Biotika a.s.
ビオティカ as.は、輸出対応の B2B チャネル向けの医薬品物質を製造します。
ビオティカ as.スロヴェンスカ・ルプカで医薬品、抗生物質、動物用製品、医薬品を製造しています。 1953 年に設立された同社は、SK、CZ、DE、PL および関連する輸出市場全体の医薬品販売業者、病院、獣医チャネル、輸出バイヤーに製品を供給しています。
- 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
- 医療およびヘルスケア用品
- Markets
- スロバキア, チェコ, ドイツ, ポーランド
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)