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WuXi Passes EMEA Inspection

WuXi PharmaTech received a certificate of GMP compliance from the Medical Products Agency (MPA) of Sweden, on behalf of the European Medicines Agency (EMEA), for its cGMP drug product manufacturing and analytical testing facilities in Shanghai.

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By: Tim Wright

Editor-in-Chief, Contract Pharma

WuXi PharmaTech received a certificate of GMP compliance from the Medical Products Agency (MPA) of Sweden, on behalf of the European Medicines Agency (EMEA), for its cGMP drug product manufacturing and analytical testing facilities in Shanghai.

The Shanghai facility produces solid oral dosage forms for use in clinical trials; the analytical testing facility develops and validates methods of analyzing APIs and formulated drug products for properties such as potency, purity and solubility. Additionally, the company offers compound stability tests and tests for the release of APIs and drug products for clinical trial use. WuXi also provides services related to regulatory compliance with chemistry, manufacturing and controls (CMC) requirements, including a readiness testing package for an IND 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. Our mission is to help our global customers to improve the success of discovery and shorten the time of development of new medical products.”

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