Apotex announced that it has secured a sterile filling partnership with Halo Pharmaceuticals through an investment that provides Apotex with access to a significant portion of the overall sterile injectable filling capacity currently being installed and qualified at Halo's Whippany, New Jersey facility.
This access is intended to support Apotex's sterile injectable manufacturing network and signals a strong investment in sterile U.S.-based manufacturing, infrastructure and research and development capabilities. The partnership aligns with Apotex's Journey of Health strategy and its broader focus on strengthening domestic manufacturing operations.
The arrangement enables Apotex to access near‑term sterile filling capacity and offers an alternative to a greenfield development approach, providing operational flexibility as part of its global manufacturing strategy.
Halo Pharmaceuticals is a strategically aligned organization providing development and manufacturing services across a range of dosage forms, including sterile injectable formats.
Through this collaboration, Apotex brings its strong sterile processing experience, regulatory readiness expertise, and commercialization capabilities while securing access to vial and pre‑filled syringe filling capacity. The partnership builds upon the existing Apotex‑Halo relationship, which currently includes non‑sterile manufacturing programs.
Halo anticipates that the Whippany facility will be subject to future regulatory inspection as part of its qualification process, consistent with applicable FDA requirements. Apotex's involvement is intended to support technical and operational readiness activities; outcomes of any regulatory inspections or approvals remain subject to FDA review and determination.
"This investment reflects our continued focus on our Made in the U.S. strategy and is consistent with Apotex's overall focus on our Journey of Health strategy," said Christine Baeder, President of Apotex U.S. and LATAM. "We believe this partnership enhances flexibility within our sterile injectables network while supporting efficient capacity utilization. It's also a strong signal of our commitment to the sterile injectables market."
"We are very excited to partner with Apotex on their Made in the U.S. strategy for injectables," said Lee Karras, Chief Executive Officer of Halo Pharmaceuticals. "We will still have ample capacity available for other customers who require vial, syringe, and cartridge sterile filling CDMO services."