BATCH-GRÖSSE: Klein, Mittel, Groß
KATEGORIE/PRODUKT: FDF / DRUG PRODUCTS
COMPLIANCE: EMA (EU-GMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), Weltgesundheitsorganisation (GMP / HACCP), MHRA (UK GMP), TGA (Australia GMP), FDA (cGMP), NMPA (China GMP), Gesundheit Kanada (Kanada GMP), MFDS/KFDA (Republik Korea GMP)
KONTROLLIERTE SUBSTANZEN: Lowest potential for abuse, High potential for abuse & medical use, Lower potential for abuse, Low potential for abuse
REGION: Europe
BSL (Biologische Sicherheitsstufe): 3, 4, 1, 2
MÄRKTE: ANVISA (Brazil), PMDA (Japan), FDA (USA), EMA (EU), MFDS (South Korea), TGA (Australia), NMPA (China), Health Canada (Canada), MHRA (UK)
VERWENDUNG: Menschlich, Veterinär
DIENSTLEISTUNGEN: Analytical / QC services, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
THERAPEUTISCHE FACHGEBIETE (ATC): (H) Systemic hormonal preparations excl. sex hormones and insulins, (L) Antineoplastic and immunomodulating agents, (G) Genito urinary system and sex hormones
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 10,000 µg/day), 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/Tag), 1 / low-hazard (PDE > 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/Tag)
