HHS Continuing Commitment to Expanding Domestic Pharmaceutical Manufacturing Capacity and Reducing Dependency on Foreign Resources
Senior leaders from the U.S. Department of Health and Human Services' (HHS) Administration for Strategic Preparedness and Response (ASPR), along with White House representatives, today visited Phlow Corp's new state-of-the-art manufacturing ecosystem that manufactures the key starting materials (KSMs), active pharmaceutical ingredients (APIs), and finished dose forms (FDFs) for 15 medicines of critical importance to the U.S. health system.
Today's campus visit is part of the ongoing collaboration between HHS-ASPR and Phlow that began in May 2020, as part of the first Trump Administration's efforts to reshore America's pharmaceutical supply chain and reduce dependency on foreign countries – particularly larger foreign suppliers, like China and India, which account for more than 70% of APIs and KSMs imported to the United States. This effort also aligns with the current Trump Administration's executive order Regulatory Relief to Promote Domestic Production of Critical Medicines.
"Disruptions in the supply of KSMs and APIs from foreign resources—whether due to geopolitical tensions, pandemics, or export restrictions—could cripple our nation's ability to produce these critical medications," said ASPR Principal Deputy Assistant Secretary John Knox. "This collaboration underscores the strategic importance of not only bolstering domestic production of finished drugs but also securing a reliable, independent supply of APIs and KSMs to ensure the resilience of the U.S. pharmaceutical supply chain."
Under the ASPR-funded effort, Phlow is establishing the domestic capability to manufacture KSMs, APIs, and FDFs for 15 drugs spanning a broad range of critical therapeutic classes: cardiovascular, pain and sedation, respiratory, antiemetic, antibacterial, and anticholinergic.
The Phlow ecosystem includes laboratories and manufacturing facilities centrally located in the Mid-Atlantic region. This location allows pharmaceuticals to move seamlessly through the complete pharmaceutical manufacturing life cycle, from development to final production.