The U.S. FDA has chosen seven firms to take part in its PreCheck pilot, an initiative aimed at speeding up the regulatory evaluation of new drug production sites. Under this program, regulators can begin assessing new plants during their construction phase, identifying and fixing problems early.
The selected companies vary widely, from the world's largest healthcare firm to small, privately owned biotechs focused on gene therapies. Most of these firms intend to produce biologic drugs or genetic treatments, a category that requires more sophisticated production processes. Eligibility for PreCheck required firms to construct a new plant that could manufacture medicines aimed at filling a supply shortage or expanding access to treatments for conditions lacking adequate options.
One example is Lilly's site in Lebanon, Indiana, which will produce the active ingredients for GLP-1 tablets and injections. Regeneron's recently announced $2 billion facility in Saratoga Springs, New York, is another selection.
Regeneron CEO Leonard Schleifer said in a statement that his company has put money into U.S. biologics manufacturing and has pushed for greater emphasis on domestic medicine production. "We're pleased to see programs like the FDA's PreCheck Pilot Program that encourage collaboration between innovators and regulators to build next generation manufacturing capabilities and strengthen America's biopharmaceutical industry," he said.
Eli Lilly said in a statement it is "evaluating how PreCheck and related regulatory improvements may impact the facility's timeline and will continue to work closely with FDA to support the program's success."
Another selected facility is Fujifilm Biotechnologies' new Holly Springs, North Carolina site, which the contract manufacturer opened last year. The site is currently generating monoclonal antibodies for clients Regeneron and Johnson & Johnson, and will expand production for additional customers as further sections of the plant come online in 2027 and 2028.
PreCheck has two main parts: a facility readiness phase, during which the FDA offers technical advice before operations start, and an application submission phase, in which participants receive deeper feedback, faster inspections, and plant evaluations. Fujifilm noted that it anticipates completing the operational readiness review by year-end thanks to the accelerated procedures, and believes the program will enable its clients to pursue swifter approval routes with the FDA.
Broader Context
The PreCheck pilot is part of a broader push by the Trump administration to encourage more domestic production of medicine. By allowing regulators to engage with manufacturers during the construction phase, the program aims to resolve compliance issues early, ultimately shortening the time it takes for new facilities to begin supplying critical medications. This collaborative model could prove especially valuable for addressing drug shortages and expanding access to advanced therapies such as gene and cell treatments, which often require complex, specialized manufacturing infrastructure. The selected companies represent a cross-section of the industry, from large multinationals to emerging biotechs, reflecting the program's potential to benefit a wide range of drug production efforts.
The seven facilities selected span a range of therapeutic areas. Amneal's New York plant will produce sterile liquid products for pain, respiratory, and ophthalmic uses. Cellares' New Jersey location is dedicated to producing gene therapies derived from cells for treating cancers and blood disorders.
Eli Lilly's Indiana facility will create active ingredients for GLP-1 oral and injectable drugs. Fujifilm Biotechnologies' North Carolina plant manufactures monoclonal antibodies. Kriya Therapeutics' North Carolina location will produce AAV-based gene therapies for chronic conditions.
Kyowa Kirin's North Carolina facility makes biologics for rare diseases. Regeneron's New York facility will manufacture biologic active ingredients, sterile injectable products, and protein-based treatments for a variety of conditions.
