Apiject Expands U.S. Manufacturing With New North Carolina Facility

Apiject Holdings, Inc. announced the signing of a lease for a 30,000-square-foot pharmaceutical manufacturing facility in Apex, North Carolina. The facility will house two advanced Blow-Fill-Seal (BFS) production lines and operate as an FDA-registered 503B outsourcing facility focused on producing essential generic injectable medicines currently on the FDA's drug shortage list. The site will also serve as the corporate headquarters of Vanguard Utility, Apiject's operational subsidiary.

The Apex announcement builds on sustained momentum across Apiject's technology, regulatory, and commercial efforts to restore U.S. control over essential medicines. The company has recently filed a New Drug Application (NDA) to the U.S. Food and Drug Administration for its first BFS-based prefilled injection device, marking a major regulatory milestone for the platform.

This investment supports national priorities to reshore critical U.S. manufacturing capacity and strengthen national resilience in key industries, including essential medicines, at a time when the United States faces persistent drug shortages and heavy reliance on foreign pharmaceutical suppliers.

"America's dependence on foreign sources for essential medicines is a strategic vulnerability," said Jay Walker, Chairman of Apiject. "Reshoring critical manufacturing – from energy and rare earth minerals to pharmaceuticals – is a national priority. This facility represents the next step in Apiject's ongoing work to translate advanced American manufacturing technology into real domestic capacity."

The U.S. faces two urgent challenges in generic drug supply: more than 200 drugs regularly appear on the FDA's shortage list, and while generic drugs account for approximately 90 percent of U.S. prescriptions, an estimated 70 to 80 percent are manufactured in China and India. This level of foreign dependence leaves the healthcare system exposed during emergencies and disruptions.

"BFS fundamentally changes the economics of generic injectable drug manufacturing," said Darren Alkins, CEO of Vanguard Utility. "With Apiject's advancements, BFS can now be used for a broad range of liquid injectable medicines, produced quickly, at scale, and at globally competitive costs – right here in the United States for both domestic and international markets."