SOFIE, an established Radiopharmaceutical Contract Manufacturing Organization and GMP radiopharmacy network, will be commercially manufacturing and distributing PYLARIFY®(piflufolastat F 18) injection, an F 18-labeled prostate-specific membrane antigen (PSMA) targeted positron emission tomography (PET) imaging agent.
With the recent announcement of the U.S. FDA approval, SOFIE will provide a dependable and scalable manufacturing and distribution network to support Lantheus' PSMA-targeted product PYLARIFY. Under a commercial supply agreement with Lantheus, SOFIE will roll out PYLARIFY via its national network, which has manufactured numerous PYLARIFY doses for Lantheus during the clinical trials.
SOFIE's Vice President of Sales & Marketing, Mike Parisi, states, "We are thrilled to partner with Lantheus to commercially supply this new and innovative prostate cancer imaging agent. We intend to scale our F-18 production as needed to help meet the anticipated widespread market demand. This not only enables us to reach a vast geographic region, but it also allows us to provide increased availability of the product throughout the day, to improve efficiency and throughput for our customers and the patients they serve."
Brian Schumer, SOFIE Chief Operating Officer, "We are very excited to support the first and only commercially available PSMA PET prostate cancer imaging agent. SOFIE's network will help meet the expected commercial demand for PYLARIFY by leveraging our expertise, experience, and distribution capabilities to successfully help serve the U.S. prostate cancer community. SOFIE is actively investing in additional resources and expanding our network to support the anticipated demand of PYLARIFY."
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