Helsinn Chemical Operations develop and manufacture Active Pharmaceutical Ingredients (APIs), Advanced Intermediates and High Potency Active Ingredients (HPAIs) for third parties on exclusive basis. The production plants are located in Switzerland and Ireland, with the Swiss plants successfully inspected by the FDA (no 483 issued),Swissmedic and the South Korean authorities. For API and cGMP Advanced Intermediates, production scale is from kgs up to tens of tons. For HPAI, production scale is from grams up 7kgs right now, hundreds of Kilograms after upgrade of a production bay of Helsinn Advanced Synthesis SA. The personal meetings with the FDA during end of Phase II, IND and NDA of Helsinn’s R&D, contributes to a particular expertise available for medium/small pharma companies that need a specialist supporting them for choosing the right and successful registration strategy for their NCE. From the chemistry point of view, with over 20 years experience in chemical contract manufacturing, Helsinn is offering a wide range of reactions performed at industrial scale. Usually the specific chemistry for a NCE is reviewed under Confidentiality Agreement and feasibility confirmed.
