Ajinomoto is an API and finished-dose manufacturer based in Japan. It holds 34 active US drug master files and 33 valid CEPs. Its filings concentrate with AIFA (IT), INFARMED (PT) and FAMHP (BE). Its GMP standing is certified by US FDA, TMDA (TZ) and MFDS (Korea), among 8 authorities. Its most recent recorded inspection, by US FDA, closed on 14 November 2025 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| California, United Arab Emirates | Not on file |
| Wetteren, Belgium | Not on file |
| Mont-St-Guibert, Belgium | Not on file |
| Belgium, Belgium | 3002807802 |
| Belgium, Belgium | 3003677791 |
| Brazil, Brazil | 1000508879 |
12 further sites are on record.
| Molecule | Regulators | Docs |
|---|---|---|
| Threonine | EDQM, SFDA (Saudi Arabia), US FDA | 10 |
| Histidine | EDQM, SFDA (Saudi Arabia), US FDA | 8 |
| Alanine | EDQM, SFDA (Saudi Arabia), US FDA | 7 |
| Arginine | EDQM, SFDA (Saudi Arabia), US FDA | 7 |
| Serine | EDQM, SFDA (Saudi Arabia), US FDA | 7 |
| Leucine | EDQM, SFDA (Saudi Arabia), US FDA | 6 |
| Lysine | EDQM, SFDA (Saudi Arabia), US FDA | 6 |
| Phenylalanine | EDQM, SFDA (Saudi Arabia), US FDA | 6 |
| Valine | EDQM, SFDA (Saudi Arabia), US FDA | 6 |
| Isoleucine | EDQM, SFDA (Saudi Arabia), US FDA | 5 |
| Proline | EDQM, SFDA (Saudi Arabia), US FDA | 4 |
| Tryptophan | 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 |
| Levodopa | EDQM, US FDA | 3 |
| Tyrosine | EDQM, SFDA (Saudi Arabia), US FDA | 3 |
| Amino Acids | US FDA | 2 |
| L-Glutamine | SFDA (Saudi Arabia), US FDA | 2 |
| Arginine Hydrochloride | EDQM | 1 |
| Brigatinib | SFDA (Saudi Arabia) | 1 |
| Gefitinib | SFDA (Saudi Arabia) | 1 |
| Histidine Hydrochloride Monohydrate | EDQM | 1 |
| Lysine Acetate | EDQM | 1 |
| Lysine Hydrochloride | EDQM | 1 |
| Miconazole | US FDA | 1 |
| Ornithine | SFDA (Saudi Arabia) | 1 |
| Prazosin | US FDA | 1 |
| 培地／培地添加物・Ｃｈｏｆｅｅｄｍｅｄｉｕｍｃｏｄｅｎｏ．Ｄｓｆ３．０ | PMDA (Japan) | 1 |
| 培地／培地添加物・Ｃｈｏｍｅｄｉｕｍｃｏｄｅｎｏ．Ａｓｆｄｓ２．０ | PMDA (Japan) | 1 |
| 培地／培地添加物・Ｃｈｏｍｅｄｉｕｍｃｔａｓｆｃｈｏ１ | PMDA (Japan) | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| AIFA (IT) | 236 | None |
| INFARMED (PT) | 185 | None |
| FAMHP (BE) | 184 | None |
| INHRR (VE) | 181 | None |
| DMP (NO) | 63 | None |
| MINSA (CR) | 57 | None |
| US FDA | None | 6 |
| TMDA (TZ) | None | 6 |
| MFDS (Korea) | None | 2 |
| NAFDAC (NG) | None | 2 |
| NCELS (KZ) | None | 1 |
| MHRA (UK) | None | 1 |
| INVIMA (CO) | None | 1 |
| EMA | None | 1 |
| 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.
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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