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The Department of Veterans Affairs is procuring Lenalidomide, an immunomodulatory drug used to treat multiple myeloma, myelodysplastic syndromes, and certain lymphomas, through a sole-source contract to ensure a continuous, compliant supply that meets FDA and REMS requirements. The contractor must deliver the drug in full compliance with cGMP and federal regulations, supporting uninterrupted patient access.
Procure and supply Lenalidomide in compliance with cGMP, FDA regulations, and the REMS program to ensure uninterrupted availability for VA patients.
This is a notice of intent to award a Sole-Source only contract and is not a request for quotes. Name of Proposed Contractor Exelan Pharmaceuticals Street Address: 370 W. Camino Gardens, Suite 204 City, State, Zip: Boca Raton, FL 334432 The
objective of this action is the procurement for: The purpose of this contract is to establish a reliable and continuous supply of Lenalidomide, an immunomodulatory drug used primarily to treat multiple myeloma, anemia in myelodysplastic syndromes (MDS) in adults, and certain types of lymphoma. Lenalidomide works by enhancing the immune system s ability to fight cancer cells. It inhibits the growth of new blood vessels in tumors and alters the immune response to target and destroy malignant cells. It comes with serious risks that require careful management and monitoring. Contractor shall provide all materials, labor, and equipment necessary to supply Lenalidomide in accordance with all applicable federal regulations, Good Manufacturing Practices (cGMP) and the Food and Drug Administration (FDA)
requirements. This is an emergent need to ensure continuous supply, to meet regulatory obligations (Risk Evaluation and Mitigation Strategy REMS) program, and to support patient access. Corey Swinton Contracting (No Street Address
2) ALBANY, NY 12208 USA to this opportunity. HCA Signed NCO 2 FOR HCA SIGNATURE - P03 - Limiting Sources over SAT MDW.pdf
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