Mumbai, April 9 -- 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 pharmaceut...