Eli Lilly, Regeneron Join FDA Pilot Designed To Accelerate US Manufacturing Readiness

The U.S.

Food and Drug Administration (FDA) on Monday named seven companies selected for its FDA PreCheck Pilot Program.

The initiative aims at strengthening domestic pharmaceutical manufacturing, improving the resilience of the U.S. drug supply chain and providing companies with earlier regulatory engagement as they build new U.S. production facilities.

Read Also: White House Denies Report Linking Trump To Eli Lilly's Experimental Obesity Treatment: 'Not For The President' Seven Companies Selected The selected participants include Amneal Pharmaceuticals Inc. (NASDAQ: AMRX ), Cellares Corp., Eli Lilly and Co. (NYSE: LLY ), FUJIFILM Biotechnologies, Kriya Therapeutics Inc., Kyowa Kirin Inc. and Regeneron Pharmaceuticals Inc. (NASDAQ: REGN ).

Their facilities will manufacture products ranging from sterile injectable medicines and active pharmaceutical ingredients to cell and gene therapies, biotechnology drug substances, and commercial-scale cell culture products.

Under the program’s two-phase model, participants will first receive technical guidance before facilities become operational through FDA reviews of facility-specific Drug Master Files.

During the second phase, companies will participate in facility-focused pre-submission meetings intended to support earlier inspections and accelerate facility evaluations during application review.

The agency launched the program in February, following Executive Order 14293 signed by President Donald Trump in May 2025 and a public meeting focused on expanding domestic manufacturing.

The initiative is designed to provide a more predictable regulatory pathway for companies planning to manufacture medicines for the U.S. market while supporting access to critical therapies.

HHS Secretary Robert F.

Kennedy Jr. said the program reflects the administration’s effort to rebuild U.S. pharmaceutical manufacturing, strengthen drug supply chains, create American jobs, and improve patient access to safe and effective medicines.

Over 80 Companies Applied According to the FDA, the agency received more than 80 participation requests.

To qualify, applicants proposed new U.S.-based manufacturing facilities capable of addressing drug supply needs or improving access to therapies for unmet medical needs.

Companies also committed to submitting a New Drug Application, Biologics License Application, Abbreviated New Drug Application or a related supplement tied to the new facility.

Acting FDA Commissioner Kyle Diamantas said the program supports the administration’s goal of expanding domestic pharmaceutical production while making FDA expectations more transparent and strengthening the U.S. drug supply chain.

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