Patheon's Italian facility receives approval
Canadian company Patheon, of Toronto, has received final regulatory approval from the Italian Ministry of Health for its new lyophilisation capabilities at its facilities in Monza and Ferentino.
The approval for the Monza facility grants authority to manufacture sterile lyophilised products and small-volume parenterals in both the newly constructed and existing sterile areas of the site, and renews Patheon's authority to manufacture the full range of non-sterile liquid and solid dosage forms manufactured at the facility.
Since acquiring the Ferentino facility in February 2002, Patheon has expanded and upgraded the site, and now has authority to manufacture sterile lyophilised products, as well as sterile various-volume parenterals.
Demand is growing for lyophilisation services, from both biotechnology companies and other pharmaceutical companies who are developing more therapeutic proteins and other traditional small molecule-based products.
'Regulatory approval of our new capabilities marks a significant milestone in our strategy to be a leading European supplier of value-added pharmaceutical manufacturing services,' said Robert Tedford, Patheon ceo. 'We are pleased that the first phase of our lyophilisation expansion programme - which involved building a new sterile area at Monza and doubling the lyophilisation capacity at Ferentino - has been completed and approved on schedule. This provides Patheon with the added capacity needed to continue to grow this specialised and value-added service offering.'