• Home
  • Solutions
  • Contract Manufacturing
  • Spray Drying Technology
  • Pharmaceuticals & Excipients

Contract Manufacturing

Contract Manufacturing

APIs
Drug intermediate (functional APIs)
Drug Products
cGMP Compliance
Quality Assurance System
Analytical Equipment

Contact Us

  • Spray Drying Technology
  • Neusilin
  • Fujicalin
  • F-MELT

cGMP Compliance

APIs, intermediates, and drug products are manufactured according to the stringent cGMP system.

Fuji Chemical has continuously passed FDA inspections 9 times since 1981 and acquired high ratings for GMP control. Production is carried out according to cGMP system covering raw material acceptance, production facility, and quality control. our GMP control is thorough and superior as reflected from various successful inspections.

Inspection History
As of December 2015
Inspected by Date
US FDA 1981
1983
1985
1989
1995
1999
2004
2010
2013
MFDS : Ministry of Food and Drug Safty
(KFDA：Korea Food and Drug administration)		 2008
EMA Inspection 2012
Pharmaceuticals and Medical Devices Agency (PMDA) 2006(2 times)
2011
Toyama prefecture Audit 1989
1991
1992 (2 times)
1994 (2 times)
1996 (3 times)
1998
1999
2000
2001
2004
2006
2009
2011
2013