Suppliers / KAKEN Pharmaceutical

KAKEN Pharmaceutical

Japan Updated 9 July 2026

KAKEN Pharmaceutical is an API manufacturer based in Japan. It holds 3 active US drug master files across a filed portfolio of 3 molecules. Its GMP standing is certified by MFDS (Korea) and US FDA. Its most recent recorded inspection, by US FDA, closed on 1 September 2023 as NAI.

3
active US DMFs
0
valid CEPs
1
registered plants 1 with an FDA FEI number
1
filings across 1 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

  • 1 September 2023 NAI US FDA
  • 22 June 2018 VAI US FDA
  • 28 March 2014 VAI US FDA
  • 14 November 2012 NAI US FDA

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

Registered plants

Site FDA FEI
Japan, Japan 3002807376

What they file, and where

Molecule Regulators Docs
Butenafine US FDA 1
Efinaconazole US FDA 1
Sofpironium US FDA 1

Also appears on these molecule pages

Efinaconazole API

Filings and GMP by regulator

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

Questions about KAKEN Pharmaceutical

Does KAKEN Pharmaceutical hold a US DMF or a CEP?
KAKEN Pharmaceutical holds 3 active US drug master files. 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 KAKEN Pharmaceutical FDA-registered?
One site operated by KAKEN Pharmaceutical 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 KAKEN Pharmaceutical's last inspection go?
The most recent inspection on record closed on 1 September 2023 as NAI (No Action Indicated: nothing objectionable was found). 4 inspections are on file.
Where does KAKEN Pharmaceutical manufacture?
1 registered site is on record, in Japan (Japan). Every site is listed on this page with the register it came from.
What does KAKEN Pharmaceutical make?
3 molecules are on record against KAKEN Pharmaceutical, including Butenafine, Efinaconazole and Sofpironium. Each links through to that molecule's full manufacturer list.
Which regulators recognise KAKEN Pharmaceutical'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 1 September 2023.

Comparable suppliers

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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