CPhI Online

Helsinn - Building quality cancer care together

16 Sep 2016

Helsinn Advanced Synthesis develops and manufactures compounds for clinical and commercial use in several containment classes: Active Pharmaceutical Ingredients (APIs), Advanced Intermediates, High Potency APIs (HPAPIs) and Anticancer compounds. These compounds are manufactured for third parties on an exclusive basis, with a high level of service and with an innovative touch.

The multi-purpose production plants, located in Biasca, Switzerland were first established in 1983 and holding a cGMP certificate since 1984, it has placed a high level of focus to our internationally recognized Quality System. Helsinn Advanced Synthesis has been successfully approved by the Swiss Authorities along with the FDA, EMA and PMDA. The last FDA inspection was in 2014 with no 483s. In 2015, the Helsinn Group was accredited with the CEO Gold Standard and its Global Sustainability report was approved by Global Reporting Initiative (GRI). Helsinn is also happy to report that Helsinn has won a 2016 CMO Leadership Award in the following categories: Quality; Reliability; Capabilities; Expertise; and Compatibility (Overall in all categories).

Beyond successful technology transfer and production, Helsinn Advanced Synthesis has the expertise and know-how to support its partners in product registrations due to experience with hundreds of projects over the past 30 years.

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