Seven Companies Selected for FDA Pilot to Strengthen US Drug Supply Chain

With domestic drug supply chain resilience under growing regulatory and political pressure, the FDA named seven pharmaceutical and biotech companies as the inaugural participants in its PreCheck Pilot Program, a two-phase initiative designed to bring earlier regulatory engagement and a more predictable regulatory pathway to companies planning to manufacture drugs for the US market.¹

Selected from more than 80 applicants, the cohort includes manufacturers ranging from sterile small-molecule producers to cell and gene therapy companies, with facilities in New York, New Jersey, Indiana, and North Carolina.¹

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.

Launched in February 2026 following an executive order and public hearing, the PreCheck program requires applicants to propose a new US facility addressing a market supply need or unmet medical need, and to commit to 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. The FDA evaluated participants on products to be manufactured, stage of facility development, anticipated timeline to market, and innovation in manufacturing operations.

How Will the FDA PreCheck Program Work?

Under a two-phase engagement model, the FDA will provide early technical guidance before each facility is operational in Phase 1, allowing the agency to assess readiness ahead of production. Phase 2 shifts to enhanced collaboration, with facility-focused pre-submission meetings intended 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.”

How Will the PreCheck Program Advance Cell and Gene Therapies?

Cellares has been building automated domestic capacity for cell therapy production, according to the company.² Through the PreCheck program, it will advance its network of good manufacturing practice IDMO Smart Factories into commercial production while validating its Cell Shuttle manufacturing platform and Cell Q quality control system prior to product application filings. The company says this will compress regulatory timelines, reduce risk for sponsors, and shorten the path to commercial readiness.

“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.

Kriya Therapeutics, the second CGT participant, will manufacture adeno-associated virus-based gene therapies for chronic diseases at its Research Triangle Park facility. The site supports both clinical and commercial production and is built around automation and digital technologies, including the company's HOPSON proprietary structured data platform, which contains more than 80 million data points.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/