Replek has achieved a significant milestone in expanding its portfolio into highly regulated international markets. With the registration of Rekonazole, a medicinal product for the treatment of dermatological conditions, in the United Kingdom, Replek has taken its first major step towards entering the UK market. The marketing authorisation for Rekonazole (ketoconazole) 2% shampoo was granted by the Medicines and Healthcare products Regulatory Agency (MHRA), the United Kingdom’s regulatory authority, which is recognised as one of the world’s most rigorous regulatory systems for assessing the quality, safety and efficacy of medicinal products. The registration confirms that this Replek medicinal product, as well as the Company’s manufacturing processes, comply with the highest international regulatory standards.
The marketing authorisation is valid for five years, while the first export shipment will be carried out through a local partner by the end of this month. Rekonazole (ketoconazole) 2% shampoo is intended for the prevention and treatment of infections caused by the Malassezia fungus, including conditions such as dandruff, seborrhoeic dermatitis and tinea versicolor.
“The registration of Rekonazole in the United Kingdom represents an important milestone for the Company and a clear confirmation of the quality, expertise and maturity of our manufacturing and quality control processes. “Replek” has development, regulatory affairs and quality control teams capable of preparing technical documentation, clinical data, Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP) compliance reports, as well as quality systems comparable to international standards. The fact that our product has successfully passed the rigorous MHRA assessment further strengthens the confidence placed in our Company by both patients and our partners. The registration of this medicinal product forms part of our long-term strategy for sustainable growth and the continuous strengthening of our presence in developed Western markets,” said Dushan Pecovski, CEO of “Replek”.
The British market is a very important global market, with clear regulatory requirements and strong purchasing power. The registration of a medicinal product in the United Kingdom means that it has successfully passed this audit, which will open the door to entering other developed markets in Western Europe. This is further proof that “Replek” has highly developed quality control systems, capable of meeting the requirements of even the most demanding markets. The registration of a medicine in the United Kingdom is a strong reference that increases confidence among future potential partners and distributors, as well as a basis for further expansion of the portfolio on international markets. With this approval, “Replek” further strengthens its position as a reliable and credible pharmaceutical manufacturer, capable of meeting the highest regulatory requirements.
Recently, Replek received the EU GMP certificate for the fifth time, confirming its compliance with the highest European standards for good manufacturing practice, quality and safety. The continuous improvement of high-quality standards and compliance with European regulations are an integral part of Replek’s corporate strategy. The quality of production is also reflected in the company’s financial results for 2025, with a significant improvement in profitability, i.e. growth of 39% compared to 2024.