cGMP-Compliant Pharmaceutical Manufacturing (API and Finished Dose)

The contract requires the manufacture of Lenalidomide active pharmaceutical ingredient and corresponding capsule dosage forms in full compliance with current good manufacturing practices, FDA regulations, and the Risk Evaluation and Mitigation Strategy program. All production activities must adhere to strict quality and safety standards to ensure product consistency, purity, and patient safety, with particular attention to regulatory documentation, process validation, and control systems. The work involves end-to-end manufacturing from API synthesis through final capsule packaging, with all facilities and procedures subject to audit and inspection by regulatory authorities. The contract is classified as a subcontract under NAICS code 325412, issued by the Department of Veterans Affairs through the 242-NETWORK Contract Office 02, with a response deadline of May 19, 2026. The place of performance is not specified but must support cGMP operations capable of meeting federal pharmaceutical standards. The solicitation was posted on May 5, 2026, and any qualified contractor must submit proposals before the deadline to qualify for award. Compliance with REMS requirements adds additional obligations around distributed supply chain controls, safety monitoring, and restricted distribution protocols specific to Lenalidomide.