Glenmark Pharmaceuticals Ltd. (Glenmark) has received the United States Food & Drug Administration (FDA) final approval 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 US by Glenmark Pharmaceuticals Inc., USA.
Glenmark’s current portfolio consists of 189 products authorized for distribution in the US marketplace and 50 ANDA’s pending approval with the US 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.
Glenmark Pharmaceuticals Limited 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 10 world-class manufacturing facilities spread across 4 continents, and operations in over 80 countries.
