Patheon wins EMEA approval for Puerto Rico plant
Patheon has received regulatory approval from the European Medicines Agency (EMEA) for its Manati, Puerto Rico solid dose manufacturing facility following a successful inspection by the Medical Products Agency of Sweden.
Patheon has received regulatory approval from the European Medicines Agency (EMEA) for its Manati, Puerto Rico solid dose manufacturing facility following a successful inspection by the Medical Products Agency of Sweden.
Patheon, a global provider of contract development and manufacturing services to the pharma industry, with US headquarters in Triangle Park, North Carolina, has so far in 2009 successfully completed 19 regulatory inspections at nine manufacturing sites, including eight US FDA inspections and two European inspections.
"The approval of our Manati facility allows us to ship solid dosage product into Europe from Puerto Rico, which provides additional benefit and flexibility for our clients," said Terry Novak, president of Patheon North America.
Manati specialises in the high volume manufacture of solid dosage forms including tablets, capsules, and powders packaged in bottles.
The 38,100m2 site comprises three separate manufacturing areas each with HVAC systems. The facility's environmental controls and ventilation systems facilitate explosion-proof manufacturing, including solvent coating of tablets. This flexible facility also has a low-humidity manufacturing suite for moisture-sensitive tablet formats.
In addition Manati offers capabilities in the manufacture of controlled release technologies, including those utilising pelletisation, matrix and coating strategies.