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Glenmark Pharmaceuticals receives ANDA approval for Chlorpromazine Hydrochloride Tablets USP, 10 mg, 25 mg, 50 mg, 100 mg, and 200 mg: Granted competitive generic therapy (CGT) designation and is eligible for 180 days of CGT exclusivity

March 24, 2021 23:30 IST | ANI Press Release
Tennis player James Blake
Glenmark Pharmaceuticals

Mumbai (Maharashtra) [India], March 24 (ANI/PRNewswire): Glenmark Pharmaceuticals Limited (Glenmark) has received final approval from the United States Food & Drug Administration (US FDA) for Chlorpromazine Hydrochloride Tablets USP, 10 mg, 25 mg, 50 mg, 100 mg, and 200 mg, the generic version of Thorazine®1 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 market2 achieved annual sales of approximately USD 108.6 million.

Glenmark's current portfolio consists of 171 products authorized 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.

For more information, visit (https://www.glenmarkpharma.com)

This story is provided by PRNewswire. ANI will not be responsible in any way for the content of this article. (ANI/ PRNewswire)

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(This story has not been edited by Business Standard staff and is auto-generated from a syndicated feed.)

 

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Glenmark Pharmaceuticals receives ANDA approval for Chlorpromazine Hydrochloride Tablets USP, 10 mg, 25 mg, 50 mg, 100 mg, and 200 mg: Granted competitive generic therapy (CGT) designation and is eligible for 180 days of CGT exclusivity

Mumbai (Maharashtra) [India], March 24 (ANI/PRNewswire): Glenmark Pharmaceuticals Limited (Glenmark) has received final approval from the United States Food & Drug Administration (US FDA) for Chlorpromazine Hydrochloride Tablets USP, 10 mg, 25 mg, 50 mg, 100 mg, and 200 mg, the generic version of Thorazine®1 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 market2 achieved annual sales of approximately USD 108.6 million.

Glenmark's current portfolio consists of 171 products authorized 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.

For more information, visit (https://www.glenmarkpharma.com)

This story is provided by PRNewswire. ANI will not be responsible in any way for the content of this article. (ANI/ PRNewswire)

DISCLAIMER


(This story has not been edited by Business Standard staff and is auto-generated from a syndicated feed.)

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