Celltrion
Биоаналоги, биологические препараты и препараты на основе антител.
Celltrion производит биоаналоги, биологические препараты и терапевтические средства на основе антител на своих предприятиях в Инчхоне. Компания поставляет системы здравоохранения, лаборатории, OEM-партнерам или регулируемым экспортным клиентам на перечисленных основных рынках.
- Type
- brand seeking distribution
- Location
- Incheon, South Korea
- Founded
- 2002
- Website
- celltrion.com
- Categories
- Медицинские товары и расходники
- Markets
- Республика Корея, Соединенные Штаты, Германия, Япония
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 2026-08-30 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)