Suppliers / Fujimoto Chemicals

Fujimoto Chemicals

Japan 1 employees Updated 9 July 2026

Fujimoto Chemicals is an API manufacturer based in Japan. It holds one active US drug master file. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 7 February 2024 as VAI.

1
active US DMFs
0
valid CEPs
2
registered plants 2 with an FDA FEI number
0
filings across 0 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
2 of 2 confirmed
Inspections
6 of 6 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 7 February 2024 VAI US FDA
  • 12 May 2023 VAI US FDA
  • 11 March 2016 NAI US FDA
  • 19 April 2013 VAI US FDA
  • 15 April 2013 NAI US FDA
  • 24 June 2009 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 3009975775
Japan, Japan 3002806358

What they file, and where

Molecule Regulators Docs
Dacarbazine US FDA 1

Also appears on these molecule pages

Dacarbazine API

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA None 2

Questions about Fujimoto Chemicals

Does Fujimoto Chemicals hold a US DMF or a CEP?
Fujimoto Chemicals holds 1 active US drug master file. 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 Fujimoto Chemicals FDA-registered?
2 sites operated by Fujimoto Chemicals carry an FDA establishment identifier (FEI), which means they are registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did Fujimoto Chemicals's last inspection go?
The most recent inspection on record closed on 7 February 2024 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 6 inspections are on file.
Where does Fujimoto Chemicals manufacture?
2 registered sites are on record, in Japan (Japan among others). Every site is listed on this page with the register it came from.
What does Fujimoto Chemicals make?
1 molecule is on record against Fujimoto Chemicals, including Dacarbazine. Each links through to that molecule's full manufacturer list.
Which regulators recognise Fujimoto Chemicals's GMP?
Current GMP certificates are on record from 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.

Comparing suppliers?

Choose your molecules and target markets. Fujimoto Chemicals comes back tiered against every other supplier able to file there.

Start for free
No sales call.

Open risk flags

  • The most recent inspection outcome was VAI, on 7 February 2024.

Comparable suppliers

Matrix Pharmacorp shares 1 molecule Suzhou Lixin Pharmaceutical shares 1 molecule Heraeus Precious Metals GmbH shares 1 molecule Mac Chem Products India shares 1 molecule

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