大分子生物药CDMO服务
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上海奥浦迈生物科技股份有限公司关于自愿披露全资子公司通过欧盟QP审计的公告
Shang Hai Zheng Quan Bao· 2025-09-26 18:18
Core Points - Shanghai Aopumai Biotechnology Co., Ltd. announced that its wholly-owned subsidiary, Shanghai Silun Biotechnology Co., Ltd., successfully passed the EU Qualified Person (QP) audit, receiving a compliance audit report [1][2] - The audit covered various aspects including quality management, production management, facilities, material systems, and packaging and labeling systems, confirming that Silun Biotechnology meets current EU GMP requirements [1] - This achievement establishes a solid foundation for the company's high-quality research and production services in the large molecule biopharmaceutical sector, facilitating further expansion into EU and international markets [2] Company Impact - The successful QP audit indicates that the quality management system of Silun Biotechnology has reached the standards required by EU GMP regulations [2] - The company has developed a comprehensive CDMO service platform for large molecule biopharmaceuticals, providing full-process support from early research to commercial production [1] - The passing of the QP audit is not expected to have a significant impact on the company's current performance [2]