Suppliers / Ishihara Sangyo Kaisha

Ishihara Sangyo Kaisha

Japan Updated 9 July 2026

Ishihara Sangyo Kaisha is an API manufacturer based in Japan. It holds one active US drug master file. Its most recent recorded inspection, by US FDA, closed on 9 September 2022 as VAI.

1
active US DMFs
0
valid CEPs
1
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

  • 9 September 2022 VAI US FDA
  • 8 September 2017 VAI US FDA
  • 5 September 2014 VAI US FDA
  • 2 September 2011 VAI 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 3002807309

What they file, and where

Molecule Regulators Docs
Cevimeline US FDA 1

Also appears on these molecule pages

Cevimeline API

Questions about Ishihara Sangyo Kaisha

Does Ishihara Sangyo Kaisha hold a US DMF or a CEP?
Ishihara Sangyo Kaisha 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 Ishihara Sangyo Kaisha FDA-registered?
One site operated by Ishihara Sangyo Kaisha 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 Ishihara Sangyo Kaisha's last inspection go?
The most recent inspection on record closed on 9 September 2022 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 4 inspections are on file.
Where does Ishihara Sangyo Kaisha 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 Ishihara Sangyo Kaisha make?
1 molecule is on record against Ishihara Sangyo Kaisha, including Cevimeline. Each links through to that molecule's full manufacturer list.

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 VAI, on 9 September 2022.

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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