The Noramco Group Invests $25M in Halo Pharma for Sterile Injectable Expansion

  • The Noramco Group is investing $25 million in its Halo Pharma facility in Whippany, New Jersey, to introduce sterile injectable manufacturing.
  • The expansion includes a high-speed filling line and aims to address U.S. injectable supply shortages, with operations expected to be qualified within 12 months.

The Noramco Group has announced a $25 million investment in its Halo Pharma facility in Whippany, New Jersey, to establish sterile injectable manufacturing capabilities. The expansion will include ready-to-use syringe, cartridge, and vial filling, addressing critical capacity shortages in the U.S. injectable supply chain.

The investment will introduce a Groninger UFVN FlexFill syringe, cartridge, and vial filling line and a SKAN isolator to enhance efficiency and regulatory compliance. The facility will support batch sizes ranging from 5,000 to 250,000 units, with an annual capacity exceeding 50 million units. Initial container systems will include 0.5 mL, 1 mL long, and 1 mL short syringes, along with 2R vials, with additional formats introduced based on demand.

With the rising demand for sterile injectables, particularly due to biologics and hospital supply needs, the U.S. market faces ongoing supply shortages. The Noramco Group’s investment aims to provide a North American-based solution for pharmaceutical companies seeking reliable domestic sterile manufacturing partners.

“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 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.”

The Whippany facility, historically focused on oral solid dose, semi-solid, and liquid formulations, will undergo renovations to support the new sterile filling line while maintaining its existing capabilities. The expansion will also comply with EU Annex 1 regulations, ensuring access to European markets. Future plans include additional investments in packaging automation by 2026 to enhance manufacturing efficiency.

This investment aligns with The Noramco Group’s broader strategy, integrating its custom API synthesis business and leveraging its Purisys business unit for new chemical entity (NCE) and generic low bioburden API production. The sterile injectable expansion reinforces the company’s role in CDMO and contract manufacturing services for pharmaceutical clients.

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