Glenmark gets USFDA approval for Prochlorperazine Maleate Tablets USP, 5 mg and 10 mg

Glenmark Pharmaceuticals has received final approval by the United States Food & Drug Administration (US FDA) for Prochlorperazine Maleate Tablets USP, 5 mg and 10 mg, the 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 US by Glenmark Pharmaceuticals.

According to IQVIA sales data for the 12-month period ending January 2023, the Compazine Tablets, 5 mg and 10 mg market achieved annual sales of approximately $26.9 million*.

Glenmark’s current portfolio consists of 182 products authorised for distribution in the US marketplace and 46 ANDAs pending approval with the US FDA.