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“When we met with the team, it was apparent we could come in with very little knowledge and you could help us develop the technology, or we could come in with the whole package and say ‘Just do it.’”

Director of fermentation, small U.S. biotechnology company

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APIs and intermediates.

Commercial Manufacturing

You need a reliable partner to go the distance with you. We won’t let you down.

Our commercial manufacturing capabilities span the requirements of Pfizer’s global small-molecule portfolio, and we put those resources to work for you to. We are able to perform both traditional and highly specialized processes, including:

  • Fermentation
  • Complex chemical synthesis
  • Milling and micronizing

Other services include:

  • Stability studies
  • Raw material sourcing
  • Process safety management
  • Specialized packaging services for customized formats or quantities
  • Ongoing regulatory and CMC support, as needed

Manufacturing locations

We carefully selected our custom API manufacturing sites to serve your needs.

  • Kalamazoo, Michigan, USA

    • Fermentation, organic synthesis and milling/micronizing capabilities on one site
    • More than one million kilograms of finished API per year
    • Sterile injectables fill-finish located on same campus
  • Cork, Ireland (Ringaskiddy and Little Island facilities)

    • Pfizer launch site for its small-molecule APIs
    • Over 200 metric tons of 30+ APIs each year for more than 100 markets

For capabilities by site, see Our Capabilities.

Small-scale cGMP manufacturing

As your API demand grows, we grow with you. While we can manufacture up to three or more metric tons, we can also go small. If you have a chemistry-based compound and need smaller batches for clinical or commercial use, we can provide the quantities you need at our cGMP small-scale/pilot facilities until you’re ready for full-scale manufacturing.

Ongoing process improvement

We don’t consider manufacturing to be the end of the journey. Your commercial team manager will proactively help you manage your API’s lifecycle, such as proposing process improvements for higher yields, improving the robustness and supply assurance of your process, or developing a second-generation process.

Ongoing investment

With its own portfolio of pharmaceuticals, Pfizer continually invests in its manufacturing sites to maintain them at the cutting edge of technology and staffed with top-notch talent. And because capacity is reserved for Pfizer CentreOne partners, these assets will be working for you throughout the life of our partnership.