喜报！赛默制药乙酰半胱氨酸取得欧盟CEP证书

2025年11月05日，百诚医药全资子公司浙江赛默制药有限公司（以下简称“赛默制药”）取得由欧洲药品质量管理局（EDQM）颁发的乙酰半胱氨酸（ACETYLCYSTEINE）CEP（Certificate of Suitability to Monograph of European Pharmacopoeia）证书。

On November 5, 2025, Zhejiang CDMO Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Bios-sincerity Pharmaceutical, received the CEP (Certificate of Suitability to Monograph of European Pharmacopoeia) certificate for acetylcysteine issued by European Directorate for the Quality of Medicines & HealthCare (EDQM).

CEP证书——国际市场的重要通行证

CEP Certificate — A Key Passport to the International Market

CEP证书，全称为“欧洲药典适用性证书（Certificate of Suitability to Monograph of European Pharmacopoeia）”，是欧洲药品质量管理局对原料药质量符合欧洲药典标准的一种认证。该证书不仅被所有欧盟成员国广泛认可，还得到加拿大、澳大利亚、新西兰等多个签订双边协定国家的承认，是国内原料药企业走向国际市场的重要通行证。

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.

高标准研发助力国际化布局再进一步

High-Standard R&D Drives Further Progress in Global Expansion

赛默制药取得乙酰半胱氨酸原料药CEP证书，标志着公司乙酰半胱氨酸原料药符合欧洲药典的质量标准，这是赛默制药国际化拓展的重要突破。公司长期坚持高标准、严要求的生产和研发理念，该项目自申请受理至成功获批，历时14个月，充分体现了团队在质量管理、研发能力、国际注册和沟通协作等方面的专业性及高效性。

Zhejiang CDMO Pharmaceutical Co., Ltd., received the CEP certificate for acetylcysteine 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 14 months from registration application to successful approval, which fully reflects the team's professionalism and efficiency in quality management, R&D capabilities, international registration, and communication and collaboration.

未来，公司将继续向更高端产业链转型，强化创新驱动，满足国际注册需求，提升全球竞争力，推动技术升级，进一步加速国际化业务拓展步伐，为全球客户提供更高质量的产品和服务。

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.

浙江赛默制药有限公司

Zhejiang CDMO Pharmaceutical Co., Ltd.

浙江赛默制药有限公司是一家原料&制剂一体化发展的，为客户提供优质高效CDMO/CMO服务的开放、合作、共融的平台型企业。公司涵盖原料药平台、固体制剂平台、口服液体制剂平台、注射剂平台、外用制剂平台、BFS滴眼剂平台和BFS吸入制剂平台。公司立足于创新科技， 服务健康的文化理念，推动生物医药产业高质量发展。

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. The company 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.

(百诚医药)