Biologics technology company WuXi Biologics (2269.HK) disclosed on Tuesday that its Drug Substance (DS) and Drug Product (DP) manufacturing facilities at Wuxi city has passed the US FDA seven-day surveillance inspection.
Under the US FDA's GMP regulations and surveillance, the three US FDA inspectors completed the inspection of the company's facilities for the production of Trogarzo, the first routine GMP inspection since product approval.
The US FDA conducts this inspection every two years upon product approval.The facilities passed the US FDA Pre-License Inspection in 2017, as well as the European Medicines Agency (EMA) Pre-Approval Inspection in March this year. It is the first and only Chinese biologics company to be approved by the US FDA, as well as EMA.
Under all three inspections, there are no issues related to data integrity, which demonstrates strong expertise in addressing this regulatory requirement, and the quality system at the company strictly adheres to the US FDA's GMP regulations.
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