North American API product and services provider Noramco has invested $25m into the sterile injectable manufacturing capabilities of its facility in Whippany, New Jersey.
The Halo Pharma facility, which has historically manufactured oral solid dosage (OSD) forms, can now handle ready-to-use (RTU), syringe, cartridge and vial filling capabilities — addressing current shortfalls in the US injectable supply chain.
This follows the Trump Administration's threats to impose tariffs on pharmaceutical imports.
Through this investment, the Noramco Group will install a high-speed Groninger UFVN FlexFill filling line with a SKAN isolator, which should enhance production efficiency while ensuring regulatory compliance.
With the new filling line, Halo Pharma will be capable of manufacturing batches up to 250,000 units; meaning the site's annual production capacity will exceed 50 million units.
Currently, the container systems will include 0.5 mL syringes, as well as long & short 1 mL iterations and 2R vials.
Filling can currently be performed by peristaltic pump or vacuum, and additional packaging formats can be introduced depending on demand.
Combatting US injectable shortages
Sterile injectables are currently the fastest growing segment of the pharmaceutical market, though according to Noramco, demand current outpaces available supply.
With many injectables currently sitting on the FDA's drug shortage list, the Noramco Group hopes to provide both branded and generic pharmaceutical companies with a North American-based manufacturing partner.
“Through this investment, we want to build on our position as one of the only fully integrated domestic supply options for our customers," notes CEO of the Noramco Group, Lee Karras.
“We recognise the current challenges facing the industry, and the need to address both immediate and long-term supply chain needs. The new line should be qualified and operational within the next year — introducing contemporary technologies to our currently portfolio," adds.
The new line will support the production of new chemical entity (NCE) and generic low-bioburden APIs for injectables, which it will achieve through its Greek Purisys business unit in Athens.
Noramco has also noted its plans to invest in packaging automation during 2026.