Aug 2, 2017
The U.S. FDA Completed Pre-License Inspection (PLI) of WuXi Biologics cGMP Manufacturing Facilities for Production of TM
TaiMed Biologics (4147.TWO) and its partner WuXi Biologics (2269.HK) today announced that the U.S. Food and Drug Administration (U.S. FDA) has completed the Pre-License Inspection (PLI) of WuXi Biologics cGMP Manufacturing Facilities for production of TMB-355 (ibalizumab) with no critical findings. The 5-inspector 13-day inspection covered both drug substance and drug product cGMP manufacturing facilities in the city of Wuxi, China. WuXi Biologics is expected to complete all follow-up actions, which should not impact the BLA review timeline of Ibalizumab.
Source：TaiMed Biologics Inc.
http://www.taimedbiologics.com/news/info/69
Source：TaiMed Biologics Inc.
http://www.taimedbiologics.com/news/info/69