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Will manufacture its lead product, NanO2, for clinical trials and commercial supply after FDA approval.
May 3, 2021
By: Tim Wright
Editor-in-Chief, Contract Pharma
NuvOx Pharma has completed construction and initiated operation of its GMP production facility for manufacturing its injectable pharmaceutical products at its Tucson, AZ facility. Construction of the GMP facility was financed by ImaRx Investments. The facility comprises an 1,800 square foot hard shell exterior space addition to the existing building located at 1635 East 18th Street. A 900 square foot ISO 5 cleanroom is housed within the exterior space. “This same ISO 5 modular cleanroom, manufactured by Terra Universal, has been successfully used by large and small pharmaceutical companies to manufacture pharmaceutical products commercially,” said Olivia Longacre, chief operating officer, NuvOx. “It is our goal to manufacture our lead product, NanO2, for pivotal clinical trials and commercial supply after FDA approval. We have invested in our Quality Management System intended to meet all FDA regulatory requirements.” Evan Unger, co-founder and CEO, NuvOx, said, “We have active Phase IIb programs for NanO2 in ischemic stroke and brain cancer following successful phase Ib/II studies in both of these indications. Our own manufacturing facility allows us to control costs, maintain continuous quality improvement and support our clinical development programs.” NuvOx Pharma is a privately held biotech company based in Tucson, Arizona.
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