Amneal Pharmaceuticals, Inc. and Apiject Systems, Corp. announced a strategic collaboration today to significantly expand domestic production capabilities for sterile injectable pharmaceuticals using advanced Blow-Fill-Seal (BFS) technology. The partnership will establish new manufacturing lines at Amneal's Brookhaven, New York facility, strengthening the U.S. pharmaceutical supply chain and creating approximately 200 new jobs.
The collaboration aims to produce a range of sterile drug dosage forms, including prefilled injectables, ophthalmics, and inhalation products, with an initial capacity of 250-300 million units annually and potential to scale beyond 400 million units over time.
"This collaboration marks a significant step in expanding our U.S. manufacturing footprint with advanced sterile pharmaceutical capabilities," said Chirag and Chintu Patel, Co-Chief Executive Officers of Amneal Pharmaceuticals. "We continue to invest in advanced pharmaceutical manufacturing in the United States, which reflects our commitment to producing essential and affordable medicines in America for Americans."
Innovative Drug Delivery Technology
Apiject's technology platform integrates two established medical innovations: Blow-Fill-Seal (BFS) manufacturing and precision injection molding of pen-style needle hubs. This combination enables the creation of sterile, single-dose prefilled injectors in a continuous, high-speed process that offers several advantages over traditional glass vials and syringes:
- More scalable production capacity
- Cost-effective manufacturing
- Streamlined supply chain
- Enhanced sustainability profile
Jay Walker, Co-Founder, Executive Chairman and CEO of Apiject, highlighted the mutual benefits: "Our collaboration with Amneal is win, win, win. It provides America with an increased domestic-based capacity to manufacture a new category of prefilled drug delivery devices with supply chain, speed, scalability, and sustainability advantages over traditional offerings."
Strengthening Domestic Pharmaceutical Manufacturing
The partnership represents a significant investment in U.S.-based pharmaceutical manufacturing infrastructure. Amneal currently maintains one of the largest pharmaceutical manufacturing footprints in the United States, with approximately 2,500 U.S. employees, the majority focused on operations, quality, and R&D.
The Brookhaven facility already employs approximately 800 workers, with the new project expected to add 200 high-quality jobs. The dedicated manufacturing lines will support both Apiject's proprietary delivery systems and Amneal's growing injectable portfolio.
Government Support and Emergency Preparedness
Apiject's technology platform was developed partly through a $180 million investment from the U.S. Department of Health and Human Services (HHS), Administration for Strategic Preparedness and Response (ASPR). This funding, provided during President Trump's administration, aimed to accelerate the development of U.S.-based, high-speed pharmaceutical manufacturing capacity.
Under its agreement with HHS-ASPR, Apiject successfully delivered domestic fill-finish capacity that served as a backup during the pandemic in case of critical supply disruptions for traditional injection materials.
Applications and Future Development
The BFS platform's speed, efficiency, and compact supply chain make it particularly well-suited for:
- Commercial pharmaceutical production
- Public health campaigns requiring large-scale vaccination
- Emergency response scenarios
- Domestic pharmaceutical security
Beyond the initial manufacturing capabilities, Amneal and Apiject will collaborate on developing additional injectable product programs utilizing the BFS platform, potentially expanding the range of medications that can benefit from this innovative delivery system.
"We believe the country has an opportunity to build a more resilient U.S. pharmaceutical supply chain and to onshore critical drug production, and we are eager to lead the charge," added the Patel brothers.
This strategic partnership represents a significant advancement in domestic pharmaceutical manufacturing capabilities, addressing vulnerabilities in the U.S. supply chain while introducing innovative drug delivery technology that could improve efficiency and accessibility across multiple therapeutic areas.
