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WuXi Biologics Completes First FDA Routine GMP Inspection

Production of Trogarzo is now approved at the Wuxi facility

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By: Tim Wright

Editor-in-Chief, Contract Pharma

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 i...

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