7 Facilities Pilot PreCheck for Faster Approval

By Katie Anderson, Chief Editor, Pharmaceutical Online

A more streamlined path to operational new pharmaceutical facilities in the U.S. may be on the horizon. Nearly a year after the PreCheck Pilot Program was introduced by the U.S. Food and Drug Administration (FDA) in August 2025, the first seven participating facilities have been announced. The program was created to strengthen both the U.S. drug supply chain and drug manufacturing in the U.S.

Out of the 80 companies that submitted a request to participate in the program, the following seven companies were selected: Amneal’s facility in Long Island, NY; Cellares Corp.’ s Bridgewater, NJ facility; Eli Lilly’s Lebanon, IN facility; the Holly Springs NC facility for FUJIFILM Biotechnologies; Kriya Therapeutics’ facility in Durham, NC; Kyowa Kirin’ s facility in Sanford, NC; and Regeneron’s facility in Saratoga Springs, NY.

The Seven Facilities Selected

These facilities were selected not only based on the drugs they intend to manufacture (they had to address a medical supply or unmet medical need), but they also were judged based on the stage of development, integration of innovation, and timeline of bringing those drugs to the U.S. market.

Of the companies selected to participate in the pilot program, Lilly’s Lebanon facility is the only dedicated to producing API. “When it starts making medicine, Lilly’s Lebanon, Indiana, facility will be the largest API production site in U.S. history. We are evaluating how PreCheck and related regulatory improvements may impact the facility's timeline and will continue to work closely with FDA to support the program's success,” noted the company in a statement sent to Pharmaceutical Online. The facility will make API for its diabetes, weight management, and cardiometabolic medicines.

Cellares, Kriya, and FUJIFILM will all be facilities dedicated to the manufacture of cell and gene therapies. While FUJIFILM will create commercial-scale cell cultures, Cellares will produce gene therapy for oncology and hematology, and Kriya will make AAV gene-therapy products for chronic diseases.

Amneal is the only generic manufacturer in the bunch, selected for its intended production of sterile liquids for pain management, respiratory, and ophthalmic diseases. “Sterile manufacturing requires a strong focus on contamination control, environmental monitoring, process design, sterility assurance, and overall operational readiness. These are often areas where questions may arise during application review. Earlier discussions with the FDA can help companies confirm that these foundational elements meet regulatory expectations before filing an application. Addressing questions up front can streamline the review process, support timely approvals, and ultimately get important medicines to patients sooner,” explained Piyush Modi, Director of Regulatory Affairs for Amneal Pharmaceuticals.

 Both Kyowa Kirin and Regeneron will produce biologics, but Regeneron also plans to produce sterile injectables and protein therapeutics in Saratoga Springs.

Readiness of the Facility

As many of us are aware, the first phase of the program is Facility Readiness. This early phase of the program puts the FDA and the manufacturer in close contact during the early phases of planning and construction. Before construction and during construction, facility design and construction as well as equipment design and qualification are assessed. At this time, PQS and personnel planning are also reviewed.

“In the traditional process, FDA engagement with a facility often happens later, such as after an application has been filed or when an inspection is scheduled. If questions arise at that stage, they can delay approval. The PreCheck Pilot is intended to provide earlier visibility into a facility's readiness, quality systems, and manufacturing controls prior to application submission. This allows companies to engage with the FDA earlier and address potential concerns, helping reduce delays during the review process,” added Modi.

As the site moves along to pre-production, the Pre-Operational Review (POR) then includes a physical verification and data review as a procedural and systems audit. This is used to produce an outcome report that is incorporated into a Type V Drug Master File (DMF), to be used to submit its New Drug Application (NDA), BLA (Biologics License Application) or Abbreviated New Drug Application (ANDA) in Phase II of the program.

“By building earlier and more structured engagement between industry and regulators throughout the development process, the program could reduce timelines and get medicines to patients faster,” explained Lilly in a company statement.

Submission of Drug Applications

With the Type V DMF in hand and operational readiness in place, the manufacturer can then move to phase 2 of the pilot program in where [hopefully] an expedited inspection and review of their drug application occur. Like phase 1, there is ongoing engagement with the FDA, starting with pre-submission meetings.

The pre-submission meetings bring together regulators and CMC professionals to ensure all the information on manufacturing strategies is provided, and feedback is given on data and logistics to facilitate a more expedient review and inspection.

Modi appreciates the cross-team collaboration that preparing for this program has facilitated. “One of the biggest benefits of the program has been the level of collaboration it encourages. Preparing for PreCheck requires close coordination among regulatory affairs, quality, manufacturing, engineering, technical operations, and supply chain teams. The program reinforces the importance of working together early, aligning expectations, and maintaining a shared focus on facility readiness and quality,” he noted.

Future Approval Benefits

If all goes as planned, the enhanced communication provided by the PreCheck Pilot Program will help new facilities become operational faster in the U.S. This, in turn, will bring drugs to market faster, and strengthen not only the supply chain in the U.S., but also the overall critical medicine supply in the U.S.

“ The PreCheck Program provides valuable learning opportunities that can benefit facilities across the organization. The experience can strengthen inspection readiness, quality culture, documentation practices, and cross-functional collaboration. More broadly, earlier engagement with the FDA may help reduce uncertainty after an application is filed, improve visibility into regulatory expectations, and support the development of stronger, higher-quality submissions,” concluded Modi.

Though participation in the program will undoubtedly be strenuous and challenging for manufacturers navigating its first year, its acceptance will no doubt result in faster approvals and inspections for additional drugs for that manufacturer in the future. If experiences and lessons learned from this program are shared between drug manufacturers, we can only imagine the massive benefit for the industry in speed to market, operational excellence, and safety.