Biotika a.s.
Biotika a.s. fabrica sustancias farmacéuticas para canales B2B listos para la exportación.
Biotika a.s. fabrica sustancias farmacéuticas, antibióticos, productos veterinarios y medicamentos en Slovenska Lupca. Fundada en 1953, la empresa abastece a distribuidores farmacéuticos, hospitales, canales veterinarios y compradores de exportación en SK, CZ, DE, PL y mercados de exportación relacionados.
- Type
- brand seeking distribution
- Location
- Slovenska Lupca, Slovakia
- Founded
- 1953
- Website
- biotika.sk
- Categories
- Suministros médicos y sanitarios
- Markets
- Eslovaquia, Chequia, Alemania, Polonia
Verified facts
- web-presence-since (green), checked 2026-08-03 Internet Archive (Wayback)
- registry-activity (green), checked 2026-08-21 Enviroportál SAŽP, centrálny informačný systém EIA/SEA (environmental impact assessment, Slovakia)
- operating-permit (green), checked 2026-08-16 EudraGMDP manufacturing authorisation register (EMA)
- facility-registered (green), checked 2026-08-30 European Industrial Emissions Portal (E-PRTR / IED), European Environment Agency
- corporate-mail-on-domain (green), checked 2026-08-06 Mail server of the company domain
- lei-active (green), checked 2026-08-30 GLEIF global LEI register (golden copy)
- sanctions-clear (green), checked 2026-08-06 OpenSanctions
- debarment-clear (green), checked 2026-08-06 OpenSanctions
- gmp-certified (green), checked 2025-12-11 EudraGMDP, EU register of GMP certificates (EMA)
Claimed certifications
- Good Manufacturing Practice
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)