Suppliers / Yuki Gosei Kogyo

Yuki Gosei Kogyo

Japan Updated 9 July 2026

Yuki Gosei Kogyo is an API manufacturer based in Japan. It holds 5 active US drug master files and 3 valid CEPs across a filed portfolio of 5 molecules. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 6 February 2026 as VAI.

5
active US DMFs
3
valid CEPs
2
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
7 of 7 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 6 February 2026 VAI US FDA
  • 28 July 2021 VAI US FDA
  • 17 November 2017 OAI US FDA
  • 2 September 2016 VAI US FDA
  • 7 March 2014 NAI US FDA
  • 22 June 2012 VAI US FDA
  • 21 July 2010 OAI 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
Japan, Japan 3002808534

What they file, and where

Molecule Regulators Docs
Glycine EDQM, SFDA (Saudi Arabia), US FDA 3
Isoniazid EDQM, US FDA 2
Trifluridine US FDA 2
Protamine Sulfate US FDA 1
Solifenacin Succinate EDQM 1

Also appears on these molecule pages

Alanine contract manufacturing Isoniazid contract manufacturing Protamine contract manufacturing Trifluridine API Solifenacin API

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA None 1

Questions about Yuki Gosei Kogyo

Does Yuki Gosei Kogyo hold a US DMF or a CEP?
Yuki Gosei Kogyo holds 5 active US drug master files and 3 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 Yuki Gosei Kogyo FDA-registered?
One site operated by Yuki Gosei Kogyo 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 Yuki Gosei Kogyo's last inspection go?
The most recent inspection on record closed on 6 February 2026 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 7 inspections are on file, of which 2 closed as OAI.
Where does Yuki Gosei Kogyo manufacture?
2 registered sites are on record, in Japan (Tokyo and Japan). Every site is listed on this page with the register it came from.
What does Yuki Gosei Kogyo make?
5 molecules are on record against Yuki Gosei Kogyo, including Glycine, Isoniazid, Trifluridine and Protamine Sulfate. Each links through to that molecule's full manufacturer list.
Which regulators recognise Yuki Gosei Kogyo'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 6 February 2026.

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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