FDA Chooses 7 Companies for PreCheck Pilot

The FDA announced on June 29, 2026 that it has selected 7 companies for the agency’s PreCheck Pilot Program.¹ The program was launched in February 2026, following the issuance of an executive order and a public hearing, to support domestic pharmaceutical manufacturing in the United States. Of the more than 80 requests to participate, the following companies were chosen:

• Amneal Pharmaceutical will manufacture small-molecule sterile liquid products at its facility in Long Island, NY.
• Cellares Corp. will manufacture cell-based gene therapy products for oncology and hematology diseases at its Bridgewater, NJ facility.
• Eli Lilly and Company will manufacture APIs for the company’s existing and future medicines at its Lebanon, IN facility.
• FUJIFILM Biotechnologies will support commercial-scale cell culture biomanufacturing at its facility in Holly Springs, NC.
• Kriya Therapeutics will manufacture gene therapy products for chronic diseases at its facility in Durham, NC.
• Kyowa Kirin will manufacture biotechnology drug substance for rare diseases at its facility in Sanford, NC.
• Regeneron Pharmaceuticals’ facility in Saratoga Springs, NY will manufacture biotechnology drug substance, sterile injectables, and novel protein therapeutics.

Companies that requested to participate were required to propose a new domestic manufacturing facility that would produce drug products specifically to address a market supply need or therapies for unmet medical needs. The applicants also had to commit to submitting a New Drug Application, Biologics License Application, Abbreviated New Drug Application, or a supplement to one of those applications that relies on the new manufacturing facility.

When deciding on the pilot participants, the agency considered the products to be manufactured, the stage of facility development, the anticipated timeline for bringing products to the US market, and innovation in facility development and manufacturing operations.

How Will the Program Work?

The participants will work with the FDA under a 2-phase model. In phase 1, early technical guidance will be given by the FDA before the facility is operational so that the agency can assess the facility’s readiness. In phase 2, enhanced engagement with the agency will include facility-focused pre-submission meetings to support expedited facility evaluation and inspections.

“The FDA's PreCheck Pilot Program will help bring pharmaceutical manufacturing back to the United States, strengthen our drug supply chains, create high-quality American jobs, and ensure patients have reliable access to safe, effective medicines. This is another important step toward making America healthier, stronger, and more self-reliant,” said Health and Human Services Secretary Robert F. Kennedy Jr., in a press release.¹

“This milestone reflects the Trump administration's commitment to strengthening domestic pharmaceutical manufacturing capacity, creating American jobs, and driving down drug costs for families. It further highlights the value of early FDA engagement in building a more resilient US drug supply chain and reducing reliance on foreign sources of pharmaceutical production,” said Acting FDA Commissioner Kyle Diamantas, J.D., in a press release.¹ “By making our regulatory processes and expectations more transparent, we ensure that American pharmaceutical manufacturers remain global leaders while securely providing high-quality treatments to patients right here at home.”

Advancing Cell and Gene Therapies

Cellares has been building automated, domestic capacity for cell therapy production, according to the company.² The PreCheck Pilot Program will help the company advance its network of good manufacturing practice IDMO Smart Factories into commercial production and allow for the validation of its Cell Shuttle manufacturing platform and Cell Q quality control system before the filing of product applications. This will allow for a compressed regulatory timeline that provides sponsor companies with reduced risk and a shorter time to commercial readiness, according to the company.

“Manufacturing and facility risks are usually the ones no one considers until a pre-approval inspection or a complete response letter, long after a sponsor has filed,” said Eric Fulmer, senior vice president of Global Quality at Cellares, in a press release.² “PreCheck moves that conversation up by several years, to a time before a facility is even in operation, which is taking it off the critical path. For the sponsors building and commercializing on Cellares’ platform, it means manufacturing is the one thing that won’t stand between their therapy and regulatory approval.”

Cellares’ Cell Shuttle cell therapy platform received the FDA’s Advanced Manufacturing Technology designation in April 2025,³ and the company achieved FDA clearance of an investigational new drug amendment for clinical manufacturing on the Cell Shuttle.

Biotech company, Kriya Therapeutics, will manufacture adeno-associated virus-based gene therapies at its Research Triangle Park facility as part of the PreCheck Pilot Program. The facility supports clinical and commercial production and leverages automation and digital technologies. The company’s HOPSON proprietary structured data platform contains more than 80 million datapoints.⁴

“Selection for the FDA PreCheck Pilot Program is an important recognition of our investments to build manufacturing as a core internal strategic capability,” said Shankar Ramaswamy, M.D., CEO & Co-Founder, Kriya, in a press release.⁴ “From day one, our vision has been to develop transformative durable medicines for chronic diseases that affect millions of Americans, and the integrated infrastructure required to manufacture them efficiently, consistently, and at scale. We look forward to collaborating with the FDA through this program as we continue advancing our pipeline towards commercialization.”

References

1. FDA selects seven participants for PreCheck Pilot Program to advance US drug manufacturing. Press release. FDA. June 29, 2026. https://www.fda.gov/news-events/press-announcements/fda-selects-seven-participants-precheck-pilot-program-advance-us-drug-manufacturing
2. Cellares accepted to FDA’s inaugural manufacturing PreCheck cohort, the only cell therapy platform among seven companies nationwide. Press release. Cellares. June 30, 2026. https://www.cellares.com/news/cellares-accepted-to-fdas-inaugural-manufacturing-precheck-cohort-the-only-cell-therapy-platform-among-seven-companies-nationwide/
3. Cellares’ Cell Shuttle receives FDA Advanced Manufacturing Technology (AMT) designation for automated cell therapy manufacturing. Press release. Cellares. April 1, 2025. https://www.cellares.com/news/cellares-cell-shuttle-receives-fda-advanced-manufacturing-technology-amt-designation-for-automated-cell-therapy-manufacturing/
4. Kriya selected for FDA PreCheck Pilot Program. Press release. Kriya Therapeutics. June 29, 2026. https://kriyatherapeutics.com/news/kriya-selected-for-fda-precheck-pilot-program/