Sol Balgaria EAD
Bulgarischer Pharmahersteller mit Lizenz der nationalen Arzneimittelbehörde.
Die bulgarische Arzneimittelbehörde listet dieses Unternehmen in ihrem Register der Herstellungsgenehmigungen unter der Genehmigung BG/MIA-0444 vom 04.06.2024 auf. Die Zulassung umfasst unsterile Arzneimittel, Primärverpackungen und medizinische Gase und gilt für 2 Produktionsstandorte. Eingetragener Name im nationalen Register: Сол България ЕАД.
- Type
- Manufacturer
- Location
- Sofia, Bulgaria
- Categories
- Chemie & Kunststoffe, 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
- Chemical substances imported into the EU above 1 tonne/year must be REACH-registered. ECHA (REACH)
- 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)