WuXi Biologics' Four Manufacturing Facilities and Biosafety Testing Center Receive Re-Certification from European Medicines Agency for Ten Biologics
Friday, August 02, 2024
WuXi Biologics (2269.HK), a prominent global Contract Research, Development, and Manufacturing Organization (CRDMO), has announced that four of its manufacturing facilities, along with the Suzhou Biosafety Testing Center in China, have earned Good Manufacturing Practice (GMP) certification from the European Medicines Agency (EMA). This recognition highlights WuXi Biologics' adherence to rigorous international quality standards across its global network.
The facilities MFG1, MFG2, MFG5, and DP1 in Wuxi received EMA GMP certification for both commercial and New Drug Application (NDA)-ready manufacturing services for eight biologics. These facilities had previously been approved by the EMA and other major regulatory bodies for the development of various biologic therapeutics. Additionally, the Suzhou Biosafety Testing Center was re-certified by the EMA to support ten novel therapies, including the eight biologics produced in Wuxi.
WuXi Biologics has a strong history of quality compliance. Since 2017, the company has successfully completed 35 inspections by global regulatory agencies, more than 1,250 GMP quality audits by international clients, and over 145 audits by EU Qualified Persons. WuXi Biologics operates 15 GMP-certified drug substance and drug product facilities worldwide.
WuXi Biologics, remarked, “We are pleased to receive re-certification from the EMA, reflecting our continued commitment to the highest quality standards. Quality audits are essential for ensuring the safety and efficacy of the pharmaceutical industry, and WuXi Biologics is dedicated to helping our clients deliver high-quality biologics to patients globally.”
Source: wuxibiologics.com
