Biopharma Ukraine
乌克兰领先的血浆衍生血液制品和生物制剂制造商
乌克兰生物制药公司在基辅的经 WHO-GMP 认证的工厂生产血浆衍生药品、免疫球蛋白、白蛋白和其他生物制品。该公司是乌克兰血浆产品的主要供应商，并向独联体国家、东欧和非洲出口医药级生物制剂。
- Type
- Manufacturer
- Location
- Kyiv, Ukraine
- Founded
- 1994
- Website
- biopharma.com.ua
- Categories
- 医疗保健用品
- Markets
- 乌克兰, 白俄罗斯, 哈萨克斯坦, 乌兹别克斯坦, 阿塞拜疆, 摩尔多瓦
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)