Celltrion
Biosimilars, biologics and antibody therapeutics.
Celltrion manufactures biosimilars, biologics and antibody therapeutics from its Incheon operations. The company supplies healthcare systems, laboratories, OEM partners or regulated export customers across its listed primary markets.
- Type
- Manufacturer
- Location
- Incheon, South Korea
- Founded
- 2002
- Website
- celltrion.com
- Categories
- Medical & Healthcare Supplies
- Markets
- South Korea, United States, Germany, Japan
Verified facts
- corporate-mail-on-domain (green), checked 2026-08-08 Mail server of the company domain
- domain-registered (green), checked 2026-08-08 Domain registry record
- debarment-clear (green), checked 2026-08-08 OpenSanctions
- sanctions-clear (green), checked 2026-08-08 OpenSanctions
- product-authorised-for-sale (green), checked 2026-08-21 Ministry of Health of Armenia, State Register of Medicinal Products (pharm.am)
- certificate-page-on-site (amber), checked 2026-08-11 Company's own certification page
- registered-manufacturer (green), checked 2026-08-18 Chemistry, Food and Drugs Division, Ministry of Health of Trinidad and Tobago, register of drugs (Food and Drugs Act Chap. 30:01)
Claimed certifications
- Good Manufacturing Practice
- FDA Registered FDA Establishment Registration
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)