October 17, 2017 — Pfizer CentreOne, a global contract manufacturing organization embedded within Pfizer, today announced that it is now offering services in Nagoya, Japan. The Nagoya site will provide in-country manufacture of highly potent oral solid dosage forms. It will also provide gateway services into Japan – inspection, packaging and testing – for highly potent oral solid drugs and sterile injectables made by Pfizer CentreOne outside the country.
“We’re pleased to add Pfizer’s Nagoya facility to our manufacturing footprint,” said Peter Stevenson, vice president of contract manufacturing, Pfizer CentreOne. “Pfizer has been manufacturing pharmaceuticals in Japan for 50 years. We deeply understand the exacting expectations of Japanese pharmacies and patients, along with the challenges they entail. That knowledge can help our biopharmaceutical partners attain a marketing edge, whether they manufacture their drug at our Nagoya site or bring it into Japan through our Japan gateway services.”
Manufacture of highly potent oral solid dosage forms
The Nagoya facility provides state-of-the-art cGMP manufacturing of highly potent oral solid drugs that require containment (to protect personnel from contact with hazardous materials) and segregation (to prevent cross-contamination of drugs in the plant).
The site manufactures:
- Highly active compounds
- Immunosuppresive drugs
- Sensitizing agents
- Controlled drugs
Dosage forms include high and multiple doses; combination products; multiple release and fixed dose.
Containment: Containment technologies at the Nagoya site span Occupational Exposure Band (OEB) one through five and Occupational Exposure Limit (OEL) down to 0.01 µg/m3. OEBs and OELs protect production personnel by categorizing the risk of the drugs they handle and setting limits to their exposure to these materials.
Inspection and packaging: Services include inspection of primary, secondary and tertiary packaging to assure drugs and their packaging are free of defects before leaving the facility; and custom packaging development to maximize functionality for the pharmacy, and appeal and user-friendliness for the user.
For more information on Pfizer CentreOne’s Japan manufacturing service, see www.pfizercentreone.com/highly-potent-solids/manufacturing-japan.
Japan gateway services
Japan gateway services – inspection, packaging and testing – are available for Pfizer CentreOne’s biopharmaceutical partners who seek to introduce their highly potent oral solid drug or sterile injectable into Japan from another Pfizer CentreOne site. Inspection and packaging services are the same as for drugs manufactured in the Nagoya facility. Additional services include cold-chain handling and, if required, in-market testing for release to the Japanese market.
For more information on Pfizer CentreOne’s Japan gateway services, see www.pfizercentreone.com/about/japan-gateway-services.
About Pfizer CentreOne
A global CDMO embedded within Pfizer, Pfizer CentreOne focuses on custom API synthesis, sterile injectables fill-finish and highly potent oral solid dosage forms; and is a leading supplier of steroid and hormone APIs and intermediates. For more than 40 years, we’ve manufactured complex compounds for our biopharmaceutical partners, guiding their drugs safely from development through commercialization. For more information, visit www.pfizercentreone.com.