合全药业无锡基地顺利通过首个制剂项目EMA上市前检查 | 会员动态

3月3日，药明康德子公司合全药业宣布，其无锡制剂基地于2021年第四季度接待了欧洲药品管理局（European Medicines Agency，EMA）针对其合作伙伴一款创新药的制剂生产进行的上市批准前检查（PAI, Pre-Approval Inspection），近日已获得GMP证书，此次成功的PAI，彰显了合全药业对质量的坚定承诺和强大的专业实力，为更好地赋能全球客户奠定了坚实基础。

2021年11月8日-12日，EMA检察官开展了为期5天的远程综合检查，范围包括质量管理体系、厂房设施及设备、质量控制实验室、制剂生产、物料管理、数据管理及完整性等。最终，结果全部顺利通过，无主要和关键发现项。随着无锡基地顺利通过此次核查，无锡基地将开始为该创新药提供制剂商业化生产服务，供应欧洲市场，造福广大病患。

合全药业无锡基地是制剂研发和生产一体化基地，针对各种不同剂型的口服制剂和注射制剂，提供从处方开发到临床及商业化的制剂产品生产等“一站式”服务。无锡基地曾于2020年通过了中国国家药品监督管理局（NMPA）的上市前核查，此次又获得EMA权威认证，再一次证明合全药业拥有符合国际标准的质量体系，将助力公司更好地为全球客户提供卓越服务。

作为全球新药合作研究开发生产领域（CDMO）的领军企业，合全药业始终将质量视作生命线和核心竞争力，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。公司近年来已成功支持合作伙伴的创新药在全球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：

我们非常高兴继外高桥基地顺利通过首个制剂项目美国FDA 的PAI后，无锡基地也通过了首个EMA对制剂项目上市前的检查。未来，我们将继续强化公司的质量管理体系，通过全球研发和生产网络，助力合作伙伴加速开发创新药物，为广大病患带来健康福音。
▼

关于合全药业

合全药业是药明康德子公司，在全球多地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.cn▼

英文原文（向下滑动查看更多）

WuXi STA Passes the First EMA 

Drug Product Pre-Approval Inspection at its Wuxi City Site

SHANGHAI, CHINA, March 3, 2022 –WuXi STA – a subsidiary of WuXi AppTec – today announced that its drug product facility in Wuxi City, China has successfully passed its first pre-approval inspection (PAI) and received the GMP Compliance Certificate from the European Medicines Agency (EMA).

The PAI focused on the drug product manufacturing of an innovative drug for one of WuXi STA’s partners. During a 5-day remote inspection from November 8 to 12 in 2021, the inspector assessed the compliance of the manufacturing operations against the EU Guideline to Good Manufacturing Practice (GMP). The inspection included a comprehensive review of the quality management system, the manufacturing & QC equipment and facilities, tablet manufacturing operations and controls, material handling and data management & integrity programs. The PAI was completed successfully with no critical or major observations, and the Wuxi City site will start provide commercial drug product manufacturing service of this innovative medicine for the European market.

WuXi STA’s drug product site in Wuxi City offers a full range of services including formulation development and manufacturing for a broad range of oral and injectable dosage forms. In 2020, the site passed PAI from China NMPA and this latest successful PAI from the EMA further demonstrates the company’s robust and reliable quality system.

High quality standard is embedded in WuXi STA’s core value. Since its initial founding, WuXi STA has passed over 50 inspections from all major regulatory agencies including US FDA, EMA, China NMPA, SwissMedic and Japan PMDA. With the industry-leading integrated CMC platform and the global quality system, products manufactured by WuXi STA 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 very pleased that after our Shanghai Waigaoqiao site passed its first drug product PAI by the US FDA last year, our Wuxi City site has also successfully passed its first drug product PAI from the EMA. We will continue to maintain the highest global quality standards and through our global R&D and manufacturing network, empower more partners to accelerate the development of their innovative medicines for patients worldwide.”

About WuXi STA

WuXi 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 development and manufacturing organization (CDMO), 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

同写意新才俱乐部

同写意论坛是中国新药研发行业权威的多元化交流平台，十八年来共举办会议论坛百余期。“同写意新药英才俱乐部”基于同写意论坛而成立，早已成为众多新药英才的精神家园和中国新药思想的重要发源地之一。同写意在北京、苏州、深圳、成都设立多个管理中心负责同写意活动的运营。

尊享多重企业/机构会员特权

• 分享庞大新药生态圈资源库；
  
• 同写意活动优享折扣；
• 会员专属坐席及专家交流机会；
• 同写意活动优先赞助权；
• 机构品牌活动策划与全方位推广；
• 秘书处一对一贴心服务。

入会请联系同写意秘书处

 MORE▶▶ 
【同写意新药英才俱乐部会员机构】上下滑动查看更多

耀海生物 | 新合生物 | 华龛生物 | 恺佧生物 | 成都凡微析 | 正帆科技 | 大橡科技 | 博雅辑因 | 因美纳 | 博雅控股集团 | 近岸蛋白 | 依科赛生物 | 利穗科技 | 东南科仪 | 倍谙基 | 辉诺医药 | 圣诺制药 | 埃格林医药 | 科镁信 | 爱思益普 | 复星医药 | 齐鲁制药 | 捷思英达丨荣昌生物丨泽璟制药丨奕安济世丨礼新医药丨维立志博丨派格生物丨赛生医药丨呈源生物丨启德医药丨双运生物丨宝船生物丨曙方医药丨澳斯康生物丨普莱医药丨维健医药丨海昶生物丨征祥医药丨智核医药丨望石智慧丨博生吉医药丨南京诺丹丨四星玻璃丨艾米能斯丨霁因生物丨普瑞康生物丨映恩生物丨康哲生物丨霍德生物丨海慈药业丨沃生生物丨睿健医药丨矩阵元丨斯微生物丨益诺思生物丨则正医药丨预立创投丨东立创新丨博安生物丨伟德杰生物丨星奕昂生物丨上海耀乘丨琅钰集团丨康德弘翼 | 原力生命科学丨上海科洲丨特瑞思丨药源丨健艾仕生物丨冠科美博丨微境生物丨天境生物丨合源生物丨泛生子丨创胜集团丨加科思药业丨丹诺医药丨凌科药业丨偶领生物丨凯斯艾生物丨成都圣诺丨松禾资本丨清普生物丨和其瑞丨开拓药业丨科兴制药丨玉森新药丨水木未来丨分享投资丨植德律所丨奥来恩丨乐明药业丨东曜药业丨君圣泰丨海创药业丨天汇资本丨再鼎医药丨济煜医药丨百英生物丨基石药业丨君实生物丨Sirnaomics,Inc.丨亦诺微丨博腾股份丨思路迪丨艾博生物丨普瑞金生物丨未知君生物丨尚健生物丨阿诺生物丨有临医药丨赛业生物丨睿智医药丨博济医药丨晶泰科技丨药明康德丨创志科技丨奥星集团丨苏雅医药丨科贝源丨合全药业丨以岭药业丨科睿唯安丨DRG丨博瑞医药丨丽珠医药丨信立泰药业丨步长制药丨华素制药丨众生药业丨上海医药丨高博医疗集团丨药渡丨君联资本丨集萃药康丨诺思格丨精鼎医药丨百利药业丨Pfizer CentreOne丨默克中国创新中心丨奥来恩丨瑞博生物丨新通药物丨广东中润丨医普科诺丨诺唯赞丨康利华丨国信医药丨昆翎丨博纳西亚丨缔脉丨一品红丨和泽医药丨博志研新丨凯莱英医药丨汉佛莱丨英派药业丨京卫制药丨海思科药业丨宏韧医药丨开心生活科技丨哈三联丨Premier Research丨宣泰医药丨先声药业丨海金格丨普瑞盛医药丨Informa丨科特勒丨谋思医药丨HLT丨莱佛士丨辉瑞丨科林利康丨中美冠科丨科文斯丨卫信康丨龙沙（Lonza）丨美迪西丨阳光诺和丨润东医药丨勃林格殷格翰（中国）丨艾苏莱生物丨领晟医疗丨驯鹿医疗丨燃石医学丨中肽生化丨鸿运华宁丨泰格医药丨易迪希丨希麦迪丨百奥赛图丨迪纳利丨青云瑞晶丨鼎丰生科资本丨中源协和丨维亚生物丨青松医药丨中科谱研丨长风药业丨艾欣达伟丨武汉鼎康丨中晟全肽丨海步医药丨勤浩医药丨奥萨丨太美医疗科技丨生特瑞丨东富龙丨Cytiva丨优辰实验室丨苏桥生物丨君达合创丨澎立生物丨南京澳健丨南京科默丨东阳光丨亚盛医药丨杰克森实验室丨恒诺康丨上海科州丨三优生物丨三迭纪丨泰诺麦博丨Cell Signaling Technology丨PPC佳生丨澳斯康丨先为达丨智享生物丨锐得麦丨宜明昂科丨明济生物丨英百瑞丨六合宁远丨天津天诚丨百拓生物丨星药科技丨亓上生物丨真实生物丨引光医药丨方达医药丨高博医疗集团丨赞荣医药丨国投创新丨药明生物丨康哲药业丨高特佳投资丨普瑞基准丨臻格生物丨微谱医药丨和玉资本 | 倚锋资本