RUBELLA BYUTI AD
Bulgarian pharmaceutical manufacturer licensed by the national drug agency.
The Bulgarian Drug Agency lists this company in its register of manufacturing authorisations under authorisation BG/MIA-0466, issued 2024-09-17. The authorisation covers investigational medicinal products, non-sterile medicinal products and is held for 2 production sites. Registered name in the national register: РУБЕЛЛА БЮТИ АД.
- Type
- Manufacturer
- Location
- Rudozem, Bulgaria
- Categories
- Fabricação farmacêutica
- Markets
- Bulgária
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)