Helsinn Advanced Synthesis Successfully Inspected by FDA
Biasca, the Swiss-based APIs (Active Pharmaceutical Ingredients) and HPAPIs (Highly Potent Active Pharmaceutical Ingredients) contract manufacturing company of the Helsinn Group, underwent a successful Inspection by the US-FDA on April 2; the inspection was concluded with "no 483 Observations".
The cGMP Inspection covered all areas involved in the manufacturing of APIs and HPAPIs and involved commercial products as well as the pre-approval inspection for one specific product. The products covered in the FDA inspection are manufactured by Helsinn, on an exclusive basis, for biotech and pharmaceutical companies based in the US.
The Swiss site has been successfully inspected previously by the US-FDA in 1996, 2003 and 2007 without the issue of a 483 Form.