Suppliers / Fukuzyu Pharmaceutical

Fukuzyu Pharmaceutical

Japan Updated 9 July 2026

Fukuzyu Pharmaceutical is an API manufacturer based in Japan. It holds one active US drug master file. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 11 November 2025 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

  • 11 November 2025 VAI US FDA
  • 19 January 2024 OAI US FDA
  • 28 July 2016 VAI US FDA
  • 15 March 2013 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 3002807025

What they file, and where

Molecule Regulators Docs
Pyrimethamine US FDA 1

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA None 1

Questions about Fukuzyu Pharmaceutical

Does Fukuzyu Pharmaceutical hold a US DMF or a CEP?
Fukuzyu Pharmaceutical 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 Fukuzyu Pharmaceutical FDA-registered?
One site operated by Fukuzyu Pharmaceutical 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 Fukuzyu Pharmaceutical's last inspection go?
The most recent inspection on record closed on 11 November 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 4 inspections are on file, of which 1 closed as OAI.
Where does Fukuzyu Pharmaceutical 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 Fukuzyu Pharmaceutical make?
1 molecule is on record against Fukuzyu Pharmaceutical, including Pyrimethamine. Each links through to that molecule's full manufacturer list.
Which regulators recognise Fukuzyu Pharmaceutical's GMP?
Current GMP certificates are on record from US FDA. 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 11 November 2025.

Comparable suppliers

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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
EudraGMDP and national regulators
GMP certificates