Recently, Monza has established a new state-of-the-art center of excellence for sterile injectables development. All manufacturing services are fully supported with comprehensive in-house analytical and bioanalytical capabilities. Additionally, the facility employs Qualified Persons (QPs) to ensure prompt release of bulk products within the European market.
Monza offers compliance with controlled drug regulations in Europe and the U.S. as well as disposable manufacturing technologies and fully integrated secondary packaging services, and has received regulatory approval from various international regulatory inspection agencies, including: ANVISA, JP PMDA, US FDA, EMA, GCC States, Canada, Russia, Taiwan, Turkey. The Monza site currently supplies over 20 countries – all the major international markets, including the U.S., Europe and Asia Pacific.
Recent Investments to Sterile Development Capabilities
Thermo Fisher Scientific recently made a $25 Millon Investment in 2017 to establish sterile development capabilities in Monza. This was part of a $150 million total investment in sterile capabilities since 2015, including investments in Greenville, NC & Ferentino, Italy.
Learn more about the specific equipment and capabilities at this site by downloading our Site Fact Sheet.