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Manufacturing

We’re committed to quality; it’s one of the core values that define how we work. We consistently upgrade our facility to maintain our market leadership and to ensure they are the highest standard for producing medicines, and we are proud of our position as a global leader in the manufacture of medicines.

Finished Drug Manufacturing

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 plant in Ireland is constantly upgraded and maintained to remain fully compliant with FDA, EMA, Swissmedic, Japanese PMDA and PIC requirements.

 

Confidence From Experience and Quality

Our extensive drug manufacturing experience has been built on successfully transferring over 150 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 ensure 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.