Suppliers / Nippon Kayaku

Nippon Kayaku

Japan Updated 9 July 2026

Nippon Kayaku is an API manufacturer based in Japan. It holds 3 active US drug master files and 2 valid CEPs across a filed portfolio of 3 molecules. Its most recent recorded inspection, by US FDA, closed on 10 July 2018 as VAI.

3
active US DMFs
2
valid CEPs
3
registered plants 1 with an FDA FEI number
3
filings across 1 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
3 of 3 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 10 July 2018 VAI US FDA
  • 3 December 2015 VAI US FDA
  • 24 May 2012 VAI US FDA

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

Registered plants

Site FDA FEI
Tokyo, Japan Not on file
Chiyoda-Ku, Japan Not on file
Japan, Japan 3002807722

What they file, and where

Molecule Regulators Docs
Etoposide EDQM, US FDA 3
Bleomycin EDQM, SFDA (Saudi Arabia) 2
Ubenimex US FDA 1

Also appears on these molecule pages

Etoposide API

Filings and GMP by regulator

Regulator Filings GMP certificates
EDA (EG) 3 None

Questions about Nippon Kayaku

Does Nippon Kayaku hold a US DMF or a CEP?
Nippon Kayaku holds 3 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 Nippon Kayaku FDA-registered?
One site operated by Nippon Kayaku 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 Nippon Kayaku's last inspection go?
The most recent inspection on record closed on 10 July 2018 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 3 inspections are on file.
Where does Nippon Kayaku manufacture?
3 registered sites are on record, in Japan (Tokyo, Chiyoda-ku and Japan). Every site is listed on this page with the register it came from.
What does Nippon Kayaku make?
3 molecules are on record against Nippon Kayaku, including Etoposide, Bleomycin and Ubenimex. Each links through to that molecule's full manufacturer list.
Where does Nippon Kayaku file?
Filings are on record with EDA (EG), 3 in total.

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 10 July 2018.

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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