WuXi PharmaTech's Shanghai analytical testing facilities gain GMP
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
"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