Eli Lilly, Regeneron in FDA PreCheck manufacturing program

Eli Lilly And Regeneration According to information obtained by CNBC, it is among the first seven companies selected by the US Food and Drug Administration for a pilot program designed to speed up inspections of new domestic drug production facilities.

Lilly, Regeneron, amnealCellares, Fujifilm Biotechnologies, Kriya Therapeutics and Kyowa Kirin will be the first companies to participate in the FDA’s PreCheck pilot program, according to FDA spokesman Benjamin Nichols. The initiative will allow regulators to begin inspecting new manufacturing facilities while they are under construction and detect and correct any problems, which the FDA estimates could save companies up to 14 months.

Producing more drugs domestically has been one of the Trump administration’s priorities. Early buyers range from the world’s most valuable healthcare company to biotech companies developing gene therapies. Many plan to make biologics or genetic drugs that require more complex manufacturing than the pills Americans know best.

To participate in the PreCheck program, companies had to build a new manufacturing facility that could produce drugs that would fill a supply gap in the market or improve access to treatments for unmet medical needs. Only facility-related medications will be covered by the program.

For example, the FDA selected Lilly’s Lebanon, Indiana, facility, which will produce the key ingredients of GLP-1 pills and vaccines. Lilly said it is “evaluating how PreCheck and related regulatory improvements may impact the facility’s timeline and will continue to work closely with the FDA to support the program’s success.”

The $2 billion Saratoga Springs, New York, site that Regeneron announced last fall has also been selected. Regeneron CEO Leonard Schleifer said in a statement that Regeneron is investing in US biologics production and advocates for a greater focus on domestic drug production.

“We are pleased to see programs like the FDA’s PreCheck Pilot Program that foster collaboration between innovators and regulators to create next-generation manufacturing capabilities and strengthen America’s biopharmaceutical industry,” he said.

Another buyer was Fujifilm Biotechnologies’ new facility in Holly Springs, North Carolina. The contract manufacturer opened the site last year. It already produces monoclonal antibodies for Regeneron customers and Johnson&JohnsonHe will produce them for other clients when more parts of the site open in 2027 and 2028.

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

Fujifilm said it expects the operational readiness review to be conducted before the end of the year, thanks to the expedited process. And he hopes the program will allow his clients to explore faster paths to approval with the FDA.