Zentiva k.s.
Tschechischer Generika-Pharmahersteller mit starker CEE-Marktpräsenz.
Zentiva stellt in seinem Werk in Prag Generika, OTC-Gesundheitsprodukte und feste Darreichungsformen her. Das 1911 gegründete Unternehmen beliefert Apothekenketten, Krankenhausvertriebshändler und Gesundheitsgroßhändler in ganz Mittel- und Osteuropa.
- Type
- brand seeking distribution
- Location
- Prague, Czechia
- Founded
- 1911
- Website
- zentiva.com
- Categories
- Medizin- & Gesundheitsbedarf
- Markets
- Tschechien, Slowakei, Polen, Rumänien
Verified facts
- market-access-eu (green), checked 2026-08-18 TRACES NT, European Commission register of approved establishments (DG SANTE)
- web-presence-since (green), checked 2026-08-03 Internet Archive (Wayback)
- registered-manufacturer (green), checked 2026-08-21 Jordan Food and Drug Administration (JFDA), approved manufacturing sites (open data portal of Jordan)
- domain-registered (green), checked 2026-08-02 Domain registry record
- certificate-page-on-site (amber), checked 2026-08-11 Company's own certification page
- places-goods-on-market (green), checked 2026-08-07 Finnish Medicines Agency (Fimea), basic register of medicinal products
- gmp-certified (green), checked 2025-05-23 EudraGMDP, EU register of GMP certificates (EMA)
- operating-permit (green), checked 2026-08-19 EudraGMDP manufacturing authorisation register (EMA)
- lei-lapsed (amber), checked 2026-08-16 GLEIF global LEI register (golden copy)
- vat-valid (green), checked 2026-08-08 VIES (European Commission)
Claimed certifications
- Good Manufacturing Practice
- ISO 9001, Quality Management IAF CertSearch
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)