Glenmark gets ANDA approval for Acetaminophen and Ibuprofen Tablets, 250 mg/125 mg

Glenmark Pharmaceuticals has received final approval by the United States Food & Drug Administration (US FDA) for Acetaminophen and Ibuprofen Tablets, 250 mg/125 mg (OTC), determined by the FDA to be bioequivalent to Advil Dual Action with Acetaminophen Tablets, 250 mg/125 mg (OTC), of Haleon US Holdings. Glenmark’s Acetaminophen and Ibuprofen Tablets, 250 mg/125 mg (OTC), will be distributed in the US by Glenmark Therapeutics, US.

According to Nielsen syndicated data for the latest 52 weeks period ending March 23, 2024, the Advil Dual Action with Acetaminophen Tablets, 250 mg/125 mg (OTC) market achieved annual sales of approximately $84.1 million*.

Glenmark’s current portfolio consists of 195 products authorised for distribution in the US marketplace and 52 ANDAs pending approval with the US FDA.