FDA picks Eli Lilly for PreCheck pilot on new US manufacturing plants
Lilly is one of seven companies in an FDA pilot meant to smooth the path for new U.S. plants, including one tied to ingredients for obesity drugs [1].
The FDA has picked Eli Lilly as one of seven companies for a pilot program meant to speed the development and review of new U.S. drug manufacturing plants, and Lilly's designated site is a Lebanon, Indiana, plant that will make active pharmaceutical ingredients (APIs) for existing and future medicines [1].
The agency named the participants on June 29, 2026: Amneal Pharmaceutical, Cellares, Eli Lilly, Fujifilm Biotechnologies, Kriya Therapeutics, Kyowa Kirin and Regeneron Pharmaceuticals [1]. The program, called PreCheck, covers one specific site for each company rather than a company's full network [1].
Under PreCheck, the FDA communicates more frequently with drugmakers and provides technical guidance plus facility-focused pre-submission meetings as companies build or expand plants in the United States [1]. The program grew out of a May 2025 directive in which President Donald Trump ordered the FDA and other federal agencies to provide regulatory relief to promote domestic drug production [1]. The FDA proposed PreCheck, and industry executives described it at an October meeting as a welcome but insufficient step [1]. The agency finalized and launched the program earlier this year [1].
Lilly's PreCheck site is a Lebanon plant the company is building to make APIs for existing and future medicines [1]. Lilly recently committed $4.5 billion to two sites in Lebanon, including a plant focused on APIs for its blockbuster obesity medicines [1]. The FDA selection does not specify whether the PreCheck site is the same facility as the obesity-focused plant, and that has not been clarified [1].
Other selected sites are spread across the country. Regeneron's PreCheck facility is in Saratoga Springs, New York; the company unveiled plans in November to invest $2 billion in a one-million-square-foot property there that is expected to more than double its manufacturing capacity in the state [1]. Fujifilm's site is a commercial-scale cell culture biomanufacturing plant in Holly Springs, North Carolina [1]. Amneal's facility is on Long Island, New York, and Cellares' plant in Bridgewater, New Jersey, is the program's only site that will make cell-based gene therapies [1]. Three of the seven PreCheck plants are in North Carolina, a state that has drawn a large share of recent U.S. production investment [1].
Denali Therapeutics was among the companies that did not make the list [1]. CEO Ryan Watts said at a Stifel event in March that the company hoped to join PreCheck so it could "really engage with the FDA" on a new facility tied to a Sanfilippo syndrome candidate, and that manufacturing the product itself was the "real rate-limiting step" for a therapy that could reach the market next year [1].
Why it matters for patients
PreCheck does not change which drugs are approved or what they cost. It affects how closely the FDA works with a company while a plant is being built, which could influence how quickly that plant is ready to supply the market [1].
For people taking obesity medicines, the practical question is whether added U.S. ingredient capacity affects supply over time. The FDA selection does not say how much capacity the Lebanon plant will add, what products it will supply, or when it will start producing, and those details have not been disclosed [1]. No link between PreCheck and the price or availability of specific GLP-1 medicines was stated in the announcement [1].
What happens next
The FDA has not published a timeline for the pilot or milestones for the individual sites [1]. Lilly has not said when the Lebanon plant is expected to be finished or which medicines it will supply first [1]. Regeneron has said its Saratoga Springs facility is planned, but a completion date was not part of the details reported [1].
Sources
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