Two US drug substance and two drug product manufacturing plants are in the works to support the rollout of Eli Lilly’s recently approved type 2 diabetes GLP-1 receptor Mounjaro (tirzepatide).

In May, the US Food and Drug Administration (FDA) approved Mounjaro, a once-weekly GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) receptor.

Mounjaro represents the first new class of type 2 diabetes medication introduced in almost a decade, and a boost for developer Eli Lilly, which has begun rolling out the product in the US. The drug has also received a positive opinion from the European Medicines Agency (EMA).

By the end of June, Lilly had seen sales of $16 million. But during its Q2 conference call, the firm said it was prepping for global demand by monitoring US uptake to determine the appropriate timing for launches across other geographies. Furthermore, through capital expenditure projects, Lilly says it is not expecting any supply constraints.

Mike Mason, president of Lilly Diabetes, said his firm has been “planning for success” with its manufacturing team “working around the clock for years to build manufacturing capacity throughout the supply chain.”

He told stakeholders during the firm’s financial calls: “We have a number of sites who make this and they’re optimizing our initial capacity on a daily basis,” before adding Lilly has also made significant investments to expand capacity over the next few years.

“We have a new parental plant at Research Triangle Park in North Carolina that’s coming online in 2023 and another one behind that in Concord, North Carolina. Also, we’re building two manufacturing facilities to make the active ingredient for Mounjaro and those will come on at a later time. So obviously, we’re planning for success and our manufacturing team is working around the clock to get as much supply as possible.”

Lilly announced it would build an injectable drug manufacturing facility in Durham County, North Carolina in early 2020 as part of a $470 million  investment. The Concord facility, representing an investment of $1 billion, was announced in January 2022, while the firm pledged a further $2.1 billion in May for an expansion in its native Indiana, set to include two active ingredient plants.