Our Monza, Italy site specializes in prefilled syringe and cartridge manufacturing, as well as mRNA drug substance manufacturing and development services.
Specialized capabilities
- mRNA drug substance manufacturing, analytical, and development
- Lipid nanoparticles (LNP) formulation manufacturing, analytical, and development
- Prefilled syringes
- Sterile lyophilized products
- Sterile liquids (SVP)
- Cartridges
- Biopharmaceuticals
- Controlled drugs
- Secondary packaging (vials)
- Commercial fill-finish lines
- Visual Inspection Capabilities
- 100% automatic visual inspection
- Semiautomatic visual inspection
- Manual visual inspection
Recently, Monza established a new state-of-the-art center of excellence for sterile injectables development. All manufacturing services are fully supported by our comprehensive in-house analytical and bioanalytical capabilities. Additionally, the facility employs Qualified Persons (QPs) to ensure the prompt release of bulk products within the European market.
Monza offers compliance with controlled drug regulations in Europe and the US, as well as disposable manufacturing technologies and fully integrated secondary packaging services. It has received regulatory approval from various international regulatory inspection agencies, including: ANVISA, JP PMDA, US FDA, EMA, GCC States, Canada, Russia, Taiwan, and Turkey.
The Monza site currently supplies over 20 countries – all the major international markets, including the U.S., Europe and Asia Pacific.
Monza offers compliance with controlled drug regulations in Europe and the US, as well as disposable manufacturing technologies and fully integrated secondary packaging services. It has received regulatory approval from various international regulatory inspection agencies, including: ANVISA, JP PMDA, US FDA, EMA, GCC States, Canada, Russia, Taiwan, and Turkey.
The Monza site currently supplies over 20 countries – all the major international markets, including the U.S., Europe and Asia Pacific.
