FDA reveals 7 facilities chosen for PreCheck Pilot program

The U.S. FDA announced the selection of seven companies to participate in the new PreCheck Pilot Program, an initiative designed to strengthen domestic drug manufacturing.

Launched in February 2026, the pilot program is intended to support the development of new U.S. pharmaceutical manufacturing facilities by encouraging earlier FDA engagement and providing a more predictable regulatory pathway for companies that plan to manufacture drugs for the U.S. market. The selected companies will get direct, ongoing engagement with the FDA during facility development and application submission periods, compressing regulatory timelines and de-risking the path to commercial-scale production.

Between February 1 and March 1, 2026, the FDA received over 80 requests to participate in the pilot program. To be eligible, companies proposed a new domestic manufacturing facility that will be capable of manufacturing drug products to address a market supply need or improve patient access to therapies for unmet medical needs. Eligible companies also committed to submitting an NDA, BLA, ANDA, or a supplement to one of those applications that relies on the new manufacturing facility.

Two CGT companies were selected for the pilot:

Cellares Corp.: Cellares’ GMP Integrated Development and Manufacturing Organization (IDMO) smart factory in Bridgewater, NJ will manufacture cell-based gene therapy products for oncology and hematology diseases. The company’s Cell Shuttle offers automated, end-to-end manufacturing workflow that reduces manual touchpoints, minimizes variability, and enables standardized execution across runs, equipment, and facilities. In April, Cabaletta Bio’s investigational CAR-T cell therapy, rese-cel, was infused into the first two patients using drug product manufactured on Cellares' Cell Shuttle.

Kriya Therapeutics: Kriya's new commercial manufacturing facility in Research Triangle Park, North Carolina, will manufacture its pipeline of AAV-based gene therapy products to address chronic diseases. The facility is designed to support both clinical and commercial production while leveraging automation, digital technologies and data-driven optimization to improve quality, scalability and efficiency. Kriya’s pipeline includes preclinical, one-time gene therapies across metabolic disease, ophthalmology and neurology.

The five additional facilites selected include:

Eli Lilly: Lilly’s facility in Lebanon, Indiana will manufacture drug substance (active pharmaceutical ingredients) in support of the company’s existing and future medicines. Lilly has committed more than $21 billion since 2020 to expanding its Indiana footprint, including three planned facilities on its Lebanon campus. The API plant participating in the pilot program will produce APIs for Zepbound and Mounjaro, but the campus is also home to Lebanon Advanced Therapies, which recently opened as the company's first dedicated genetic medicine manufacturing facility.

FUJIFILM Biotechnologies: FUJIFILM's facility in Holly Springs, North Carolina will support commercial-scale cell culture biomanufacturing. In 2021, FUJIFILM Biotechnologies selected Holly Springs for a planned $2 billion commercial-scale cell culture manufacturing campus, then billed as the largest cell culture biopharmaceutical CDMO facility in North America.

Kyowa Kirin: Kyowa’s facility in Sanford, North Carolina will manufacture biotechnology drug substance for rare diseases. The Sanford facility, which broke ground in late 2024 and is on track to be operational by 2027, will serve as a core U.S. hub for manufacturing innovative biologic therapies, with a strong emphasis on next-generation antibodies for rare and orphan diseases.

Regeneron Pharmaceuticals: Regeneron’s facility in Saratoga Springs, New York will manufacture biotechnology drug substance, sterile injectables, and novel protein therapeutics for multiple diseases. Company acquired the1 million-square foot property in 2025.The site will place emphasis on manufacturing of biologics for infectious diseases and cancer.

Amneal Pharmaceutical: Amneal’s sterile injectable facility in Long Island, New YOrk will manufacture small molecule sterile liquid products for pain management, respiratory and ophthalmic diseases. The 75,000-square-foot facility will manufacture the sterile finished dosage forms using advanced aseptic processing, automation, and integrated systems that ensure quality is embedded from the ground up