APIs & Pharmaceutical Excipients
Features of Asahi Kasei Finechem (AFC) ’s technology
AFC (Nobeoka Pharmacueticals Plant) has been manufacturing nucleoside analogues as anti-cancer drug since 1976, utilizing our own accumulated synthesis and fermentation technologies. In addition, we have been achieving satisfactory results in manufacture of injectable high potent APIs and meeting customer’s demands as an expert of containment technology.
Contract Manufacturing
Facilities
AFC’s Facilities for Manufacturing Anti-Cancer APIs
| Facility | Scale | OEL (mg/m3) | Progress |
|---|---|---|---|
| Laboratory | ～3L | ＜0.1 | Completion in 2009 |
| Pilot Plant | 100～200Ｌ | ＜0.1 | Fiscal 2010 planned |
| Manufacturing Facility | 1～5 m3 | - | Containment under consideration |
QA/QC of AFC
- We have experiences in DMF registration in EU and US.
- Always meeting inspection requirements by FDA, customers, and authorities around the world.
| Year | Companies | Nations of Inspectors |
|---|---|---|
| 2004 | 7 | USA , GBR |
| 2005 | 9 | ITA , SUI , AUS , USA |
| 2006 | 7 | JPN , SUI |
| 2007 | 7 | USA |
| 2008 | 9 | ISR , USA , JPN |
| 2009 | 10 | JPN , USA , ISR , SUI |