合全药业上海金山化学原料药生产地根据法国EMA监督检查WuXi STA’s Jinshan Facility Passes EMA Inspection中国上海，2019年10月28日--药明康德全资子公司合全药业公布其坐落于上海金山的化学原料药生产地顺利完成法国药物管理处（European Medicines Agency，EMA）的监督检查。这再度证实合全药业做为备受全球顾客信任的合作伙伴，可以出示符合国际产品质量标准的GMP生产制造服务项目，颠覆式创新顾客加快促进药物发售系统进程，惠及众多患者。 “它是合全金山基地接纳的第一次EMA查验，5位检查官进行了历时5天的查验，范畴包含了EMA近些年准许的11个商品。本次顺利完成查验，再度说明合全已具有完善的质量认证体系和财务审计招待工作能力，能够常态接纳全球监管部门的查验。”合全药业质量承诺高级副总裁郝玫女性表达。 2019年，合全药业在搭建合乎国家标准的质量管理体系层面获得众多进度。3月，合肥滨湖新区新中药制剂生产地初次根据欧盟国家药物管理处（European Medical Products Agency，MPA）GMP验证；6月，金山基地初次根据日本国疫苗药品医疗机械综合性组织（Pharmaceuticals and Medical Devices Agency，PMDA）查验；7月，常州市基地和合肥滨湖新区剖析服务站再度根据英国食品类药监局（Food and Drug Administration，FDA）查验。 “本次金山基地顺利完成法国EMA查验，再度证明材料了合全有着合乎国家标准的质量管理体系。人们会一如既往地坚持不懈‘质量第一’ 的标准，根据出示高效率、灵活性的一体化解决方法，颠覆式创新全球合作伙伴，加快其药物发售的系统进程。” 合全药业ceo陈民章博士研究生表达。合全药业金山产品研发基地设计效果图合全药业深耕细作自主创新药的产品研发与生产制造十余年，为全球合作伙伴出示从临床医学前到产品化，高效率、灵活性、高品质的一站式CMC（有机化学、生产制造和操纵）解决方法。近些年，合全更持续把产品研发和生产量自小分子结构拓宽到寡核苷酸和活性多肽等新式药品。在服务平台经营规模的基本建设上，合全药业近些年也获得了令业内注目的考试成绩：比邻金山基地，全新升级的合全药业化学原料药产品研发基地将交付使用，提升3万平方的产品研发试验室和800余名科技人员。落成后，金山基地将会变成继常州市基地以后，合全第二个能为全球合作伙伴出示化学原料药从产品研发到生产制造一体化解决方法的基地。除此之外，合全药业常州市化学原料药产品研发和生产地也在2019年起动了基本建设占地达211亩的常州市基地三期工程项目，这将进一步巩固合全药业一体化平台的经营规模和工作能力优点，为全球合作伙伴出示更高品质的服务项目。有关合全药业合全药业是先在美二地均有经营的药明康德全资子公司，服务项目于生物科学制造行业，有着优胜的有机化学创新药研究和生产制造的工作能力和技术性服务平台。做为全球药物协作科学研究开发设计生产制造行业（CDMO）的领军人才公司，合全药业着眼于为全球合作伙伴出示从临床医学前到产品化，高效率、灵活性、高品质的一站式CMC（有机化学、生产制造和操纵）解决方法。其他信息，请浏览企业官网：www.STApharma.com.cn有关药明康德药明康德（股票号：603259.SH/2359.HK）为全球生物技术制造行业出示多方位、一体化的新药研究和生产制造服务项目。根据颠覆式创新全球制药业、生物工程和医疗设备公司，药明康德着眼于促进新药研究系统进程，为病人产生开创性的医疗计划方案。秉着以科学研究为第一任，客户至上的服务宗旨，药明康德根据性价比高和高效率的产品研发服务项目，助推顾客提高产品研发高效率，服务项目范畴包含有机化学药产品研发和生产制造、体细胞及基因疗法产品研发生产制造、医疗机械检测等行业。现阶段，药明康德的颠覆式创新服务平台正背负着来源于全球30好几个國家的3600好几家合作伙伴的产品研发创新项目，着眼于将大量药物、好药带来全球患者，尽早保持“让天地沒有难做的药，不易治的病”的希望。其他信息，请浏览企业官网：www.wuxiapptec.comWuXi STA’s Jinshan Facility Passes EMA InspectionSHANGHAI, October 28, 2019: STA Pharmaceutical Co., Ltd., (WuXi STA) – a subsidiary of WuXi AppTec – announced today that its Jinshan manufacturing facility in Shanghai, China has successfully passed an inspection by the European Medicines Agency (EMA) with no critical and no major findings. This demonstrates that as the trusted partner of global customers, WuXi STA can provide high quality GMP manufacturing services in compliance with global regulatory standards, to enable customers accelerate the development and manufacturing of new medicines for patients around the world. “It’s the first time that our Jinshan facility is audited by the EMA, with five auditors conducting a five-day inspection, spanning 11 products approved by the EMA in recent years. We continue to keep up a state of perpetual readiness across all our sites and actively welcome global regulators or client audits at any time. This is a direct testament to our organization’s culture of quality first, and real-time GMP monitoring.” commented Ms. Mei Hao, Vice President of Quality at WuXi STA. This quality inspection approval marks a significant year for WuXi STA in exceeding global regulatory standards. In March, the company’s new drug product manufacturing facility in Shanghai Waigaoqiao passed its GMP inspection by the European Medical Products Agency (MPA), and in June, its Jinshan manufacturing facility passed a Pre-Approval Inspection (PAI) by Japan’s Pharmaceutical and Medical Device Agency (PMDA) for an innovative drug. Further, in July, WuXi STA’s Analytical Service Unit (ASU) in Shanghai and active pharmaceutical ingredient (API) process R&D and manufacturing facility in Changzhou passed two inspections by the U.S. Food and Drug Administration (FDA) within the same week, with no Form 483s issued. “The successful EMA inspection at Jinshan is yet further proof of WuXi STA's commitment to enforcing the highest global quality systems. We will continue to pursue a ‘quality first’ commitment, constantly enhancing our platform with new services to enable our customers to bring better medicines to patients faster,” noted Dr. Minzhang Chen, CEO of WuXi STA. WuXi STA has been engaged in new drug development and manufacturing for more than a decade, offering global partners efficient, flexible and high-quality solutions from preclinical to commercial uses with the integrated CMC (Chemical, Manufacturing, and Control) platform. More recently, WuXi STA expanded its platform to support oligonucleotides and peptides. The company has started construction of a new API process R&D center next to the current Jinshan site, adding 30,000 square meters of laboratories and more than 800 scientists. After completion, the Jinshan facility will become the second integrated site after Changzhou to support process R&D and manufacturing of innovative APIs for global partners. This year WuXi STA also initiated the third phase construction of a Changzhou API process development and manufacturing facility, which covers an additional 35 acres. About WuXi STASTA 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 De
