Fermion invests $33m to add HPAPI capacity at Hanko plant
The firm said the expansion – which is due to be completed in 2018 – will increase reactor capacity to around 400m3 and introduce isolators and containment technologies.
Around 25m3 of the new reactor capacity will be dedicated to the production on Occupational exposure banding 5 (OEB5) classified high potency active pharmaceutical ingredients (API), which require a containment level of 0,1 µg/m3.
Company president Arto Toivonen said: “The expansion lifts Fermion to a new level in the global arena of API and especially HAPI manufacturing, improving Fermion’s capability to meet increasing demand.”
He added that: “The new unit alone will be able to produce 100 metric tons HPAPI per year increasing the total production capacity of Fermion to over 400 metric tons API/year. Fermion’s scale of HPAPI development and production will now be complete with capabilities from grams to tons.”
News of the expansion comes a few months after Fermion's other API facility in Oulu passed an inspection by Brazilian regulator, ANVISA.
Fermion passed successfully ANVISA Inspection 2016 with three minor recommendations.
According to Fermion: "The Quality System and Manufacturing Facilities were reviewed and as commented by the Inspector in the summary meeting: 'You have a very good Quality System, we have rarely seen such systematic procedures'."
Sales decline
Fermion is a subsidiary of Orion Corporation. According to an Orion financial report the API unit generated revenue of €53m in 2015, down 8% year-on-year.
The decline has continued into the first quarter of 2016 according to Orion.
"Fermion’s net sales in January– March 2016 excluding pharmaceutical ingredients supplied for Orion’s own use were down by 28% at €11m and accounted for nearly two-thirds of Fermion’s entire net sales. The decrease was mainly due to the timing of product deliveries."
