Teams at facilities being developed by Eli Lilly, Regeneron and other companies will receive early technical guidance and additional perks from the FDA.
The FDA has selected seven companies to participate in a pilot program designed to support the creation of new U.S. pharmaceutical manufacturing facilities.
In May 2025, President Donald Trump ordered the FDA and other federal agencies to provide regulatory relief to promote domestic drug production. The directive prompted the FDA to propose PreCheck, a program that provides drugmakers with technical guidance and facility-focused pre-submission meetings. The industry hailed PreCheck as a welcome but insufficient step at a meeting in October.
Having finalized and launched the program earlier this year, the FDA selected seven companies for the pilot project on June 29: Amneal Pharmaceutical, Cellares, Eli Lilly, Fujifilm Biotechnologies, Kriya Therapeutics, Kyowa Kirin and Regeneron Pharmaceuticals.
The program covers one specific site for each company. Lilly’s PreCheck facility is a plant in Lebanon, Indiana, that the company is building to manufacture active pharmaceutical ingredients (APIs) for existing and future medicines. The pharma giant recently committed $4.5 billion to two sites in Lebanon, including a plant focused on APIs for its blockbuster obesity medicines.
Regeneron’s PreCheck facility is in Saratoga Springs, New York. In November, the company unveiled plans to invest $2 billion in a one-million-square-foot property in Saratoga Springs. The facility is expected to more than double Regeneron’s manufacturing capacity in the state. Regeneron will make biotech drug substances, sterile injectables and novel protein therapeutics for multiple diseases at the plant, the FDA said.
Fujifilm’s PreCheck site is a commercial-scale cell culture biomanufacturing plant in Holly Springs, North Carolina. Last year, Regeneron partnered with Fujifilm to source bulk drug product of its commercial biologic medicines from the service provider’s Holly Springs site. Months later, Johnson & Johnson inked a $2 billion deal with Fujifilm to secure a dedicated manufacturing facility at the Holly Springs site.
Facilities in North Carolina—a state that has been one of the main beneficiaries of the wave of investment in U.S. production—make up three of the seven PreCheck plants. Fujifilm’s plant is joined by Kriya Therapeutics’ viral vector gene therapy facility in Durham and Kyowa Kirin’s biotech drug substance site in Sanford.
Amneal Pharmaceutical’s Long Island facility joins Regeneron’s Saratoga Springs plant on the list of PreCheck sites in New York. The Amneal facility will make small molecule sterile liquid products for pain management and for respiratory and ophthalmic diseases. Cellares’ facility in Bridgewater is the only PreCheck plant in New Jersey, as well as the only facility in the program that will make cell-based gene therapies.
Denali Therapeutics is among the companies to miss out. The company hoped to be part of PreCheck so it could “really engage with the FDA” on a new facility to help accelerate a Sanfilippo syndrome asset, Denali CEO Ryan Watts said at a Stifel event in March. Denali’s intention to manufacture the product itself is the “real rate-limiting step” for a candidate that could come to market next year, Watts said.
