Bioton S.A.
Produsen biofarmasi Polandia untuk insulin dan protein rekombinan.
Bioton S.A. memproduksi insulin manusia, insulin biosimilar, dan API protein rekombinan di Macierzysz. Didirikan pada tahun 1989, perusahaan ini memasok distributor farmasi, lembaga pengadaan kesehatan masyarakat, dan grosir rumah sakit di CEE, CIS, dan Asia.
- Type
- manufacturer (our classification of the record, not a statement by the company)
- Role
- Manufacturer
- Location
- Macierzysz, Poland
- Founded
- 1989
- Website
- bioton.pl
- Categories
- Perlengkapan Medis & Kesehatan, Suplemen & Kesehatan
- Markets
- Polandia, Ukraina, Tiongkok
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)