Glenmark Pharma gets US FDA nod for generic Prochlorperazine tablets

Glenmark Pharmaceuticals said that it has received final approval by the United States Food & Drug Administration (US FDA) for Prochlorperazine Maleate tablets, the generic version of Compazine tablets of GlaxoSmithKline.

Prochlorperazine is used in the treatment of nausea, vomiting, and migraine caused by various conditions. It is also used to treat vertigo (dizziness) due to ear problems (Meniere's syndrome). Additionally, this medicine is also used in mental illnesses such as short-term anxiety.

The drug maker's Prochlorperazine Maleate Tablets would be distributed in the U.S. by Glenmark Pharmaceuticals Inc., USA.

According to IQVIA sales data for the 12-month period ending January 2023, the Compazine tablets market had 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.

Glenmark Pharmaceuticals is a global innovation-driven pharmaceutical company with presence across specialty, generics and OTC businesses.

The company's consolidated net profit rose 21.13% to Rs 290.76 crore on 8% increase in net sales to Rs 3,392.24 crore in Q3 FY23 over Q3 FY22.

The scrip shed 0.71% to currently trade at Rs 437.60 on the BSE.

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