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

Questions about Taiho Pharmaceutical

Does Taiho Pharmaceutical hold a US DMF or a CEP?
Taiho Pharmaceutical holds 2 active US drug master files. 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 Taiho Pharmaceutical FDA-registered?
2 sites operated by Taiho Pharmaceutical 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 Taiho Pharmaceutical's last inspection go?
The most recent inspection on record closed on 26 January 2024 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 4 inspections are on file.
Where does Taiho Pharmaceutical manufacture?
3 registered sites are on record, in Japan (Tokushima and Japan among others). Every site is listed on this page with the register it came from.
What does Taiho Pharmaceutical make?
2 molecules are on record against Taiho Pharmaceutical, including Tipiracil and Trifluridine. Each links through to that molecule's full manufacturer list.
Which regulators recognise Taiho Pharmaceutical's GMP?
Current GMP certificates are on record from US FDA and ANVISA (Brazil). 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.

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Open risk flags

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

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Sources on this page

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