27 August 2015 Text size Home About Fermion APIs CMO Contacts Orion Corporation News from Fermion Fermion opened new suite for high potency APIs Fermion’s strategy to develop its capabilities to fulfill customers’... (4 March 2015) Arto Toivonen has been appointed as President of Fermion Oy Arto Toivonen has been appointed as President of Fermion Oy, effective January... (14 January 2015) Fermion connected chemists at the 6th Nordic Process Chemistry Forum In total 67 chemists and chemical engineers came together to listen to 14... (6 June 2014) Fermion's Hanko Plant maintains the status "acceptable" by the FDA Fermion passed successfully the FDA 2014 Inspection with three minor 483... (20 March 2014) Fermion's Oulu Plant maintains the status “acceptable" by the FDA Fermion passed successfully the FDA 2013 Inspection with no 483 remarks and... (10 February 2014) FERMION Manufacturer of Active Pharmaceutical Ingredients (API) for both generic and proprietary drug products since 1970. Contract manufacturing services for APIs including oncology and highly potent compounds. Meet us at: ChemOutsourcing, 14-17 September 2015, Long Beach, NJ, USA CPhI Worldwide, 13-15 October 2015, Madrid, Spain QUICK LINKS List of API's MSDS Responsible care Standard Sales and Delivery Conditions Fermion Oy, Koivu-Mankkaan tie 6A, FI-02200 Espoo, Finland TEL. +358 10 4261 FAX: +358 9 452 1764 e-mail: fermionSales@orion.fi Contacts

14 August 2015 Text size Home About Fermion APIs CMO Contacts Orion Corporation Home / News / 10 February 2014 Print Fermion's Oulu Plant maintains the status as “acceptable" by the FDA Fermion passed successfully the FDA 2013 Inspection with no 483 remarks and continued the good trend of the FDA Inspection History. The Audit was carried out on 9th - 13th December, 2013 in Fermion’s Oulu Plant. The inspection was a routine surveillance inspection, and during the audit focus was on Fermion’s veterinary products Atipamezole and Dexmedetomidine. Our Quality System and Manufacturing Facilities were reviewed during the five-day Inspection and our GMP level was found to fully comply with the FDA requirements, as assessed by the inspector. Fermion’s Oulu plant passed its first FDA Inspection in 1979. During the history of Fermion, nineteen FDA Inspections in total have been carried out in our Plants in Oulu and Hanko, as well as in our Pilot Plant in Espoo, which all are located in Finland.The high number of FDA Inspections is related to the dual nature of Fermion’s business as a Manufacturer of generic APIs and innovative new molecules for Orion Corporation (Fermion’s mother company). After each Inspection, Fermion has received the status as “acceptable”. Fermion Oy, Koivu-Mankkaan tie 6A, FI-02200 Espoo, Finland TEL. +358 10 4261 FAX: +358 9 452 1764 e-mail: fermionSales@orion.fi Contacts