The FDA has selected seven companies for its PreCheck Pilot Program, a new initiative designed to support domestic pharmaceutical manufacturing and strengthen the US drug supply chain.
The first participants are Amneal Pharmaceutical, Cellares, Eli Lilly and Company, Fujifilm Biotechnologies, Kriya Therapeutics, Kyowa Kirin, and Regeneron Pharmaceuticals. The selected facilities span small molecules, biologics, sterile injectables, biotechnology drug substance, cell-based gene therapies, AAV-based gene therapies, and commercial-scale cell culture biomanufacturing.
The program was launched on February 1, 2026, following a 2025 executive order on domestic drug manufacturing. The aim is to give companies earlier technical feedback from the FDA as they develop new U.S. manufacturing sites, reducing uncertainty around facility readiness and application review.
The FDA said it received more than 80 requests to participate between February 1 and March 1, 2026. To be eligible, companies had to propose a new US manufacturing facility capable of addressing a market supply need or improving patient access to therapies for unmet medical needs. They also had to commit to submitting an NDA, BLA, ANDA, or supplement that relies on the new facility.
Selected companies will take part in a two-phase process. In the first phase, Facility Readiness, participants will receive early technical guidance before the site becomes operational, including FDA review of facility information submitted through a facility-specific Drug Master File. In the second phase, Application Submission, companies will have facility-focused pre-submission meetings intended to support earlier inspections and more efficient facility evaluation during review.
The selected facilities include Amneal’s Long Island, New York, site for small-molecule sterile liquid products; Cellares’s Bridgewater, New Jersey, facility for cell-based gene therapy products; Eli Lilly’s Lebanon, Indiana, facility for active pharmaceutical ingredient manufacturing; Fujifilm Biotechnologies’s Holly Springs, North Carolina, site for commercial-scale cell culture biomanufacturing; Kriya Therapeutics’s Durham, North Carolina, facility for AAV-based gene therapy products; Kyowa Kirin’s Sanford, North Carolina, facility for biotechnology drug substance; and Regeneron’s Saratoga Springs, New York, facility for biotechnology drug substance, sterile injectables, and novel protein therapeutics.
The pilot does not approve the facilities or products in advance. Instead, it is intended to surface manufacturing issues earlier, before they become deficiencies that could delay drug or biologics applications.
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