FDA selects 7 companies for domestic drug manufacturing pilot

The U.S. Food and Drug Administration has selected seven companies to participate in its PreCheck Pilot Program, an initiative aimed at supporting the development of new domestic pharmaceutical manufacturing facilities.

The FDA launched the program on February 1, 2026, following Executive Order 14293 signed by President Trump in May 2025. Between February 1 and March 1, 2026, the agency received more than 80 requests to participate. FDA drug and biologic experts evaluated all requests using a scoring framework that considered products to be manufactured, stage of facility development, anticipated timelines, and manufacturing innovation.

The seven selected companies and their planned facilities are:

Amneal Pharmaceutical — Long Island, NY (small molecule sterile liquid products for pain management, respiratory, and ophthalmic diseases); Cellares Corp. — Bridgewater, NJ (cell-based gene therapy for oncology and hematology); Eli Lilly and Company — Lebanon, IN (active pharmaceutical ingredients); Fujifilm Biotechnologies — Holly Springs, NC (commercial-scale cell culture biomanufacturing); Kriya Therapeutics, Inc. — Durham, NC (AAV-based gene therapy for chronic disease); Kyowa Kirin, Inc. — Sanford, NC (biotechnology drug substance for rare diseases); Regeneron Pharmaceuticals, Inc. — Saratoga Springs, NY (biotechnology drug substance, sterile injectables, and novel protein therapeutics).

The program operates in two phases. In Phase 1, participants receive early technical guidance from the FDA before facilities become operational, including reviews through a facility-specific Drug Master File. In Phase 2, participants engage in facility-focused pre-submission meetings intended to support expedited facility evaluation and earlier inspections during the review cycle.

To be eligible, companies were required to propose a new domestic manufacturing facility addressing a market supply need or unmet medical need, and commit to submitting a New Drug Application, Biologics License Application, Abbreviated New Drug Application, or a supplement relying on the new facility.

The FDA said it will continue evaluating the pilot program and assess opportunities to inform future program development.

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