WuXi PharmaTech's Shanghai analytical testing facilities gain GMP certification
9 March 2010
WuXi PharmaTech (NYSE:WX) , a pharmaceutical, biotechnology and medical device research and development outsourcing company has received European GMP compliance certification for its c-GMP drug product manufacturing and analytical testing facilities in Shanghai.
The company, which has operations in China and the United States has received the formal certificate of GMP compliance from the Medical Products Agency (MPA) of Sweden, acting on behalf of the European Medicines Agency (EMEA).
WuXi produces solid oral dosage forms-tablets and capsules-for use in clinical trials in its Shanghai c-GMP manufacturing facility. In its analytical testing facility, WuXi develops and validates methods of analyzing APIs and formulated drug products for properties such as potency, purity and solubility.
The company also offers compound stability tests and tests necessary for the release of APIs and drug products for clinical trial use. WuXi also delivers services related to regulatory compliance with chemistry, manufacturing and controls, or CMC, requirements, including creation of a readiness testing package for an Investigational New Drug filing and development of a full CMC package.
"We are very pleased to have passed this EMEA audit," said Dr. Ge Li, Chairman and Chief Executive Officer of WuXi PharmaTech. "The agency's inspection outcome confirms that these two facilities meet international GMP standards.
"We pride ourselves on the quality of our facilities, processes, and people," Dr Li continued. "Research manufacturing and analytical testing are important functions in a continuum of integrated drug discovery and development services that WuXi provides to our global customers. Our mission is to help our global customers to improve the success of discovery and shorten the time of development of new medical products."