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Glenmark Pharma gets ANDA approval for chlorpromazine hydrochloride tablets

Granted competitive generic therapy designation and is eligible for 180 days of CGT exclusivity

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Glenmark Pharmaceuticals has received final approval by the United States Food and Drug Administration for chlorpromazine
hydrochloride tablets USP, 10 mg, 25 mg, 50 mg, 100 mg, and 200 mg, the generic version of Thorazine1 tablets, 10 mg, 25 mg, 50 mg, 100 mg, and 200 mg, of GlaxoSmithKline.

Glenmark has been granted a competitive generic therapy (CGT) designation for Chlorpromazine hydrochloride tablets USP, 10 mg, 25 mg, 50 mg, 100 mg, and 200 mg, therefore, with this approval, Glenmark is the first approved applicant for such competitive generic therapy and is eligible for 180 days of CGT exclusivity upon commercial marketing.

According to IQVIATM sales data for the 12 month period ending January 2021, the Thorazine 1 tablets, 10 mg, 25 mg, 50 mg, 100 mg, and 200 mg market achieved annual sales of approximately $108.6
million.

Glenmark’s current portfolio consists of 171 products authorised for distribution in the US marketplace and 41 ANDA’s pending approval with the US 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.

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