Fermion has successfully passed another FDA-inspection. The audit of the Hanko facility was carried out in summer 2011 during four business days.  A form 483 with three remarks was filed which was answered within days. Most importantly, on February 6, 2012, FDA informed that it classifies Fermion’s API plant in Hanko as “acceptable”.

Fermion’s plant in Hanko has passed its first FDA-inspection in 1979. During the last 20 years, fourteen inspections have been carried out, during which Fermion’s plants in Oulu and Hanko, as well as its pilot facility in Espoo (all located in Finland), have been audited. In all cases, Fermion could maintain its status as “acceptable”, which now is in its 33^rd year without interruption.

The high number of FDA-inspections is related to the dual nature of Fermion’s business. Established as a manufacturer of generic APIs at the beginning of its existence, innovative products were added to the product palette as a result of Orion Corporation’s (Fermion’s mother company) decision to develop innovative pharmaceuticals. As a result, FDA-inspections were triggered by FDA’s Center for Drug Evaluation and Research for approving innovative medicines as well as generic pharmaceuticals.

Fermion today manufactures approx. 20 generic APIs as well as 10 innovative products, of which 8 are approved worldwide and two are in registration phases.  Over the years, Fermion became a specialist in manufacturing anticancer APIs and as a result of this development; many more innovative APIs are now in different clinical phases, with a customer base ranging over all parts of the world.