Glenmark Pharmaceuticals Ltd.

DUBLIN and MUMBAI, India, Dec. 1, 2025 /PRNewswire/ -- Cosmo Pharmaceuticals N.V. (SIX: COPN) ("Cosmo") and Glenmark Pharmaceuticals Limited (Glenmark), announced that the European Commission (EC) has granted Marketing Authorization (MA) for Winlevi® (clascoterone 10 mg/g cream), 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 <18 years, with usage in adolescents limited to facial application. With receipt of this approval, Glenmark will initiate commercializing Winlevi® across 17 countries in EU namely Belgium, Bulgaria, the Czech Republic, Denmark, Finland, France, Greece, Hungary, Iceland, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Spain, and Sweden.

Giovanni Di Napoli, Chief Executive Officer of Cosmo, commented, "This approval reflects the strength of our collaboration with Glenmark and our shared commitment to advancing dermatologic care. Winlevi represents a first-in-class topical innovation that redefines how acne is treated, and we are excited to see it become accessible to patients throughout Europe."

Christoph Stoller, President & Business Head – Europe and Emerging Markets, Glenmark Pharmaceuticals, said, "The approval is a key milestone in executing our mission to become a research-led, global pharmaceutical company. Winlevi is the first NCE launch of Glenmark in Europe and is key to strengthening our presence in Dermatology in the region. We are committed to executing successful launches with urgency and precision, ensuring timely access for patients in full alignment with regulatory and access frameworks."

About Glenmark Pharmaceuticals Ltd.

Glenmark Pharmaceuticals Ltd. (BSE: 532296) (NSE: GLENMARK) is a research‐led, global pharmaceutical company, having a presence across Branded, Generics, and OTC segments; with a focus on therapeutic areas of respiratory, dermatology and oncology. The company has 11 world-class manufacturing facilities spread across 4 continents, and operations in over 80 countries. Scrip 100 positions Glenmark amongst the Top 100 biopharmaceutical companies ranked by Pharmaceutical Sales in 2023; while Generics Bulletin places it in the Top 50 Generics and biosimilar companies ranked by sales in 2024. Glenmark's Green House Gas (GHG) emission reduction targets have been approved in 2023 by the Science Based Target initiative (SBTi), making it only the second pharmaceutical company in India to achieve this. The organization has impacted over 3.3 million lives over the last decade through its CSR interventions. For more information, visit www.glenmarkpharma.com. You can follow us on LinkedIn (Glenmark Pharmaceuticals) and Instagram (Glenmark_pharma).

About Cosmo

Cosmo is a life sciences company focused on MedTech AI, dermatology, gastrointestinal diseases, and contract development and manufacturing (CDMO). We design, develop, and manufacture advanced solutions that address critical medical needs and raise the standard of care. Our technologies are trusted by leading global pharmaceutical and MedTech companies and reach patients and healthcare providers around the world. Guided by our purpose – Building Health Confidence – our mission is to empower patients, healthcare professionals, and partners by innovating at the intersection of science and technology. Founded in 1997, Cosmo is headquartered in Dublin, Ireland, with offices in San Diego (USA), and in Lainate, Rome, and Catania (Italy). For more information, visit www.cosmohealthconfidence.com

Logo - https://mma.prnewswire.com/media/451507/PRNE_Glenmark_Logo.jpg

View original content:https://www.prnewswire.co.uk/news-releases/cosmo-and-glenmark-announce-market-authorisation-of-winlevi-clascoterone-10-mgg-cream-for-treatment-of-acne-in-17-countries-in-europe-302629170.html

ELMWOOD PARK, N.J., Oct. 24, 2025 /PRNewswire/ -- Glenmark Pharmaceuticals Inc., USA (Glenmark) is pleased to announce the upcoming launch¹ of Ropivacaine Hydrochloride Injection USP, 40 mg/20 mL (2mg/mL), 150 mg/30 mL (5 mg/mL), and 200 mg/20 mL (10 mg/mL) Single-Dose Vials. Glenmark's Ropivacaine Hydrochloride Injection USP, 40 mg/20 mL (2mg/mL), 150 mg/30 mL (5 mg/mL), and 200 mg/20 mL (10 mg/mL) Single-Dose Vials is bioequivalent and therapeutically equivalent to the reference listed drug, Naropin®² Injection, 40 mg/20 mL (2 mg/mL), 150 mg/30 mL (5 mg/mL), and 200 mg/20 mL (10 mg/mL), of Fresenius Kabi USA, LLC NDA – 020533. Glenmark will begin distribution in November 2025.

According to IQVIA® sales data for the 12-month period ending August 2025, the Naropin® Injection, 40 mg/20 mL (2 mg/mL), 150 mg/30 mL (5 mg/mL), and 200 mg/20 mL (10 mg/mL) market³ achieved annual sales of approximately $20.9 million*.

Commenting on the launch, Marc Kikuchi, President & Business Head, North America, said, "We are pleased to announce the launch of Ropivacaine Hydrochloride Injection USP, 40 mg/20 mL (2mg/mL), 150 mg/30 mL (5 mg/mL), and 200 mg/20 mL (10 mg/mL) Single-Dose Vials. This launch represents another important addition to Glenmark's expanding injectable portfolio and reinforces our dedication to bring quality and affordable alternatives to market for patients in need."

¹Glenmark's Ropivacaine Hydrochloride Injection USP, 40 mg/20 mL (2mg/mL), 150 mg/30 mL (5 mg/mL), and 200 mg/20 mL (10 mg/mL) Single-Dose Vials is only approved for the indication(s) listed in Glenmark's approved label.

²All brand names and trademarks are the property of their respective owners.

³Market includes brand and all available therapeutic equivalents. Note: IQVIA® data obtained by Glenmark is only available for all approved RLD indications. Glenmark's product is only approved for the indications listed in Glenmark's approved label and is not marketed for all RLD indications.

*IQVIA® National Sales Perspectives: Retail & Non-Retail, August 2025

About Glenmark Pharmaceuticals Ltd.

Glenmark Pharmaceuticals Ltd. (BSE: 532296) (NSE: GLENMARK) is a research‐led, global pharmaceutical company, having a presence across Branded, Generics, and OTC segments; with a focus on therapeutic areas of respiratory, dermatology and oncology. The company has 11 world-class manufacturing facilities spread across 4 continents, and operations in over 80 countries. Scrip 100 positions Glenmark amongst the Top 100 biopharmaceutical companies ranked by Pharmaceutical Sales in 2023; while Generics Bulletin places it in the Top 50 Generics and biosimilar companies ranked by sales in 2024. Glenmark's Green House Gas (GHG) emission reduction targets have been approved in 2023 by the Science Based Target initiative (SBTi), making it only the second pharmaceutical company in India to achieve this. The organization has impacted over 3.3 million lives over the last decade through its CSR interventions.

For more information, visit www.glenmarkpharma.com. You can follow us on LinkedIn (Glenmark Pharmaceuticals) and Instagram (Glenmark_pharma).

Logo: https://mma.prnewswire.com/media/451507/PRNE_Glenmark_Logo.jpg

View original content:https://www.prnewswire.com/news-releases/glenmark-pharmaceuticals-inc-usa-to-launch-ropivacaine-hydrochloride-injection-usp-40-mg20-ml-2mgml-150-mg30-ml-5-mgml-and-200-mg20-ml-10-mgml-single-dose-vials-302593933.html

SOURCE Glenmark Pharmaceuticals