Lek Pharmaceuticals
Lek Pharmaceuticals manufactures generic medicines for export-ready B2B channels.
Lek Pharmaceuticals manufactures generic medicines, biosimilars, and pharmaceutical products in Ljubljana. Founded in 1946, the company supplies pharmacies, hospitals, pharma partners, and export distributors across SI, AT, DE, HR and related export markets.
- Type
- Manufacturer
- Location
- Ljubljana, Slovenia
- Founded
- 1946
- Website
- lek.si
- Categories
- Medical & Healthcare Supplies
- Markets
- Slovenia, Austria, Germany, Croatia
Verified facts
- web-presence-since (green), checked 2026-08-02 Internet Archive (Wayback)
- debarment-clear (green), checked 2026-08-09 OpenSanctions
- sanctions-clear (green), checked 2026-08-09 OpenSanctions
- domain-registered (green), checked 2026-08-09 Domain registry record
- corporate-mail-on-domain (green), checked 2026-08-09 Mail server of the company domain
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)