Shanghai Plumino Amino Acid is an API manufacturer based in China. It holds one active US drug master file and 14 valid CEPs across a filed portfolio of 13 molecules. Its GMP standing is certified by MFDS (Korea), EMA and US FDA. Its most recent recorded inspection, by US FDA, closed on 15 December 2023 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 | 3005253125 |
| Molecule | Regulators | Docs |
|---|---|---|
| Arginine | EDQM | 2 |
| Histidine | EDQM | 2 |
| Alanine | EDQM | 1 |
| Amino Acids | US FDA | 1 |
| Aspartic Acid | EDQM | 1 |
| Isoleucine | EDQM | 1 |
| Leucine | EDQM | 1 |
| Lysine | EDQM | 1 |
| Phenylalanine | EDQM | 1 |
| Proline | EDQM | 1 |
| Serine | EDQM | 1 |
| Threonine | EDQM | 1 |
| Valine | EDQM | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| MFDS (Korea) | None | 2 |
| EMA | None | 1 |
| US FDA | None | 1 |
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