MÄRKTE: DIGEMID (Peru), ANMAT (Argentina), EDE (UAE), ANVISA (Brazil), ISP (Chile), PMDA (Japan), FDA (USA), MSPAS (Guatemala), Russian Health Authorities, EMA (EU), COFEPRIS (Mexico), MFDS (South Korea), SFDA (Saudi Arabia), TGA (Australia), NMPA (China), Health Canada (Canada), INVIMA (Colombia), MHRA (UK)
BATCH-GRÖSSE: Klein, Mittel, Groß
KATEGORIE/PRODUKT: FDF / DRUG PRODUCTS, SERVICES, PARTICLE ENGINEERING
COMPLIANCE: EMA (EU-GMP), PMDA/MHLW (Japan GMP), UAE Ministry of Health & Prevention, ANVISA (Brazil B-GMP), Weltgesundheitsorganisation (GMP / HACCP), MHRA (UK GMP), Französischer Dienst - öffentlich (CIR), TGA (Australia GMP), FDA (cGMP), NMPA (China GMP), ECOVADIS, ISO, Halal-Forschungsrat, Gesundheit Kanada (Kanada GMP), TITCK (Turkish Health Authorities), MFDS/KFDA (Republik Korea GMP)
VERWENDUNG: Menschlich, Veterinär
DIENSTLEISTUNGEN: Analytical / QC services, Logistics, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 10,000 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/Tag), 1 / low-hazard (PDE > 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/Tag)
REGION: North America
THERAPEUTISCHE FACHGEBIETE (ATC): (C) Cardiovascular system, (A) Digestive tract and metabolism