Patheon’s Manati solid dose manufacturing facility in Puerto Rico has received regulatory approval from the European Medicines Agency (EMEA), following the completion of inspection by the Medical Products Agency of Sweden.
So far in 2009, Patheon has completed 19 regulatory inspections at nine manufacturing sites, including eight FDA inspections and two European inspections.
Terry Novak, president at Patheon, said: “Patheon’s track record of regulatory compliance underscores our commitment to quality and reliability for our customers. We are particularly pleased with this recent result in Puerto Rico, as it represents the latest in a successful number of recent 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.”