Novo Nordisk has started construction, at least symbolically, on its $1.8 billion project in Clayton, NC, part of a two-continent manufacturing expansion that will give it the production heft it needs in the U.S., which now accounts for half of its business. And while construction is just getting started, 100 new employees are already on board.
The Danish diabetes drug maker held its ceremonial groundbreaking on Monday to mark the start of construction on its first API plant in the U.S. When complete in 2020, the new facility will manufacture the active ingredients for oral semaglutide, its experimental daily oral treatment for Type 2 diabetes, as well as other current and future Novo insulin products.
The company said Monday that the 833,000-square-foot facility will have a footprint of 417,639 square feet, which it said equates to about 7 football fields. The plant will sit adjacent to Novo’s current manufacturing facilities in Clayton: a 457,000-square-foot facility which handles formulation, filling and packaging of diabetes meds. When the new plant is complete, the company will add about 700 jobs to its site in Clayton.
Even before construction began, the company added its first 100 new employees for the project, Novo’s Gary Lohr told FiercePharmaManufacturing in a telephone interview Monday. Lohr serves as a project director and is deputy site head for diabetes active pharmaceutical ingredients in the U.S. Lohr explained that Novo has hired some engineers and quality assurance folks who are helping with the design portion of the project but will shift over to operating the plant when it is ready to go.
“Earth work” is next at the site, as design details are finished up over the next 6 months. It will take about three years to complete all of the construction and another two “to do all of the qualification and compliance related activity,” Lohr said.
The new plant is not only Novo’s first API facility in the U.S, it is also Novo’s first outside of its home in Denmark. A diabetes epidemic in the U.S. has dramatically pushed up demand for Novo products, making a plant in the U.S. a logical step in manufacturing, Lohr said. “Demand is growing, and the U.S. is the focus for our new GLP-1 drug, which is in Phase III trials,” Lohr said, “so the need for the plant is demand and capacity-driven.”
The Clayton buildup is part of $2 billion expansion the drugmaker announced it August, which also includes a new production facility in Måløv, Denmark. That facility will handle tableting and packaging of oral semaglutide as well as other oral meds it develops. The $200 million investment in Måløv will create roughly another 100 jobs there.
By Eric Palmer
Source: Fierce Pharma MAnufacturing
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