Shanghai Ajinomoto Amino Acid is an API manufacturer based in China. It holds 7 active US drug master files across a filed portfolio of 7 molecules. Its GMP standing is certified by MFDS (Korea), US FDA and EMA. Its most recent recorded inspection, by US FDA, closed on 10 May 2024 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Shanghai, China | Not on file |
| China, China | 3004567034 |
| Molecule | Regulators | Docs |
|---|---|---|
| Phenylalanine | SFDA (Saudi Arabia), US FDA | 2 |
| Alanine | US FDA | 1 |
| Isoleucine | US FDA | 1 |
| Leucine | US FDA | 1 |
| Lysine | US FDA | 1 |
| Threonine | US FDA | 1 |
| Valine | US FDA | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| MFDS (Korea) | None | 2 |
| US FDA | None | 1 |
| EMA | None | 1 |
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