Glenmark Pharmaceuticals (Glenmark) and Cosmo Pharmaceuticals N.V. (SIX: COPN) (Cosmo) have received Marketing Authorization (MA) for Winlevi (clascoterone 10 mg/g cream) from European Commission (EC), following the positive opinion issued by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) on August 25, 2025.
Winlevi is authorized in EU for the treatment of acne vulgaris in both adults and adolescents aged 12 to below 18 years, with usage in adolescents limited to facial application. With receipt of this approval, Glenmark will initiate commercializing Winlevi across 15 countries in EU namely Bulgaria, the Czech Republic, Denmark, Finland, France, Hungary, Iceland, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Spain and Sweden.
Glenmark Pharmaceuticals is a global research-led pharmaceutical company with presence across Generics, Specialty and OTC business with operations in over 50 countries.
