Glenmark Pharma gets USFDA nod for generic version of Thorazine tablets

On Wednesday, Glenmark Pharmaceuticals Limited announced that it has received final approval from United States Food & Drug Administration (USFDA) for Chlorpromazine Hydrochloride tablets USP in the strengths of 10 mg, 25 mg, 50 mg, 100 mg, and 200 mg.  

The above-mentioned drug is the generic version of Thorazine tablets, 10 mg, 25 mg, 50 mg, 100 mg & 200 mg of GlaxoSmithKline and achieved annual sales of approximately US$ 108.6 million for the 12-month period ending January 2021, according to data from IMS Health (IQVIA).  

Glenmark was also granted a competitive generic therapy (CGT) designation for Chlorpromazine Hydrochloride tablets. With this approval, the company first approved applicant for such competitive generic therapy and is eligible for 180 days of CGT exclusivity upon commercial marketing.  

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

At 2.24 pm on Wednesday, the shares of Glenmark Pharmaceuticals Limited were trading at Rs 464.25, down by 0.30 per cent or Rs 1.40 per share, against a 1.23 per cent decline in the benchmark index. The 52-week high of the company is recorded at Rs 572.70 while its 52-week low is Rs 187.70 on BSE.