Glenmark Pharma gets USFDA nod for generic anti-inflammatory drug

New Delhi: Glenmark Pharmaceuticals on Monday said it has received approval from the US health regulator to sell a generic version of an anti-inflammatory drug in the American market.

The company has received approval from the US Food and Drug Administration (USFDA) for Acetaminophen and Ibuprofen tablets (250 mg/125 mg), the Mumbai-based drug maker said in a statement.

The company's product is the generic version of Haleon US Holdings, LLC's Advil 2 Dual Action with Acetaminophen Tablets, 250 mg/125 mg (OTC), it added.

Glenmark Therapeutics Inc, USA will distribute the drug in the US market, the drug maker said.

According to Nielsen syndicated data for the latest 52-week period ending March 23, 2024, the Advil Dual Action with Acetaminophen Tablets, 250 mg/125 mg achieved annual sales of around USD 84.1 million.

Glenmark said its current portfolio consists of 195 products authorised for distribution in the US marketplace and 52 abbreviated new drug applications (ANDAs) pending approval with the USFDA.

Shares of Glenmark Pharma were trading marginally up at Rs 1,080.45 apiece on the BSE.