Just down the road from Charlotte Motor Speedway in Concord, North Carolina, is one of pharmaceutical giant Eli Lilly’s most advanced, state-of-the-art manufacturing facilities. Equipped with high-speed lines, robotics, and automated systems, the Lilly site started commercial production at the end of 2024 after completing construction in only two years — more than twice as fast as the industry average of five years, according to the company.
“At the end of 2024, we were not only making medicine, but we were able to ship medicine to patients,” said Rosa Manso, Lilly’s site head in Concord. “That was very fast,” she commented. “The site was built with unprecedented speed.”
When construction began in 2022, Lilly planned to invest $1 billion to create a new injectable products and devices manufacturing site, along with nearly 600 jobs. However, the drugmaker subsequently doubled its investment in the Concord facility to $2 billion to try and keep pace with the growing demand for its diabetes and obesity medicines — injectable GLP-1 drugs Mounjaro and Zepbound — and now has more than 750 employees.
“This is a platform that we are leveraging for existing products that Lilly has on the market right now for diabetes and obesity,” Manso said. “And it’s a platform that will be leveraged in the future to support Lilly’s robust pipeline.”
The facility, built on the 400-acre site of the old Philip Morris building in Concord, covers an area of 1.3 million square feet with 10 interconnected buildings including two main manufacturing buildings: parenteral (injectable) products and device assembly.
“The site is home to wetlands so we were very intentional in how we were building on the land,” Manso said. “Only 20% of the acres that we bought are being used for buildings and the rest of it is sustained.”
The Concord site includes administrative offices, quality control laboratories, packaging and labeling, centralized utilities, waste management, a cafeteria, fitness center, as well as shipping and receiving operations. Lilly uses robotics extensively in various parts of the site’s operations, in addition to forklift-like Automated Guided Vehicles and a fully automated warehouse.
The site was selected by Lilly to leverage North Carolina’s “reliable manufacturing workforce and partner with top-tier research and medical institutions as well as community colleges with strong programs in science, technology, engineering and math (STEM),” according to the company.
The facility is Lilly’s second manufacturing site in North Carolina, following its $470 million investment in 2020 in an injectable drug and device plant at Raleigh-Durham’s Research Triangle Park.
Trying to keep pace with demand
Lilly acknowledged in its 2024 annual report, released in February 2025, that there were periods of time last year when demand for the company’s incretin medicines exceeded production and while the supply of tirzepatide — the active ingredient in Mounjaro and Zepbound — currently exceeds demand in the U.S., it’s a situation that remains fluid.
“Despite our ongoing efforts to meet projected future demand by obtaining additional internal and contracted manufacturing capacity, there can be no assurances that such capacity increases that we expect will be needed to meet future demand will be realized as expected or that we will meet demand in launched markets in the future,” Lilly said in its annual report.
Still, the company continues to “expand manufacturing capacity and progress efforts to bring tirzepatide to patients via different delivery presentations, such as single-use vials and multi-use pens.” Lilly said that to support anticipated demand for its current and future products, the company has undertaken “significant” investments to increase manufacturing capacity, including in North Carolina.
Lilly credited the FDA’s willingness to work together with the company to ensure the Concord facility was built to the agency’s specifications in a streamlined licensing process. However, CEO Dave Ricks complained in a recent interview with Fox Business about permit delays from the FDA and other challenges in building drug manufacturing plants in the U.S.
“They take time to build. We need to speed that up. That’s been a challenge,” Ricks said. “There’s always talk of permitting reform and getting clearance from the FDA faster. Those are things we could use some help with to speed these factories getting built.”
In February, Lilly announced a $27 billion investment to build four new U.S. pharmaceutical manufacturing sites — three for active pharmaceutical ingredients (APIs) and one to manufacture injectable products and devices.
However, in comments last month in response to a Department of Commerce investigation into the importation of certain pharmaceuticals and pharma ingredients, Lilly warned that “some measures — like tariffs — that increase the cost of medicines or decrease the capital available to manufacturers will actually worsen the problem this Administration seeks to address.”
While it remains to be seen whether President Trump imposes tariffs on pharmaceuticals, he signed an executive order in May instructing the FDA to expedite the approval process for U.S. pharma facilities. The order directs the FDA to reduce the amount of time it takes to approve domestic drug manufacturing plants by eliminating duplicative and unnecessary requirements, streamlining reviews, and working with manufacturers to provide early support before facilities come online.
Trump’s order notes that building new pharma manufacturing plants can take as long as five to 10 years, as manufacturers “must navigate myriad Federal, State, and local requirements ranging from building standards and zoning restrictions to environmental protocols that together diminish the certainty needed to generate investment for large manufacturing projects.” The directive is designed to speed up timelines for building U.S. sites by reducing regulatory barriers to construction.
However, data and analytics firm GlobalData contends that Trump’s order “has ignited a wave of skepticism within the industry regarding its potential effectiveness.” Kathryn Kinch, GlobalData’s senior pharma product manager, said in a statement that critics are “raising eyebrows over the lack of clarity” surrounding the implementation of the order and as federal agencies including the FDA “scramble to develop actionable guidelines, the pharmaceutical sector watches closely.”
