Eli Lilly and Regeneron join FDA PreCheck manufacturing program

Eli Lilly and regeneron The company is among the first seven companies selected by the U.S. Food and Drug Administration for a pilot program aimed at speeding up the review of new drug manufacturing facilities in the country, CNBC has learned.

Lilly, Regeneron, No treatmentCellares, Fujifilm Biotechnologies, Kriya Therapeutics, and Kyowa Kirin are the first companies to participate in the FDA’s PreCheck pilot program, according to FDA spokesperson Benjamin Nichols. The initiative allows regulators to begin reviews to find and fix problems during the construction of new manufacturing facilities, which the FDA estimates could save companies up to 14 months.

Producing more medicine domestically is a priority for the Trump administration. Initial recipients range from the world’s most valuable healthcare companies to closely-knit biotech companies developing gene therapies. Most plan to manufacture biological or genetic medicines, which require more complex manufacturing.

To qualify for the PreCheck program, companies had to build new manufacturing facilities capable of producing medicines that address supply gaps in the market or improve access to treatments for unmet medical needs. Only facility-dependent medications are eligible for the program.

For example, the FDA selected Lilly’s facility in Lebanon, Indiana, which manufactures the main ingredient in GLP-1 tablets and shots. “We are evaluating how PreCheck and related regulatory improvements will impact facility schedules and will continue to work closely with the FDA to support the program’s success,” Lilly said in a statement.

Regeneron’s $2 billion Saratoga Springs, New York, site announced last fall was also selected. Regeneron CEO Leonard Schleifer said in a statement that Regeneron is investing in U.S. biologics manufacturing and advocates for a greater focus on domestic production of drugs.

He said, “I am pleased to see programs like FDA’s PreCheck Pilot Program that foster collaboration between innovators and regulators to build next-generation manufacturing capacity and strengthen the U.S. biopharmaceutical industry.”

Another host is Fujifilm Biotechnologies’ new facility in Holly Springs, North Carolina. The contract manufacturer launched the site last year. The company already produces monoclonal antibodies for Regeneron and Regeneron customers. johnson & johnsonplans to produce them for other customers as more parts of the site open in 2027 and 2028.

The PreCheck program includes two components. One is facility preparation, where FDA provides technical guidance to companies before opening a facility. The other is application submission, which allows participants to get more actionable feedback from FDA and expedite inspections and facility evaluations.

Fujifilm said that thanks to the expedited process, it expects the operational readiness review to be completed by the end of the year. And the company hopes this program will allow its customers to explore a faster approval path with the FDA.