Pfizer CentreOne, a global contract manufacturing organization (CMO) embedded within Pfizer, today announced that it has grown its service portfolio to include contract manufacturing of highly potent solid oral dose medicines. The service will be provided at the Pfizer Newbridge, Ireland, facility, which is now part of Pfizer CentreOne’s contract manufacturing network. The Pfizer site, near Dublin, has a long history of contract manufacturing and packaging highly potent solid oral drugs with advanced technologies.
“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.
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).
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 deep 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
- 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. For more information on Pfizer CentreOne’s highly potent solid oral dose capabilities, visit www.pfizercentreone.com/highly-potent-solids.
“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.