Eli Lilly, Regeneron in FDA PreCheck Manufacturing Program

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

Lilly, Regeneron, AmnealCellares, Fujifilm Biotechnologies, Kriya Therapeutics and Kyowa Kirin are 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 to identify and correct any problems, which the FDA estimates could save companies up to 14 months of time.

Producing more drugs domestically has been a priority for the Trump administration. Initial recipients range from the world’s most valuable healthcare company to closely affiliated biotech companies developing gene therapies. Most of them plan to produce biological drugs or genetic drugs, which are more complex to produce.

To be eligible for the PreCheck program, companies had to build a new manufacturing facility capable of producing medicines that would fill a market supply gap or increase access to therapies for unmet medical needs. Only facility-dependent medications are covered by the program.

Lilly Chairman and CEO Dave Ricks speaks during a press conference for Eli Lilly and Co. in Houston, Texas, September 23, 2025.

Antranik Tavitian | Reuters

For example, the FDA has selected Lilly’s facility in Lebanon, Indiana, which will produce the main ingredients of GLP-1 pills and syringes. 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 success of the program.”

The $2 billion Saratoga Springs, New York, site that Regeneron announced last fall was also selected. In a statement, Regeneron CEO Leonard Schleifer said Regeneron has invested in producing biologics in the U.S. and has advocated for a greater focus on domestic drug production.

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

Another recipient is Fujifilm Biotechnologies’ new facility in Holly Springs, North Carolina. The contract manufacturer opened the location last year. The company already produces monoclonal antibodies for customers Regeneron and Johnson & Johnsonand will produce them for other customers when additional parts of the site open in 2027 and 2028.

The PreCheck program has two components: operational readiness, where the FDA provides technical guidance to companies before site opening, and application submission, where participants can receive more practical feedback from the FDA as well as expedited inspections and facility assessments.

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

First participants in FDA’s PreCheck pilot program

Amneal Pharmaceuticals: Amneal’s New York facility will produce sterile, liquid, small molecule products for pain, respiratory and eye diseases.
Cellar: Cellares facility in New Jersey, which will produce cell-based gene therapies for oncological and hematological diseases.
Eli Lilly: Eli Lilly’s Indiana facility will produce the key ingredients for GLP-1 pills and syringes
Fujifilm Biotechnologies: Fujifilm’s North Carolina facility, which will produce monoclonal antibodies.
Kriya Therapeutics: Kriya’s North Carolina facility, which will produce adeno-associated virus-based gene therapies for chronic diseases.
Kyowa’s North Carolina facility will produce biologics for rare diseases.
Regeneron: Regeneron’s New York facility will produce biologics, sterile injectables and protein therapeutics for a variety of diseases.