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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
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]
奥浦迈(688293.SH)子公司通过欧盟QP审计
智通财经网· 2025-09-26 10:21
Core Viewpoint - Aopu Mai (688293.SH) announced that its wholly-owned subsidiary, Shanghai Silun Biotechnology Co., Ltd. (referred to as "Silun Biotechnology"), successfully passed the EU Qualified Person (QP) audit, receiving a compliance audit report issued by the QP [1] Group 1 - The successful completion of the QP audit indicates that Silun Biotechnology's quality management system meets the EU GMP regulatory requirements [1] - This achievement ensures high-quality research and production services in the field of macromolecular biopharmaceuticals [1] - The accomplishment lays a solid foundation for the company to further expand into international markets, including the EU [1]
奥浦迈子公司通过欧盟QP审计
Zhi Tong Cai Jing· 2025-09-26 10:20
Core Viewpoint - The company, Aopumai (688293.SH), announced that its wholly-owned subsidiary, Shanghai Silun Biotechnology Co., Ltd. (referred to as "Silun Biotechnology"), successfully passed the Qualified Person (QP) audit by the European Union, receiving a compliance audit report [1] Group 1 - The successful completion of the QP audit indicates that Silun Biotechnology's quality management system meets the EU GMP regulatory requirements [1] - This achievement ensures high-quality research and production services in the field of macromolecular biopharmaceuticals [1] - The compliance lays a solid foundation for the company to further expand into international markets, including the EU [1]