MÄRKTE: TGA (Australia), EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MSPAS (Guatemala), COFEPRIS (Mexico), DIGEMID (Peru), MHRA (UK), ANMAT (Argentina), INVIMA (Colombia), SFDA (Saudi Arabia), MFDS (South Korea), Turkish Health Authorities, EDE (UAE), CDSCO (India)
THERAPEUTISCHE FACHGEBIETE (ATC): (G) Genito urinary system and sex hormones, (C) Cardiovascular system, (D) Dermatologicals, (H) Systemic hormonal preparations excl. sex hormones and insulins, (J) Antiinfectives for systemic use, (L) Antineoplastic and immunomodulating agents, (N) Nervous system, (R) Respiratory system, (S) Sensory organs, (A) Digestive tract and metabolism
OEB (Occupational Exposure Banding): 2 (PDE = 1.000 - 5.000 µg/Tag), 3 (PDE = 100 - 1.000 µg/Tag), 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/Tag), 1 / low-hazard (PDE > 5,000 µg/day)
COMPLIANCE: Französischer Dienst - öffentlich (CIR), ANMAT (Argentinien neue GMP), EMA (EU-GMP), Gesundheit Kanada (Kanada GMP), Weltgesundheitsorganisation (GMP / HACCP), MHRA (UK GMP), MFDS/KFDA (Republik Korea GMP), FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), TGA (Australia GMP), UAE Ministry of Health & Prevention, SFDA (Saudi Food & Drug Authority)
BATCH-GRÖSSE: Klein, Mittel, Groß
KATEGORIE/PRODUKT: BIOLOGIEN, DIENSTLEISTUNGEN, FDF/DROGENPRODUKTE, CHEMISCH-SYNTHETISCH
KONTROLLIERTE SUBSTANZEN: High potential for abuse & medical use, Lowest potential for abuse, Low potential for abuse, High potential for abuse & no medical use, Lower potential for abuse
REGION: Europe
VERWENDUNG: Menschlich
DIENSTLEISTUNGEN: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
