Glenmark Pharma received USFDA approval for Chlorpromazine Hydrochloride tablets.
Glenmark has been granted a competitive generic therapy (CGT) designation for Chlorpromazine Hydrochloride Tablets USP, 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, it added.
According to IQVIATM sales data for the 12 month period ending January 2021, the Thorazine Tablets 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 ANDAs' pending approval with the USFDA.
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