Apiject Systems Corp. announced the submission of its New Drug Application (NDA) to the Food and Drug Administration for regulatory approval of the world's first injectable medicine to use the company's single-dose, single-use prefilled plastic syringe. The submission centers on glycopyrrolate delivered through Apiject's innovative injection device, marking a potential breakthrough in drug delivery technology.
Revolutionary Manufacturing Platform
The NDA submission features a drug delivery development platform that integrates two proven medical technologies: Blow-Fill-Seal (BFS) liquid packaging technology and precision injection molding of pen-style needle hubs. This combination enables the creation of a new category of prefilled drug delivery devices that are more scalable and affordable than traditional glass vials and prefilled syringes.
"Today's submission is an exciting and significant step forward for Apiject," said Jay Walker, Co-Founder, Executive Chairman and CEO of Apiject. "We have spent the last 5 years preparing BFS to play a central role in the future of drug delivery, because it meets the needs of the new challenges of today's healthcare realities."
The BFS technology operates as a continuous manufacturing process at high-speed and relies on a single raw material that is available domestically. The FDA formally recognized BFS as an advanced aseptic process in 2004, defining it as an "automated process by which containers are formed, filled, and sealed in a continuous operation" in its guidance document on sterile drug products.
Significant Manufacturing Advantages
The Apiject system offers substantial improvements over conventional manufacturing approaches. Manufacturing the Apiject device creates less than half the carbon output of a glass vial and syringe, and uses less plastic than traditional syringes. The system reduces costs, complexity, and supply chain risks compared to the multi-step, multi-factory process of making and filling glass drug containers.
Walker emphasized the broader implications: "Simplified manufacturing, compact supply chains, flexible production that can scale quickly, reduced foreign dependencies, lower carbon output, and more affordable prefilled solutions are what the U.S. and the world needs right now – for commercial use, public health campaigns, and emergency response."
Government Partnership and Strategic Development
Apiject's underlying technology was developed through an Other Transaction Agreement and Contract worth approximately $181 million from the U.S. Department of Health and Human Services (HHS), Administration for Strategic Preparedness and Response (ASPR) during President Trump's first term. The project represents America's commitment to building new U.S.-based, high-speed, population-scale pharmaceutical manufacturing capacity that reduces dependence on foreign suppliers, particularly China and India.
Under the HHS-ASPR agreement, with contract management support from the U.S. Department of Defense, Apiject delivered emergency domestic fill-finish capacity on-time and on-budget. The development has been supported by equal private sector investment, creating a true public-private partnership.
Clinical Application and Future Pipeline
Glycopyrrolate is indicated for use in adults as adjunctive therapy for the treatment of peptic ulcer by reducing acid production. The Apiject device is designed to be drug agnostic, with this NDA representing the first of future combination product filings leveraging the Apiject system currently in development.
Dr. Molly Weaver, Chief Operating Officer and NDA Project Leader, noted: "Almost five years of intensive R&D has prepared BFS – drug containers, devices, process equipment – to play a critical role in Apiject's innovative platform across all major routes of injectable drug administration."
The company's innovation team is led by Apiject co-founder Marc Koska, inventor of the K-1 auto-disabled syringe credited with saving millions of lives globally. Other projects in development include a nasal delivery device filled with naloxone to treat opioid overdoses from fentanyl exposure.
Manufacturing Expansion
Apiject recently announced a strategic collaboration with Amneal Pharmaceuticals to expand domestic production of its BFS-based injectable platform at Amneal's Brookhaven, New York facility. The simple, lightweight and sterile BFS Container and Needle Hub with Connector are designed for easy push-assembly by healthcare professionals just prior to patient injection.
The BFS technology demonstrates high flexibility in container design and sizes to accommodate various medical applications including eye drops, ear drops, nasal drops, wound care and sterile water, with expansion planned for inhalants and infusions.
