Fermion has been in the API business since 1970 and is well known for its APIs developed for the generic pharmaceutical market.
Activities in developing APIs for innovative pharmaceutical companies started in the 1980s.Ten new medicinal entities have been launched worldwide or are in advanced stages of registration (past P III).
Fermion's turnover is exceeding $100 million and continues to grow. In addition to successful launch of generic products, the launch of new products developed for third parties becomes more and more significant. All countries belonging to the regulated market are served. Two thirds of Fermion's turnover is carried out with external customers, and a third consists of supplies of innovative products to its mother company, Orion Corporation.
The manufacturing capacity of Fermion is very high. With its 320m3 reactor capacity, it allows a theoretical API-output in the range of up to 400t.
Fermion's plants are inspected by the US FDA since 1979, thus Fermion has more than 30 years of experience of working with government authorities. In all this time, Fermion has never ever received a Warning Letter issued by the US FDA, and also passed the most recent inspection of its plant in Oulu, which was carried out in September 2010 by 2 inspectors during five business days. Its plant in Hanko was inspected most recently in June 2011, and also this plant has maintained its status as "acceptable".
Fermion is today cGMP certified by the US FDA, the Finnish Medicines Agency (representing the EU), the Ministry of Health and Welfare in Japan as well as authorities from Brazil, Korea and Mexico.
Fermion is in compliance with all environmental regulations and is prepared to open its reports carried out during government inspections to its customers during a QA audit.
Fermion has 20 DMF's active which are updated and accessed. The compounds include anticancer agents, CNS product, immunosuppressants as well as narcotic compounds. The reactor capacity ranges from 60l glass lined to 6300l glass lined/stainless steel. The batch size ranges from 3kg up to 2000kg. There are almost no restrictions with respect to the type of chemical reactions that can be processed.
Fermion is well introduced to companies in the generic industry. Its customers are very impressed by Fermion's flexible approach to changes in the demand of APIs on order, direct and easy communication skills and level of technical documentation. The same also holds for its reputation as a producer of APIs who gives reliable times of delivery, is strictly compliant with cGMP, and has competent personnel throughout its management.
Outsourcing: contract research and manufacturing services (CRAMS):
As a consequence of Orion's strategic decision to develop innovative drug products, back in the 1980s, Fermion started developing the chemistry section of the CMC-part of all of Orion's New Drug Applications. Still today, Fermion produces all of Orion's innovative APIs. This service has been extended to other pharmaceutical companies for producing Big Pharma's products now generic or soon becoming generic, as well as innovative drug products and/or substances for virtual pharmaceutical companies.
Fermion is searching for additional business opportunities in the CRAMS-area, especially in the field of oncology products and compounds which require demanding processes.
One area where Fermion made its name well known is in the field of preparing fully synthetic camptothecin derivatives. Today, all the camptothecin products approved worldwide can be produced with Fermions manufacturing process, which is extremely reproducible and shows a lower impurity profile compared to nature-derived compounds. The versatility of its manufacturing process has been shown to several companies in the field in a very convincing way, as some of them have spontaneously decided to switch from nature-derived camptothecin derivatives to compounds prepared by full chemical synthesis.
Fermion has built a new manufacturing facility intended for commercial production of potent compounds, OEL class V (< 1 µg/m3). This new three-storey building is intended for manufacturing anticancer compounds (antifolates, topomerase inhibitors as well as cytotoxics).
The batch size in this new suite varies from 3-15 kg, and the total annual volume is approx. 400-500kg.
Glove box technology is applied on large-scale for the charging as well as the collecting and isolation area. All reactors are fully automated and operate in a closed class 100'000 environment. Isolation of API occurs through a 0.32m2 pressure filter dryer with separated, closed areas for grinding, packing and weighting. All solid and liquid wastes are collected and incinerated; air handling is dedicated to the unit. Charging of reactors occurs through installed glove boxes or using split-valve technology.
This brand-new facility represents state-of-the-art manufacturing technology of potent compounds and has generated a tremendous interest among our clientele.
Koivu-Mankkaantie 6 A
Attn: Kari Lappalainen, Ph.D.
Phone: +358 10 426 4222
Mobile: +358 50 966 4222
Email: Contract research and manufacturing services: CRAMS@orion.fi
Email: Generic products: fermionSales@orion.fi