Edmond Pharma is an API manufacturer based in Italy. It holds 10 active US drug master files across a filed portfolio of 12 molecules. Its filings concentrate with INFARMED (PT), AIFA (IT) and MINSA (CR). Its GMP standing is certified by EMA. Its most recent recorded inspection, by US FDA, closed on 15 July 2022 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Italy, Italy | 3003659426 |
| Paderno Dugnano, Italy | Not on file |
| Molecule | Regulators | Docs |
|---|---|---|
| Dexmedetomidine | SFDA (Saudi Arabia), US FDA | 3 |
| Levobupivacaine | SFDA (Saudi Arabia), US FDA | 2 |
| Chloroprocaine | US FDA | 1 |
| Clenbuterol | US FDA | 1 |
| Isoprenaline | US FDA | 1 |
| Lornoxicam | SFDA (Saudi Arabia) | 1 |
| Lurasidone | US FDA | 1 |
| Midodrine | US FDA | 1 |
| Norepinephrine | US FDA | 1 |
| Ropivacaine | US FDA | 1 |
| Tirofiban | SFDA (Saudi Arabia) | 1 |
| Tulobuterol | US FDA | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| INFARMED (PT) | 5 | None |
| AIFA (IT) | 4 | None |
| MINSA (CR) | 2 | None |
| EMA | 1 | 1 |
| UZPHARM (UZ) | 1 | None |
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