The Noramco Group, an integrated North American-based API and drug product supply chain product and services provider, today announced a $25 million investment in its Halo Pharma facility in Whippany, New Jersey, to establish sterile injectable manufacturing capabilities, including ready-to-use, syringe, cartridge, and vial filling. This expansion aims to address critical capacity shortages in the US injectable supply chain and meet the growing demand from pharmaceutical companies seeking reliable domestic sterile manufacturing partners.
The investment includes the installation of a high-speed, state-of-the-art Groninger UFVN FlexFill syringe, cartridge, and vial filling line and a SKAN isolator to enhance production efficiency and regulatory compliance. The new capabilities will allow Halo Pharma to manufacture batches ranging from 5,000 to 250,000 units, with an annual production capacity exceeding 50 million units. The initial container systems will include 0.5 mL, 1 mL long, and 1 mL short syringes, along with 2R vials, all in ready-to-fill formats. Container filling can be performed via peristaltic pump or vacuum. Additional syringe, cartridge, and vial options will be introduced based on demand.
Meeting Industry Needs for Sterile Injectable Manufacturing Products and Services With sterile injectables representing the fastest-growing segment of the pharmaceutical market, demand for commercial and clinical-scale capacity continues to outpace available supply. Many injectable products remain on the FDA’s drug shortage list, exacerbated by the surge in demand for biologics and by the critical needs of the U.S. hospital supply chain. The Noramco Group’s investment will provide branded and generic pharmaceutical companies with a North American-based solution for sterile injectable manufacturing, strengthening the domestic production of critical drugs and reinforcing supply chain security and reliability.
“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.”
Expanding Capabilities While Maintaining Core Expertise
The Whippany facility, which was historically focused on manufacturing oral solid dose (OSD), semi-solid, and liquid formulations for the past 20 years, will undergo significant renovations to support the new sterile filling line while maintaining its primary production capabilities. The sterile line installation will be carried out over the remainder of 2025, with facility upgrades to meet EU Annex 1 compliance for European market access while maintaining rigorous U.S. quality standards.
The new line strengthens the Noramco Group’s offerings, taking advantage of its already established custom API synthesis business, and supporting the production of new chemical entity (NCE) and generic low bioburden APIs for injectable finished products through its Purisys business unit in Athens, GA. Further investments in packaging automation are planned for 2026, ensuring continued advancements in manufacturing efficiency and quality.
To explore how the Noramco Group can support your supply needs from APIs to drug products, visit noramco-group.com. To learn more about the new sterile injectable manufacturing
capabilities at Halo Pharma’s Whippany, NJ facility, please see Noramco Group executives at DCAT Week (March 17-20, 2025) in New York City.
