With more than 30 years of experience in classical Active Pharmaceutical Ingredients (APIs), and 15 years in High Potency Active Ingredients (HPAPIs), Helsinn has built a formidable reputation in the custom manufacture of these products. We manufacture our own products, those for our partners and those for third-party contracts, which virtual global partners to some of the world’s largest pharmaceutical companies. All of our products meet the most stringent global quality, safety and environmental standards, and the new Anticancer APIs facility is completely separate from HPAPI and API warehousing, labs and manufacturing areas.
For over 20 years, Helsinn has also manufactured formulations of drug products to supply its licensing partners worldwide. In 1997, the Group constructed a green-field facility to support the growth of its licensing business, which today supplies over 50 markets including the US, EU and Japan. Production occurs onsite at its state-of-the-art manufacturing and packaging facilities and also throughout a network of external manufacturing service providers (CMOs). Our plants in Switzerland and Ireland are constantly upgraded and maintained to remain fully compliant with FDA, EMA, Swissmedic, Japanese PMDA and PIC requirements.
Our extensive drug manufacturing experience has been built on successfully transferring over 100 projects over the last three decades. Helsinn manufacturing organization supports a wide range of Chemistry, Manufacturing and Control (CMC) and regulatory activities pertaining to Good Manufacturing Practice (cGMP) production, from clinical trial material to commercial launch and supply. Robust and market-oriented production processes assure the seamless delivery of finished, ready-to-market products that our partners can confidently launch shortly after approval. Operating a Project Management system staffed with specialists from Helsinn’s European and American companies means that our plants are qualified sites for supply to many of the world’s largest pharmaceutical companies.