Hanmi Pharmaceutical Co., Ltd.
生产仿制药、生物仿制药和创新药的领先韩国制药公司；标志…
生产仿制药、生物仿制药和创新药的领先韩国制药公司；向全球制药公司授予重要的研发许可。
- Type
- Manufacturer
- Location
- Seoul, South Korea
- Founded
- 1973
- Website
- hanmipharm.com
- Categories
- 医疗保健用品
- Markets
- 韩国, 美国, 德国, 法国, 中国
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)