Understanding vulnerabilities in the supply of APIs to the U.S.

The majority of active pharmaceutical ingredients (APIs), the components of medicines that produce the desired therapeutic effect, are manufactured overseas. This creates supply chain vulnerabilities, security risks, and prolonged shortages. In addition, the production of key starting materials (KSMs), the chemical building blocks for medicines, also largely occurs in foreign geographically concentrated locations.

What’s at stake 

An over concentration of API and KSM production in few locations increases risks of supply interruption of essential medicines to the U.S. In addition, complex manufacturing steps involving multiple suppliers, opaque sourcing of intermediates and KSMs, and varying synthetic processes, creates a fragmented supply chain vulnerable to unexpected disruptions. Greater transparency about where products are made is vital to strengthening supply chain resilience and protecting national security.

 

Mapping and analyzing API production will help signal where the U.S. could expand, stabilize, and reshore manufacturing of essential pharmaceuticals.

Project at-a-glance
Project at-a-glance

Project at-a-glance

  • Timeline: 2025 – 2026
  • Funder: The Henry Jackson Foundation for the Advancement of Military Medicine (HJF)
  • Technical areas: Advanced manufacturing technologies, foundational factor analysis

Project goal 

Funded by HJF and led by the Center for Health Services Research at the Uniformed Services University of the Health Sciences (USU), in collaboration with USP, this project aims to: 

  • Conduct end-to-end supply chain mapping, risk analysis, and recommendations for 25 APIs used for essential medicines.

Key milestones 

  • Segment and classify select APIs used for essential medicines, including KSMs and excipients, using upstream supply chain data and analysis.
  • Evaluate global supply data to establish geographic and manufacturer dependencies, identify vulnerabilities, and highlight potential alternate suppliers.
  • Conduct a comprehensive risk assessment and develop a final report consolidating segmentation, mapping, risk analysis, and recommendations. 

Related resources 

Advanced manufacturing technologies 

Reducing barriers to innovation to make more quality medicines in more places. 

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Federal government solutions

Federal government solutions 

Delivering standards and solutions for end-to-end medicines supply chain security in collaboration with U.S. government, industry, and academic institutions. 

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