Halo Pharma to Activate Sterile Injectable Line in NJ

Editor’s Take: The amount of money going into U.S. manufacturing is hard to miss. Lilly, Merck, Roche, Johnson & Johnson and AstraZeneca each recently announced multiyear U.S. investment plans of $50 billion or more.

Halo Pharma, a CDMO specializing in drug product pharmaceutical development and manufacturing services, is close to activating a new sterile injectable manufacturing line at its Whippany, NJ facility.

This milestone follows a $45 million facility investment designed to address the growing demand from U.S.-based pharmaceutical companies that are seeking reliable domestic sterile manufacturing partners.

“The domestic supply chain for injectables is at capacity, and this is the exact right time to bring this investment online,” said Lee Karras, CEO of Halo Pharma. “This state-of-the-art asset introduces the advanced capabilities and high standards that both emerging biotech and large pharma companies expect from a premium CDMO partner.”

Purpose-built to support sterile injectable manufacturing from clinical development through commercial production, Halo Pharma’s new platform features a high-speed Groninger UFVN FlexFill syringe, cartridge, and vial filling line, along with an integrated SKAN isolator to enhance production efficiency and support EU Annex 1 compliance. Once online, the platform will allow Halo Pharma to manufacture batch sizes ranging from 250-250,000 units with annual capacity to produce more than 50 million units, based on 1 ml syringes and 250L batches. This expands on the company’s offerings in oral solid dose, semi-solid, and liquid formulation development.

Halo Pharma is now proceeding through the Good Manufacturing Practice (GMP) qualification process. The line is expected to be brought online later this year.

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Halo Pharma became a standalone business earlier this year as a result of the sale of the Noramco API and associated businesses to Siegfried.