Wednesday, 15 July 2020

Glenmark receives ANDA approval for Chlorzoxazone Tablets

27 May 2020 | News

Glenmark’s first ANDA approval out of their new U.S. facility

Source: Shutterstock

Source: Shutterstock

Glenmark Pharmaceuticals 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 IQVIATM, sales data for the 12-month period ending March 2020, the Chlorzoxazone Tablets, 375 mg and 750 mg market2 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.

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