On January 16, 2026, Apiject Holdings Inc. announced the signing of a lease for a 30,000-square-foot pharmaceutical manufacturing facility in Apex, North Carolina. This site is designed to address a critical national security issue: the United States’ heavy reliance on foreign suppliers for essential medicines.
The facility will serve a dual purpose as both a high-tech production hub and the corporate headquarters for Apiject’s operational subsidiary, Vanguard Utility.
Facility and Technology Breakdown
The Apex site is specialized to utilize advanced Blow-Fill-Seal (BFS) technology, which forms, fills, and seals a plastic container in one continuous, automated process.
- Production Lines: The facility will house two advanced BFS lines.
- BFS Evolution: Traditionally used for eye drops, Apiject (with support from the HHS/ASPR) has evolved this tech into a standardized platform for liquid injectable medicines.
- Material Resilience: Unlike traditional vials, BFS uses domestically available plastic resin, entirely bypassing the fragile and often foreign-dependent glass supply chain.
Strategic Operations: The 503B Pathway
The facility will operate as an FDA-registered 503B outsourcing facility. This is a strategic choice that allows Apiject to bypass some of the lengthy timelines associated with traditional pharmaceutical manufacturing for specific needs.
| Feature | Impact |
| Shortage Focus | Exclusively targets medicines on the FDA’s Drug Shortage List. |
| Speed to Market | The 503B status allows for the compounding and distribution of large batches of sterile drugs to hospitals and clinics without individual prescriptions. |
| National Security | Acts as a “domestic buffer” to provide essential injectables when offshore production or shipping is disrupted. |
Recent Regulatory Momentum
The Apex announcement follows a major milestone for the company:
- NDA Filing: In late 2025, Apiject filed its first New Drug Application (NDA) with the FDA for a BFS-based prefilled injection device (Glycopyrrolate), marking the first time this specific platform has been submitted for full regulatory drug approval.
- Amneal Partnership: This facility complements a separate 2025 collaboration with Amneal Pharmaceuticals in New York to scale BFS production to 400 million units annually.
“America’s dependence on foreign sources for essential medicines is a strategic vulnerability. This facility represents the next step in translating advanced American manufacturing technology into real domestic capacity.” — Jay Walker, Chairman of Apiject.
