin Tablets in strengths of 5 mg and 10 mg in the United States, following approval of its abbreviated new drug application (ANDA) by the U.S. Food and Drug Administration.

The company?s product is a bioequivalent version of Farxiga and will be marketed for indications as per the approved labeling.

Dapagliflozin is indicated for the treatment of conditions including Type 2 Diabetes and certain cardiovascular and renal disorders.

The launch marks Lupin?s continued expansion in the US generics market and strengthens its presence in the oral anti-diabetic segment.

Lupin is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. It specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients.

The pharmaceutical company reported a 37.46% surge in consolidated net profit to Rs 1,175.55 crore in Q3 FY26 as against Rs 855.16 crore posted in Q3 FY25. Total revenue from operations jumped 24.26% year-on-year to Rs 7,167.52 crore in the quarter ended 31 December 2025.

Shares of Lupin shed 0.88% to currently trade at Rs 2,312.10 on the BSE.

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