Glenmark Pharmaceuticals Ltd. on Wednesday said its subsidiary has received approval from the U.S. 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 U.S. Food and Drug Administration for Chlorzoxazone tablets USP, in strength of 375 mg and 750 mg, the drug maker said in a statement.
This marks company's first Abbreviated New Drug Application 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 U.S. while 45 ANDAs are pending with the U.S. FDA, 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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