Glenmark receives ANDA approval for Prochlorperazine Maleate Tablets

Glenmark receives ANDA approval for Prochlorperazine Maleate Tablets

By: IPP Bureau

Last updated : March 21, 2023 10:44 am



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 US $26.9 million


Glenmark Pharmaceuticals Ltd., an innovation-driven, global pharmaceuticals company has received final approval by the United States Food & Drug Administration (USFDA) 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 Inc., USA.

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 US $26.9 million.

Glenmark’s current portfolio consists of 182 products authorized for distribution in the US marketplace and 46 ANDA’s pending approval with the USFDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.

Glenmark Pharmaceuticals Ltd. USFDA

First Published : March 21, 2023 12:00 am