Investigational Medicinal Products license was given to Dublin plant.
Helsinn’s drug product manufacturing facility in Dublin, Ireland, obtained an investigational medicinal products (IMP) license from the Irish Medicines Board.
This authorizes Helsinn to package, test, store, and release material for use in clinical trials. The first packaging run has been completed for a study involving Helsinn’s lead compound, palonosetron.
“Having this authorization expands the range of development activities we can manage within the company and can offer as a service to our partners and confirms again the company’s advanced quality systems and technical capabilities,” says Giorgio Calderari, Ph.D., COO at Helsinn.
