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.
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.