Zentiva k.s.
Czech generics pharmaceutical manufacturer with a strong CEE market presence.
Zentiva manufactures generic medicines, OTC health products, and solid dosage forms at its Prague facility. Founded in 1911, the company supplies pharmacy chains, hospital distributors, and healthcare wholesalers across Central and Eastern Europe.
- Type
- brand seeking distribution
- Location
- Prague, Czechia
- Founded
- 1911
- Website
- zentiva.com
- Categories
- Medical & Healthcare Supplies
- Markets
- Czechia, Slovakia, Poland, Romania
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)