合全药业三个研发生产基地顺利通过韩国食品药品安全部上市前检查

2022-10-16

中国上海，2022年10月12日，全球新药合同研究、开发与生产（CRDMO）领军企业合全药业今日宣布，公司顺利通过了韩国食品药品安全部（Ministry of Food and Drug Safety, MFDS）对中国3个研发生产基地的累计4场远程上市批准前检查（PAI, Pre-Approval Inspection）。MFDS检察官在4周时间内，针对3款创新药进行了4场全面综合的上市批准前检查，包括常州基地2场（针对2款不同创新药的原料药生产条件），上海金山基地1场（针对1款创新药的原料药生产条件），上海外高桥基地1场（针对1款创新药的制剂生产条件）。4场成功的韩国MFDS PAI再次证明合全药业在亚洲、北美和欧洲的各基地均施行统一的质量体系，严格恪守全球最高质量标准。截至目前，合全药业已累计50余次顺利通过美国FDA、EMA、中国NMPA、瑞士SwissMedic、日本PMDA等监管机构的官方审计，可以满足全球客户的质量需求。公司凭借一体化CRDMO平台以及符合国际标准的质量体系，2017年以来已成功支持合作伙伴的36款创新药获批，生产的新药在全球105个国家上市。药明康德联席首席执行官、合全药业首席执行官陈民章博士表示：“非常高兴我们的多个基地在1个月内通过韩国MFDS的4场PAI。未来，合全药业将继续恪守全球最高质量监管标准，通过全球化的CRDMO平台赋能合作伙伴加速新药开发，为患者谋福祉。”关于合全药业合全药业是药明康德子公司，在亚洲、北美及欧洲地区均设有研发及生产基地。合全药业服务于生命科学行业，拥有卓越的化学创新药研发和生产的能力和技术平台。作为全球新药合同研究、开发与生产领域（CRDMO）的领军企业，合全药业致力于为全球合作伙伴提供高效、灵活、高质量的一站式解决方案，以支持包括小分子、寡核苷酸、多肽及各种复杂化学偶联药物的研发与生产。更多信息，请访问公司网站：www.stapharma.com.cnWuXi STA Successfully Passes Four Pre-Approval Inspections by South Korea’s Ministry of Food and Drug Safety at Three Manufacturing Sites in ChinaSHANGHAI, CHINA, October 12, 2022 – WuXi STA, a leading global Contract Research, Development, and Manufacturing Organization (CRDMO), today announced that its three manufacturing sites in China have successfully passed four remote pre-approval inspections (PAI) by South Korea’s Ministry of Food and Drug Safety (MFDS).Within four weeks, the MFDS completed four PAIs for three innovative drugs, including two API manufacturing inspections at the Changzhou site, one API manufacturing inspection at the Shanghai Jinshan site, and one drug product manufacturing inspection at the Shanghai Waigaoqiao site.The successful completion of four inspections is another testimony to WuXi STA’s high global quality standard across all sites in Asia, North America, and Europe. To date, WuXi STA has passed over 50 inspections from all major regulatory agencies, including US FDA, EMA, China NMPA, SwissMedic, and Japan PMDA. With the integrated CRDMO platform and the global standard quality system, WuXi STA has supported 36 new drug approvals since 2017 and the products WuXi STA manufactured have been launched in 105 countries around the world.Dr. Minzhang Chen, Co-CEO of WuXi AppTec and CEO of WuXi STA, commented, “I am pleased to see that our manufacturing sites successfully passed four pre-approval inspections by MFDS within a month. As a CRDMO committed to empowering more global partners, WuXi STA will maintain the highest global quality standard and strengthen our global R&D and manufacturing network to accelerate more innovative medicines for patients worldwide.”About WuXi STAWuXi STA (stapharma.com), a subsidiary of WuXi AppTec (wuxiapptec.com), is a leading pharmaceutical development and manufacturing capability and technology platform company serving the life sciences industry, with global operations. As a premier Contract Research, Development, and Manufacturing Organization (CRDMO), WuXi STA offers its worldwide partners efficient, flexible and high-quality solutions for integrated chemical, manufacturing and controls (CMC) from preclinical to commercial uses, including the development and manufacturing of small molecule, oligonucleotide, peptide and various complex chemical conjugate.For more information, please visit: http://www.STApharma.com