Lupin Limited has received approval from the U.S. Food and Drug Administration for its Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets in multiple strengths. The product, which is bioequivalent to Xigduo® XR, marks a significant addition to the company’s anti-diabetic portfolio. Additionally, the company secured tentative approval for the 2.5 mg/1,000 mg strength, further expanding its reach in the United States pharmaceutical market.
Key Product Approval
On April 8, 2026, Lupin Limited announced a major regulatory milestone with the U.S. FDA approval for its generic version of Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets. The approved dosages include 5 mg/500 mg, 5 mg/1,000 mg, 10 mg/500 mg, and 10 mg/1,000 mg. This treatment is widely used for patients requiring management of blood glucose levels.
Strategic Expansion in the U.S.
The newly approved tablets are recognized as bioequivalent to the reference product, Xigduo® XR. In addition to the final approvals for the primary dosage strengths, Lupin also received tentative approval for the 2.5 mg/1,000 mg variant. This development reinforces Lupin’s commitment to providing affordable healthcare solutions in the U.S. market, where the company maintains a strong presence across several critical therapeutic areas, including cardiovascular and anti-diabetic segments.
Source: BSE
