Radiopharmaceutical Manufacturing and Formulation

The contract pertains to the specialized manufacturing, formulation, and quality control of Pylarify (Piflufolastat F-18), a radiopharmaceutical used in diagnostic imaging. It encompasses all critical phases including radiolabeling with Fluorine-18, sterile filling into final dosage forms, and comprehensive batch release testing to ensure safety, purity, and potency in compliance with regulatory standards. The work requires strict adherence to currentGood Manufacturing Practices and involves a highly controlled environment due to the radioactive nature of the product and the short half-life of F-18. This subcontract is issued under the NAICS code 325412 for Pharmaceutical Preparation Manufacturing and is managed by the Department of Veterans Affairs through the 246-NETWORK Contracting Office 6. The contract does not specify a place of performance or point of contact, indicating that execution details may be coordinated directly with the prime contractor or subcontractor. The solicitation was posted in August 2026 and is not subject to any set-aside provisions, meaning it is open to qualified vendors regardless of small business status. The scope demands advanced radiopharmaceutical expertise, validated processes, and robust quality systems to support timely and consistent delivery of a critical diagnostic agent.