Helsinn announces completion of its new Stability Centre at its Irish drug product manufacturing facility
Dublin, Ireland (ots)
Helsinn announces the completion of its state of the art Stability Centre at its Helsinn Birex Pharmaceuticals facility in, Dublin, Ireland.
The new facility which has a total storage capacity of 24 cu meters, contains a range of stability chambers which will operate at ICH conditions of 25°C/60% RH, 30°C/65% RH, and 40°C/75% RH. It also has a refrigerated chamber to store samples at 5°C and a freezer at minus 20°C.
The centre has the capacity to meet foreseeable stability requirements of the Helsinn Group for commercial and development products currently in the Helsinn pipeline. It is also available as a service for third party clients.
The centre possesses state of the art monitoring and recording systems for Security and operational performance, and for emergency back up in the case of power failure or other unforeseen events.
"The completion of this new stability center at Helsinn Birex Pharmaceuticals provides an important addition to Helsinn's capability to monitor the quality of its product portfolio as part of its commitment to excellent service to its customers worldwide", says Padraig Somers, General Manager. "Additionally, it complements Helsinn's capabilities to optimize its product formulations during the development process".
About Helsinn Group
Helsinn is a privately owned pharmaceutical group with headquarters in Lugano, Switzerland, and subsidiaries in USA and Ireland. Helsinn's unique business model is focused on the licensing of pharmaceuticals and medical devices in therapeutic niche areas. The Group in-licenses early stage new chemical entities, completes their development from the performance of pre-clinical/clinical studies and Chemistry, Manufacturing and Control (CMC) development, to the filing for and attainment of their market approval worldwide.
Helsinn's products are sold directly, through the Group subsidiaries, or eventually out-licensed to its network of local marketing and commercial partners, selected for their deep in-market knowledge and know-how, and assisted and supported with a full range of product and scientific management services, including commercial, regulatory, financial, legal and medical marketing advice.
The active pharmaceutical ingredients and the finished dosage forms are manufactured at Helsinn's cGMP facilities in Switzerland and Ireland, and supplied worldwide to its customers. Helsinn is the worldwide licensor of palonosetron, a second generation 5-HT3 receptor antagonist, for the prevention of chemotherapy-induced nausea and vomiting (CINV) and of post-operative nausea and vomiting (PONV) in patients with cancer, and of the original nimesulide, a non-steroidal anti-inflammatory drug (NSAID) distributed in more than 50 countries worldwide. Helsinn, with a workforce of around 450 employees in Switzerland, Ireland and USA, reported a 2008 turnover of over CHF 280.3 million (about EUR 178 million), covering 75 countries worldwide, with over 20% of this turnover invested in R&D.
For more information about Helsinn Group, please visit the website: www.helsinn.com
Contact:
Helsinn Healthcare SA
Paola Bonvicini
Head of Communication & Press Office
Tel: +41/91/985'21'21
E-Mail: info-hhc@helsinn.com