FDF / DRUG PRODUCTS in APAC
Our facility provides best-in-class manufacturing of tablets and ampoules, English and Japanese outstanding customer service, and has more than 330 high skilled...
About the plant
Adragos Kawagoe is our cutting-edge manufacturing and end-to-end production facility located at the north west of Tokyo with a strategic location that aligns with the heartbeat of pharmaceutical innovation in Japan.
Oral Solids: Tablets
Technology:
Granulation and compression of tablets
Uncoated / Film-coated /Orally Dissolving Tablets (ODT) / Double-Layer Tablets
Capacity:
Tableting: 2 billion per year
Packaging: 2 billion per year
Sterile Liquids: Ampoules
Technology:
Terminal sterilization
1 fully automatic filling line
Capacity:
Batch size up to 900 liters
30 million per year
From 1ml to 30ml
Certifications
- EMA (EU GMP)
- FDA (cGMP)
- PMDA/MHLW (Japan GMP)
Activity
- Oral solids / OSD, Injectables, Tablets, Terminal sterilization, Glass ampoules, 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)
- DEA: Schedule II (high potential for abuse / medical use), Schedule III (lower potential for abuse), Schedule IV (low potential for abuse), Schedule V (lowest potential for abuse)
- BSL:
- Therapeutic areas: N/A
- Markets: FDA (USA), EMA (EU), PMDA (Japan), CDSCO (India), Health Canada (Canada), MHRA (UK), TGA (Australia), NMPA (China), EDE (UAE), ANVISA (Brazil), ANMAT (Argentina), MFDS (South Korea), SFDA (Saudi Arabia)
Batch Size / Reactor
- Large
Services
- Regulatory services, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging, Logistics, Stability studies design, Stability studies execution, ICH Stability studies, Batch records, Analytical methods development, Analytical methods validation, Release testing of raw materials, Release testing of product, Bioanalysis, Analytical methods transfer, Batch certification / release, GMP documentation, Primary packaging, Secondary packaging, Storage, Distribution, CMC regulatory support
Other plants of this company
FDF / DRUG PRODUCTS SERVICES in Europe Specializes in the development of Value Added Medicines and has been recently upgraded with HPAPI capabilities.
FDF / DRUG PRODUCTS in Europe Semi-solid and non-sterile liquid pharmaceuticals. With over 100 years of experience, we have a track record of providing first class service and customer focused manufacturing.
FDF / DRUG PRODUCTS in Europe Sterile liquids and suppositories manufacturing. We handle more than 100 molecules and provide stability studies, narcotics handling and analytical testing services.
