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Helsinn is pleased to announce that its manufacturing plant in pharmacological Dublin (Ireland), Helsinn Birex Pharmaceuticals, has recently obtained a license for the manufacture of investigational medicinal products (IMP) for products for use in Human Medical Committee under the Irish EU Directive 2001/20/EC.

The license allows IMP Helsinn Birex Pharmaceuticals packaging, test, save and send the material used in clinical trials, an important development for the company and Helsinn Group. "Having this authorization expands the range of development activities that we can manage within the company and we can offer as a service to our partners and again confirms an advanced quality system and technical capabilities of the company," said director of operations Helsinn, Dr. Giorgio Calderari. Since 2007 the company has invested in packaging and labeling equipment and facilities for primary and secondary packaging of these products. In the future, these activities can be managed directly by Helsinn, ensuring better control the cost and the ability to react to changes in the last minute can often arise with development projects.

The first packing operation has been completed for a study that involved the main compound of the group, Palonosetron (ALOXI (R), ONICIT (R)). Licensed IMP is the result of the successful inspection of Birex Helsinn Pharmaceuticals by U.S. FDA earlier this year.