WuXi PharmaTech Awarded GLP Certificate from SFDA for Suzhou Toxicology Facility
Nov 11, 2010
Nov 11, 2010 – WuXi PharmaTech (NYSE: WX), a leading pharmaceutical, biotechnology and medical device research and development outsourcing company with operations in China and the United States, today announced that it had been awarded a Certificate of Good Laboratory Practice (GLP) compliance from the State Food and Drug Administration (SFDA), China's regulatory authority for pharmaceuticals, for its toxicology facility in Suzhou. Good Laboratory Practice is a quality system concerned with the organizational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived, and reported.
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. WuXi qualified for this certification as a result of SFDA review of its management, personnel, test facilities, standard operating procedures, and study operations. Receipt of this certification is necessary in order to perform toxicology studies to be filed in Investigational New Drug (IND) applications with the SFDA.
In September, WuXi announced that the Suzhou facility had received GLP certification from the Organization for Economic Cooperation and Development.
"This certificate from the SFDA is an important milestone in offering our clients toxicology studies that meet both domestic and international GLP quality standards for filing INDs both in China and other countries," said Dr. Ge Li, chairman and CEO of WuXi PharmaTech. "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."
About WuXi AppTec and WuXi PharmaTech
WuXi PharmaTech is a leading pharmaceutical, biotechnology, and medical device R&D outsourcing company, with operations in China and the United States. As a research-driven and customer-focused company, we provide a broad and integrated portfolio of laboratory and manufacturing services throughout the drug and medical device R&D process. Our services are designed to help our global partners to improve the success of research and shorten the time of development cost effectively in discovering and developing drugs and medical devices. Please visit: http://www.wuxiapptec.com.