Glenmark announcing ANDA approval for Prochlorperazine Maleate Tablets USP, 5 mg and 10 mg
Glenmark Pharmaceuticals has received final approval by the United States Food & Drug Administration (U.S. FDA) for Prochlorperazine Maleate Tablets USP, 5 mg and 10 mg, the generic version of Compazine1 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.
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.