Currently approved to supply pharmaceuticals in more than 100 markets, the site’s regulatory approvals include the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), Agência Nacional de Vigilância Sanitária (ANVISA) (Brazil) and Pharmaceuticals and Medical Devices Agency (PDMA) (Japan).
“We are pleased to add the Newbridge facility to our network to offer a wider array of services and state-of-the-art containment, manufacturing and packaging technologies to our partners around the globe,” said Peter Stevenson, vice president and general manager, Pfizer CentreOne.
The Newbridge site manufactures high-potency non-cytotoxic solid oral dosage forms for human use. In addition to conventional manufacturing processes, the local team has experience with compounds that require complex processes, such as modification of powder and particle properties to create novel drug formulations, or those with enhanced solubility and dissolution properties.
Pfizer CentreOne manufactures the following compound types:highly active compounds, hormones, immunosuppressants, sensitizers, and controlled drugs.Containment technologies span Occupational Exposure Band (OEB) 1-5 (Occupational Exposure Limit down to 0.01 µg/m3). Specialized technologies include active coating, low-dosage formulations and modified/extended release.
"Our team knows high-potency drugs inside and out, and we look forward to working with companies seeking a devoted contract manufacturing partner,” said John Sourke, Pfizer Newbridge site lead.
Visit Pfizer CentreOne at Interphex booth 1418.