Glenmark Pharma receives market authorisation for acne treatment cream in 15 European countries; shares rise over 14% YTD

Glenmark Pharmaceuticals, along with Dublin-based Cosmo Pharmaceuticals N.V., received market authorisation (MA) from the European Commission (EC) on Tuesday, November 18, for an acne treatment cream in 15 European countries.

The EC granted the authorisation 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, Glenmark Pharma said in a regulatory filing.

With receipt of the approval, Glenmark will initiate the commercialisation of Winlevi across 15 countries in the European Union (EU), including Bulgaria, the Czech Republic, Denmark, Finland, France, Hungary, Iceland, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Spain, and Sweden.

Commenting on the authorisation, Giovanni Di Napoli, Chief Executive Officer of Cosmo, said: “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.”

Winlevi has been authorised in the EU for the treatment of acne vulgaris in both adults and adolescents (from 12 to less than 18 years old), with usage in the latter limited to facial application.

“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,” said Christoph Stoller, President & Business Head – Europe and Emerging Markets, Glenmark Pharmaceuticals.

Shares of Glenmark Pharma were trading 1.38% lower at ₹1,843.20 apiece on the National Stock Exchange (NSE) at around 3:09 pm on Tuesday, despite the approval.

Intraday, the stock fell as much as 2.72% to a low of ₹1,818 apiece. However, the market authorisation announcement came in after it had its intra-day low.

It has advanced more than 1% over the last five days but lost 0.5% over the month. It has gained above 28% in the past six months. On a year-to-date basis, it has surged over 14%.

While the scrip reached its 52-week high of ₹2,284.80 on July 11, 2025, it touched a year’s low of ₹1,275.50 per equity share on February 28, 2024.

Glenmark Pharma has a total market capitalisation of ₹51,967.28 crore, as of November 18, 2025, according to data on the NSE.