Apiject Holdings Inc. has secured a 30,000-square-foot pharmaceutical site in Apex, North Carolina, to bolster domestic production of critical healthcare supplies. Operating as an FDA-registered 503B outsourcing facility, the plant will serve as the corporate headquarters for Vanguard Utility and focus on mitigating nationwide drug shortages.
Advanced manufacturing and national resilience The Apex facility is designed to strengthen the U.S. pharmaceutical infrastructure through several key initiatives:
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Blow-Fill-Seal (BFS) technology: The site will house two high-tech BFS production lines. This aseptic process forms, fills, and seals containers in one continuous operation, ensuring high sterility for injectable products.
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Addressing shortages: Production will prioritize generic injectable medicines currently listed as scarce by the FDA, providing a stable domestic source for healthcare providers.
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Strategic reshoring: Leadership at Apiject emphasizes that this investment aligns with the national priority of reducing reliance on overseas suppliers for essential medical goods, thereby enhancing national security.
By utilizing the FDA’s 503B regulatory pathway, the facility can deploy domestically manufactured drugs faster than offshore competitors, addressing immediate clinical needs while strengthening the long-term resilience of the American medical supply chain.