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
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
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
Filings and GMP by regulator
| Regulator | Filings | GMP certificates |
| US FDA | None | 1 |
Comparing suppliers?
Choose your molecules and target markets. AGC comes back tiered against every other
supplier able to file there.
Start for free No sales call.
Open risk flags
- The most recent inspection outcome was VAI, on 27 October 2023.
Sources on this page
- FDA
- Drug master files, establishment registration, inspection classifications
- EDQM
- Certificates of suitability
- EudraGMDP and national regulators
- GMP certificates