Endo International plc announced that its subsidiary, Par Sterile Products, LLC (Par Sterile), has entered into a cooperative agreement to expand its sterile fill-finish manufacturing production capacity and capabilities at its Rochester, Michigan plant to support the U.S. government's national defense efforts regarding production of critical medicines advancing pandemic preparation.
Under the terms of the agreement, Par Sterile's Rochester facility will establish a new sterile fill-finish manufacturing asset capable of processing liquid or lyophilized products requiring Biosafety Level (BSL) 2 containment. It will also provide expanded product inspection and packaging capacity as well as sterile fill-finish manufacturing services to the U.S. Government. Under the terms of the agreement, the U.S. government will fund approximately $90 million of the program's total expected cost of approximately $120 million.
"Endo strives to be a force for good, and we are proud to partner with the U.S. government in its efforts to expand and accelerate domestic manufacturing in support of future pandemic preparedness," said Blaise Coleman, President and CEO of Endo. "This collaboration underscores our longstanding history as a U.S. manufacturer of high-quality medicines."
The agreement is a result of efforts defined under the Defense Production Act to address vulnerabilities in critical product supply chains and strengthen the advancement of manufacturing and on-shoring of domestic essential medicines production.
The Department of Defense's Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) Joint Assisted Acquisition team in partnership with Army Contracting Command– Aberdeen Proving Ground (ACC - APG) – COVID Response are the awarding and administering acquisition offices. This work was supported by the ACC - APG – COVID Response, under the authority of 31 U.S.C. 6305 pursuant to Section 3101 of the American Rescue Plan Act (Public Law 117-2) and Title III of the Defense Production Act of 1950 (50 U.S.C. 4533) under Award No. W58P05-22-2-0001. Opinions, interpretations, conclusions and recommendations are those of the author and are not necessarily endorsed by the JPEO-CBRND or ACC – APG – COVID Response.
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