Glenmark Pharmaceuticals’ arm receives USFDA’s approval for Chlorzoxazone Tablets

27 May 2020 Evaluate
Glenmark Pharmaceuticals’ subsidiary -- Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (USFDA) for Chlorzoxazone Tablets USP, 375 mg and 750 mg. This marks Glenmark’s first ANDA approval out of their new North American manufacturing facility based in Monroe, North Carolina.

According to IQVIA sales data for the 12 month period ending March 2020, the Chlorzoxazone Tablets, 375 mg and 750 mg market achieved annual sales of approximately $20.9 million. 

Glenmark’s current portfolio consists of 163 products authorized for distribution in the U.S. marketplace and 45 ANDA’s pending approval with the USFDA. 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.

Glenmark Pharmaceuticals (GPL) is a global research-led pharmaceutical company with presence across Generics, Specialty and OTC business with operations in over 50 countries.

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