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27-Mar2018

Glenmark receives ANDA approval for Clobetasol Propionate Spray

Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (US FDA) for Clobetasol Propionate Spray, 0.05%, the generic version of Clobex Spray, 0.05%, of Galderma Laboratories, L.P. This product will be manufactured at Glenmark's Baddi plant in India.

According to IQVIA sales data for the 12 month period ending January 2018, the Clobex Spray, 0.05% market achieved annual sales of approximately $30.5 million.

Glenmark's current portfolio consists of 131 products authorized for distribution in the US marketplace and 63 ANDA's pending approval with the US 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.


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