Polpharma
仿制药、原料药、生物制剂和非处方药。
Polpharma 通过其 Starogard Gdanski 工厂生产仿制药、原料药、生物制剂和非处方药。该公司向其上市主要市场的药房渠道、医院买家、医疗保健分销商或出口客户提供服务。
- Type
- manufacturer (our classification of the record, not a statement by the company)
- Role
- Manufacturer
- Location
- Starogard Gdanski, Poland
- Founded
- 1935
- Website
- polpharma.com
- Categories
- 医疗保健用品, 补充剂与健康
- Markets
- 波兰, 德国, 捷克, 哈萨克斯坦
What is established and what is not
No facet of this company has been investigated yet. The facts below are collected records, not an assessment: nothing here confirms manufacturing, ownership or trading status beyond what each record literally says.
Verified facts
- sanctions-clear (green), checked 2026-08-12 - screened by name only: no legal entity is established for this record, so this is not a clearance OpenSanctions
- debarment-clear (green), checked 2026-08-12 - screened by name only: no legal entity is established for this record, so this is not a clearance OpenSanctions
- domain-registered (green), checked 2026-08-12 Domain registry record
Claimed certifications, not confirmed by us
- Good Manufacturing Practice
- 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)