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Quality

Compliance inspections
by regulatory authorities

Food and Drug Administration (FDA)

'August 2011 Inspection before application for veterinary drug approval
'May 2007 TypeⅡ DMF registration
(Registration number #9998)
'April 2008 Regular inspection
'March 2013 Regular inspection
'July 2016 Regular inspection
'May 2021 Regular inspection
'January 2024 Regular inspection

Pharmaceuticals and
Medical Devices Agency (PMDA)

'March 2003 Regular inspection
'February 2005 Regular inspection
'October 2006 Regular inspection
'June 2009 Regular inspection
'September 2012 Survey before application for partial changes

Toyama prefecture

'May 2008 Survey after changing structural equipment
'July 2008 Regular survey
'November 2010 Survey before renewal of pharmaceutical manufacturing license, Survey before application for partial changes, Regular survey
'August 2011 Survey before renewal of veterinary drug manufacturing license
'January 2014 Regular survey
'October 2015 Survey before renewal of pharmaceutical manufacturing license
Regular survey
'September 2017 Regular survey
'July 2019 Regular survey、Survey after changing structural equipment
'July 2021 Survey before renewal of pharmaceutical manufacturing license, Regular survey
'August 2023 Regular survey

Ministry of Food and Drug Safety (MFDS)

'May 2014 Inspection before application for approval

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