▎药明康德/报道合全药业上海分析服务部及常州基地零缺陷通过美国FDA现场检查 今日，药明康德子公司合全药业宣布其位于上海的分析服务部和常州的原料药研发及生产基地在同一周内均以零缺陷的结果顺利通过美国FDA的现场检查。这不仅标志着合全药业的质量体系可以常态化接受全球监管机构的检查，也再次印证了合全药业领先的新药研发和生产一体化平台，能够为全球客户提供符合国际最高质量监管标准的服务，助力更多新药、好药早日进入市场，造福病患。 “此次检查从发出通知到FDA抵达现场分别只有7天和5天的时间，且通知中并未告知检查的项目和范围。我们非常自豪在如此短的时间内，上海分析服务部和常州基地均以零缺陷通过了FDA检查，这彰显了合全药业拥有国际标准的质量体系，质量文化的构建已经全面迈入常态化，”合全药业全球质量副总裁郝玫女士表示，“我们将继续秉承精益求精、追求卓越的精神，为全球合作伙伴提供高质量的一体化服务。” 合全药业从2013年至今先后7次通过美国FDA的现场检查，合全生产的化学创新药目前已在全球95个国家获批上市。此次接受检查的合全药业分析服务部（ASU）能为客户提供从原料药到制剂的分析方法开发，验证和检测及稳定性研究等服务，全面支持从临床前至商业化等不同阶段的新药开发项目需求。合全药业常州原料药研发和生产基地占地近16万平方米，拥有包括喷雾干燥、流体化学、寡核苷酸和多肽等在内的多项先进的技术研发和生产能力。常州基地曾于2018年首次以零缺陷顺利通过美国FDA的现场检查。 “构建符合国际标准的质量管理体系是合全发展的重中之重。此次上海分析服务部和常州基地同时顺利通过美国FDA的检查再次印证了我们对 ‘质量第一’ 的承诺。合全将继续恪守全球最高的质量监管标准，深耕行业全产业链，更好地助力合作伙伴加速创新药物的上市进程，造福全球病患。”合全药业首席执行官陈民章博士表示。 关于合全药业 合全药业是在中美两地均有运营的药明康德子公司，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。作为全球新药合作研究开发生产领域（CDMO）的领军企业，合全药业致力于为全球合作伙伴提供从原料药（API）到制剂，高效、灵活、高质量的一站式解决方案。更多信息，请访问公司网站：www.STApharma.com.cn 关于药明康德 药明康德（股票代码：603259.SH/2359.HK）是国际领先的开放式能力与技术平台公司，为全球制药及医疗器械等领域提供从药物发现、开发到市场化的全方位一体化的实验室研发和生产服务。本着以研究为首任，以客户为中心的宗旨，药明康德通过高性价比、高效率的服务平台帮助全球客户缩短药物及医疗器械研发周期、降低研发成本。药明康德平台涵括小分子药物研发及生产、细胞疗法与基因疗法研发生产、医疗器械测试等，正承载着来自全球30多个国家的3500多家创新合作伙伴的数千个研发创新项目，致力于将最新和最好的医药和健康产品带给全球病患，实现“让天下没有难做的药，难治的病”的梦想。更多信息，请访问公司网站：www. WuXi STA Shanghai & Changzhou Facilities Pass U.S. FDA Inspections Today，STA Pharmaceutical Co., Ltd., (WuXi STA) – a subsidiary of WuXi AppTec – announces that its Analytical Service Unit (ASU) in Shanghai and active pharmaceutical ingredient (API) process R&D and manufacturing facility in Changzhou, have successfully passed two inspections from the U.S. Food and Drug Administration (FDA) within the same week, with no Form 483s issued. This not only marks a milestone for WuXi STA on running a continual state of regulatory readiness, with real time GMP monitoring and an ingrained internal quality culture, but also shows its commitment on providing integrated R&D and manufacturing services with the highest quality standard for customers. “It’s a point of great pride that our quality systems allow us to be inspected at short notice by any applicable regulatory agency in the world. In this case, we received two separate inspection notices from FDA only seven days and five days in advance of the inspections, respectively. It’s an endorsement of the real time monitoring and quality culture we run across all parts of the company,” commented Ms. Mei Hao, Vice President of Quality at WuXi STA. “It’s another key example of the rigorous nature of our global standard quality systems. It is also another milestone for our platform, and in our efforts to have geographically integrated capabilities for both drug product and drug substance.” WuXi STA has now successfully passed seven inspections from the U.S. FDA since 2013, producing branded drugs marketed in 95 countries. Its Analytical Service Unit provides clients with a full spectrum of analytical method development, validation and testing services from preclinical to commercial. The Changzhou facility with over 1,700,000 square feet has established a variety of new technology platforms such as spray dried dispersion, continuous processing (flow chemistry), oligonucleotides and peptides. It successfully completed the first U.S. FDA inspection in 2018. 'WuXi STA takes high priority on building quality system meeting global regulatory standards. These successful FDA inspections to ASU and Changzhou facility reflects WuXi STA's commitment to ‘quality first’. We will continue to enhance our platform with highest quality service to better enable our customers to bring better medicines faster for patients.” added Dr. Minzhang Chen, CEO of WuXi STA. About WuXi STA STA Pharmaceutical Co., Ltd., a subsidiary of WuXi AppTec (WuXi STA), is a leading pharmaceutical development and manufacturing capability and technology platform company serving the life sciences industry, with operations in China and the United States. As a premier Contract Development and Manufacturing Organization (CDMO), WuXi STA offers our worldwide partners efficient, flexible and high-quality solutions for Active Pharmaceutical Ingredients (APIs) and finished dosage forms. For more information, please visit: http://www.STApharma.com About WuXi AppTec WuXi AppTec is a leading pharmaceutical and medical device open-access capability and technology platform company with global operations. As an innovation-driven and customer-focused company, WuXi AppTec provides a broad and integrated portfolio of services to help our worldwide customers and partners shorten the discovery and development time and lower the cost of drug and medical device R&D through cost-effective and efficient solutions. With its industry-leading capabilities such as small molecule R&D and manufacturing, cell therapy and gene therapy R&D and manufacturing, and medical device testing, the WuXi platform is enabling more than 3,500 innovative collaborators from more than 30 countries to bring innovative healthcare products to patients, and to fulfill WuXi's dream that 'every drug can be made and every disease can be treated.' Please visit: http://www.
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