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Did you know?

Japan is the 3rd largest individual pharmaceutical market worldwide, forecast to reach US$72B by 2021.*

*CPhI PharmaInsights Japan Report: 2018 - A Big Year for Japanese Pharma. January 2018

Exclusively for our contract manufacturing partners:Pfizer CentreOne Japan Gateway Services - Sterile Injectables

You need to enter the Japanese market; Pfizer has been there for 50 years.

The Japanese marketplace is like no other. You need a partner that knows not only the regulatory standards but the cultural norms. Our experts at Pfizer CentreOne’s Nagoya, Japan, facility can help you introduce your drug smoothly – and with a marketing edge.

What’s different about the Japanese pharmaceutical market?

Quality

Any drug entering Japan must go through a thorough re-inspection for quality. For sterile injectables, that includes confirmation the drug is free of particles; the container closure is secure and without defect; and the fill-volume is correct.

Aesthetics

The drug and its packaging must be free of any defects to be acceptable to the Japanese public: no scratches on vials; no ink smears on cartons; no stray marks or dents on cartons; and the package color must be perfect. Imperfections could imply a lack of integrity of the medicine itself.

We deeply understand the exacting expectations of Japanese pharmacies and patients.

Our Nagoya experts have years of experience inspecting primary, secondary and tertiary packaging and will make sure your product is free of defects before leaving our facility. When it comes to package design, our custom packaging team knows how to meet the exact size and technical specifications that pharmacies demand.

Our Japan gateway capabilities

Packaging inspection (quality and cosmetic)

  • Primary, secondary and tertiary packaging inspection

Packaging services, sterile injectables

  • Pre-filled syringe kitting
  • Multi-vial cartons
  • Blister trays
  • Tamper-evident or security labels

Packaging development

  • Collaborative, customized packaging design to meet the functional and technical specifications of Japanese healthcare providers

Cold chain

  • Refrigerated temperature control (2-8°C)
  • Cold-chain reception and storage of drugs in warehouse
  • Inspection and packing onsite under cold-chain conditions

Analytical testing

  • If required, in-market testing for release to the Japanese market