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Helsinn Gets CTM License

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Helsinn Birex Pharmaceuticals, Helsinn‘s drug product manufacturing facility in Dublin, Ireland, recently obtained authorization for Manufacture of Investigational Medicinal Products (IMP) for products for human use from the Irish Medicines Board according to EU Directive 2001/20/EC.

The IMP licence enables Helsinn Birex Pharmaceuticals to package, test, store and release of material for use in clinical trials. “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,” said Helsinn’s chief operations officer, Dr. Giorgio Calderari.

Since 2007 the company has invested in packaging and labelling equipment and facilities to enable it to do both primary and secondary packaging of such products. In the future these activities can be managed directly by Helsinn, giving the company better cost control and ability to react to last-minute changes, according to a company statement.

The first packaging run has been completed for a study involving the Groups lead compound Palonosetron (ALOXI, ONICIT). Obtaining the IMP licence, follows on from the successful inspection of Helsinn Birex Pharmaceuticals by the FDA earlier this year.

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