Biotika a.s.
Biotika als produceert farmaceutische stoffen voor exportklare B2B-kanalen.
Biotika als produceert farmaceutische stoffen, antibiotica, diergeneeskundige producten en medicijnen in Slovenska Lupca. Het bedrijf werd opgericht in 1953 en levert aan farmaceutische distributeurs, ziekenhuizen, veterinaire kanalen en exportkopers in SK, CZ, DE, PL en aanverwante exportmarkten.
- Type
- manufacturer (our classification of the record, not a statement by the company)
- Role
- Manufacturer
- Location
- Slovenska Lupca, Slovakia
- Founded
- 1953
- Website
- biotika.sk
- Categories
- Medische en gezondheidszorgbenodigdheden
- Markets
- Slowakije, Tsjechië, Duitsland, Polen
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
- 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)
- corporate-mail-on-domain (green), checked 2026-08-06 Mail server of the company domain
- lei-active (green), checked 2026-09-07 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), effective since 2025-12-11 EudraGMDP, EU register of GMP certificates (EMA)
- facility-registered (green), checked 2026-09-07 European Industrial Emissions Portal (E-PRTR / IED), European Environment Agency
- registry-id-verified (green), checked 2026-09-10 GLEIF Global LEI record
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)