FDA Picks Seven Companies for PreCheck Pilot on New US Drug Plants

The Food and Drug Administration has selected seven companies to take part in its PreCheck Pilot Program, an initiative meant to speed the development of new US pharmaceutical manufacturing plants by bringing in agency reviewers earlier, the FDA announced on June 29.

The companies and sites are Amneal Pharmaceutical in Long Island, New York; Cellares in Bridgewater, New Jersey; Eli Lilly and Company in Lebanon, Indiana; Fujifilm Biotechnologies in Holly Springs, North Carolina; Kriya Therapeutics in Durham, North Carolina; Kyowa Kirin in Sanford, North Carolina; and Regeneron Pharmaceuticals in Saratoga Springs, New York, according to the agency.

What the plants will make

The FDA said Amneal's facility will make small-molecule sterile liquid products for pain management and respiratory and ophthalmic diseases, and Lilly's will make active pharmaceutical ingredients for existing and future medicines. Cellares plans cell-based gene therapy products for oncology and hematology, Kriya AAV-based gene therapies for chronic diseases, Kyowa Kirin biotechnology drug substance for rare diseases and Regeneron biotechnology drug substance, sterile injectables and novel protein therapeutics. Fujifilm's site will support commercial-scale cell culture biomanufacturing.

The agency launched the pilot on February 1 in response to an executive order President Trump signed in May 2025, and received more than 80 requests to participate between February 1 and March 1. Eligible companies had to propose a new domestic facility able to make drug products that address a market supply need or improve access to therapies for unmet medical needs, and commit to filing a new drug application, biologics license application, abbreviated application or supplement that relies on the plant. FDA drug and biologic experts scored the requests using an objective framework, considering the products to be made, the stage of facility development, the expected timeline to market and innovation in facility development and manufacturing operations.

How the two phases work

In the first phase, facility readiness, participants receive early technical guidance before a plant becomes operational, including FDA review of facility information submitted through a facility-specific drug master file. In the second, application submission, they can hold facility-focused pre-submission meetings intended to support expedited facility evaluation and earlier inspections in the review cycle, the agency said. It said the approach is meant to identify facility issues before they become deficiencies that could delay or prevent approval.

"It further highlights the value of early FDA engagement in building a more resilient U.S. drug supply chain and reducing reliance on foreign sources of pharmaceutical production," Acting FDA Commissioner Kyle Diamantas said.

Kriya chief executive Shankar Ramaswamy said selection was "an important recognition of our investments to build manufacturing as a core internal strategic capability," according to Pharmaceutical Technology, which cited the company's release. The FDA said it will continue to evaluate how the pilot is implemented and assess opportunities to shape future development of the program.