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 Dexchlorpheniramine API Diphenhydramine API

Filings and GMP by regulator

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

Questions about Kongo Chemical

Does Kongo Chemical hold a US DMF or a CEP?
Kongo Chemical holds 5 active US drug master files and 2 valid CEPs. A drug master file is a submission to the FDA describing how an ingredient is made; a CEP is the EDQM's certificate that the substance meets its European Pharmacopoeia monograph. Both are filings rather than approvals.
Is Kongo Chemical FDA-registered?
One site operated by Kongo Chemical carries an FDA establishment identifier (FEI), which means it is registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did Kongo Chemical's last inspection go?
The most recent inspection on record closed on 8 September 2023 as NAI (No Action Indicated: nothing objectionable was found). 4 inspections are on file.
Where does Kongo Chemical manufacture?
2 registered sites are on record, in Japan (Toyama City and Japan). Every site is listed on this page with the register it came from.
What does Kongo Chemical make?
5 molecules are on record against Kongo Chemical, including Chlorpheniramine, Dexchlorpheniramine, Carbinoxamine and Diphenhydramine. Each links through to that molecule's full manufacturer list.
Which regulators recognise Kongo Chemical's GMP?
Current GMP certificates are on record from MFDS (Korea) and US FDA. GMP recognition covers the manufacturing site, separately from any filing on the substance itself.

Answered from this company's own record. Where a register holds nothing, the question is not asked rather than answered with a zero. How we count our figures.

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Open risk flags

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

Comparable suppliers

Supriya Lifescience shares 4 molecules Keshava Organics shares 3 molecules Specgx shares 2 molecules Malladi Drugs & Pharmaceuticals shares 2 molecules Far Specialty Products Inc Dba Far Chemical shares 2 molecules

Ranked by shared active ingredients where we have them, otherwise by country and comparable credentials.

Sources on this page

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