Bioton S.A.
波兰胰岛素和重组蛋白生物制药制造商。
Bioton S.A. 在 Macierzysz 生产人胰岛素、生物仿制药胰岛素和重组蛋白 API。该公司成立于 1989 年，为中东欧、独联体和亚洲的药品经销商、公共卫生采购机构和医院批发商提供服务。
- Type
- manufacturer (our classification of the record, not a statement by the company)
- Role
- Manufacturer
- Location
- Macierzysz, Poland
- Founded
- 1989
- Website
- bioton.pl
- Categories
- 医疗保健用品, 补充剂与健康
- Markets
- 波兰, 乌克兰, 中国
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
- registry-activity (green), checked 2026-08-21 REGON national business register (GUS, Poland)
- gmp-certified (green), effective since 2025-11-07 EudraGMDP, EU register of GMP certificates (EMA)
- corporate-mail-on-domain (green), checked 2026-08-06 Mail server of the company domain
- domain-registered (green), checked 2026-08-06 Domain registry record
- debarment-clear (green), checked 2026-08-06 OpenSanctions
- certificate-page-on-site (amber), checked 2026-09-18 Company's own certification page
- registered-address (green), checked 2026-08-20 Ministry of Finance VAT white list (Poland)
- facility-registered (green), checked 2026-08-16 European Industrial Emissions Portal (E-PRTR / IED), European Environment Agency
- operating-permit (green), checked 2026-08-16 EudraGMDP manufacturing authorisation register (EMA)
- media-mention (green), checked 2026-07-18 marketscreener.com
- sanctions-clear (green), checked 2026-08-06 OpenSanctions
- vat-valid (green), checked 2026-08-06 VIES
Claimed certifications, not confirmed by us
- ISO 9001, Quality Management IAF CertSearch
Import rules for these goods
- Food supplements sold in the EU follow Directive 2002/46/EC: most member states require a notification to the national authority before the first sale. European Commission (supplements)
- 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)