Suppliers / Ajinomoto

Ajinomoto

Japan AJI.MU Updated 9 July 2026

Ajinomoto is an API manufacturer based in Japan. It holds 9 active US drug master files and 33 valid CEPs across a filed portfolio of 23 molecules. Its filings concentrate with MINSA (CR), DIGEMAPS (DO) and EDE (AE). Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 14 November 2025 as VAI.

9
active US DMFs
33
valid CEPs
6
registered plants 3 with an FDA FEI number
7
filings across 4 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
3 of 3 confirmed
Inspections
8 of 8 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 14 November 2025 VAI US FDA
  • 18 July 2025 VAI US FDA
  • 22 February 2019 VAI US FDA
  • 15 February 2019 NAI US FDA
  • 19 February 2016 VAI US FDA
  • 27 September 2013 VAI US FDA
  • 29 September 2011 VAI US FDA
  • 29 September 2011 NAI US FDA

NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.

Registered plants

Site FDA FEI
California, United Arab Emirates Not on file
Mont-St-Guibert, Belgium Not on file
Tokyo, Japan Not on file
Japan, Japan 3002806334
Japan, Japan 1000542796
Japan, Japan 3002806335

What they file, and where

Molecule Regulators Docs
Arginine EDQM, SFDA (Saudi Arabia), US FDA 7
Threonine EDQM, SFDA (Saudi Arabia) 7
Alanine EDQM, SFDA (Saudi Arabia) 4
Histidine EDQM, SFDA (Saudi Arabia) 4
Phenylalanine EDQM, SFDA (Saudi Arabia), US FDA 4
Aspartic Acid EDQM, SFDA (Saudi Arabia), US FDA 3
Glutamic Acid EDQM, SFDA (Saudi Arabia), US FDA 3
Isoleucine EDQM, SFDA (Saudi Arabia) 3
Leucine EDQM, SFDA (Saudi Arabia) 3
Levodopa EDQM, US FDA 3
Show all 23 molecules on file
Lysine EDQM, SFDA (Saudi Arabia), US FDA 3
Serine EDQM, SFDA (Saudi Arabia) 3
Tyrosine EDQM, SFDA (Saudi Arabia), US FDA 3
Valine EDQM, SFDA (Saudi Arabia) 3
Proline EDQM, SFDA (Saudi Arabia) 2
Tryptophan EDQM, SFDA (Saudi Arabia) 2
Arginine Hydrochloride EDQM 1
Brigatinib SFDA (Saudi Arabia) 1
Histidine Hydrochloride Monohydrate EDQM 1
L-Glutamine SFDA (Saudi Arabia) 1
Lysine Acetate EDQM 1
Lysine Hydrochloride EDQM 1
Ornithine SFDA (Saudi Arabia) 1

Also appears on these molecule pages

Levodopa API Lysine API

Filings and GMP by regulator

Regulator Filings GMP certificates
MINSA (CR) 3 None
DIGEMAPS (DO) 2 None
EDE (AE) 1 None
INVIMA (CO) 1 None
US FDA None 2

Scale

Year Revenue Exports Destinations
2024 $320.0M Not reported Not reported

Export figures are customs aggregates. We do not publish the identity of any buyer. Revenue shown in US dollars, converted from the reported currency.

Comparing suppliers?

Choose your molecules and target markets. Ajinomoto comes back tiered against every other supplier able to file there.

Start for free
No sales call.

Open risk flags

  • 42 active litigation matters are on record.
  • The most recent inspection outcome was VAI, on 14 November 2025.

Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates
Company filings
Revenue as reported