Amneal and Apiject to Expand Sterile and Blow-Fill-Seal (BFS) Capabilities for Advanced Pharmaceutical Manufacturing in the U.S.

-Adds BFS platform technology to provide large-scale production capacity for sterile drug dosage forms, including injectables, ophthalmics and inhalation

-Expands Amneal's extensive domestic pharmaceutical manufacturing footprint

BRIDGEWATER, N.J., May 08, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (NASDAQ:AMRX) ("Amneal" or the "Company"), an American biopharmaceutical company, and Apiject Systems, Corp. ("Apiject"), a medical technology company focused on advanced drug delivery, today 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 U.S. pharmaceutical manufacturing footprints in the industry. This collaboration underscores Amneal's commitment to strengthening U.S. drug supply through domestic pharmaceutical manufacturing. Currently, the Company has approximately 2,500 employees in the U.S., 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 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. 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."

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 U.S. 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 U.S. 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 U.S.-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.

About Amneal

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 United States. 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 U.S. federal government, retail, and institutional markets. For more information, please visit www.amneal.com and follow us on LinkedIn.

About Apiject Systems

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.

Cautionary Statement on Forward-Looking Statements

Certain statements contained herein, regarding matters that are not historical facts, may be forward-looking statements (as defined in the U.S. Private Securities Litigation Reform Act of 1995). Such forward-looking statements include statements regarding management's intentions, plans, beliefs, expectations, financial results, or forecasts for the future, including among other things: discussions of future operations; expected or estimated operating results and financial performance; and statements regarding our positioning, including our ability to drive sustainable long-term growth, and other non-historical statements. Words such as "plans," "expects," "will," "anticipates," "estimates," and similar words, or the negatives thereof, are intended to identify estimates and forward-looking statements. The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in the Company's filings with the Securities and Exchange Commission, including under Item 1A, "Risk Factors" in the Company's most recent Annual Report on Form 10-K and in its subsequent reports on Forms 10-Q and 8-K. Forward-looking statements included herein speak only as of the date hereof and we undertake no obligation to revise or update such statements to reflect the occurrence of events or circumstances after the date hereof.

Amneal Investor Contact

Anthony DiMeo

VP, Investor Relations

[email protected]

Amneal Media Contact

Brandon Skop

Sr. Director, Corporate Communications

[email protected]

Apiject Contact

Steven Hofman

[email protected]