Drug Manufacturing

We’re committed to quality; it’s one of the core values that define how we work. Because we consistently upgrade our facilities and maintain them to the highest standards for producing medicines, we can be proud of our position as a global leader in the manufacture of medicines.

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 integrity of both our own products and those of our clients. HAS 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)

We operate a state-of-the-art drug product development and manufacturing facility for the production of oral, solid and topical dosage forms. We produce and deliver world-class finished products and services and manage an external network of Contract Manufacturing Organization (CMO) partners to provide global supply of group products to partners. Over many years we have been consistently recognized internationally by industry awards for industrial safety and responsible care. In 2011, further investments increased the analytical testing capacity at this site. The site is approved by the European Medicines Agency and US FDA, and exports to over 50 countries worldwide.