The US firm announced the manufacturing expansion last week, adding it has also set up inspection, packaging and testing capacity for both oral solid dosage forms and sterile injectable drugs at the site.
The investment – financial terms of which were not disclosed – is part of an effort to attract drug developers interested in the Japanese market according to Pfizer.
A spokeswoman told us “Japan is the second largest individual pharmaceutical market and many of Pfizer CentreOne’s biopharmaceutical partners are looking to expand into this important market."
“However,” she continued “the Japanese pharmaceutical marketplace is like no other” adding the country’s exacting quality and aesthetic standards, pharmacy expectations make it a challenge for manufacturers.
She cited Japan’s ease of use requirements as an example, explaining that to be compliant “the package design itself, not just the label, should help the patient know when and how to take the drug.”
She added that: “Japan presents a great growth opportunity for small, mid-sized and large biopharmaceutical companies if they can overcome the obstacles for entering the market.”
While the Nagoya expansion is focused on helping drug firms tap the Japanese market, the facility will also make drugs for other countries.
The Pfizer spokeswoman told us “Pfizer Nagoya supports the local Japan market but also exports products to Asia Pacific markets. Nagoya has been inspected by MHLW, PMDA, US FDA, EMA, Korean FDA, ANVISA and AIFA.”