Injectable Plants

GMP certificate

Approved by the following regulatory agencies:

FDA (USA)

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)