Amneal & Apiject to Expand Sterile & Blow-Fill-Seal Capabilities for Advanced Pharmaceutical Manufacturing in the US

Amneal Pharmaceuticals, Inc. and Apiject Systems, Corp. recently announced a strategic collaboration to expand domestic production of Apiject’s BFS-based injectable platform at Amneal’s Brookhaven, NY facility. The collaboration will enable large-scale capacity to produce a range of sterile drug dosage forms, including prefilled injectables, ophthalmics, and inhalation.

Today, Amneal has one of the largest US pharmaceutical manufacturing footprints in the industry. This collaboration underscores Amneal’s commitment to strengthening US drug supply through domestic pharmaceutical manufacturing. Currently, the company has approximately 2,500 employees in the US, with the majority focused on operations, quality, and R&D. At the Brookhaven, NY, facility, Amneal has approximately 800 employees and this project is expected to create approximately 200 high-quality jobs.

“This collaboration marks a significant step in expanding our US 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 US, 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 US pharmaceutical supply chain and to onshore critical drug production, and we are eager to lead the charge.”

Amneal will install dedicated manufacturing lines to support Apiject’s proprietary delivery systems across government and commercial programs, including applications for emergency preparedness and reshoring domestic pharmaceutical manufacturing, as well as Amneal’s growing injectable portfolio. The new infrastructure is expected to have capacity to produce approximately 250 to 300 million units annually, with potential to scale to more than 400 million units over time. In addition, Amneal and Apiject will collaborate on the development of additional injectable product programs utilizing Apiject’s BFS platform.

Jay Walker, Co-Founder, Executive Chairman and CEO of Apiject, said “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 US and global market.”

Apiject’s technology integrates two proven 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—offering a more scalable, cost-effective, and efficient alternative to traditional glass vials and syringes. The platform’s speed, efficiency, and compact supply chain make it particularly well-suited for commercial use, public health campaigns, and emergency response.

Apiject’s underlying technology was developed, in part, through a $180 million investment by the US Department of Health and Human Services (HHS), Administration for Strategic Preparedness and Response (ASPR) during President Trump’s first term in office. The project highlights the Trump Administration’s commitment to accelerate the building of new US-based, high-speed, population-scale capacity for pharmaceutical manufacturing.

Under the agreement with HHS-ASPR, Apiject delivered on-time and on-budget a domestic fill-finish capacity that served as a backup in the event of critical supply disruptions for traditional injection materials during the pandemic.

Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX), headquartered in Bridgewater, NJ, is a global biopharmaceutical company. We make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of over 280 pharmaceuticals, primarily within the US. In its Affordable Medicines segment, the company is expanding across a broad range of complex product categories and therapeutic areas, including injectables and biosimilars. In its Specialty segment, Amneal has a growing portfolio of branded pharmaceuticals focused primarily on central nervous system and endocrine disorders. Through its AvKARE segment, the Company is a distributor of pharmaceuticals and other products for the US federal government, retail, and institutional markets. For more information, visit www.amneal.com.

Apiject Systems, Corp. is a public-benefit medical technology company that has pioneered a new category of prefilled injection devices with economic, supply chain, and sustainability advantages over traditional offerings. Our mission is to make the safety and performance benefits of prefilled injections affordable and available for most, if not all, injections around the world. The company’s technology platform is anchored by a well-established manufacturing process called Blow-Fill-Seal (BFS). BFS is a widely used sterile liquid packaging technology that has been recognized by the FDA as an advanced aseptic process. For more information, visit www.apiject.com.