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Glenmark Pharmaceuticals Ltd Secures European Commission Approval for Acne Treatment Winlevi in 15 Countries

Healthcare/Biotech

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Published on 18th November 2025, 10:19 AM

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Author

Simar Singh | Whalesbook News Team

Overview

Glenmark Pharmaceuticals and Cosmo Pharmaceuticals have received marketing authorisation from the European Commission (EC) for Winlevi (clascoterone 10 mg/g cream), an acne vulgaris treatment, across 15 European Union countries. This approval, following a positive opinion from the European Medicines Agency's CHMP, signifies Glenmark's first new chemical entity launch in Europe and aims to bolster its dermatology presence. The cream is indicated for adults and adolescents aged 12-18. Glenmark will now proceed with commercialising Winlevi in the approved European nations.