Injectable Plants
GMP certificate
Approved by the following regulatory agencies:
FDA (USA)
PMDA (Japan)
AEMPS (Spain)
ANVISA (Brazil)
MHRA (UK)
KFDA (Korea)
Russian Agency (Russia)
Kazajstan Agency (Kazajstan)
Bielorusian Agency (Biolorusia)
Turkish Agency (Turkey)
Gulf Cooperation Council (GCC)
Manufacturing products with CE marking
Madrid Excelente license
Quality Standards
OHSAS 18001
ISO 14001
ISO 14644-1, -2, -3 and -4, regarding cleanrooms
CPMP/ICH/2736/99-Q1A (R2), regarding stability testing
EAL-G19, USP (latest edition), UNE-EN 45501, CGA-ENAC-LE, LEA-ENAC-LC, regarding calibration
ISO 9000-3, and 21 CFR (FDA)
ISO 13408-1, regarding media-fill validation
ICH Q8, Q9 and Q10, regarding quality systems for pharmaceutical products
Solid Forms Plant
GMP certificate
We have received approval from the following regulatory authorities:
FDA (USA)
AEMPS (Spain)
ANVISA (Brazil)
COFEPRIS (Mexico)
NIHS (Japan)
Gulf Cooperation Council (GCC)
The Center for Examinations and Tests in Health Service (Belarus)
Pharmacy and Poisons Board (Kenya)