Glenmark Pharma gets final USFDA nod for Schizophrenia drug Prochlorperazine Maleate
Advertisement
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.
Our comments section is governed by our Comments Policy . By posting comments at Medical Dialogues you automatically agree with our Comments Policy , Terms And Conditions and Privacy Policy .
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.