尊龙凯时-人生就是搏!「CHINA」官方网站

    Home/Newsroom/Detail

    Topfond Pharmaceutical's Troxerutin API Earns European Approval

    06 2025-06

    Topfond Pharmaceutical, a subsidiary of Genertec Meheco, has received the Certificate of Suitability to the Monographs of the European Pharmacopoeia (CEP) for Troxerutin API from the European Directorate for the Quality of Medicines & Healthcare (EDQM) (Certificate No: CEP-2023-419 Rev 00). For details, please refer to the company's announcement numbered L 2025-031, released on April 30, 2025. The obtained CEP is a key qualification for the product's entry into the European market. The application process was complex and involved strict standards, including the organization of technical documentation, compliance verification, communication, and supplementary tasks. Meng Lisha from the Topfond Drug Research Institute, responsible for foreign registration, completed the preparation of the project registration documents (M1, M2, and M3 sections) and relevant application tasks with a strong sense of responsibility and exceptional professional capability, ensuring the scientificity, completeness, and compliance of the application materials. Meng noted that this was their first CEP application, and each communication with the EDQM presented challenges; however, they were confident in their product and overcame all difficulties during the process. They hope this achievement will serve as a starting point for more of the company's products to enter developed markets and compete effectively.