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
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