Bioton S.A.
Polnischer biopharmazeutischer Hersteller von Insulin und rekombinanten Proteinen.
Bioton S.A. stellt in Macierzysz Humaninsulin, Biosimilar-Insulin und rekombinante Protein-API her. Das 1989 gegründete Unternehmen beliefert Pharmahändler, öffentliche Gesundheitsbeschaffungsagenturen und Krankenhausgroßhändler in Mittel- und Osteuropa, der GUS und Asien.
- Type
- brand seeking distribution
- Location
- Macierzysz, Poland
- Founded
- 1989
- Website
- bioton.pl
- Categories
- Medizin- & Gesundheitsbedarf, Nahrungsergänzung & Wellness
- Markets
- Polen, Ukraine, China
Verified facts
- registry-activity (green), checked 2026-08-21 REGON national business register (GUS, Poland)
- gmp-certified (green), checked 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 2026-08-30 Company's own certification page
- registered-address (green), checked 2026-08-20 Ministry of Finance VAT white list (Poland)
- registered-since (green), checked 1993-07-05 Ministry of Finance VAT white list (Poland)
- tax-filing-active (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
- vat-valid (green), checked 2026-08-06 VIES
- sanctions-clear (green), checked 2026-08-06 OpenSanctions
Claimed certifications
- Good Manufacturing Practice
- 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)