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皓元医药:积极推进自有工厂GMP体系国际化认证进程
Xin Lang Cai Jing· 2026-02-04 10:38
Core Viewpoint - The company is actively advancing its GMP certification process for new production capacities and has successfully passed FDA certification, indicating a commitment to international quality standards and market-oriented quality management systems [1] Group 1: GMP Certification Progress - The company has established a comprehensive cGMP system at its Ma'anshan industrial base, which is crucial for regulatory compliance and operational efficiency [1] - The Shandong Heze industrial base has obtained ISO "three systems" certification, while the Jiangsu Qidong GMP production base has passed ISO 14001 and ISO 45001 certifications, enhancing its operational standards [1] - The Chongqing antibody-conjugated CDMO base successfully passed the EU QP audit in June 2025, meeting EU GMP standards, which supports its international GMP system development [1] Group 2: Future Plans and Customer Focus - The company aims to enhance its international GMP certification process and improve its ability to undertake high-end overseas product orders, driven by a customer value-oriented approach [1] - The company emphasizes continuous technological advancement and service optimization to better meet customer needs [1]