6505--VISN IDIQ LENALIDOMIDE Sole Source Justification
Closed Special Notice Posted
- Solicitation number
- 36C24226F0064
- Agency
-
Veterans Integrated Service Network 2
Veterans Health Administration, Department of Veterans Affairs
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 325412 Pharmaceutical Preparation Manufacturing
- PSC
- 6505 Drugs And Biologicals
- Points of contact
Notice details come from SAM.gov. Updated .
About this opportunity
The Department of Veterans Affairs, Veterans Integrated Service Network 2, announced its intent to award a sole-source contract to Exelan Pharmaceuticals for continuous supply of Lenalidomide, with a response deadline of May 19, 2026. This is a notice of intent to award under GSAR 538.7104-4 (Items Peculiar to One Manufacturer) and is not a request for quotes. The estimated contract value is $26.3 million.
Lenalidomide is an immunomodulatory drug used to treat multiple myeloma, anemia in myelodysplastic syndromes in adults, and certain types of lymphoma. It enhances immune system function, inhibits tumor blood vessel growth, and alters immune response to destroy malignant cells. The procurement addresses an emergent need to ensure continuous supply, meet Risk Evaluation and Mitigation Strategy (REMS) regulatory obligations, and support patient access. The product will be supplied in six dosage strengths (2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg capsules).
The contractor must provide all materials, labor, and equipment necessary to supply Lenalidomide in compliance with federal regulations, current Good Manufacturing Practices (cGMP), and FDA requirements. Market research verified that Exelan's generic lenalidomide is more cost-effective than the brand name Revlimid, is on the VA National Formulary, and is dispensed only through REMS-certified pharmacies. The order is placed against GSA Federal Supply Schedule Contract 36F79720D0227. The point of contact is Contract Specialist Corey Swinton at Corey.Swinton@va.gov.
Notice text
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.
Files
| File | Type | Posted |
|---|---|---|
| 36F79720D0227 36C24226F0064.docx | DOCX document | |
| HCA Signed NCO 2 FOR HCA SIGNATURE - P03 - Limiting Sources over SAT MDW.pdf |
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