Glenmark receives ANDA approval for fluphenazine hydrochloride tablets

Nov 07,2023

Mumbai: GlenmarkPharmaceuticals has obtained final approval from 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. These tablets will be distributed in the United States by Glenmark Pharmaceuticals Inc., USA.

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

Glenmark currently has 189 authorised products available in the U.S. marketplace and 50 ANDA’s awaiting approval from the USFDA. In addition to these internal submissions, Glenmark is actively seeking external development partnerships to enhance and expedite the growth of its existing pipeline and portfolio.

Source: Pharma