Zentiva k.s.
Fabricant tchèque de produits pharmaceutiques génériques avec une forte présence sur le marché des PECO.
Zentiva fabrique des médicaments génériques, des produits de santé en vente libre et des formes posologiques solides dans son usine de Prague. Fondée en 1911, l'entreprise fournit des chaînes de pharmacies, des distributeurs hospitaliers et des grossistes de soins de santé en Europe centrale et orientale.
- Type
- brand seeking distribution
- Location
- Prague, Czechia
- Founded
- 1911
- Website
- zentiva.com
- Categories
- Fournitures médicales et de santé
- Markets
- Tchéquie, Slovaquie, Pologne, Roumanie
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)