WuXi Biologics Again Passed GMP Inspection by Japan PMDA
WuXi Biologics (2269.HK) has successfully passed a GMP inspection by Japan's Pharmaceuticals and Medical Devices Agency (PMDA) for its drug substance facilities MFG2 and MFG5 in Wuxi city. The inspection, which evaluated the facilities' quality processes and production system, concluded without issues.
The company has now achieved a total of 42 regulatory inspections and received 97 license approvals from drug administration agencies across multiple countries including the U.S., Europe, China, Singapore, Japan and Canada. This track record demonstrates the company's compliance with global regulatory standards and robust quality system.
WuXi Biologics (2269.HK) ha superato con successo un'ispezione GMP da parte dell'Agenzia giapponese dei farmaci e dei dispositivi medici (PMDA) per i suoi impianti di sostanze farmaceutiche MFG2 e MFG5 nella città di Wuxi. L'ispezione, che ha valutato i processi di qualità e il sistema di produzione degli impianti, si è conclusa senza problemi.
L'azienda ha ora raggiunto un totale di 42 ispezioni regolatorie e ha ricevuto 97 approvazioni di licenza da agenzie di amministrazione dei farmaci in diversi paesi, tra cui Stati Uniti, Europa, Cina, Singapore, Giappone e Canada. Questo record dimostra la conformità dell'azienda agli standard regolatori globali e a un sistema di qualità robusto.
WuXi Biologics (2269.HK) ha pasado con éxito una inspección GMP por parte de la Agencia de Productos Farmacéuticos y Dispositivos Médicos de Japón (PMDA) para sus instalaciones de sustancias farmacéuticas MFG2 y MFG5 en la ciudad de Wuxi. La inspección, que evaluó los procesos de calidad y el sistema de producción de las instalaciones, concluyó sin problemas.
La empresa ha logrado un total de 42 inspecciones regulatorias y ha recibido 97 aprobaciones de licencia de agencias de administración de medicamentos en varios países, incluidos EE. UU., Europa, China, Singapur, Japón y Canadá. Este historial demuestra el cumplimiento de la empresa con los estándares regulatorios globales y un sistema de calidad sólido.
우시 바이오로직스 (2269.HK)는 중국 우시시에 있는 약물 물질 시설 MFG2 및 MFG5에 대해 일본의 의약품 및 의료기기청(PMDA)의 GMP 검사를 성공적으로 통과했습니다. 이 검사는 시설의 품질 프로세스와 생산 시스템을 평가했으며, 문제 없이 결론지어졌습니다.
회사는 현재까지 총 42건의 규제 검사를 수행하였고, 미국, 유럽, 중국, 싱가포르, 일본 및 캐나다를 포함한 여러 국가의 약물 관리 기관으로부터 97건의 라이센스 승인을 받았습니다. 이 기록은 회사가 글로벌 규제 기준을 준수하고 강력한 품질 시스템을 갖추고 있음을 보여줍니다.
WuXi Biologics (2269.HK) a réussi avec succès une inspection GMP par l'Agence japonaise des produits pharmaceutiques et des dispositifs médicaux (PMDA) pour ses installations de substances médicamenteuses MFG2 et MFG5 dans la ville de Wuxi. L'inspection, qui a évalué les processus de qualité et le système de production des installations, s'est conclue sans problèmes.
L'entreprise a désormais atteint un total de 42 inspections réglementaires et a reçu 97 approbations de licence de la part d'agences de réglementation des médicaments dans plusieurs pays, y compris les États-Unis, l'Europe, la Chine, Singapour, le Japon et le Canada. Ce bilan démontre la conformité de l'entreprise aux normes réglementaires mondiales et un système de qualité robuste.
WuXi Biologics (2269.HK) hat erfolgreich eine GMP-Inspektion der japanischen Arzneimittel- und Medizinproduktebehörde (PMDA) für seine Wirkstoffanlagen MFG2 und MFG5 in der Stadt Wuxi bestanden. Die Inspektion, die die Qualitätsprozesse und das Produktionssystem der Anlagen bewertete, wurde ohne Beanstandungen abgeschlossen.
Das Unternehmen hat nun insgesamt 42 regulatorische Inspektionen durchgeführt und 97 Lizenzgenehmigungen von Arzneimittelbehörden in mehreren Ländern, darunter die USA, Europa, China, Singapur, Japan und Kanada, erhalten. Diese Erfolgsbilanz zeigt die Einhaltung globaler regulatorischer Standards und ein robustes Qualitätssystem des Unternehmens.
- Passed PMDA GMP inspection without issues
- Achieved 42 successful regulatory inspections globally
- Obtained 97 license approvals across major markets
- None.
This onsite inspection covered the facilities' quality processes and the entire production system. It concluded without issues, demonstrating the company's robust expertise in meeting global regulatory requirements.
To date, WuXi Biologics has successfully passed 42 regulatory inspections and has received 97 license approvals from drug administration agencies across multiple countries and regions, including the
Dr. Chris Chen, CEO of WuXi Biologics, commented, "Our world-class quality system is the cornerstone to maintain the company's strong sustainable growth and has laid a solid foundation for our global network to support our clients worldwide. WuXi Biologics will continue to enable global partners in delivering life-saving treatments with speed and efficacy, ultimately benefiting patients worldwide."
About WuXi Biologics
WuXi Biologics (stock code: 2269.HK) is a leading global Contract Research, Development and Manufacturing Organization (CRDMO) offering end-to-end solutions that enable partners to discover, develop and manufacture biologics – from concept to commercialization – for the benefit of patients worldwide.
With over 12,000 skilled employees in
WuXi Biologics views Environmental, Social, and Governance (ESG) responsibilities as an integral component of our ethos and business strategy, and we aim to become an ESG leader in the biologics CRDMO sector. Our facilities use next-generation biomanufacturing technologies and clean-energy sources. We have also established an ESG committee led by our CEO to steer the comprehensive ESG strategy and its implementation, enhancing our commitment to sustainability.
For more information about WuXi Biologics, please visit: www.wuxibiologics.com.
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SOURCE WuXi Biologics
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