Suppliers / Kongo Chemical

Kongo Chemical

Japan Updated 9 July 2026

Kongo Chemical is an API manufacturer based in Japan. It holds 5 active US drug master files and 2 valid CEPs across a filed portfolio of 5 molecules. Its GMP standing is certified by MFDS (Korea) and US FDA. Its most recent recorded inspection, by US FDA, closed on 8 September 2023 as NAI.

5
active US DMFs
2
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
4 of 4 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 8 September 2023 NAI US FDA
  • 11 July 2018 NAI US FDA
  • 4 December 2014 NAI US FDA
  • 2 July 2009 VAI US FDA

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

Registered plants

Site FDA FEI
Toyama City, Japan Not on file
Japan, Japan 3002807405

What they file, and where

Molecule Regulators Docs
Chlorpheniramine EDQM, US FDA 2
Dexchlorpheniramine EDQM, US FDA 2
Carbinoxamine US FDA 1
Diphenhydramine US FDA 1
Pheniramine US FDA 1

Also appears on these molecule pages

Chlorphenamine API Chlorpheniramine API Diphenhydramine API

Filings and GMP by regulator

Regulator Filings GMP certificates
MFDS (Korea) None 2
US FDA None 1

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Open risk flags

  • The most recent inspection outcome was NAI, on 8 September 2023.

Sources on this page

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