Lupin gets USFDA nod for diabetes drug tablets, boosting presence in key US market

Drugmaker Lupin Ltd on Wednesday, April 8, said it has received approval from the US Food and Drug Administration for its Dapagliflozin and Metformin Hydrochloride extended-release tablets in multiple strengths in the United States.

The approval covers tablets in 5 mg/500 mg, 5 mg/1,000 mg, 10 mg/500 mg and 10 mg/1,000 mg strengths, while a 2.5 mg/1,000 mg variant has received tentative approval.

The approved product is bioequivalent to Xigduo XR and will be used for the same indications as per the approved label,

the company said. The development strengthens Lupin’s presence in the US market in the anti-diabetic segment.

Separately, Lupin earlier this month said its Netherlands-based subsidiary Nanomi BV will acquire an additional 43.38% stake in Multicare Pharmaceuticals Philippines Inc. (MPPI) for up to $39.6 million. Nanomi already holds a 56.28% stake in MPPI, and the transaction is aimed at increasing control and deepening integration of the Philippines business.

The company said the acquisition will help strengthen its market position in the Philippines, while providing strategic flexibility to streamline emerging-market operations and drive long-term growth.

Shares of Lupin Ltd ended marginally lower on Wednesday, April 8, by 0.18% at ₹2,294.10 on the NSE.

Also Read: Manappuram Finance reports insider trading code violation after director's PMS share trade