Manufacture and Supply of Rho(D) Immune Globulin

The contract entails the full-scale manufacturing and supply of Rho(D) Immune Globulin in the form of 300 mcg, 1 mL pre-filled syringes intended for intramuscular injection. The production must comply with United States Pharmacopeia (USP) standards, current Good Manufacturing Practices (cGMP), and all relevant federal regulatory requirements to ensure product safety, sterility, and quality. Responsibilities include sterility testing and comprehensive batch documentation to maintain traceability and regulatory compliance. Issued by the Department of Defense's Medical Supply Chain Pharmacy FSA, the subcontract aligns with NAICS code 325412, which pertains to pharmaceutical preparation manufacturing. The place of performance is designated as FPO with the zip code 09579. The solicitation was posted on May 19, 2026, with a response deadline set for May 26, 2026. This contract represents a critical supply component for medical readiness and immunological support.