Hanmi Pharmaceutical Co., Ltd.
Leading Korean pharmaceutical company producing generics, biosimilars, and innovative drugs; sign…
Leading Korean pharmaceutical company producing generics, biosimilars, and innovative drugs; significant R&D licensing to global pharma.
- Type
- Manufacturer
- Location
- Seoul, South Korea
- Founded
- 1973
- Website
- hanmipharm.com
- Categories
- Medical & Healthcare Supplies
- Markets
- South Korea, United States, Germany, France, China
Verified facts
- domain-registered (green), checked 2026-08-10 Domain registry record
- sanctions-clear (green), checked 2026-08-10 OpenSanctions
- debarment-clear (green), checked 2026-08-10 OpenSanctions
Claimed certifications
- Good Manufacturing Practice
- FDA Registered FDA Establishment Registration
- ISO 9001, Quality 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)