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Glenmark receives ANDA approval for generic version of Temovate Cream

11 May 2018 Evaluate

Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (USFDA) for Clobetasol Propionate Cream USP, 0.05%, the generic version of Temovate Cream, 0.05%, of Fougera Pharmaceuticals, Inc.

According to IQVIA sales data for the 12 month period ending March 2018, the Temovate Cream, 0.05% market achieved annual sales of approximately $118.0 million.

Glenmark’s current portfolio consists of 134 products authorized for distribution in the US marketplace and 61 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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Company Name CMP
Sun Pharma. Inds. 1752.50
Dr. Reddys Labs. 1180.00
Cipla 1305.00
Lupin 1942.00
Zydus Lifesciences 1115.20
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