Glenmark Pharmaceuticals gets USFDA’s final approval for Fluphenazine Hydrochloride Tablets

07 Nov 2023 Evaluate

Glenmark Pharmaceuticals has received final approval by the United States Food & Drug Administration (USFDA) for Fluphenazine Hydrochloride Tablets USP, 1 mg, 2.5 mg, 5 mg, and 10 mg, the generic version of Prolixin Tablets, 1 mg, 2.5 mg, 5 mg, and 10 mg, of Apothecon Inc. Glenmark’s Fluphenazine Hydrochloride Tablets USP, 1 mg, 2.5 mg, 5 mg, and 10 mg, will be distributed in the U.S. by Glenmark Pharmaceuticals Inc., USA.

According to IQVIATM sales data for the 12?month period ending September 2023, the Prolixin Tablets, 1 mg, 2.5 mg, 5 mg, and 10 mg market achieved annual sales of approximately $18.1 million.  

Glenmark’s current portfolio consists of 189 products authorized for distribution in the U.S. marketplace and 50 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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