USFDA grants approval to Glenmark’s generic formulation to treat schizophrenia

November 7, 2023
News
39 secs read

Source: Financial Express

Glenmark Pharmaceuticals Ltd. on Tuesday announced that it has received final approval from the United States Food & Drug Administration (U.S. FDA) for Fluphenazine Hydrochloride Tablets USP, 1 mg, 2.5 mg, 5 mg, and 10 mg.

It is the generic version of Prolixin Tablets, 1 mg, 2.5 mg, 5 mg, and 10 mg, of Apothecon Inc.

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 market 2 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.

Pharmaways

Pharmaways Global Private Limited is a company established in 2022. Headed by a group of professionals with over 25 years of experience. A team of professionals who have excelled in their respective fields of Pharma, Legal & Information Technology. We have global exposure and hands-on experience of the global Pharma industry. We are in pursuit of bringing the global Pharma Industry on a platform where they can connect, collaborate and work towards mutual growth. We have taken a step into the future by innovating a technology that will help global Pharma players to empower, excel and accelerate in their business. A platform that has been developed exclusively for the Pharma fraternity. We are a New Delhi based company with overseas offices in America and the United Kingdom.