Radiopharmaceutical Manufacturing and Formulation

The contract pertains to the production of AMYVID (florbetapir F-18), a radiopharmaceutical used for PET imaging, and involves manufacturing under current Good Manufacturing Practice (cGMP) conditions. The scope includes the complete synthesis process, comprehensive quality control measures, and the batch release necessary to ensure the product's safety and efficacy for clinical use. Issued as a subcontract by the Department of Veterans Affairs through the 242-NETWORK Contract Office 02, this contract falls under the NAICS code 325412, which relates to pharmaceutical manufacturing. While specific location details and points of contact are not provided, the contract emphasizes strict adherence to regulatory standards in radiopharmaceutical formulation and quality processes to support diagnostic imaging needs.