WuXi PharmaTech has completed a general GMP and Pre-Approval Inspection (PAI) from the FDA for the manufacturing facility of WuXi’s wholly owned subsidiary Shanghai SynTheAll Pharmaceutical Co. Ltd. (STA). No Form 483 was issued.

STA has a manufacturing pipeline of small molecule APIs and advanced intermediates for global clients through its integrated platform, which extends from process research and research manufacturing to commercial manufacturing. The inspection outcome confirms STA’s capabilities.  

“The result of this inspection speaks to WuXi’s high standards of quality,” said Dr. Ge Li, chairman and chief executive officer of WuXi PharmaTech. “We continue to leverage our knowledge and that of our partners to build and operate a first-class quality system in China that meets global regulatory requirements.”