Emona Biopharma d.o.o.
Slovenian industrial manufacturer and exporter
Emona Biopharma d.o.o. is listed by Sloexport in the other manufacturing sector. Its directory profile describes operations including Emona Biopharma, a GMP certified company based in Ljubljana that specialises in the developing and out-licensing of generics to the European (EU) markets. Emona Biopharma offers a diverse range of pharmaceuticals: solid forms OTCs and Rx, as well as a number of hospital injectables. Our product pipeline keeps on growin.
- Type
- Manufacturer
- Location
- Ljubljana, Slovenia
- Website
- https://emonabio.com
- Categories
- Pharmaceutical Manufacturing, Medical & Healthcare Supplies
- Markets
- Slovenia, Austria, Germany, Italy, Croatia
Listed in a source registry
Verified facts
- debarment-clear (green), checked 2026-08-08 OpenSanctions
- sanctions-clear (green), checked 2026-08-08 OpenSanctions
- corporate-mail-on-domain (green), checked 2026-08-08 Mail server of the company domain
- domain-registered (green), checked 2026-08-08 Domain registry record
- web-presence-since (green), checked 2026-08-03 Internet Archive (Wayback)
- vat-valid (green), checked 2026-08-08 VIES
- export-registered (green), checked 2026-07-30 EU EORI validation (European Commission)
- registry-id-verified (green), checked 2026-08-16 Poslovni register Slovenije (AJPES)
- registered-manufacturer (green), checked 2026-08-16 Seznam davčnih zavezancev (FURS, Finančna uprava RS)
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)