Glenmark Pharma Receives FDA Approval for Anti-Psychotic Tablets

Glenmark Pharmaceuticals Ltd. announced today that it has received final approval from the U.S. Food and Drug Administration (FDA) for its generic version of Prolixin (fluphenazine hydrochloride) tablets in four strengths – 1 mg, 2.5 mg, 5 mg, and 10 mg.

Glenmark’s fluphenazine hydrochloride tablets are the generic version of Prolixin tablets from Apothecon Inc. They will be sold in the United States by Glenmark’s subsidiary, Glenmark Pharmaceuticals Inc., USA.

Fluphenazine belongs to the class of medications called phenothiazines and works by helping restore the balance of certain natural substances in the brain. Prolixin tablets are prescribed for the management of manifestations of psychotic disorders.

According to IQVIA sales data, Prolixin tablets had annual sales of around $18.1 million in the United States for the 12 months ending September 2023. Glenmark’s launch of the generic version can provide a more affordable treatment option for patients.

Glenmark has a robust portfolio in the central nervous system therapeutic area and already markets several products, including generic versions of branded drugs like Abilify, Lamictal, and Zyprexa.

The company now has 189 products authorized for distribution in the U.S. market and 50 ANDAs pending approval with the FDA. Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.

Glenmark’s fluphenazine hydrochloride approval further consolidates its position as a leading generics player in the U.S. and enables it to continue offering affordable medicines to patients.

The company has 8 manufacturing facilities approved by leading regulatory agencies globally, including the US FDA and UK MHRA. Glenmark’s API manufacturing facility in Ankleshwar was recently cleared by the European Directorate for the Quality of Medicines & HealthCare.

With operations across 5 continents and major therapeutic areas like dermatology, respiratory and oncology, Glenmark serves markets around the world. The company invests over 10% of its revenue on R&D every year and has commercialized several innovative medicines globally in the last decade.

Glenmark’s GHG emission reduction targets have been approved by the Science Based Target initiative (SBTi). Recently, Glenmark joined the global ‘Race to Zero’ campaign and committed to achieving net zero emissions by 2050.

The company also runs one of India’s largest CSR programs focused on providing access to medicines, education and community development. Glenmark’s efforts in this area have benefited over 2.9 million lives in India over the past 10 years.