Suppliers / Taiho Pharmaceutical

Taiho Pharmaceutical

Japan 171 employees Updated 9 July 2026

Taiho Pharmaceutical is an API manufacturer based in Japan. It holds 2 active US drug master files across a filed portfolio of 2 molecules. Its filings concentrate with NPRA (MY), US FDA and ARCSA (EC). Its GMP standing is certified by US FDA and ANVISA (Brazil). Its most recent recorded inspection, by US FDA, closed on 26 January 2024 as VAI.

2
active US DMFs
0
valid CEPs
3
registered plants 2 with an FDA FEI number
13
filings across 5 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
2 of 2 confirmed
Inspections
4 of 4 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 26 January 2024 VAI US FDA
  • 13 October 2023 NAI US FDA
  • 22 May 2015 NAI US FDA
  • 15 May 2015 NAI US FDA

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

Registered plants

Site FDA FEI
TOKUSHIMA, Japan Not on file
Japan, Japan 3002646390
Japan, Japan 3010872322

What they file, and where

Molecule Regulators Docs
Tipiracil US FDA 1
Trifluridine US FDA 1

Also appears on these molecule pages

Tipiracil API Trifluridine API

Filings and GMP by regulator

Regulator Filings GMP certificates
NPRA (MY) 4 None
US FDA 3 2
ARCSA (EC) 2 None
EDA (EG) 2 None
DIGEMAPS (DO) 2 None
ANVISA (Brazil) None 1

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Open risk flags

  • The most recent inspection outcome was VAI, on 26 January 2024.

Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates