Glenmark Pharma receives ANDA approval for Fluphenazine Hydrochloride Tablets USP, 1 mg, 2.5 mg, 5 mg, and 10 mg

Mahwah, New Jersey, USA and Bangalore, India, November 7, 2023: Glenmark Pharmaceuticals Ltd. (Glenmark) has received final approval by the United States Food & Drug Administration (U.S. FDA) for Fluphenazine Hydrochloride Tablets USP, 1 mg, 2.5 mg, 5 mg, and 10 mg, the generic version of Prolixin®¹ 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 IQVIA^TM sales data for the 12-month period ending September 2023, the Prolixin® Tablets, 1 mg, 2.5 mg, 5 mg, and 10 mg market² 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 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.