RUBELLA BYUTI AD
Bulgarischer Pharmahersteller mit Lizenz der nationalen Arzneimittelbehörde.
Die bulgarische Arzneimittelbehörde listet dieses Unternehmen in ihrem Register der Herstellungsgenehmigungen unter der Genehmigung BG/MIA-0466 vom 17.09.2024 auf. Die Genehmigung gilt für Prüfpräparate und nicht sterile Arzneimittel und gilt für zwei Produktionsstandorte. Eingetragener Name im nationalen Register: РУБЕЛЛА БЮТИ АД.
- Type
- Manufacturer
- Location
- Rudozem, Bulgaria
- Categories
- Pharmazeutische Produktion
- Markets
- Bulgarien
Listed in a source registry
Bulgarian Drug Agency (ИАЛ), registers of manufacturers, importers and traders
Verified facts
- registered-manufacturer (green), checked 2026-08-20 Bulgarian Drug Agency (Изпълнителна агенция по лекарствата), register of manufacturing and import authorisations under art. 19 of the Medicinal Products Act
- operating-permit (green), checked 2026-08-20 Bulgarian Drug Agency (Изпълнителна агенция по лекарствата), register of manufacturing and import authorisations under art. 19 of the Medicinal Products Act
Import rules for these goods
- 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)