Amneal And Apiject Partner To Expand Sterile & Blow-Fill-Seal (BFS) Capabilities For Advanced U.S. Pharmaceutical Manufacturing

Amneal Pharmaceuticals, Inc., an American biopharmaceutical company, and Apiject Systems, Corp., a medical technology firm focused on advanced drug delivery, have announced a strategic collaboration to enhance domestic production of Apiject’s Blow-Fill-Seal (BFS)-based injectable platform at Amneal’s Brookhaven, NY manufacturing facility. This collaboration will allow for large-scale production of a variety of sterile drug dosage forms, including prefilled injectables, ophthalmics, and inhalation treatments.

Amneal, which already boasts one of the largest U.S. pharmaceutical manufacturing operations in the industry, is committed to strengthening the U.S. drug supply by expanding its domestic manufacturing capabilities. The company currently employs approximately 2,500 people in the U.S., with a significant portion dedicated to operations, quality control, and R\&D. The Brookhaven facility alone employs around 800 individuals, and this new project is expected to create approximately 200 additional high-quality jobs.

As part of the collaboration, Amneal will install dedicated manufacturing lines to support Apiject’s proprietary delivery systems for government and commercial programs. These include applications for emergency preparedness, reshoring domestic pharmaceutical manufacturing, and expanding Amneal’s injectable product portfolio. The new infrastructure is expected to produce approximately 250 to 300 million units annually, with the potential to scale up to more than 400 million units over time. Amneal and Apiject will also work together to develop additional injectable product programs using Apiject’s BFS platform.

Apiject’s BFS technology combines two established medical innovations: Blow-Fill-Seal (BFS) manufacturing and precision injection molding of pen-style needle hubs. This combination enables the production of sterile, single-dose, prefilled injectors in a continuous, high-speed process, offering a more scalable, cost-effective, and efficient alternative to traditional glass vials and syringes. The BFS platform’s speed, efficiency, and compact supply chain make it an ideal solution for commercial use, public health campaigns, and emergency response.

Chirag and Chintu Patel, Co-Chief Executive Officers of Amneal Pharmaceuticals, said in a statement, “This collaboration marks a significant step in expanding our U.S. manufacturing footprint with advanced sterile pharmaceutical capabilities. 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. 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.”

Jay Walker, Co-Founder, Executive Chairman and CEO of Apiject, mentioned, “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. It provides Amneal increased manufacturing options to serve its current and future commercial customers. And it provides Apiject a trusted company to bring a wide range of critical injectable drugs to the U.S. and global market.”

The technology behind Apiject’s platform was partially developed through a $180 million investment from the U.S. Department of Health and Human Services (HHS), under the Administration for Strategic Preparedness and Response (ASPR) during President Trump’s first term. This initiative was part of the government’s effort to build high-speed, U.S.-based pharmaceutical manufacturing capacity to address potential supply disruptions during public health emergencies. Under its agreement with HHS-ASPR, Apiject delivered domestic fill-finish capacity, which served as a backup during the pandemic to ensure the availability of critical injection materials.