The approval covers multiple strengths, including 5 mg/500 mg, 5 mg/1,000 mg, 10 mg/500 mg, and 10 mg/1,000 mg, as per the company’s regulatory filing dated April 8.

The company has also received tentative approval for Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets (2.5 mg/1,000 mg). The approved product is bioequivalent to Xigduo XR and will be used for the same indications as per the approved label.

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 0.35% to Rs 2,285.60 on the BSE.