WuXi STA, a subsidiary of WuXi AppTec, has successfully passed its first pre-approval inspection (PAI) and received the GMP Compliance Certificate from the European Medicines Agency (EMA) for its drug product facility in Wuxi City, China  
 
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, 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. 
 
Dr. Minzhang Chen, Co-CEO of WuXi AppTec and CEO of WuXi STA, said, “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.”