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CONTRACTED MANUFACTURE

受託製造

PHARMACEUTICAL

Inspection and auditing history

Pharmaceuticals and Medical Devices Agency

  • August 2006:GMP investigation associated with the application of the pharmaceutical product compliance investigation (change by addition of a manufacturing site/implementation)
  • August 2014 to March 2015:GMP investigation associated with the application for a pharmaceutical product (change by addition of a manufacturing site/document)
  • September 2017:GMP compliance investigation (regular interval/implementation)

Miyazaki prefecture

  • 2012:GMP compliance investigation by the Miyazaki Prefecture Pharmaceutical Affairs Section (regular interval/export)
  • 2017:GMP compliance investigation by the Miyazaki Prefecture Pharmaceutical Affairs Section (regular interval/export)
  • 2018:GMP compliance investigation by the Miyazaki Prefecture Pharmaceutical Affairs Section (special inspection)

Fukushima prefecture

  • May 2012:Pharmaceutical product compliance investigation by the Fukushima Prefecture Pharmaceutical Affairs Section (regular interval/export)
  • November 2013:Simultaneous monitoring guidance of Fukushima Prefecture pharmaceutical products
  • March 2015:Pharmaceutical product compliance investigation by the Fukushima Prefecture Pharmaceutical Affairs Section (change of the manufacturing method)
  • May 2017:Pharmaceutical product compliance investigation by the Fukushima Prefecture Pharmaceutical Affairs Section(regular interval/export)
  • November 2017:GMP compliance investigation by the Fukushima Prefecture Pharmaceutical Affairs Section (addition of a manufacturing site)

Overseas authorities
FDA license acquisition (2016)
Undergoes quality audits by domestic and overseas clients
About 5 to 10 cases every year
MF (registry of APIs)
Yes
DMF (Drug Master File)
Yes