Noramco Group Invests $25M in Halo Pharma for Sterile Injectables
The Noramco Group Invests $25 Million in Halo Pharma’s Whippany Facility to Establish Sterile Injectable Manufacturing
The Noramco Group, a fully integrated North American-based supplier of active pharmaceutical ingredients (APIs) and drug product solutions, has announced a significant $25 million investment in its Halo Pharma facility in Whippany, New Jersey. This investment will establish new sterile injectable manufacturing capabilities, including ready-to-use syringe, cartridge, and vial filling. The expansion is expected to address the pressing need for increased capacity in the U.S. sterile injectable supply chain while providing pharmaceutical companies with a reliable, domestic manufacturing partner.
Addressing Critical Capacity Shortages in the U.S. Injectable Market
The U.S. pharmaceutical industry is experiencing a growing demand for sterile injectables, driven by the increasing use of biologics, critical hospital medicines, and specialty treatments. However, manufacturing capacity remains limited, contributing to persistent drug shortages. The Noramco Group’s investment in Halo Pharma aims to alleviate some of these challenges by expanding domestic production and offering pharmaceutical companies a scalable and efficient solution for sterile injectable drug manufacturing.
The new capabilities at the Whippany facility will support the manufacturing of a broad range of injectable products, reinforcing supply chain security and ensuring a more stable supply of essential medicines.
Cutting-Edge Manufacturing Technology and Capacity Expansion
A major component of this investment is the installation of state-of-the-art equipment to enhance production efficiency and regulatory compliance. The expansion will include the implementation of a high-speed Groninger UFVN FlexFill syringe, cartridge, and vial filling line, as well as a SKAN isolator system. These advancements will enable Halo Pharma to:
- Manufacture batch sizes ranging from 5,000 to 250,000 units
- Achieve an annual production capacity exceeding 50 million units
- Offer filling capabilities for 0.5 mL, 1 mL long, and 1 mL short syringes, as well as 2R vials, all in ready-to-fill formats
- Utilize peristaltic pump and vacuum filling technologies to accommodate various formulations
As market demand evolves, Halo Pharma plans to introduce additional syringe, cartridge, and vial formats, ensuring flexibility and adaptability to meet the needs of pharmaceutical clients.
Meeting the Needs of Branded and Generic Pharmaceutical Companies
The sterile injectable segment is the fastest-growing sector within the pharmaceutical industry, but it continues to face supply shortages and manufacturing bottlenecks. Many injectable products remain on the FDA’s drug shortage list, and the need for domestic production has become more urgent than ever. By investing in sterile injectable manufacturing, The Noramco Group aims to fill these critical gaps, supporting both branded and generic drug manufacturers.
“This investment is a significant step in our commitment to build on our position as one of the only fully integrated domestic supply options for our customers,” said Lee Karras, CEO of The Noramco Group. “We recognize the challenges facing the industry and are dedicated to providing solutions that address both immediate and long-term supply chain needs. We anticipate the new line to be qualified and operational within the next 12 months, ensuring we can support customers with the high-quality capacity they require. While this investment enhances our capabilities with contemporary technologies, with the addition of sterile manufacturing we remain committed to our already established and proven focus on manufacturing APIs, oral solid dose, and liquid dosage forms, which continue to be essential in meeting our customers’ needs.”
Maintaining Core Competencies While Expanding into Sterile Manufacturing
The Whippany facility has been a cornerstone of Halo Pharma’s operations for over 20 years, primarily focused on the production of oral solid dose (OSD), semi-solid, and liquid formulations. While the new investment will support the transition into sterile injectable manufacturing, the facility will maintain its existing capabilities, ensuring uninterrupted service to current clients.
In preparation for the expansion, the facility will undergo significant renovations throughout 2025, including upgrades to meet EU Annex 1 compliance standards for access to the European market while maintaining stringent U.S. FDA quality standards. The modifications will ensure that Halo Pharma can cater to both domestic and international clients, reinforcing its position as a global leader in pharmaceutical manufacturing.
Leveraging Synergies Across The Noramco Group
This expansion aligns with The Noramco Group’s broader strategy to provide end-to-end pharmaceutical manufacturing solutions. The company’s Purisys business unit in Athens, GA, specializes in the production of new chemical entity (NCE) and generic low bioburden APIs for injectable finished products. By integrating sterile injectable manufacturing at Halo Pharma, The Noramco Group can now offer a seamless supply chain solution, covering everything from API synthesis to final drug product manufacturing.
Looking ahead, The Noramco Group is also planning additional investments in packaging automation in 2026, further enhancing efficiency, quality, and scalability.
Strategic Impact on the Pharmaceutical Industry
The Noramco Group’s investment in sterile injectable manufacturing is expected to have a profound impact on the pharmaceutical industry by:
- Reducing reliance on overseas manufacturing: By strengthening North American production capabilities, The Noramco Group can help mitigate the risks associated with global supply chain disruptions.
- Improving drug availability: The expansion will directly address drug shortages and support the continued growth of the sterile injectable sector.
- Enhancing regulatory compliance: The investment ensures that all manufacturing processes adhere to the highest standards of safety and quality, meeting both U.S. and European regulatory requirements.
- Supporting innovation in biologics and specialty injectables: As the demand for biologics and specialty pharmaceuticals increases, Halo Pharma will be well-positioned to provide critical manufacturing solutions for these complex drug products.
Join The Noramco Group at DCAT Week 2025
To learn more about The Noramco Group’s new sterile injectable manufacturing capabilities and how they can support your pharmaceutical supply needs, visit www.noramco-group.com. Additionally, The Noramco Group’s executives will be available at DCAT Week (March 17-20, 2025) in New York City to discuss this expansion and explore potential partnerships with pharmaceutical companies looking for high-quality sterile manufacturing solutions.
