Apiject Announces New Facility in N.C. for Generic Injectable Drug Production

Apiject's New Manufacturing Facility

Apiject Holdings, Inc. has officially announced a transformative step towards enhancing U.S. pharmaceutical manufacturing by securing a lease for a new 30,000-square-foot facility located in Apex, North Carolina. This site marks a significant investment in essential drug production, particularly focusing on generic injectable medications that are currently facing shortages nationwide.

The Apex facility will be equipped with two advanced Blow-Fill-Seal (BFS) production lines, enabling Apiject to operate as an FDA-registered 503B outsourcing facility. This means the manufacturing process will focus on producing generic injectable medicines that are listed as shortage drugs by the FDA. Furthermore, the site will also serve as the corporate headquarters for Vanguard Utility, Apiject's operational subsidiary dedicated to the production of essential drugs.

Apiject's initiative aligns closely with the increasing national demand for reshoring critical drug manufacturing capacity within the United States. As drug shortages have become a pressing issue, the significance of such a facility cannot be understated. Jay Walker, the Chairman of Apiject, commented on the strategic vulnerability posed by the country's reliance on foreign pharmaceutical suppliers, stating that reversing this trend by reshoring manufacturing is of utmost importance.

Currently, the U.S. finds itself in a precarious situation, with more than 200 drugs on the FDA's shortage list. While generic drugs comprise around 90% of U.S. prescriptions, approximately 70 to 80% of them are produced overseas, specifically in countries like China and India. This heavy dependence poses risks during national emergencies or supply disruptions. To combat this, Apiject's innovative approach leverages advanced BFS technology—a method traditionally used for packaging eyedrops and inhalation products.

According to Apiject, the BFS technology enables a streamlined process: it creates the drug container, fills it with medicine, and seals the dose, all in one continuous automated procedure. This approach minimizes reliance on fragile global supply chains, particularly those involving foreign glass production. The use of a single domestically sourced material for BFS represents a significant shift towards a more reliable supply chain for generic drugs.

Darren Alkins, the CEO of Vanguard Utility, emphasized that BFS technology is pivotal in altering the economics of generic injectable drug manufacturing. With the advancements made by Apiject, BFS can accommodate a broad spectrum of liquid injectable medicines, produced rapidly and at scale, making domestic production both competitive and practical for both U.S. and international markets.

In addition to the facility's capabilities, Apiject has expanded its presence through commercial partnerships and licensing agreements aimed at enhancing sterile BFS manufacturing methodologies for injectable drugs in America. This collaborative approach has also received recognition and support from the Administration for Strategic Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services.

By operating under the FDA’s 503B pathway, the new Apex facility will prioritize the speedy production of injectable medicines that are currently listed as shortages. This strategic advantage ensures that essential drugs manufactured domestically can be delivered more swiftly than those produced offshore.

Apiject credits the leadership of the White House and ASPR for fostering advanced manufacturing strategies that bolster U.S. public health preparedness. Walker remarked that restoring domestic manufacturing would not only require sound policy decisions but also ongoing technological advancements that make local production viable and resilient.

About Apiject

Apiject Holdings, Inc. positions itself as a leader in healthcare technology, committed to strengthening the domestic pharmaceutical supply chain through advanced drug packaging and delivery systems.

About Vanguard Utility

Vanguard Utility is a subsidiary of Apiject that focuses on producing essential injectable medicines in the U.S. using cutting-edge Blow-Fill-Seal technology. Their headquarters are located in Apex, North Carolina.