Lupin gets USFDA’s nod for Dapagliflozin and Metformin Hydrochloride Tablets

08 Apr 2026 Evaluate

Lupin has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application for Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets, 5 mg/500 mg, 5 mg/1,000 mg, 10 mg/500 mg, 10 mg/1,000 mg. The company also received tentative approval for Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets, 2.5 mg/1,000 mg. 

The USFDA has approved the company’s Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets as bioequivalent to Xigduo XR for the indications in the approved labeling.

Lupin is an innovation led transnational pharmaceutical company producing, developing and marketing a wide range of branded and generic formulations, biotechnology products and active pharmaceutical ingredients (APIs) globally.

Lupin Share Price

2293.55 -3.05 (-0.13%)
08-Apr-2026 16:59 View Price Chart
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