- WuXi Biologics' DP5 and DPPC facilities received GMP certification from the UK MHRA.
- The facilities passed a four-day inspection with no critical findings.
- WuXi Biologics has passed 46 regulatory inspections and obtained 136 facility license approvals.
- The company operates 15 GMP-certified facilities globally.
GMP Certification Achievement
WuXi Biologics announced that its Drug Product Facility 5 (DP5) and Drug Product Packaging Center (DPPC) in Wuxi have received GMP certifications from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for the commercial manufacturing of an ophthalmic biologic. The certification follows a four-day inspection with no critical findings, highlighting the company's robust quality and compliance systems.
Facility Capabilities
DP5 is WuXi Biologics' first commercial pre-filled syringe manufacturing facility, offering solutions for both clinical and commercial manufacturing. DPPC provides end-to-end customized packaging services, compliant with international traceability code requirements. Both facilities have previously received approvals from major global regulatory authorities for producing multiple biologic therapeutics.
Regulatory Success
As of the end of 2025, WuXi Biologics has successfully passed 46 regulatory inspections, including 22 by the FDA and EMA, and obtained 136 facility license approvals. The company maintains a 100% pass rate for FDA Pre-License Inspections and has completed over 1,800 GMP quality audits by global clients, including more than 230 audits by EU Qualified Persons.
Global Operations
WuXi Biologics operates 15 GMP-certified drug substance and drug product facilities within its global network. The company's world-class quality and compliance capabilities are fundamental to maintaining client trust and supporting its extensive global operations.
