Profile
Client: Global API trading house
Indication: Injectable API intended for intravenous application
Market: Europe
Indication: Injectable API intended for intravenous application
Market: Europe
IDrug
assignment
assignment
| » | The client wanted to screen various manufacturers in order to provide a risk assessment of each potential supply source and benchmark current available suppliers. |
| » | The API has a peculiar varied milieu which is difficult to reproduce. |
| » | IDrug compared 4 different API manufacturers, incl. one originator, establishing impurity profiles and polymer profiles by MALDI. |
Result
| » | IDrug’s analysis showed that only the originator has the required quality and correct composition of milieu which other suppliers could not manage to copy. |
| » | The risk assessment showed that the “generic” final dosage form potentially has an inferior safety profile than the one shown by the originator molecule in clinical studies. |