STAMFORD, CT, September 25, 2025 — Apiject Systems, Corp., a leading medical technology innovator, submitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the world’s first injectable medicine using Apiject’s prefilled single-use plastic syringe. This milestone marks a major step in advancing scalable, sustainable, and affordable drug delivery systems globally.
Science Significance
The Apiject device integrates Blow-Fill-Seal (BFS) liquid packaging technology with precision injection molding of pen-style needle hubs, creating a new category of prefilled drug delivery systems. This combination ensures high-speed, continuous manufacturing, which is critical for reducing contamination risks and improving reproducibility.
BFS, recognized by the FDA in 2004 as an advanced aseptic process, is highly flexible in container design and size. The technology accommodates diverse medical applications, including injections, inhalants, and sterile liquids. Apiject’s prefilled platform is designed to simplify production, lower costs, and minimize supply chain complexity, offering significant advantages over traditional glass vials and syringes.
Regulatory Significance
The NDA submission for Glycopyrrolate marks Apiject’s first regulatory filing leveraging its innovative device platform. Glycopyrrolate, indicated for reducing gastric acid in adults with peptic ulcer, serves as the initial drug for this first-of-its-kind device.
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The FDA submission aligns with current guidance on sterile drug products produced by aseptic processing, reinforcing Apiject’s commitment to quality, safety, and compliance. The device is drug-agnostic, paving the way for future combination product filings, expanding potential applications across multiple therapeutic areas.
Business Significance
Apiject’s platform addresses global demand for injectable medicines, which continues to grow at a double-digit pace. The BFS-based system reduces manufacturing costs, carbon output, and complexity while enabling rapid domestic production.
Through a strategic collaboration with Amneal Pharmaceuticals, Apiject is expanding its U.S.-based production, ensuring scalable commercial supply for Glycopyrrolate and future products. Additionally, the device platform benefits from public-private partnerships, including approximately $181 million in contracts from HHS-ASPR and U.S. Department of Defense support, highlighting its potential to meet national emergency preparedness goals.
Patients’ Significance
Apiject’s prefilled syringe is designed for single-use and single-dose administration, minimizing the risk of cross-contamination and errors in clinical settings. The simplified workflow allows healthcare professionals to assemble and administer injections efficiently, reducing time and improving patient safety.
By enabling a more affordable and widely available alternative to glass vials, the device has the potential to increase patient access to essential injectable medicines globally. The platform also supports applications such as nasal delivery of Naloxone for opioid overdose and other high-need therapies.
Policy Significance
The Apiject platform addresses critical public health and national security priorities by reducing reliance on foreign suppliers for injectable drug manufacturing. Its domestic, scalable production capabilities align with federal initiatives to enhance healthcare resilience, emergency preparedness, and sustainable manufacturing.
The technology demonstrates the benefits of public-private collaboration, combining government funding with private sector innovation to improve national and global health infrastructure.
Transaction Highlights
Apiject’s NDA submission represents the culmination of five years of intensive R&D and strategic development, integrating Blow-Fill-Seal technology with precision injection molding to create a scalable, prefilled drug delivery system. The company has established strategic collaborations with Amneal Pharmaceuticals to expand domestic production capacity, ensuring commercial readiness for Glycopyrrolate and future drugs. Previously, Apiject partnered with HHS-ASPR and the U.S. Department of Defense, delivering emergency fill-finish capacity and demonstrating the platform’s reliability for public health emergencies. Supported by a combination of public and private funding, this milestone reflects Apiject’s ability to advance innovative medical technologies while reducing supply chain risks, lowering costs, and meeting both national and global healthcare demands.
Source: ApiJect Systems, Corp. Press Release
