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Pharmaceutical Manufacturing in America

BARDA'S COMMITMENT TO EXPANDING PHARMACEUTICAL MANUFACTURING IN THE UNITED STATES

BARDA
launched a strategic partnership
in May 2020 to foster and expand
Pharmaceutical
Manufacturing in America
by increasing U.S.-based manufacturing capacity to produce active pharmaceutical ingredients and generic medicines needed during the
COVID-19
response
, and during future public health emergencies.

manufacturing

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

chemicals
Phlow
stockpile
AMPAC Fine Chemicals
vials
CivicaRx
flow
Virginia Commonwealth University
Infrastructure & Expansion Support

BARDA is making critical investment to accelerate the expansion of domestic manufacturing capacity for ancillary supplies (Needles, Syringes, Vials) as part of BARDA commitment to foster and expand Pharmaceutical Manufacturing in America

EXPANDING PHARMACEUTICAL MANUFACTURING IN THE UNITED STATES Support Services MCM Portfolio Clinical Trials

Website Refresh

www.medicalcountermeasures.gov is pleased to announce a phased launch of our newly redesigned public website. We are making website improvements to provide a more modern and customer-centric web experience. Over the next several months you will see differences throughout the site while we continue implementing updates. Thank you for your understanding and please let us know if you have any questions: techwatchinbox@hhs.gov