Research & Development
WuXi Biologics successfully concludes first US FDA routine GMP Inspection at its facilities
17 April 2019 -

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.