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Cosmo and Glenmark Secure Approval for Winlevi® Cream in Europe

In a significant advancement in dermatological treatment, Cosmo Pharmaceuticals N.V. and Glenmark Pharmaceuticals Limited have jointly announced that the European Commission (EC) has granted marketing authorization for Winlevi® (clascoterone 10 mg/g cream). This product is specifically designed for the treatment of acne vulgaris in both adults and adolescents aged between 12 and 17 years, although its application for adolescents is limited to facial use only. The approval, dated December 1, 2025, follows a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency on August 25, 2025.

This new medication received authorization for distribution across 17 EU countries, including Belgium, Bulgaria, Denmark, Slovakia, Spain, Finland, France, Greece, Hungary, Iceland, Norway, the Netherlands, Poland, Portugal, the Czech Republic, Romania, and Sweden. With this broad approval, Glenmark is poised to take a significant step in establishing its presence in the European dermatology market.

Giovanni Di Napoli, CEO of Cosmo, commented on the importance of this approval, stating, "This authorization highlights the strength of our partnership with Glenmark and our mutual commitment to advancing dermatological care. Winlevi® represents a groundbreaking topical innovation, and we are excited to make it accessible for patients across Europe."

Similarly, Christoph Stoller, President and Head of Business for Europe and Emerging Markets at Glenmark Pharmaceuticals, expressed that this milestone aligns with their mission to become a global research-based pharmaceutical company. He elaborated, "Winlevi® marks our first product launch in Europe and is crucial for enhancing our dermatology portfolio in the region. We are dedicated to executing successful launches with urgency and precision, ensuring timely patient access in full compliance with regulatory frameworks."

About Glenmark Pharmaceuticals

Founded in India, Glenmark Pharmaceuticals Ltd. operates in several therapeutic segments, including respiratory ailments, dermatology, and oncology. Recognized as one of the leading global pharmaceutical companies, Glenmark ranks among the 100 top biopharmaceutical companies based on sales according to Scrip 100 in 2023. Additionally, they were listed among the top 50 companies for generics and biosimilars in 2024 by Generics Bulletin. The company maintains 11 world-class manufacturing facilities across four continents and has a strong footprint in over 80 countries. Their commitment to sustainability is evident, with greenhouse gas reduction targets approved by the Science Based Target initiative (SBTi) in 2023, marking them as the second Indian pharmaceutical company to achieve this.

Over the last decade, Glenmark has impacted the lives of over 3.3 million individuals through its corporate social responsibility initiatives. For further information, visit Glenmark Pharmaceuticals.

About Cosmo Pharmaceuticals

Cosmo is a life sciences company focusing on MedTech AI, dermatology, gastrointestinal diseases, and contract development and manufacturing. With a mission to empower patients, healthcare professionals, and partners through innovative science and technology, Cosmo designs and manufactures advanced solutions for critical medical needs. Headquartered in Dublin, Ireland, with offices in San Diego, USA, and Lainate, Rome, and Catania, Italy, Cosmo collaborates with leading pharmaceutical and MedTech companies worldwide. For more information, visit Cosmo Health.

With the launch of Winlevi®, both Cosmo and Glenmark are set to redefine the treatment landscape for acne, providing effective solutions and addressing critical dermatological needs for patients across Europe.