Helsinn Group core manufacturing activities lie in the development and production of Active Pharmaceutical Ingredients (APIs), High Potency Active Ingredients (HPAIs) and Drug Products for the Group and for third parties acting as specialized contract manufacturer.
High level manufacturing technologies, an internationally recognized quality system, classified and qualified containment systems, integrated supply chain management and great attention paid to Health, Safety and Environment (HSE) are pillars of the Helsinn industries, operated by a skilled and flexible workforce.
Helsinn continues to increase the production capacity of the Group's plants by adding new technologies and increasing production flexibility. In 2011, Helsinn further expanded the services at the Helsinn Advanced Synthesis SA site in Biasca, Switzerland, with a new investment for a plant dedicated to the development, analysis and manufacturing of cytotoxic molecules which will be operational in 2012.
With over 25 years' experience in the manufacturing of classical APIs and 10 years' experience in the manufacturing of HPAIs, Helsinn's reputation and reliability in the custom manufacturing field is legendary.
In 2009, the Group invested in its Dublin subsidiary, Helsinn Birex Pharmaceuticals Ltd, with the support of the Irish development Authority, and built an R&D Centre-of-Excellence for oral solid dosage forms and the Stability centre focused in developing group products of the future. In 2011, further investments were made to increase the analytical testing capacity on the site. Helsinn has invested substantially in dedicated capacity at the sites of its strategic contract manufacturing partners to guarantee all elements of the supply chain for development and commercial products.
Production of the Helsinn‘s products (nimesulide, oxaprozin, palonosetron, Klean-Prep®, netupitant and anamorelin) is performed or coordinated at Helsinn’s modern facilities where worldwide distribution is also managed, thus providing to Helsinn’s partners the highest possible assurance of quality and reliability.
The Group operates according to the “Integrated Manufacturing” concept which means that Helsinn understands its partners’ specific needs and specific requirements to develop a process able to deliver few grams of APIs, small scale units of drug products, or full commercial scale batches as needed.
Helsinn’s Manufacturing Operations is fully committed to coordinating the CMC development and preparation of the regulatory dossier of products and to assuring that APIs or Drug Products are delivered to Helsinn’s licensing or contract manufacturing partners.