Noramco Invests $25M in Halo Pharma’s Whippany Facility for Sterile Injectable Manufacturing

Noramco Invests $25M in Halo Pharma’s Whippany Facility for Sterile Injectable Manufacturing

The Noramco Group, a North American provider of integrated API and drug product supply chain services, has announced a $25 million investment in its Halo Pharma facility in Whippany, New Jersey. This investment will enable the facility to offer sterile injectable manufacturing capabilities, including ready-to-use syringe, cartridge, and vial filling. The expansion is designed to help alleviate critical capacity shortages in the U.S. injectable supply chain and meet the increasing demand from pharmaceutical companies seeking reliable, domestic sterile manufacturing partners.

The Noramco Group, a prominent North American provider of integrated supply chain solutions for active pharmaceutical ingredients (APIs) and drug products, has announced a significant $25 million investment in its Halo Pharma facility in Whippany, New Jersey. This investment will focus on the establishment of sterile injectable manufacturing capabilities, marking a strategic expansion for the company. The new infrastructure will include a high-speed, state-of-the-art Groninger UFVN FlexFill syringe, cartridge, and vial filling line, complemented by a SKAN isolator, to enhance both production efficiency and regulatory compliance.

This cutting-edge addition will enable the Halo Pharma facility to manufacture batches ranging from 5,000 to 250,000 units, with an annual production capacity exceeding 50 million units. The initial container systems available for production will include 0.5 mL, 1 mL long, and 1 mL short syringes, as well as 2R vials, all in ready-to-fill formats. The container filling process can be conducted using either peristaltic pumps or vacuum technology, offering flexibility to meet varying customer needs. The company plans to introduce additional syringe, cartridge, and vial options as market demand increases, ensuring a broad range of products to accommodate diverse customer requirements.

Addressing Critical Industry Needs

The sterile injectable market represents one of the fastest-growing segments of the global pharmaceutical industry, driven by the increasing demand for biologics and injectable drugs. However, capacity for both commercial and clinical-scale manufacturing of sterile injectables has struggled to keep up with this rapid growth, creating a significant gap in supply. As a result, many injectable products remain on the FDA’s drug shortage list, contributing to ongoing challenges in the U.S. hospital supply chain.

The Noramco Group’s new investment aims to alleviate some of these pressures by offering a domestic solution for sterile injectable manufacturing, ensuring a reliable, North American-based source for both branded and generic pharmaceutical companies. This expansion will not only help meet the growing demand for injectable products but also strengthen the domestic production of critical drugs, enhancing overall supply chain security and reliability.

Lee Karras, CEO of The Noramco Group, commented on the strategic importance of the investment, saying, “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. 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.”

Karras further emphasized that while the new sterile manufacturing capabilities will add to the company’s offerings, Noramco remains committed to its core expertise in the production of APIs, oral solid doses, and liquid dosage forms—areas that continue to be essential to meet customer needs.

Expanding Capabilities Without Compromising Core Operations

The Whippany facility, which has historically focused on manufacturing oral solid dose (OSD), semi-solid, and liquid formulations, will undergo significant renovations to accommodate the new sterile injectable production line. These upgrades are designed to enhance the facility’s manufacturing capabilities while maintaining the plant’s primary production functions. The sterile filling line installation is expected to take place over the remainder of 2025, with the facility undergoing further improvements to meet EU Annex 1 compliance, ensuring access to the European market while adhering to rigorous U.S. quality standards.

The investment in sterile injectable manufacturing at Halo Pharma will strengthen The Noramco Group’s overall offering by building on its established custom API synthesis business. It will also support the production of new chemical entity (NCE) and generic low bioburden APIs for injectable finished products through the company’s Purisys business unit, based in Athens, Georgia. Looking ahead, Noramco plans additional investments in packaging automation, scheduled for 2026, further advancing the company’s manufacturing efficiency and quality standards.

This expansion aligns with Noramco’s broader strategy to offer end-to-end solutions for customers in the pharmaceutical industry, from clinical development to commercial manufacturing of both APIs and drug products.

Future Plans and Industry Engagement

Noramco will be showcasing its new sterile injectable manufacturing capabilities at DCAT Week in New York City from March 17-20, 2025, where executives will be available to discuss the new advancements and how they can support pharmaceutical supply needs.

For more information about how The Noramco Group can assist with pharmaceutical manufacturing and supply chain solutions, including their full range of API and drug product services, visit their website at noramco-group.com.

About The Noramco Group

The Noramco Group offers a comprehensive, integrated supply chain solution for APIs and drug products across North America. Through its subsidiaries—Noramco, Purisys, and Halo Pharma—the group provides end-to-end services ranging from clinical development to commercial manufacturing of APIs and drug products. Noramco, located in Wilmington, Delaware, supplies commercial APIs worldwide, supporting medical treatments in areas like pain management and drug abuse treatment. Purisys, based in Athens, Georgia, focuses on specialized clinical API development and manufacturing services, particularly for controlled substances and pharmaceutical reference standards. Halo Pharma operates in Whippany, New Jersey, and Montreal, Quebec, providing contract development and manufacturing services (CDMO) across a wide array of dosage forms for both branded and generic pharmaceutical companies.

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