Suppliers / AGC

AGC

Japan 4 duplicate records merged Updated 9 July 2026

AGC is an API manufacturer based in Japan. It holds one active US drug master file across a filed portfolio of 3 molecules. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 27 October 2023 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
3 of 3 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 27 October 2023 VAI US FDA
  • 4 December 2015 VAI US FDA
  • 4 August 2011 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 3003282601

What they file, and where

Molecule Regulators Docs
Tafluprost PMDA (Japan), US FDA 2
トラフェルミン原液 PMDA (Japan) 1
重炭酸ナトリウム（製造専用）日本薬局方炭酸水素ナトリウム PMDA (Japan) 1

Also appears on these molecule pages

Tafluprost API

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA None 1

Questions about AGC

Does AGC hold a US DMF or a CEP?
AGC 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 AGC FDA-registered?
One site operated by AGC 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 AGC's last inspection go?
The most recent inspection on record closed on 27 October 2023 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 3 inspections are on file.
Where does AGC 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 AGC make?
3 molecules are on record against AGC, including Tafluprost, トラフェルミン原液 and 重炭酸ナトリウム（製造専用）日本薬局方炭酸水素ナトリウム. Each links through to that molecule's full manufacturer list.
Which regulators recognise AGC'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 27 October 2023.

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