Glenmark Pharmaceuticals Ltd. on Monday said that it has received final approval from the United States Food and Drug Administration (USFDA) for Prochlorperazine Maleate tablets.
The company said that Prochlorperazine Maleate Tablets 5 mg and 10 mg will be distributed in the US by Glenmark Pharmaceuticals Inc., USA.
The Prochlorperazine Maleate Tablet is the generic version of the Compazine Tablets of GlaxoSmithKline.
According to IQVIA data, total sales of Compazine tablets for the 12-month period ending in January 2023 stood at $26.9 million.
Earlier this month, Glenmark Pharma entered into a supply and distribution agreement with Cediprof Inc for the supply and distribution of tablets used in the treatment of mental disorders.
The two companies have signed the deal for Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate tablets in the strength of 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg. The drugs are generic versions of Adderall 1 tablets in the strength of 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg of Teva Women’s Health, Inc.
Glenmark has a wide portfolio of 182 products authorised for the US market. As many as 46 ANDAs are pending with the USFDA for approval. Further, Glenmark continues to explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.
Glenmark has 10 world-class manufacturing facilities spread across four continents, and operations in over 80 countries.
Shares of Glenmark Pharma are trading 0.25 percent lower at Rs 439.75.
