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Becomes the first biologics company in China to do so
February 22, 2019
By: Tim Wright
Editor-in-Chief, Contract Pharma
The European Medicines Agency (EMA) has completed the Pre-Approval Inspection (PAI) of Wuxi Biologics’ cGMP drug substance (DS) and drug product (DP) manufacturing facilities for the production of TaiMed Biologics’ Trogarzo with no critical findings. WuXi Biologics will submit responses to the EMA inspection report in March 2019 and expects to obtain GMP certification for its facilities in May 2019. According to the company, this is the first inspection of its kind in China. Upon complet...
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