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Pfizer CentreOne Expands Contract Mfg. to Nagoya, Japan

10.23.17

Site will provide in-country manufacture of highly potent oral solid dosage forms

Pfizer CentreOne, a global contract manufacturing organization (CMO) embedded within Pfizer, 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.”
 
The Nagoya facility provides 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 and controlled drugs. Dosage forms include high and multiple doses; combination products; multiple release and fixed dose.

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.