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U.S. Pharmaceutical Supply Chain Gets a Boost from APIIC Initiative

The API Innovation Center receives funding to lead the development and domestic production of three critical APIs.

The API Innovation Center (APIIC) has been awarded funding by the Administration for Strategic Preparedness and Response’s (ASPR) Center for Industrial Base Management and Supply Chain (IBMSC) to lead the development and domestic production of three critical active pharmaceutical ingredients (APIs) used in the treatment of asthma, diabetes, and anxiety disorders.
 
Each API was chosen for its vital role in U.S. health care, shortage history, as well as inclusion on essential medicines lists:
 

  • Albuterol: Used to treat asthma and other respiratory conditions.
  • Desmopressin Acetate: Used to treat diabetes insipidus & blood coagulation conditions.
  • Lorazepam: Used to treat anxiety.
 
APIIC will leverage advanced manufacturing technologies and cutting-edge research to further national strength in pharmaceutical innovation and supply chain resilience.
 
IBMSC will provide $14 million in funding and APIIC will invest an additional $2.4 million into the development of these critical APIs. This funding marks a significant step forward in securing the U.S. pharmaceutical supply chain and addressing national health security risks.
 
“This funding represents both a financial commitment and a significant step towards securing America’s pharmaceutical resiliency and patient access to critical medicines. By focusing on developing these high-impact molecules, we are creating a private-public blueprint for driving self-reliance that is essential for national health security and can be replicated across the country,” said Tony Sardella, chair and founder of APIIC.

Partnership and Impact

This project harnesses the strengths of APIIC’s extensive partner network, including collaborations with leading universities, pharmaceutical manufacturers, and suppliers of KSMs. APIIC will unite the resources and advanced manufacturing technologies of Mallinckrodt Specialty Generics, Apertus Pharmaceuticals, MilliporeSigma, and the University of Missouri–St. Louis (UMSL) to enhance the quality, efficiency, and global competitiveness of U.S.-based pharmaceutical manufacturing.
 
These strategic collaborations form a dynamic product team, capitalizing on each member’s specific expertise, with APIIC providing funding and support to harness their strengths and advanced manufacturing capabilities.

A Roadmap for a Resilient Supply Chain in Missouri

APIIC, together with the State of Missouri and the Missouri Technology Corporation, has been developing a state-supported model in the St. Louis region and a strategic framework for creating a resilient national pharmaceutical manufacturing ecosystem. This model is designed to be a replicable blueprint that compliments Missouri’s strengths in infrastructure and workforce development to restore U.S. leadership in pharmaceutical production.
 
To date, the State of Missouri has committed approximately $18 million to API reshoring efforts, demonstrating to other states how to support the “Missouri Model” and take the lead in addressing national supply chain challenges.
 
As it looks to the future, APIIC is committed to driving the U.S. towards pharmaceutical self-reliance, ensuring every hospital, pharmacy, and patient has access to domestically produced critical medication to support national health security.

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