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ASPR Partners with Departments of Commerce, War to Strengthen Supply Chain for Key Starting Materials Used in Medicines

The U.S. Department of Health and Human Services’ (HHS) Administration for Strategic Preparedness and Response (ASPR), in partnership with the U.S. Department of Commerce’s Bureau of Industry and Security (BIS) and the U.S. Department of War’s Office of the Assistant Secretary of War for Health Affairs (OASW(HA)), is conducting a comprehensive assessment of the U.S. pharmaceutical key starting materials (KSM) industrial base to identify supply chain vulnerabilities and inform strategies to strengthen domestic manufacturing capabilities. 

KSMs are the chemical precursors and intermediates used to manufacture active pharmaceutical ingredients (APIs), the components that give medicines their therapeutic effects. The assessment will examine the upstream supply chain that supports U.S. pharmaceutical manufacturing, including limited domestic production capacity and reliance on foreign or single sources of critical materials. 

“Ensuring access to essential medicines starts with the materials needed to make them,” said ASPR Principal Deputy Assistant Secretary Sean Kaufman. “Our partnership with Commerce and War will help the Trump Administration understand where those materials come from, identify vulnerabilities, and inform efforts to strengthen domestic production and prepare for public health emergencies.” 

ASPR’s Center of Industrial Base Management and Supply Chain (IBMSC), BIS’s Office of Strategic Industries and Economic Security, and OASW(HA) are collaborating on the assessment. The findings will help the federal government develop funding strategies to support the availability, quality, and security of materials essential to a resilient pharmaceutical supply chain. 

BIS is surveying U.S. manufacturers, chemical suppliers, distributors, procurers, and customers under its survey collection authority pursuant to section 705 of the Defense Production Act of 1950, as amended. The one-time survey will collect information on production capabilities, sourcing practices, customers, supply chain disruptions, workforce, and research and development. 

“A clearer picture of the KSM industrial base will help us identify gaps in manufacturing capacity and dependencies that could disrupt the production of essential medicines,” said IBMSC Deputy Assistant Secretary Arlene Joyner. “The assessment will provide information to guide future investments and strengthen the supply chains needed to respond to public health emergencies.” 

The findings will be compiled into a comprehensive report on the state of the U.S. KSM industrial base, including production capacity, supply chain vulnerabilities, and emergency response capabilities. The report will include recommendations to improve supply chain resilience and public health emergency preparedness. 

The KSM assessment builds on BIS’s API industrial base survey, conducted in partnership with ASPR and completed earlier in 2026. That survey examined pharmaceutical manufacturers’ production capabilities, sourcing practices, and supply chain disruptions. The new assessment extends that work further upstream to examine the materials and suppliers on which U.S. API manufacturers depend. 

IBMSC has invested in domestic KSM manufacturing, including work with Manus Bio to support production of shikimic acid, a starting material for the influenza medicine oseltamivir, at its facility in Augusta, Georgia. IBMSC has also supported Antheia Inc. in expanding domestic production of thebaine, a starting material used in medicines for pain management, alcohol use disorder, and opioid overdose reversal, at its facility in Menlo Park, California. 

Together, these manufacturing investments and supply chain assessments support the pharmaceutical supply chain resilience goals outlined in President Trump’s Executive Order 14336, Ensuring American Pharmaceutical Supply Chain Resilience by Filling the Strategic Active Pharmaceutical Ingredients Reserve. 

 

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