Glenmark Pharmaceuticals receives ANDA approval for Acetaminophen and Ibuprofen Tablets, 250 mg/125 mg (OTC)
April 29, 2024: Glenmark Pharmaceuticals Ltd. (Glenmark) has received final approval by the United States Food & Drug Administration (U.S. FDA) for Acetaminophen and Ibuprofen Tablets, 250 mg/125 mg (OTC), determined by the FDA to be bioequivalent1 to Advil®2 Dual Action with Acetaminophen Tablets, 250 mg/125 mg (OTC), of Haleon US Holdings, LLC. Glenmark’s Acetaminophen and Ibuprofen Tablets, 250 mg/125 mg (OTC), will be distributed in the U.S. by Glenmark Therapeutics Inc., USA.
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) market3 achieved annual sales of approximately $84.1 million*.
Glenmark’s current portfolio consists of 195 products authorized for distribution in the U.S. marketplace and 52 ANDA’s pending approval with the U.S. FDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.
