OVERVIEW

• Facility area:
  • 344,000 ft²  (31,950 m²)
• Regulatory approval:
  • DVMF Ministero della Salute (Italy)
  • U.S. FDA
  • HPFBI (Canada)
  • GCC (Middle East)

Monza Operations, Italy, manufactures a range of conventional solid dosage forms, and offers significant sterile lyophilization capacity.

Monza Operations features three separate sterile areas housing six lyophilization units ranging in size from 322 ft² (30 m²) to 398 ft² (37 m²), and offering a total of 2,150 ft² (200 m²) of lyophilization capacity. These state-of-the-art lyophilization systems are ideal for the commercial manufacture of biopharmaceuticals and small molecules. The facility has experience manufacturing lyophilized products for major international markets, including the U.S. and Europe.

Patheon’s Ferentino Operations also offer development and commercial lyophilization capacity. Click here to learn more about Ferentino Operations.

Monza Operations offers a range of fill and finish solutions for sterile pharmaceutical products, including aseptic filling and terminal sterilization of parenterals in vials.

The site also provides high-volume manufacturing capabilities for a range of conventional solid dosage forms. All manufacturing services are fully supported with comprehensive in-house analytical and bio-analytical capabilities. Patheon’s European facilities each employ a Qualified Person (QP) to ensure prompt release of products within the European market. The facility also offers compliance with controlled drug regulations in the EU and USA.