Glenmark Pharma gets USFDA nod for Acetaminophen and Ibuprofen Tablets
New Jersey: Glenmark Pharmaceuticals Ltd. has received final approval from 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 bioequivalent 1 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) market 3 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,” the Company stated.
Glenmark Pharmaceuticals Ltd. is a research‐led, global pharmaceutical company, having a presence across Branded, Generics, and OTC segments; with a focus on therapeutic areas of respiratory, dermatology and oncology. The company has 11 world-class manufacturing facilities spread across 4 continents, and operations in over 80 countries. Glenmark’s Green House Gas (GHG) emission reduction targets have been approved in 2023 by the Science Based Target initiative (SBTi), making it only the second pharmaceutical company in India to achieve this.
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