WuXi Biologics (Cayman) Inc.
CDMO biologi global yang menawarkan layanan pengembangan dan manufaktur menyeluruh untuk monoklonal…
CDMO biologi global menawarkan layanan pengembangan dan manufaktur menyeluruh untuk antibodi monoklonal, vaksin, serta terapi sel dan gen. Mengoperasikan kapasitas bioreaktor cGMP di Tiongkok, Irlandia, Jerman, dan Amerika Serikat, melayani lebih dari 600 klien global.
- Type
- Manufacturer
- Location
- Wuxi, China
- Founded
- 2010
- Website
- wuxibiologics.com
- Categories
- Perlengkapan Medis & Kesehatan
- Markets
- Tiongkok, Amerika Serikat, Jerman, Inggris Raya, Irlandia
Verified facts
- domain-registered (green), checked 2026-08-10 Domain registry record
- sanctions-clear (green), checked 2026-08-10 OpenSanctions
- corporate-mail-on-domain (green), checked 2026-08-10 Mail server of the company domain
- debarment-clear (green), checked 2026-08-10 OpenSanctions
Claimed certifications
- ISO 9001, Quality Management IAF CertSearch
- Good Manufacturing Practice
- FDA Registered FDA Establishment Registration
- ISO 14001, Environmental Management IAF CertSearch
Import rules for these goods
- Medical devices sold in the EU must carry CE marking under the Medical Device Regulation (EU) 2017/745, with a conformity assessment matched to the device risk class. European Commission (MDR)
- For the US market, the maker must have an FDA device establishment registration and product listing; most instruments also need 510(k) premarket clearance. US FDA (devices)