Glenmark Pharmaceuticals gets USFDA’s final approval for Acetaminophen and Ibuprofen Tablets

29 Apr 2024 Evaluate

Glenmark Pharmaceuticals (Glenmark) has received final approval by the United States Food & Drug Administration (USFDA) 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, 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) market 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 USFDA. 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. 

Glenmark Pharmaceuticals is a global research-led pharmaceutical company with presence across Generics, Specialty and OTC business with operations in over 50 countries. 


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