API Innovation Center Secures $14M to Boost U.S. Pharma Independence

The Biden-Harris Administration has awarded its first Defense Production Act Title III funds to the API Innovation Center (APIIC) to bolster the U.S. production of essential pharmaceutical ingredients. This initiative, coordinated by the Administration for Strategic Preparedness and Response’s (ASPR) Center for Industrial Base Management and Supply Chain (IBMSC), aims to enhance the domestic supply chain for critical active pharmaceutical ingredients (APIs) that are vital in treating conditions such as asthma, diabetes, and anxiety disorders.

APIIC will receive $14 million in funding from IBMSC and will contribute an additional $2.4 million to develop these APIs. The objective is to increase U.S. pharmaceutical manufacturing resilience and reduce dependency on foreign suppliers, which currently account for the majority of small-molecule APIs used in generic medicines. This over-reliance has led to vulnerabilities in the U.S. supply chain, including exposure to shortages and geopolitical tensions.

The initiative focuses on three specific APIs: Albuterol, used for asthma and respiratory conditions; Desmopressin Acetate, used for diabetes insipidus and blood coagulation conditions; and Lorazepam, used for anxiety disorders. This project aims to secure the availability of these essential medicines domestically and represents a significant step towards improving national health security.

APIIC’s project leverages a broad network of partners, including universities, pharmaceutical manufacturers, and suppliers of key starting materials (KSMs). Notable partners include Mallinckrodt Specialty Generics, Apertus Pharmaceuticals, MilliporeSigma, and the University of Missouri–St. Louis (UMSL). These collaborations are designed to enhance the quality, efficiency, and competitiveness of U.S. pharmaceutical manufacturing through the application of advanced manufacturing technologies and cutting-edge research.

Stephen Welch, executive vice president of Mallinckrodt Specialty Generics, emphasized the importance of this initiative in addressing the drug shortage challenges in the U.S. and strengthening domestic manufacturing capabilities. David Gindelberger, CEO of Apertus Pharmaceuticals, highlighted the collaboration’s role in scaling research and development efforts to support this national initiative.

MilliporeSigma will also contribute significantly, utilizing its expertise in organic synthesis and bioconjugation of active pharmaceutical ingredients. Mark Cooley, site director at MilliporeSigma, noted that this partnership would mitigate risks associated with supply disruptions and could enhance the U.S. bioeconomy.

Dr. Chris Spilling, vice chancellor at UMSL, expressed pride in the university’s role in supporting a more secure pharmaceutical supply chain through research, workforce development, and community engagement.

The initiative also highlights the collaborative efforts between APIIC, the state of Missouri, and the Missouri Technology Corporation. Together, they are developing a state-supported model in the St. Louis region aimed at creating a resilient national pharmaceutical manufacturing ecosystem. This model, known as the “Missouri Model,” aims to restore U.S. leadership in pharmaceutical production by leveraging Missouri's strengths in infrastructure and workforce development.

Governor Mike Parson of Missouri acknowledged the state’s leadership in addressing national health security issues by focusing on local production of essential pharmaceutical ingredients. The state’s investment of approximately $18 million in reshoring efforts, combined with federal support, underscores Missouri’s commitment to securing the pharmaceutical supply chain.

APIIC remains dedicated to driving the U.S. towards pharmaceutical self-reliance, ensuring that critical medications are readily available to support national health security.

The APIIC, a nonprofit based in St. Louis, aims to foster health security and economic growth through the U.S.-based production of essential medicines. By collaborating with leading specialists, APIIC is committed to ensuring that every hospital, pharmacy, and patient has access to domestically produced critical medications.