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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 facilities 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 plants in Switzerland and Ireland are 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.

State-of-the-Art Drug Manufacturing

All Active Pharmaceutical Ingredients for our products are manufactured at Helsinn Advanced Synthesis (HAS). Batches of API are then transferred to Helsinn Birex Pharmaceuticals (HBP), where the final product is manufactured and packaged. HBP also coordinates the supply chain of the products manufactured by our Contract Manufacturing Organization (CMO) partners. Our worldwide logistics are centralized at HBP, and from there our products are shipped to our business partners worldwide.

Helsinn Advanced Synthesis

Today APIs, HPAPIs, and Anticancer API for third parties are developed and manufactured at our Biasca facility. Our state-of-the-art segregated facility has advanced containment technologies that protect the products. Helsinn Advanced Synthesis maintains a successful quality record with global regulatory agencies. More than half of our third-party clients have products that are NDA submitted or on the market. Our Biasca site has been ISO 14001 certified since 2000, showing our commitment towards environmental protection. Health and Safety OHSAS 18001 certified in 2005 (the first chemical plant in Switzerland to reach this standard).

Helsinn Birex Pharmaceuticals Ltd., Dublin (HBP)

From its facility in Dublin Ireland, Helsinn manages global supply of group products to its partners worldwide, including notably Europe, the US, Japan and China. Products are developed and manufactured both in-house and using its external network of Contract Manufacturing Organization (CMO) partners. Furthermore, we label package and serialize a wide range of package formats ready for local distribution. Over many years we have been consistently recognized internationally for excellent standards of occupational safety and sustainability. The site is approved by several regulatory agencies including the European Medicines Agency, US FDA, and the Japanese PMDA, and exports to over 50 countries worldwide.