WuXi PharmaTech, a pharmaceutical, biotechnology and medical device research and development outsourcing company with operations in China and the United States, announced today that the small molecule API and advanced intermediate manufacturing facility of WuXi's wholly owned subsidiary Shanghai SynTheAll Pharmaceutical Co. Ltd. (STA) completed a general GMP and Pre-Approval Inspection from the U.S. Food and Drug Administration with no Form 483s issued.
STA has built a substantial manufacturing pipeline of small molecule APIs and advanced intermediates for our global clients through its integrated platform, which extends from process research and research manufacturing to commercial manufacturing. This inspection outcome confirms STA's capabilities in helping the clients move their new chemical entities through clinical development stages and eventually to commercial launch in the global market.
"The result of this inspection speaks to WuXi's high standards of quality," said Dr. Ge Li, Chairman and CEO 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."