Glenmark Pharma gets USFDA approval for generic Prochlorperazine tablets

Glenmark Pharmaceuticals announced that it has received final approval from the US Food and Drug Administration (US FDA) for Prochlorperazine Maleate tablets, the generic version of GlaxoSmithKline’s Compazine tablets. Prochlorperazine is used to treat nausea, vomiting, and migraines caused by a variety of medical conditions. It is also used to treat dizziness (vertigo) caused by ear problems (Meniere’s syndrome). This medication is also used to treat mental illnesses such as short-term anxiety.

Glenmark Pharmaceuticals Inc., USA will distribute the drugmaker’s Prochlorperazine Maleate Tablets in the United States. The Compazine tablets market had annual sales of approximately $26.9 million in the 12-month period ending January 2023, according to IQVIA sales data. Glenmark’s current portfolio includes 182 products that are authorised for distribution in the United States, as well as 46 ANDAs that are awaiting FDA approval.

Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio, in addition to these internal filings.
Glenmark Pharmaceuticals is a global, innovation-driven pharmaceutical company with operations in specialty, generics, and over-the-counter (OTC).

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