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HHS announces $354 million in funding for private industry to manufacture generic drugs in the US from raw materials to finished product.
The US Department of Health and Human Services (HHS) announced on May 19, 2020 a four-year, $354-million agreement with private industry to produce-from raw materials to finished drug product-generic sterile injectable medicines for public health emergencies and the national stockpile.
The program is funded with federal resources from the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at HHS, with an option to extend to 10 years for a total of $812 million, according to an HHS press statement.
The private industry partners are led by Phlow Corporation (Richmond, VA), which was recently formed as a public benefit pharmaceutical manufacturing company. Other members of the partnership are AMPAC Fine Chemicals, a custom API manufacturer with three US facilities; Civica Rx, a non-profit 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, a non-profit organization dedicated to advancing drug manufacturing processes.
In press statements about the announcement, the partners and HHS cited the need to reduce US dependence on foreign suppliers and manufacturers of pharmaceutical raw ingredients, APIs, and finished dosage forms. The partnership will employ advanced manufacturing practices such as continuous manufacturing and “will also complete a technology transfer of novel continuous manufacturing process to organizations or businesses designated by the US government,” the HHS statement reported.
The HHS statement noted that the partnership will provide immediate, US-based capacity to produce APIs and the chemical compounds for those ingredients to help alleviate or prevent drug shortages. The Medicines for All Institute will develop and commercialize chemical process technologies to enable domestic end-to-end drug manufacturing.
Civica Rx will manufacture finished dosage forms, including vials and syringes, through its existing network of contract manufacturers; the organization also announced that it will build a finished dosage manufacturing facility at the same location as Phlow’s precursor and API production facilities.
Phlow reported that with its partners, it provided more than 1.6 million doses of generic medications including antibiotics, pain management medications, and neuromuscular blocking agents to the national stockpile in response to the COVID-19 pandemic.
Phlow is also building the first US Strategic Active Pharmaceutical Ingredients Reserve (SAPIR), a long-term, national stockpile to secure key ingredients used to manufacture essential medicines, the company reported in a press statement.