Eli Lilly, Regeneron in FDA PreCheck manufacturing program

Eli Lilly and Regeneron are among the first seven companies the U.S. Food and Drug Administration selected for a pilot program designed to accelerate reviews of new domestic pharmaceutical manufacturing facilities, CNBC has learned.

Lilly, Regeneron, Amneal, Cellares, Fujifilm Biotechnologies, Kriya Therapeutics and Kyowa Kirin are the first companies that will participate in the FDA’s PreCheck pilot program, according to FDA spokesperson Benjamin Nichols. The initiative will allow regulators to start reviewing new manufacturing facilities while they’re under construction to catch and correct any issues, which the FDA estimates could save companies up to 14 months.

Producing more drugs domestically has been a priority for the Trump administration. The initial recipients range from the most valuable healthcare company in the world to closely held biotechs developing gene therapies. The majority of them plan to make biologic drugs or genetic medicines, which involve more complex manufacturing.

To be eligible for the PreCheck program, companies needed to build a new manufacturing facility capable of making drugs that would address a market supply gap or improve access to therapies for unmet medical needs. Only drugs that rely on the facility will be covered by the program.

For example, the FDA selected Lilly’s Lebanon, Indiana, facility that will make the main ingredients of GLP-1 pills and shots. Lilly said it’s “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.”

The $2 billion Saratoga Springs, New York, site that Regeneron announced last fall was also chosen. In a statement, Regeneron CEO Leonard Schleifer said Regeneron has invested in U.S. biologics manufacturing and advocated for increased focus on domestic production of medicines.

“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.

Another recipient is Fujfilm Biotechnologies’ new facility in Holly Springs, North Carolina. The contract manufacturer opened the site last year. It’s already making monoclonal antibodies for customers Regeneron and Johnson & Johnson, and will produce them for other customers as more parts of the site open in 2027 and 2028.

The PreCheck program includes two components: facility readiness, where the FDA gives the companies technical guidance before the site opens, and application submission, where participants can get more hands-on feedback from the FDA and expedited inspections and facility evaluation.

Fujifilm said it expects the operational readiness review before the end of the year thanks to the expedited process. And it expects the program will allow its customers to explore faster approval pathways with the FDA.