AMINO is an API manufacturer based in Germany. It holds 15 active US drug master files and 22 valid CEPs across a filed portfolio of 21 molecules. Its filings concentrate with SWISSMEDIC (CH) and EDE (AE). Its GMP standing is certified by ZLG (DE) and EMA. Its most recent recorded inspection, by US FDA, closed on 12 May 2022 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Belp, United Arab Emirates | Not on file |
| Gebenstorf, Switzerland | Not on file |
| Gebenstorf, Switzerland | Not on file |
| Germany, Germany | 3002806319 |
| Lower Saxony, Germany | Not on file |
| Frellstedt, Germany | Not on file |
| Molecule | Regulators | Docs |
|---|---|---|
| Leucine | EDQM, SFDA (Saudi Arabia), US FDA | 6 |
| Threonine | EDQM, SFDA (Saudi Arabia), US FDA | 4 |
| Tyrosine | EDQM, SFDA (Saudi Arabia), US FDA | 4 |
| Alanine | EDQM, SFDA (Saudi Arabia), US FDA | 3 |
| Betaine | SFDA (Saudi Arabia), US FDA | 3 |
| Histidine | EDQM, SFDA (Saudi Arabia), US FDA | 3 |
| Isoleucine | EDQM, SFDA (Saudi Arabia), US FDA | 3 |
| Phenylalanine | EDQM, SFDA (Saudi Arabia), US FDA | 3 |
| Serine | EDQM, SFDA (Saudi Arabia) | 3 |
| Tryptophan | EDQM, SFDA (Saudi Arabia), US FDA | 3 |
| Valine | EDQM, SFDA (Saudi Arabia), US FDA | 3 |
| Arginine | EDQM, SFDA (Saudi Arabia) | 2 |
| Aspartic Acid | EDQM, US FDA | 2 |
| Methionine | EDQM, US FDA | 2 |
| N-Acetyltyrosine | EDQM, US FDA | 2 |
| Asparagine | EDQM | 1 |
| Glutamic Acid | EDQM | 1 |
| Glycine | EDQM | 1 |
| Lysine | EDQM | 1 |
| N-Acetyltryptophan | EDQM | 1 |
| Proline | SFDA (Saudi Arabia) | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| SWISSMEDIC (CH) | 138 | None |
| EDE (AE) | 4 | None |
| ZLG (DE) | None | 6 |
| EMA | None | 3 |
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