Glenmark Pharmaceuticals on Wednesday said it has been granted final approval by the United States Food & Drug Administration (US FDA) to market Chlorzoxazone Tablets, which is used to treat muscle pain, in the American market.
In a regulatory filing, the company said, “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 achieved annual sales of approximately US$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 U.S. FDA.
“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,” the company said.