04.23.19
WuXi Biologics said that its drug substance (DS) and drug product (DP) manufacturing facilities at Wuxi city successfully completed a seven-day FDA surveillance inspection by three inspectors for the production of Trogarzo, the first routine GMP inspection since product approval. FDA typically conducts this inspection every two years upon product approval.
The facilities passed the U.S. FDA Pre-License Inspection in 2017, as well as the European Medicines Agency (EMA) Pre-Approval Inspection in March this year. During all three inspections, the company reported no issues related to data integrity, which demonstrates expertise in addressing this regulatory requirement. WuXi Biologics is the first and only Chinese biologics company to be approved by the U.S. FDA, as well as the first and only biologics company in China to be approved by EMA.
"Once again we are very proud of successfully completing the FDA inspection. It is a strong testament to our commitment in maintaining the highest global quality standards," said Chris Chen, chief executive officer, WuXi Biologics. "This result provides powerful support for our unique manufacturing paradigm, “Global Dual Sourcing within WuXi Biologics,” as we expand biomanufacturing capacity and capabilities in China, Ireland, Singapore and the U.S. WuXi Biologics will continue to advance its global biomanufacturing network to ensure that biologics are manufactured at the highest quality and with a robust supply chain to enable partners and benefit patients worldwide."
The facilities passed the U.S. FDA Pre-License Inspection in 2017, as well as the European Medicines Agency (EMA) Pre-Approval Inspection in March this year. During all three inspections, the company reported no issues related to data integrity, which demonstrates expertise in addressing this regulatory requirement. WuXi Biologics is the first and only Chinese biologics company to be approved by the U.S. FDA, as well as the first and only biologics company in China to be approved by EMA.
"Once again we are very proud of successfully completing the FDA inspection. It is a strong testament to our commitment in maintaining the highest global quality standards," said Chris Chen, chief executive officer, WuXi Biologics. "This result provides powerful support for our unique manufacturing paradigm, “Global Dual Sourcing within WuXi Biologics,” as we expand biomanufacturing capacity and capabilities in China, Ireland, Singapore and the U.S. WuXi Biologics will continue to advance its global biomanufacturing network to ensure that biologics are manufactured at the highest quality and with a robust supply chain to enable partners and benefit patients worldwide."
