Glenmark Wins EC Nod for Acne Drug Winlevi in Europe

Glenmark Pharmaceuticals has obtained marketing approval from the European Commission (EC) for Winlevi (clascoterone 10 mg/g cream), an innovative topical solution for acne, in 15 European nations.

The approval stemmed from a partnership between Glenmark and Cosmo Pharmaceuticals N.V. It pertains to the treatment of acne vulgaris in adults and adolescents from 12 to fewer than 18 years, with adolescent use limited to facial application.

Glenmark will market the product in 15 European nations: Bulgaria, the Czech Republic, Denmark, Finland, France, Hungary, Iceland, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Spain, and Sweden.

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Christoph Stoller, President & Business Head Europe and Emerging Markets at Glenmark Pharmaceuticals, stated, the approval marks a significant step in fulfilling our goal to transform into a research-driven, global pharmaceutical firm.

Winlevi represents Glenmark's inaugural NCE launch in Europe and is crucial for enhancing our dermatology presence in the area. We are dedicated to carrying out successful launches swiftly and accurately, guaranteeing prompt access for patients in complete compliance with regulatory and access standards.

Glenmark Pharmaceuticals is involved in the development, production, and promotion of pharmaceutical products, including both formulations and active pharmaceutical ingredients, for regulated and semi-regulated markets. Glenmark Pharmaceuticals announced a 72.3% rise in consolidated net profit to Rs 610.25 crore, alongside a 76.6% growth in revenue from operations to Rs 6,003.79 crore for Q2 FY25.