Glenmark Pharmaceuticals receives approval from USFDA to market generic drug for muscle pain in American market
Glenmark Pharmaceuticals on Wednesday said its subsidiary has received approval from the US health regulator to market Chlorzoxazone tablets, used to treat muscle pain, in the American market
New Delhi: Glenmark Pharmaceuticals on Wednesday said its subsidiary has received approval from the US health regulator to market Chlorzoxazone tablets, used to treat muscle pain, in the American market.
Glenmark Pharmaceuticals Inc, USA has been granted final approval by the US Food and Drug Administration (USFDA) for Chlorzoxazone tablets USP, in the strength of 375 mg and 750 mg, the drug maker said in a statement.
Glenmark Pharma gets @US_FDA approval for Chlorzoxazone Tablets USP, 375 mg & 750 mg. This marks co's first ANDA approval out of its new North American manufacturing facility based in Monroe, North Carolina pic.twitter.com/9kG7xfPkgl
— CNBC-TV18 (@CNBCTV18Live) May 27, 2020
This marks company's first abbreviated new drug application (ANDA) approval out of its new North American manufacturing facility based in Monroe, North Carolina, it added.
According to IQVIATM sales data, for the 12 month period ending March 2020, the Chlorzoxazone had annual sales of around $20.9 million.
Glenmark's current portfolio now consists of 163 products authorised for distribution in the US while 45 ANDAs are pending with the USFDA, the company said.
In addition to these internal filings, the company continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio, it added.
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