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Apiject Plans New Generic Injectable Drug Manufacturing Facility in North Carolina

Will produce essential generic injectable medicines currently on the FDA's drug shortage list.

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By: Charlie Sternberg

Associate Editor, Contract Pharma

Apiject Holdings Inc. has signed a lease for a 30,000-square-foot pharmaceutical manufacturing facility in Apex, North Carolina, which 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.

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.”

Operating under the FDA’s 503B pathway, the Apex facility will prioritize the production of generic shortage-listed injectable medicines, allowing faster deployment of essential drugs manufactured domestically—an advantage that offshore producers cannot replicate.

Last year, Novartis announced plans to expand its operations in North Carolina, creating a new flagship manufacturing hub with end-to-end manufacturing capabilities.

More recently, Johnson & Johnson announced an expansion in Wilson County, North Carolina via a new multibillion-dollar facility that will create up to 500 new jobs in the community.

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