Small Molecule API

We work closely with you throughout the synthesis of your small molecule API, implementing operational excellence across our entire process to ensure uncompromised quality from development through to manufacturing. You can rely on us for high-quality API synthesis, from process development through long-term supply

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Capabilities at a glance

Analytical development

  • cGMP-compliant laboratories
  • Full suite of analytical tools
  • Method development services
  • Structure elucidation

Process development

  • Route selection
  • Process optimization, including: Telescoping and reaction monitoring through PAT
  • Process throughput
  • Cleaning method development, validation and recovery studies


  • Pilot/scale-up
  • Stability
  • Raw material sourcing
  • Cleaning validation
  • Process safety management
  • Starting material justification
  • Regulatory submission support
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Small Molecule API Development

With cGMP-compliant laboratories and a full suite of analytical tools, we offer comprehensive support throughout the entire development process of your small molecule API from initial discovery to commercial manufacturing. We have a range of analytical development and process development capabilities to suite your needs. 

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Small Molecule API Manufacturing

As your API demand grows, we grow with you. While we can manufacture volumes in 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 offer the quantities you need at our cGMP small-scale/pilot facilities until you’re ready for full-scale manufacturing.

We work to scale with you, every step of the journey. We have a roster of analytical chemists, organic chemists and engineers who are adept at developing and troubleshooting analytical methods and processes and have the expertise to help scale up your API process.

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Expert Content

Small Molecule APIs: Aligning Drug Strategy with Partnering Strategy

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Explore an altogether different approach to small molecule manufacturing, from process development through long-term supply

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The key trends shaping the development and manufacturing strategies across the pharmaceutical industry

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Global Pfizer expertise to help ensure the success of your custom small molecule API

A legacy of expertise

  • Drawing on decades of experience to help improve your API
  • Manufacturing capabilities spanning the requirements of Pfizer’s global small-molecule portfolio
  • Fermentation and bioprocessing expertise including biotransformations, enzymatic conversions and resin adsorption
  • As your API demand grows, we grow with you

Capabilities and quality

  • Process development and scale-up lab, to pilot, to clinical, to small or large-scale commercial
  • Route selection in process development for organic synthesis
  • Fermentation and bioprocessing up to 150,000L scale with a range of isolation and downstream purification technologies
  • Particle sizing via various milling and micronization capabilities
  • Pfizer's robust quality systems

World-class site

  • Located in Kalamazoo, USA, it is the largest API site in the world
  • More than one million kilograms of finished API per year
  • Support for most small molecules (excluding cytotoxics and beta-lactams)
  • Batches from 100 grams to 3+ metric tons
  • cGMP-compliant analytical development laboratories with a full suite of analytical tools