Novartis: The Vaccine Manufactured In Rosia Can Be Exported In The US
The US Food and Drug Administration (FDA) has officially approved the Novartis Vaccines site of Rosia near Siena to package Fluvirin™, an injectable flu vaccine for the US market. This is the first FDA approval that Novartis Vaccine has received in Italy and is particularly important both for the Italian sites and the US market. It is also important for Italy's image across the pond.
The approval was obtained thanks to a large number of activities aimed at ensuring that the new building to be used for packaging and vial filling was designed and built according to the highest standards and met all regulatory requirements. These activities also involved making sure that quality systems met FDA's extremely rigorous criteria
The building, which is extremely advanced from an engineering and manufacturing point of view, has been recently completed near Novartis Vaccines plant in Rosia.
"We are proud of this result which is fundamental in order to implement this year's flu strategy which provides for important supplies to the US market. FDA's approval will enable us to package a larger number of vials and to deliver a greater number of doses to north America thus strengthening Rosia's position as a centre of excellence", highlighted Francesco Gulli, the CEO of Novartis Vaccines & Diagnostics in Italy
"Above all, though, we are proud because FDA's approval is the highest recognition for the investments that have been made so far and strengthens the value of future investments aimed at further enhancing manufacturing activities".
Siena and Rosia's plants - covering a total area of 250,000 m2 - are Novartis V&D centre of excellence for primary and secondary production of vaccines, particularly against meningitis and flu. Every year, Siena and Rosia manufacture hundreds of millions of doses of vaccine to protect millions of people in more than 115 countries.
Novartis Vaccines and Diagnostics
This is the only biotechnology company in Italy dealing with vaccines and is the only one in Italy researching, developing and manufacturing vaccines. Thanks to its two manufacturing sites in Siena and Rosia, its scientific skills and its high level of technological innovation, the Italian company plays a strategic role within the Group and bears witness to the industrial capabilities and biotechnological research in Italy.
22/04/2008 (INTOSCANA.IT)
