Biotika a.s.
Biotika a.s. manufactures pharmaceutical substances for export-ready B2B channels.
Biotika a.s. manufactures pharmaceutical substances, antibiotics, veterinary products, and medicines in Slovenska Lupca. Founded in 1953, the company supplies pharmaceutical distributors, hospitals, veterinary channels, and export buyers across SK, CZ, DE, PL and related export markets.
- Type
- Manufacturer
- Location
- Slovenska Lupca, Slovakia
- Founded
- 1953
- Website
- biotika.sk
- Categories
- Medical & Healthcare Supplies
- Markets
- Slovakia, Czechia, Germany, Poland
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 2026-08-16 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 2026-08-23 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)