#Ireland #Dublin #Glenmark Pharmaceuticals #Winlevi #Cosmo Pharmaceuticals

Cosmo and Glenmark Achieve Milestone for Winlevi® Cream

On December 2, 2025, Cosmo Pharmaceuticals N.V. and Glenmark Pharmaceuticals Limited jointly announced the approval of Winlevi® (Clascoteron 10 mg/g cream) by the European Commission (EC) for the treatment of acne. This significant approval comes after a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) on August 25, 2025.

Winlevi® is now authorized in the European Union for the treatment of acne vulgaris in adults and adolescents aged 12 to 17, with its application limited to the facial area for younger patients. Glenmark plans to initiate the marketing of Winlevi® across 17 EU countries, which include Belgium, Bulgaria, the Czech Republic, Denmark, Finland, France, Greece, Hungary, Iceland, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Spain, and Sweden.

Giovanni Di Napoli, CEO of Cosmo, commented on this achievement, stating, "This approval reflects the strength of our collaboration with Glenmark and our shared commitment to advancing dermatological care. As a first-in-class topical treatment, Winlevi redefines acne therapy, and we are excited that it will now be accessible to patients throughout Europe."

Christoph Stoller, President and Head of the Europe and Emerging Markets Business at Glenmark Pharmaceuticals, expressed his enthusiasm as well. He noted, "This approval is a key milestone in realizing our mission to become a research-driven global pharmaceutical company. Winlevi represents Glenmark’s first new chemical entity (NCE) introduction in Europe and is pivotal for enhancing our dermatology presence in the region. We are committed to executing successful launches with urgency and precision, ensuring timely access for patients while adhering to all regulatory and access requirements."

About Glenmark Pharmaceuticals

Glenmark Pharmaceuticals Ltd., listed on the BSE and NSE, is a research-focused global pharmaceutical company engaged in the segments of branded medications, generics, and over-the-counter products. The company specializes in areas such as respiratory diseases, dermatology, and oncology, boasting 11 state-of-the-art manufacturing facilities across four continents. Glenmark is represented in over 80 countries and is ranked among the top 100 biopharmaceutical companies by Scrip in 2023, while also being recognized among the top 50 generic and biosimilar companies by Generics Bulletin in 2024. Glenmark's goals for reducing greenhouse gas emissions have been validated by the Science Based Targets Initiative (SBTi) for 2023, making it the second pharmaceutical company in India to achieve these targets. For more information, visit Glenmark's website.

About Cosmo Pharmaceuticals

Cosmo is a specialized life sciences company focused on MedTech AI, dermatology, gastrointestinal diseases, and contract development and manufacturing (CDMO). The company designs, develops, and produces advanced solutions that meet critical medical needs and elevate standards of care. Cosmo's technologies are trusted by leading pharmaceutical and MedTech companies worldwide, reaching patients and healthcare providers globally. Founded in 1997 and headquartered in Dublin, Ireland, Cosmo also has offices in San Diego (USA), Lainate, Rome, and Catania (Italy). For more details, you can find them on their website at Cosmo Health Confidence.