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金凯生科:公司医药领域的产品主要为医药中间体及原料药
(编辑 丛可心 袁冠琳) 证券日报网讯 12月24日,金凯生科在互动平台回答投资者提问时表示,公司医药领域的产品主要为医 药中间体及原料药,严格规范的质量管理始终贯穿于产品研发、生产到交付的整个服务周期。公司国内 生产基地建立了ISO管理体系并持续获得认证通过,公司美国生产基地建立了cGMP体系并获得美国、 日本的药品监督管理机构现场检查通过。前述的质量体系建设是公司能够通过国际制药企业审厂并成为 其合格供应商的基础,也是公司产品质量能够符合标准的根本保证。 ...
祝贺!西峡这家企业通过国家CNAS实验室认可
Sou Hu Cai Jing· 2025-07-15 04:21
Core Viewpoint - Zhongjing Wanshi Pharmaceutical's testing center has received the CNAS laboratory accreditation, marking its entry into the international laboratory mutual recognition framework, which enhances the quality and credibility of traditional Chinese medicine [1][3]. Group 1: CNAS Accreditation - CNAS accreditation is one of the highest authorities in laboratory testing capabilities in China, aligning with international standards such as ISO/IEC 17025, providing international credibility to the company's testing data [3]. - The accreditation allows the company to achieve mutual recognition in over 100 countries and regions, enhancing its core competitiveness and global expansion opportunities [3]. Group 2: Testing Capabilities and Innovations - The testing center is equipped with advanced detection equipment, including ICP-MS, LC-MS, and GC-MS, focusing on precision, efficiency, and rigor to ensure drug quality and safety [3]. - The center has published six papers in national core journals and holds over ten patents, demonstrating its commitment to innovation and high-standard testing services [3]. Group 3: Quality Management and Standards - Zhongjing Wanshi Pharmaceutical emphasizes quality system construction and has participated in drafting quality standards for various traditional Chinese medicine products, establishing 19 industry standards and norms [5]. - The company has implemented a comprehensive quality control mechanism from seedling to consumer, continuously improving drug standardization management [5]. - The quality technology leader stated that CNAS recognition is both an affirmation of the existing system and a motivation for future improvements, aiming to provide higher quality and more reliable traditional Chinese medicine products [5].