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Pharmaceutical Manufacturing in America


formed a
strategic partnership
in May 2020 to foster and expand
Manufacturing in America
by increasing U.S.-based manufacturing capacity to produce active pharmaceutical ingredients and generic medicines needed during the
, and also during future public health emergencies.


The Challenge

Currently, a majority of active pharmaceutical ingredients (APIs) and their chemical compounds needed for critical medicines are manufactured outside the United States. They are typically manufactured using slow and less efficient processes.

Shipping the ingredients or finished drugs to the U.S. wastes valuable time that can slow down our country’s response to a pandemic or other public health emergency. Such global dependencies put our national health supply chain at risk. The U.S. national medical supply also is placed at further risk during a global health emergency when individual countries can close borders and potentially curtail access to these critical materials.

The Opportunities

With funding provided by congress under “Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020” and “Coronavirus Aid, Relief, and Economic Security Act’’ (CARES Act’), BARDA was able to invest in and enhance U.S.-based manufacturing capacity.

BARDA has made previous investments to expand U.S.-based biological manufacturing capacity by helping private sector partners build or retrofit manufacturing lines, establishing three Centers for Innovation and Advanced Manufacturing (CIADMs), and a Fill Finish Manufacturing Network (FFMN). COVID-19 funding and authorization provides BARDA the resources and opportunity to build on that experience to expand into new public-private partnerships that further increase U.S. based pharmaceutical manufacturing.

By partnering with the Phlow-led team, BARDA has initiated a new effort that seeks to increase U.S.based capacity for producing the APIs and the chemical compounds necessary to make critical medicines and help alleviate or prevent drug shortages, particularly during the COVID-19 pandemic. The partnership provides a unique opportunity to develop an end-to-end advanced domestic manufacturing capability to significantly improve our nation’s domestic pharmaceutical supply chain.

The Impact

In public health emergencies, the “Pharmaceutical Manufacturing in America” strategic effort holds the potential to provide patients in the United States with critical essential medicines faster, reduce the likelihood of drug shortages, and increase U.S. preparedness.

How Partners Work Together

AMPAC Fine Chemicals
Virginia Commonwealth University

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