Glenmark receives USFDA approval for muscle pain relievers
Pharma major, Glenmark announced on Wednesday that it has received approval for Chlorzoxazone Tablets USP, 375 mg and 750 mg from United States Food & Drug Administration (USFDA).
This Abbreviated New Drug Application (ANDA) approval is the first one for the company's new North American manufacturing facility based in Monroe, North Carolina.
The company's current portfolio consists of 163 products authorized for distribution in the US, with 45 ANDA's pending approval with the USFDA.
The Chlorzoxazone Tablets, 375 mg and 750 mg market achieved annual sales of about USD 20.9 million for the 12-month period ending March 2020, according to sales data from IMS Health and Quintiles (IQVIA). These tablets have been used in treating muscle pain in the American market.
Glenmark Pharmaceuticals Ltd (GPL) is a research-led pharmaceutical company spanning across generics, speciality and over-the-counter (OTC) operations with a presence in over 50 countries. It ranks among the top 80 pharma & biotech companies of the world in revenue terms.
Despite the announcement of this new development, the stock was down by 0.47 per cent or Rs 1.65 per share, trading at Rs 346.40, at 12.45 pm on Wednesday. The 52-week high is recorded at Rs 575 and the 52-week low is Rs 168 on BSE.