KRKA, tovarna zdravil, d. d., Novo mesto
Slovenian industrial manufacturer and exporter
KRKA, tovarna zdravil, d. d., Novo mesto is listed by Sloexport in the other manufacturing sector. Its directory profile describes operations including Krka is among top generic pharmaceutical companies in the world. Krka’s basic line of business is the production and sale of prescription pharmaceuticals, non-prescription products and animal health products. The company’s activities are supplemented by health resort and tourist services.
- Type
- Manufacturer
- Location
- Novo Mesto, Slovenia
- Website
- https://krka.si
- Categories
- Pharmaceutical Manufacturing, Medical & Healthcare Supplies
- Markets
- Slovenia, Austria, Germany, Italy, Croatia
Listed in a source registry
Verified facts
- web-presence-since (green), checked 2026-08-09 Internet Archive (Wayback)
- corporate-mail-on-domain (green), checked 2026-08-09 Mail server of the company domain
- lei-active (green), checked 2026-08-09 GLEIF
- sanctions-clear (green), checked 2026-08-09 OpenSanctions
- debarment-clear (green), checked 2026-08-09 OpenSanctions
- domain-registered (green), checked 2026-08-09 Domain registry record
- aeo-certified (green), checked 2026-08-16 EU AEO register (European Commission)
- gmp-certified (green), checked 2026-04-02 EudraGMDP, EU register of GMP certificates (EMA)
Claimed certifications
- Good Manufacturing Practice
- AEO, Authorised Economic Operator EU AEO database
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)
- Medicines imported into the EU must come from a site holding an EU GMP certificate, and the importer needs a manufacturing/import authorisation. European Medicines Agency (GMP)