Germany Europe
FDF / DRUG PRODUCTS in Europe
N/A
Certifications
- ISO
- EMA (EU GMP)
- FDA (cGMP)
- PMDA/MHLW (Japan GMP)
Activity
- Implants, Injectables, Terminal sterilization, Fill&Finish, Small volume vials, Large volume vials / Bottles, Glass ampoules, PFS (Prefilled Syringes), Cartridges, FDF / DRUG PRODUCTS manufacturing
Features
- Uses: Commercial (Phase IV), Human
- Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1,000 - 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 5 / HPAPI (PDE < 10 µg/day)
- Controlled substance: N/A
- BSL: 2
- Therapeutic areas: N/A
- Markets: N/A
Batch Size / Reactor
- Small, Medium, Large
Services
- Development services, Manufacturing services
