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

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Open risk flags

  • The most recent inspection outcome was VAI, on 10 July 2018.

Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability