Bioton S.A.
Polish biopharmaceutical manufacturer of insulin and recombinant proteins.
Bioton S.A. manufactures human insulin, biosimilar insulin, and recombinant protein API in Macierzysz. Founded in 1989, the company supplies pharmaceutical distributors, public health procurement agencies, and hospital wholesalers across CEE, CIS, and Asia.
- Type
- Manufacturer
- Location
- Macierzysz, Poland
- Founded
- 1989
- Website
- bioton.pl
- Categories
- Medical & Healthcare Supplies, Supplements & Wellness
- Markets
- Poland, 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)
- certificate-page-on-site (amber), checked 2026-08-11 Company's own certification page
- 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
- vat-valid (green), checked 2026-08-06 VIES
- 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
- 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)