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.
AbbVie's ELAHERE receives full US FDA approval
Johnson & Johnson's OPSYNVI receives US FDA approval
Outlook Therapeutics receives positive CHMP opinion for ONS-5010 in wet AMD treatment
Human Immunology Biosciences receives ODD from FDA for felzartamab
Eton Pharmaceuticals acquires PKU GOLIKE, expanding rare disease portfolio
Vertex receives FDA clearance for VX-407 Investigational New Drug Application for ADPKD
Phanes Therapeutics receives FDA Fast Track designation for PT886
Bio-Thera Solutions signs new licensing agreement with SteinCares
FDA accepts resubmission of Citius Pharmaceuticals, Inc's BLA for LYMPHIR
GSK Plc reports positive Phase III Jemperli data for endometrial cancer
ImmVira receives FDA Fast Track designation for MVR-T3011 IT