Apiject Holdings, Inc. announced it has signed a lease for a 30,000-square-foot pharmaceutical manufacturing facility in Apex, North Carolina. The site will include two state-of-the-art Blow-Fill-Seal production lines and operate as an FDA-registered 503B outsourcing facility dedicated to producing critical generic injectable medicines currently on the FDA’s shortage list. The Apex facility will also serve as the corporate headquarters of Vanguard Utility, Apiject’s operational subsidiary. This development builds on Apiject’s ongoing efforts to bring essential medicine production back to the United States and strengthen domestic supply chains.
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The company recently submitted a New Drug Application to the FDA for its first BFS-based prefilled injection device, marking a significant regulatory milestone for its platform. Jay Walker, Chairman of Apiject, emphasized the national importance of the project, stating, “America’s dependence on foreign sources for essential medicines is a strategic vulnerability. Reshoring critical manufacturing from pharmaceuticals to energy and rare earth minerals is a national priority. This facility represents the next step in translating advanced American manufacturing technology into real domestic capacity.” The U.S. currently faces persistent shortages, with more than 200 generic drugs regularly listed as scarce, while roughly 70 to 80 percent of these medicines are produced in China and India. Apiject’s BFS technology addresses these vulnerabilities by forming, filling, and sealing drug doses in a single automated process, eliminating reliance on fragile glass supply chains and enabling rapid, scalable production.
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Darren Alkins, CEO of Vanguard Utility, explained, “BFS transforms the economics of generic injectable drug production. Apiject can now manufacture a wide range of liquid injectables quickly, at scale, and at competitive costs within the United States, serving both domestic and international markets.” The Apex facility will prioritize shortage-listed injectables under the FDA’s 503B framework, ensuring faster domestic access to critical medicines. Apiject also credited the White House and the Department of Health and Human Services’ Administration for Strategic Preparedness and Response for supporting the company’s technology and public health objectives. Walker added, “Rebuilding U.S. manufacturing capacity for essential medicines requires both policy guidance and continuous innovation. We value the Administration’s commitment to strengthening domestic production and making it resilient and sustainable for the future.”
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