合全药业外高桥基地顺利通过首个制剂项目美国FDA上市前检查

NEWS

中国上海，2022年1月4日，药明康德子公司合全药业宣布，其上海外高桥基地在2021年10月22日至26日接待了美国FDA针对其合作伙伴的1款创新药的制剂研发和生产进行的上市批准前检查（PAI, Pre-Approval Inspection）。日前得到消息，该PAI已顺利通过。

FDA检察官开展了为期5天的现场综合检查，范围包括厂房设施及设备、实验室、质量管理体系、制剂生产、物料管理、计算机控制系统以及数据完整性等。覆盖范围广、涉及明细多。

尤其值得一提的是，在接受美国FDA检查的同一周，合全药业外高桥基地还同时接待了中国NMPA，针对其另外2个合作伙伴的2款创新药的制剂研发和生产条件进行的PAI，且均已顺利通过。一周内同时接待美国FDA和中国NMPA 共3个制剂项目PAI，具备应对如此检查强度的能力再一次证明了合全药业拥有符合国际标准的质量体系，可以为合作伙伴的创新药上市提供坚实的质量保证。

目前，合全药业外高桥基地可提供从药物固态研究、处方前开发、处方开发、到临床及商业化GMP的制剂产品供应的研发和生产一体化服务，能够提供各种不同剂型的口服制剂。此次是外高桥基地针对制剂项目首次完成FDA药品上市批准前检查，将助力合全药业更好地为全球客户提供制剂商业化生产服务。

作为全球新药合作研究开发生产领域（CDMO）的领军企业，合全药业一直将质量视作生命线和核心竞争力。截至目前，合全药业已累计40余次顺利通过美国食品药品监督管理局（FDA）、中国国家药品监督管理局（NMPA）、欧洲药品管理局（EMA）、日本医药品医疗器械综合机构（PMDA）等监管机构的官方审计，可以满足全球客户的质量需求，支持多国申报。此外，合全药业在北美、欧洲和中国八大研发生产基地施行统一的质量体系，保障产品质量，为赋能全球合作伙伴奠定了坚实基础，近年来已成功支持合作伙伴的34款创新药获批，并在全球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：

很高兴合全药业制剂业务平台首次通过FDA药品上市前检查，这是公司发展的又一里程碑，表明我们的制剂业务平台将开始面向美国市场为客户提供制剂商业化生产服务。符合国际标准的质量体系是合全继续拓展全球布局，更好地赋能全球合作伙伴的重要基础。未来，我们将继续通过一体化CMC平台以及全球研发和生产网络，赋能更多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

WuXi STA Passes the First U.S. FDA Drug Product Pre-Approval Inspection at its Shanghai Waigaoqiao site

NEWS

SHANGHAI, CHINA, January 4, 2022 – WuXi STA – a subsidiary of WuXi AppTec, announced that its Waigaoqiao site in Shanghai, China, successfully passed the first drug product pre-approval inspection (PAI) by the US FDA.

During the 5-day inspection from Oct. 22 - 26, 2021, the FDA inspector conducted a comprehensive onsite assessment including manufacturing facility and equipment, laboratories, quality management system, tablet production, material handling, computer control systems, and data integrity. Within the same week, the site also successfully passed two additional drug product PAIs by the China NMPA for two innovative drugs from its partners. Three successful drug product PAIs during one single week is a testimony to WuXi STA’s robust and reliable quality system.

WuXi STA’s drug product services at the Shanghai Waigaoqiao site include solid-state development, pre-formulation, formulation development, and clinical to commercial manufacturing for a broad range of oral dosage forms.

WuXi STA has passed over 40 inspections from all major regulatory agencies including US FDA, EMA, China NMPA and Japan PMDA. All eight sites across North America, Europe and Asia, follow the same quality system ensuring high-quality products manufactured for its partners worldwide. To date, WuXi STA has supported 34 new drug approvals globally. 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 our drug product platform in Waigaoqiao has successfully passed its first PAI by the US FDA. It is another milestone that the site starts to provide commercial drug product manufacturing services to the US market. With our industry-leading global CMC platform and proven quality system, we strive to empower more partners to accelerate their innovative medicines to market 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