HHS provides funds to expand U.S. pharmaceutical manufacturing

May 20, 2020

The U.S. Department of Health and Human Services (HHS) will provide $354 million under a four-year contract to Phlow Corporation to produce the active pharmaceutical ingredients (APIs) needed for medications to treat patients with COVID-19 and related illnesses, the department announced in a press release.

Phlow is a startup pharmaceutical manufacturing company based in Richmond, VA.

The funds will be awarded through the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at HHS. The contract can be extended for up to a total of $812 million over a total of 10 years to maintain the system and supplies, the department said.

The APIs will be manufactured at facilities in the United States, HHS said.

In a separate news release, Phlow officials said they had already delivered more than 1.6 million doses of five generic medicines used to treat COVID-19 patients to the U.S. Strategic National Stockpile (SNS), including medicines used for sedation to help patients requiring ventilator support, medicines for pain management, and certain antibiotics.

Phlow officials also said the company is building the United States' first Strategic Active Pharmaceutical Ingredients Reserve (SAPIR), a long-term, national stockpile.

Phlow is working with a team of private industry partners. Those partners include: AMPAC, a custom API manufacturer; Civica Rx, a nonprofit generic drug company established by hospital systems and philanthropies to alleviate drug shortages; and the Medicines for All Institute at Virginia Commonwealth University’s College of Engineering.

To lower production costs, reduce waste and improve yields of these ingredients, the team will use advanced manufacturing processes, including continuous manufacturing.

Currently, many APIs or their chemical ingredients for critical medicines are manufactured outside the United States, which puts the United States at risk for shortages during a pandemic if these countries close their borders or limit access to these supplies.

In addition to producing the APIs, the team will expand advanced manufacturing capability in the U.S. to provide further capacity for producing finished generic drugs, HHS said.

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