Eli Lilly and Regeneron are in the first slate of drugmakers included in a new US scheme to expedite the construction of new pharmaceutical manufacturing facilities.
Lilly and Regeneron are amongst seven companies selected by the US Food and Drug Administration (FDA) for the PreCheck Pilot Program – an initiative designed to strengthen the US medicine supply chain by making it easier to build drug plants.
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Eli Lilly’s facility in Lebanon, Indiana, will manufacture drug substance, while Regeneron’s facility in New York’s Saratoga Springs will manufacture biotechnology drug substance, sterile injectables, and novel protein therapeutics for multiple diseases.
Amneal Pharmaceutical, Cellares, FUJIFILM Biotechnologies, Kriya Therapeutics, and Kyowa Kirin make up the other five participants in the FDA’s initial selection. Their facilities will manufacture therapies for oncology, haematology, chronic diseases, and rare diseases, amongst others. Three of these are located in North Carolina, with others in New Jersey and New York.
The FDA based its selection on several aspects including what products will be manufactured, the stage of facility development, the anticipated timeline for bringing products to the US market, and innovation in facility development and manufacturing operations.
Participants will now go through the programme via a two-step process. The first stage, called the Facility Readiness phase, will allow more frequent communication with the FDA to discuss facility design, construction, and pre-production. Companies will be encouraged to provide information on their proposed facilities, such as site operations layouts and quality control (QC) elements. The Application Submission phase, the second portion of the scheme, focuses on chemistry, manufacturing, and controls.
The scheme is designed to facilitate earlier interactions between agency and company, minimising uncertainty associated with manufacturing readiness. For example, the FDA can identify potential facility issues before they delay application approvals.
The FDA launched the PreCheck programme in February 2026, though it was first unveiled in June 2025. Developed in response to an executive order signed by President Donald Trump, it became the first FDA policy directed at bolstering US pharma manufacturing.
US health secretary Robert F. Kennedy (RFK) Jr commented: “President Trump is rebuilding America’s pharmaceutical manufacturing base because our nation’s health and security depend on it. The FDA’s PreCheck Pilot Program will help bring pharmaceutical manufacturing back to the US, strengthen our drug supply chains, create high-quality American jobs, and ensure patients have reliable access to safe, effective medicines. This is another important step toward making America healthier, stronger, and more self-reliant.”
More than half of the pharmaceuticals distributed in the US are manufactured overseas, making the country particularly exposed in the active pharmaceutical ingredients (APIs) supply chain. Of the manufacturers that produce APIs used in FDA-approved products, only 11% are based in the US.
In October, the FDA also debuted a pilot scheme aimed at fast-tracking generic approvals. A prioritisation programme within the abbreviated new drug application (ANDA) framework will see drugmakers who test and produce their therapies in the US rewarded with faster review times.
The PreCheck programme is part of a concerted effort by the Trump administration to reduce this reliance. Threats of tariffs have forced many drugmakers to pour billions of dollars into bolstering their manufacturing footprints in the US, while a legislative focus on partnerships with Chinese companies has led some to consider domestic partnerships.
