Suppliers / International Chemical Entity Japan

International Chemical Entity Japan

Japan Updated 9 July 2026

International Chemical Entity Japan is an API manufacturer based in Japan. It holds one active US drug master file and one valid CEP. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 5 September 2025 as VAI.

1
active US DMFs
1
valid CEPs
2
registered plants 1 with an FDA FEI number
0
filings across 0 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
2 of 2 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 5 September 2025 VAI US FDA
  • 22 March 2019 VAI US FDA

NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.

Registered plants

Site FDA FEI
Iwaki, Japan Not on file
Japan, Japan 3004546088

What they file, and where

Molecule Regulators Docs
Ursodeoxycholic Acid EDQM, US FDA 2

Also appears on these molecule pages

Ursodeoxycholic Acid API

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA None 1

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Open risk flags

  • The most recent inspection outcome was VAI, on 5 September 2025.

Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates