Samsung Biologics
Biologics contract development and manufacturing services.
Samsung Biologics manufactures biologics contract development and manufacturing services 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
- 2011
- Website
- samsungbiologics.com
- Categories
- Medical & Healthcare Supplies
- Markets
- South Korea, United States, Germany, Singapore
Verified facts
- certificate-page-on-site (amber), checked 2026-08-11 Company's own certification page
- domain-registered (green), checked 2026-08-09 Domain registry record
- sanctions-clear (green), checked 2026-08-09 OpenSanctions
- debarment-clear (green), checked 2026-08-09 OpenSanctions
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)