WuXiPharmaTech’s subsidiary, Shanghai SynTheAll Pharmaceutical Co. Ltd. (STA), passed an FDA inspection in July for the manufacture of the API for an undisclosed branded commercial drug.
This is the first FDA inspection of STA's facilities for the manufacture of an API. The company had previously received FDA approval for the manufacture of an advanced intermediate. STA provides process research to commercial manufacturing.
"We are very pleased to have passed a second FDA inspection of our manufacturing facilities," said Dr. Ge Li, chairman and chief executive officer of WuXiPharmaTech. "These favorable outcomes reflect our dedication to maintaining the highest quality standards throughout our organization."