The certification covers single-dose and multiple-dose toxicology studies in both rodents and non-rodents, GeneTox studies (Ames, micronucleus, and chromosome aberration), and toxicokinetic studies.
According to WuXi PharmaTech, the SFDA has qualified the company for this certification depending on its review of the company’s management, personnel, test facilities, standard operating procedures, and study operations.
In September, WuXi’s Suzhou facility had received GLP certification from the Organisation for Economic Cooperation and Development.
WuXi PharmaTech chairman and CEO Ge Li said that this certificate from the SFDA is an important milestone in offering the clients toxicology studies that meet both domestic and international GLP quality standards for filing INDs both in China and other countries.
"With this award, WuXi moves a step closer to achieving its goal of offering our pharmaceutical and biotech clients a comprehensive, fully integrated platform of pharmaceutical R&D services," Li said.