The Noramco Group announced a $25 million investment in its Halo Pharma facility in Whippany, New Jersey, to establish sterile injectable manufacturing capabilities. The investment, revealed on March 10, 2025, aims to address what the company describes as "critical capacity shortages" in the U.S. injectable supply chain.
The expansion will add ready-to-use syringe, cartridge, and vial filling capabilities to the facility, which has historically focused on oral solid dose, semi-solid, and liquid formulation manufacturing for the past two decades. The new manufacturing line is expected to be qualified and operational within the next 12 months.
"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."
Technical Specifications and Manufacturing Capacity
The investment includes 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.
Initially, the facility will support 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, with additional syringe, cartridge, and vial options planned based on market demand.
Addressing Market Needs and Supply Chain Vulnerabilities
The expansion comes at a critical time for the pharmaceutical industry, with sterile injectables representing the fastest-growing segment of the pharmaceutical market. Demand for both commercial and clinical-scale capacity continues to outpace available supply, with many injectable products remaining on the FDA's drug shortage list.
This shortage has been exacerbated by the surge in demand for biologics and critical needs within the U.S. hospital supply chain. The Noramco Group's investment aims to provide branded and generic pharmaceutical companies with a North American-based solution for sterile injectable manufacturing, strengthening domestic production of critical drugs.
Facility Upgrades and Regulatory Compliance
The Whippany facility will undergo significant renovations to support the new sterile filling line while maintaining its primary production capabilities. The installation will be carried out over the remainder of 2025, with facility upgrades designed to meet EU Annex 1 compliance for European market access while maintaining rigorous U.S. quality standards.
Karras emphasized that while this investment enhances the company's capabilities with contemporary technologies, The Noramco Group remains committed to its established focus on manufacturing APIs, oral solid dose, and liquid dosage forms.
Integrated Supply Chain Approach
The new sterile manufacturing capabilities strengthen The Noramco Group's position as an integrated supply chain solution provider. The expansion leverages the company's established custom API synthesis business and supports the production of new chemical entity (NCE) and generic low bioburden APIs for injectable finished products through its Purisys business unit in Athens, Georgia.
Further investments in packaging automation are planned for 2026, ensuring continued advancements in manufacturing efficiency and quality.
Company Background
The announcement comes just days before the one-year anniversary of the launch of The Noramco Group, which was established on March 14, 2024, as the umbrella organization for Noramco's API manufacturing business and its subsidiaries Purisys and Halo Pharma.
Halo Pharma, which Noramco acquired in November 2023 (formerly Cambrex Drug Product Business Unit), operates facilities in both Whippany, New Jersey, and Montreal, Quebec. The Noramco Group, based in Wilmington, Delaware, provides end-to-end services from clinical development to commercial manufacturing of APIs and drug products.
The company will be showcasing its new sterile injectable manufacturing capabilities at the upcoming 2025 Drug, Chemical & Associated Technologies Association (DCAT) Week, to be held from March 17-20 in New York City.
