Amneal and Apiject to Expand Sterile and Blow-Fill-Seal (BFS) Capabilities for Advanced Pharmaceutical Manufacturing in the U.S.
Amneal Pharmaceuticals (NASDAQ: AMRX) and Apiject Systems have announced a strategic collaboration to expand domestic production of Apiject's Blow-Fill-Seal (BFS) injectable platform at Amneal's Brookhaven, NY facility. The partnership will create approximately 200 new jobs and enable production capacity of 250-300 million units annually, scalable to over 400 million units.
The collaboration integrates BFS manufacturing with precision injection molding of pen-style needle hubs, creating sterile, single-dose, prefilled injectors. This technology, partially developed through a $180 million investment from HHS, offers a more efficient alternative to traditional glass vials and syringes. The project will enhance Amneal's U.S. manufacturing capabilities for sterile drug dosage forms, including injectables, ophthalmics, and inhalation products.
Amneal Pharmaceuticals (NASDAQ: AMRX) e Apiject Systems hanno annunciato una collaborazione strategica per ampliare la produzione nazionale della piattaforma iniettabile Blow-Fill-Seal (BFS) di Apiject presso lo stabilimento Amneal di Brookhaven, NY. La partnership creerà circa 200 nuovi posti di lavoro e consentirà una capacità produttiva di 250-300 milioni di unità all'anno, espandibile oltre i 400 milioni di unità.
La collaborazione integra la produzione BFS con lo stampaggio a iniezione di precisione di hub ago a penna, creando iniettori sterili, monodose e pre-riempiti. Questa tecnologia, sviluppata in parte grazie a un investimento di 180 milioni di dollari dal Dipartimento della Salute e dei Servizi Umani (HHS), rappresenta un'alternativa più efficiente rispetto ai tradizionali flaconi di vetro e siringhe. Il progetto potenzierà le capacità produttive statunitensi di Amneal per forme farmaceutiche sterili, inclusi iniettabili, prodotti oftalmici e per inalazione.
Amneal Pharmaceuticals (NASDAQ: AMRX) y Apiject Systems han anunciado una colaboración estratégica para ampliar la producción nacional de la plataforma inyectable Blow-Fill-Seal (BFS) de Apiject en la instalación de Amneal en Brookhaven, NY. La asociación creará aproximadamente 200 nuevos empleos y permitirá una capacidad de producción de 250-300 millones de unidades anuales, escalable a más de 400 millones de unidades.
La colaboración integra la fabricación BFS con el moldeo por inyección de precisión de núcleos de aguja tipo bolígrafo, creando inyectores estériles, monodosis y prellenados. Esta tecnología, desarrollada en parte gracias a una inversión de 180 millones de dólares del Departamento de Salud y Servicios Humanos (HHS), ofrece una alternativa más eficiente a los frascos de vidrio y jeringas tradicionales. El proyecto mejorará las capacidades de fabricación de Amneal en EE.UU. para formas farmacéuticas estériles, incluyendo inyectables, oftálmicos y productos para inhalación.
Amneal Pharmaceuticals (NASDAQ: AMRX)와 Apiject Systems는 뉴욕 브루클헤이븐에 위치한 Amneal 시설에서 Apiject의 Blow-Fill-Seal(BFS) 주사 플랫폼의 국내 생산을 확대하기 위한 전략적 협력을 발표했습니다. 이번 파트너십을 통해 약 200개의 신규 일자리가 창출되며 연간 2억 5천만~3억 개의 생산 능력이 확보되고 4억 개 이상으로 확장 가능합니다.
이번 협력은 BFS 제조와 펜 스타일 주사 바늘 허브의 정밀 사출 성형을 결합하여 무균, 단회용, 사전 충전 주사기를 만듭니다. 이 기술은 미국 보건복지부(HHS)의 1억 8천만 달러 투자를 일부 기반으로 개발되었으며 전통적인 유리 바이알과 주사기에 비해 효율적인 대안입니다. 이 프로젝트는 Amneal의 미국 내 무균 약물 투여 형태, 주사제, 안과용 및 흡입 제품 제조 역량을 강화할 것입니다.
Amneal Pharmaceuticals (NASDAQ : AMRX) et Apiject Systems ont annoncé une collaboration stratégique pour étendre la production nationale de la plateforme injectable Blow-Fill-Seal (BFS) d'Apiject dans l'usine d'Amneal à Brookhaven, NY. Ce partenariat créera environ 200 nouveaux emplois et permettra une capacité de production de 250 à 300 millions d'unités par an, extensible à plus de 400 millions d'unités.
La collaboration intègre la fabrication BFS avec le moulage par injection de précision des embouts d'aiguilles de type stylo, créant des injecteurs stériles, monodoses et préremplis. Cette technologie, partiellement développée grâce à un investissement de 180 millions de dollars du Département de la Santé et des Services sociaux (HHS), offre une alternative plus efficace aux flacons en verre et seringues traditionnels. Le projet renforcera les capacités de fabrication américaines d'Amneal pour les formes pharmaceutiques stériles, y compris les injectables, les produits ophtalmiques et les inhalateurs.
Amneal Pharmaceuticals (NASDAQ: AMRX) und Apiject Systems haben eine strategische Zusammenarbeit angekündigt, um die inländische Produktion der Blow-Fill-Seal (BFS) Injektionsplattform von Apiject in der Amneal-Anlage in Brookhaven, NY, auszubauen. Die Partnerschaft wird etwa 200 neue Arbeitsplätze schaffen und eine Produktionskapazität von 250-300 Millionen Einheiten pro Jahr ermöglichen, die auf über 400 Millionen Einheiten skalierbar ist.
Die Zusammenarbeit integriert die BFS-Herstellung mit der Präzisionsspritzgussfertigung von penförmigen Nadelköpfen und schafft sterile, einzeldosierte, vorgefüllte Injektoren. Diese Technologie, teilweise durch eine Investition von 180 Millionen US-Dollar des Gesundheitsministeriums (HHS) entwickelt, bietet eine effizientere Alternative zu herkömmlichen Glasfläschchen und Spritzen. Das Projekt wird die US-amerikanischen Fertigungskapazitäten von Amneal für sterile Arzneiformen, einschließlich Injektions-, Augen- und Inhalationsprodukte, verbessern.
- Creation of 200 new high-quality jobs at the Brookhaven facility
- Large production capacity of 250-300 million units annually, scalable to 400+ million units
- Expansion of domestic manufacturing capabilities for critical drug production
- Integration of advanced BFS technology for more efficient drug delivery systems
- Strategic partnership backed by $180 million HHS investment
- None.
Insights
Amneal's partnership with Apiject brings advanced BFS technology to U.S. manufacturing, expanding domestic sterile production capacity and technological capabilities.
The Amneal-Apiject collaboration marks a significant advancement in Amneal's manufacturing strategy by integrating Blow-Fill-Seal (BFS) technology with precision injection molding for prefilled injectable delivery systems. This strategic expansion addresses several critical market dynamics:
First, the domestic manufacturing expansion improves supply chain resilience - a critical factor given recent global disruptions that exposed vulnerabilities in pharmaceutical supply chains. By establishing BFS capacity at Brookhaven, Amneal positions itself to meet increasing demand for U.S.-manufactured sterile pharmaceuticals.
The technology combination offers significant operational advantages over traditional filling processes. BFS systems typically reduce contamination risk through fewer human interventions while enabling faster production cycles and lower per-unit costs at scale. These efficiencies could provide Amneal with cost advantages in competitive sterile product markets.
The planned capacity of 250-300 million units annually (expandable to 400+ million) represents substantial volume, suggesting Amneal anticipates significant demand for these delivery systems. The addition of approximately 200 high-quality jobs indicates the material scale of this expansion.
Apiject's technology validation through prior
For Amneal, this collaboration complements their existing injectable portfolio while opening potential new market opportunities in prefilled drug delivery systems. The partnership structure allows Amneal to leverage Apiject's specialized technology without developing it independently.
This expansion represents a forward-looking investment in advanced pharmaceutical manufacturing that aligns with broader industry trends toward more efficient, flexible, and domestically-secured production capacity.
-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
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
anthony.dimeo@amneal.com
Amneal Media Contact
Brandon Skop
Sr. Director, Corporate Communications
brandon.skop@amneal.com
Apiject Contact
Steven Hofman
shofman@ext.apiject.com
FAQ
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