Eli Lilly is one of seven companies chosen for the FDA PreCheck Pilot Program, targeting faster construction and approval of its Lebanon, Indiana drug substance manufacturing plant. Launched February 2026, the programme grants early FDA feedback on facility design and quality control to strengthen the US medicine supply chain.
The FDA PreCheck Pilot Program aims to bolster domestic medicine manufacturing by allowing selected drugmakers to engage with regulators earlier in the facility development process. Seven companies, including Eli Lilly, were chosen based on product types, facility development stages and innovation in manufacturing operations.
Eli Lilly’s upcoming plant in Lebanon, Indiana will focus on manufacturing drug substance for its pipeline products. Early inclusion in the pilot will help the company finalize site layouts, equipment specifications and quality control measures before construction is complete.
Participants enter a Facility Readiness phase for frequent FDA discussions on design and quality control, followed by an Application Submission phase covering chemistry, manufacturing and controls. This structure is designed to identify and resolve potential issues prior to formal approval submissions.
By reducing uncertainty around manufacturing readiness, the programme seeks to shorten timelines for new drug supplies reaching the US market. Early FDA engagement is expected to strengthen supply chain resilience, support job creation in Indiana and mitigate risks of production delays.
