WuXi PharmaTech ( WX),
a leading pharmaceutical, biotechnology and medical device research and
development outsourcing company with operations in China and the United States,
announced today that it received the formal certificate of GMP compliance from
the Medical Products Agency (MPA) of Sweden, acting on behalf of the European
Medicines Agency (EMEA), for its c-GMP drug product manufacturing and
analytical testing facilities located in Shanghai.
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," commented 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."