Glenmark Pharmaceuticals has received final approval from the United States Food & Drug Administration (USFDA) for Sodium Phenylbutyrate Tablets USP, 500 mg, the generic version of Buphenyl Tablets, 500 mg, of Horizon Therapeutics, LLC. Glenmark’s Sodium Phenylbutyrate Tablets USP, 500 mg, will be distributed in the U.S. by Glenmark Pharmaceuticals Inc., USA.
The Buphenyl market achieved annual sales of approximately $8.7 million for the 12-month period ending September 2022, according to IQVIA sales data. Glenmark’s current portfolio consists of 177 products authorized for distribution in the U.S. marketplace and 46 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.
