Glenmark Pharmaceuticals Ltd, announced that the company has received final approval by the United States Food & Drug Administration (U.S. FDA) for Prochlorperazine Maleate Tablets USP, via an exchange filing.
Prochlorperazine Maleate is the generic version of Compazine1 Tablets, 5 mg and 10 mg, of GlaxoSmithKline.
Glenmark’s Prochlorperazine Maleate Tablets USP of 5 mg and 10 mg, will be distributed in the U.S. by Glenmark Pharmaceuticals Inc., USA.
According to IQVIATM sales data for the 12-month period ending January 2023, the Compazine Tablets, 5 mg and 10 mg market2 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.
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.
