Dipharma is an API manufacturer based in Italy. It holds 6 active US drug master files across a filed portfolio of 5 molecules. Its filings concentrate with DKMA (DK), SWISSMEDIC (CH) and ANSM (FR).
| Site | FDA FEI |
|---|---|
| Chiasso, Switzerland | Not on file |
| Molecule | Regulators | Docs |
|---|---|---|
| Sapropterin | US FDA | 2 |
| Carglumic Acid | US FDA | 1 |
| Migalastat | US FDA | 1 |
| Miglustat | US FDA | 1 |
| Nitisinone | US FDA | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| DKMA (DK) | 7 | None |
| SWISSMEDIC (CH) | 5 | None |
| ANSM (FR) | 1 | None |
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