State-Of-The-Art Manufacturing

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

Drug Substance manufacturing

With more than 30 years’ 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 for our third-party pharmaceutical partners.
We manufacture our own products as well as those for our partners, and for third-party contracts including global partners from virtual to some of the world’s largest pharmaceutical companies.
All of our products meet the most stringent quality, safety, and environmental standards globally, and the new Anticancer API facility maintains complete separation from HPAPIs and API warehousing, labs and manufacturing areas.

Finished Dosage manufacturing

For more than 20 years Helsinn has also manufactured formulations of drug products for supply to its licensing partners worldwide. In 1997 the Group constructed a greenfield facility to support the growth of its licensing business and today supplies over 50 markets including the US, EU and Japan. Production is carried out onsite in its manufacturing and packaging facilities and also at 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.

Helsinn Advanced Synthesis (HAS), Biasca, Switzerland

  • Today APIs, HPAPIs, and Anticancer API compounds for third parties are developed and manufactured at our Biasca facility
  • A state-of-the-art segregated facility with advanced containment technologies that protect the integrity of both Helsinn and our clients’ products
  • 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 site in Biasca has been ISO 14001 certified since 2000, confirming a commitment towards environmental protection
  • Health & Safety OHSAS 18001 certified in 2005 (the first chemical plant in Switzerland to reach this standard)

Helsinn Birex Pharmaceuticals Ltd, Dublin, Ireland

  • 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 consistently been recognised 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

Experience and quality equals confidence

Our extensive experience has been built on successfully transferring over 100 projects over the last three decades. Helsinn manufacturing organisation 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.

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