Glenmark Pharma gets final USFDA nod for Schizophrenia drug Prochlorperazine Maleate
Mumbai: Glenmark Pharmaceuticals Ltd. has announced that the company has received final approval from the United States Food & Drug Administration (U.S. FDA) for Prochlorperazine Maleate Tablets USP, 5 mg and 10 mg.
The product is a generic version of Compazine Tablets, 5 mg and 10 mg, of GlaxoSmithKline. Glenmark’s Prochlorperazine Maleate Tablets USP, 5 mg and 10 mg, will be distributed in the U.S. by Glenmark Pharmaceuticals Inc., USA.
Prochlorperazine Maleate Tablets are used to treat Schizophrenia and severe conditions of vomiting and nausea.
According to IQVIA sales data for the 12-month period ending January 2023, the Compazine Tablets, 5 mg and 10 mg market 2 achieved annual sales of approximately $26.9 million*.
Glenmark’s current portfolio consists of 182 products authorized for distribution in the U.S. marketplace and 46 ANDA’s pending approval with the U.S. FDA.
Headquartered in Mumbai, Glenmark Pharmaceuticals Ltd. is a global pharmaceutical company with a presence across Branded, Generics, and OTC segments; with a focus on therapeutic areas of respiratory, dermatology and oncology. The company was established in 1977 by Late Mr Gracias Saldanha.
The company has 10 manufacturing facilities spread across 4 continents, and operations in over 80 countries. The company has been Great Place To Work Certified in India, in 2023.
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