Glenmark gets USFDA nod for Chlorpromazine Hydrochloride

Glenmark Pharmaceuticals on Wednesday before trading hours today announced that the company has received a final approval from the USFDA for Chlorpromazine Hydrochloride Tablets.

Chlorpromazine Hydrochloride Tablets are generic version of Thorazin Tablets of GlaxoSmithKline.

Glenmark Pharmaceuticals announced that it has been granted a competitive generic therapy (CGT) designation for Chlorpromazine Hydrochloride Tablets USP. With this approval, Glenmark said it is the first approved applicant for such competitive generic therapy and is eligible for 180 days of CGT exclusivity upon commercial marketing.

According to IQVIA sales data for the 12-month period ended January 2021, Thorazine Tablets, achieved annual sales of approximately $108.6 million.

Glenmark said its current portfolio consists of 171 products authorized for distribution in the U.S. marketplace and 41 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.

Shares of Glenmark Pharmaceuticals were trading 0.61% higher at Rs 468.50 on BSE.

Glenmark Pharmaceuticals is a global research-led pharmaceutical company with presence across generics, specialty and over-the-counter (OTC) business with operations in over 50 countries. Glenmark's key therapy focus areas globally are respiratory, dermatology and oncology.

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