喜報！百誠醫藥全資子公司賽默製藥米諾地爾首次獲歐盟CEP證書

2025年3月5日，百誠醫藥全資子公司浙江賽默製藥有限公司（以下簡稱“賽默製藥”）取得由歐洲藥品質量管理局（EDQM）頒發的CEP（Certificate of Suitability to Monograph of the European Pharmacopoeia）證書，是賽默製藥首個原料藥CEP證書。On March 5, 2025, Zhejiang CDMO Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Bios-sincerity Pharmaceutical, received the CEP certificate (Certificate of Suitability to Monograph of the European Pharmacopoeia) issued by European Directorate for the Quality of Medicines & HealthCare (EDQM). It is the first CEP certificate for APIs of CDMO Pharmaceutical.

CEP 證書重磅加碼 國際化拓展的關鍵一步

CEP certificate, a crucial step in international expansion

CEP證書，全稱爲“歐洲藥典適用性證書（Certificate of Suitability to Monograph of European Pharmacopoeia）”，是歐洲藥品質量管理局對原料藥質量符合歐洲藥典標準的一種認證。該證書不僅被所有歐盟成員國廣泛認可，還得到加拿大、澳大利亞、新西蘭等多個簽訂雙邊協定國家的承認，是國內原料藥企業走向國際市場的重要通行證。

CEP certificate (Certificate of Suitability to Monograph of European Pharmacopoeia), is a certification issued by EDQM that the quality of APIs conforms to the requirement of European Pharmacopoeia. This certificate is not only widely recognized by all EU member states, but also recognized by many countries that have signed bilateral agreements, such as Canada, Australia, and New Zealand. It is an important pass for domestic API companies to enter the international market.

賽默製藥首次獲得米諾地爾原料藥CEP證書，標誌着公司米諾地爾原料藥符合歐洲藥典的質量標準，這是賽默製藥國際化拓展的重要突破。公司長期堅持高標準、嚴要求的生產和研發理念，該項目自申請受理至成功獲批，歷時僅8個月，充分體現了團隊在質量管理、研發能力和溝通協作等方面的高質高效性。

CEP certificate for minoxidil API is an important breakthrough for CDMO Pharmaceutical in international expansion. The high-standard and strict production and R&D concepts enabled the project to take only 8 months from registration application to successful approval, which fully reflects the team's high quality and efficiency in quality management, R&D capabilities, communication and collaboration.

未來，公司將繼續向更高端產業鏈轉型，強化創新驅動，滿足國際註冊需求，提升全球競爭力，推動技術升級，進一步加速國際化業務拓展步伐，爲全球客戶提供更高質量的產品和服務。

In the future, the company will transform to a higher-end industrial chain, strengthen innovation-driven development, meet international registration needs, enhance global competitiveness, promote technological upgrades, further accelerate the pace of international business expansion, and provide global customers with higher quality products and services.

浙江賽默製藥有限公司

Zhejiang CDMO Pharmaceutical Co., Ltd.

浙江賽默製藥有限公司是一家原料&製劑一體化發展的，爲客戶提供優質高效CDMO/CMO服務的開放、合作、共融的平臺型企業，實現創新研發和規模生產一體化聯動發展。項目涵蓋原料藥平臺、固體制劑平臺、口服液體制劑平臺、注射劑平臺、外用製劑平臺、BFS滴眼劑平臺和BFS吸入製劑平臺。公司立足於創新科技， 服務健康的文化理念，推動生物醫藥產業高質量發展。

Zhejiang CDMO Pharmaceuticals Co., Ltd. is an open, cooperative, and inclusive platform enterprise that integrates APIs and drug product, provides customers with high-quality and efficient CDMO/CMO services, and realizes the integrated development of innovative research and development and large-scale production. The project covers the API platform, solid preparation platform, oral liquid preparation platform, injection platform, topical preparation platform, BFS eye drop platform, and BFS inhalation preparation platform. Based on the cultural concept of innovative technology and serving health, the company promote the high-quality development of biopharmaceutical industry.

(百誠醫藥)