Research & Development
WuXi Biologics announces EMA Pre-Approval Inspection of cGMP DS and DP Facilities
19 February 2019 -

Biologics technology company WuXi Biologics (stock code:2269.HK) reported on Monday the receipt of European Medicines Agency (EMA) Pre-Approval Inspection (PAI) for its cGMP Drug Substance (DS) and Drug Product (DP) manufacturing facilities with no critical findings.

The European Medicines Agency (EMA) Pre-Approval Inspection (PAI) for WuXi Biologics' cGMP Drug Substance (DS) and Drug Product (DP) manufacturing facilities allows the company to begin the production of TaiMed Biologics' Trogarzo .

Following this inspection, the company will submit responses to the EMA inspection report in March 2019 and expects to obtain GMP certification in May 2019.

Upon completion of this inspection, WuXi Biologics said it will have the first cGMP biologics DS facility, the first cGMP biologics DP facility and the first cGMP cell banking facility in China to be approved by the EMA for commercial manufacturing.

WuXi Biologics added that its DS and DP facilities are the first in China to pass the US FDA inspection enabling the facilities to supply biologics globally.

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