6505--Dimethyl Fumarate Capsules
ID: 36E79726R0003Type: Presolicitation
Overview

Buyer

VETERANS AFFAIRS, DEPARTMENT OFVETERANS AFFAIRS, DEPARTMENT OFNAC PHARMACEUTICALS (36E797)HINES, IL, 60141, USA

NAICS

Pharmaceutical Preparation Manufacturing (325412)

PSC

DRUGS AND BIOLOGICALS (6505)
Timeline
    Description

    The Department of Veterans Affairs (VA) is seeking offers for the procurement of Dimethyl Fumarate Capsules (120MG and 240MG delayed-release) through solicitation 36E79726R0003. This contract aims to establish a reliable supply source for these pharmaceutical products to support VA, Department of Defense (DoD), Indian Health Service (IHS), and Bureau of Prisons (BOP) facilities, with a contract structure that includes a one-year base ordering period and four one-year options. The products are critical for treating specific medical conditions, and offerors must comply with stringent requirements, including FDA regulations, Drug Supply Chain Security Act (DSCSA) compliance, and the provision of unique National Drug Codes (NDCs). The deadline for submitting offers has been extended to December 9, 2025, at 2:30 PM CST, and interested parties can contact Contract Specialist Kenneth Lay at Kenneth.Lay@va.gov for further information.

    Point(s) of Contact
    Kenneth LayContract Specialist
    (708) 786-4879
    Kenneth.Lay@va.gov
    Files
    Title
    Posted
    This government solicitation, Amendment 0001 to 36E79726R0003, issued by the Department of Veterans Affairs, National Acquisition Center, extends the offer due date to December 4, 2025, at 2:30 PM CST. It aims to establish a supply source for Dimethyl Fumarate Capsules (120MG and 240MG delayed-release) for VA, DoD, IHS, and BOP facilities through Pharmaceutical Prime Vendor (PPV) Programs. The contract will have a one-year base ordering period and four one-year options. Offerors must provide prices for both line items across all years, including a 0.5% Cost Recovery Fee. Key requirements include unique 11-digit National Drug Codes (NDCs) for all offered products, compliance with Drug Supply Chain Security Act (DSCSA) regulations, and adherence to FDA Current Good Manufacturing Practices (cGMP) standards. Offerors must also have an FDA-approved New Drug Application (NDA), Abbreviated NDA (ANDA), or Biologics License Application (BLA) if required for their products. The contract emphasizes timely product availability, with provisions for backorders and potential termination for cause. Payments will be made by PPV programs, not directly by the government.
    The Department of Veterans Affairs (VA) National Acquisition Center has issued an amendment (Amendment 0002) to solicitation 36E79726R0003, extending the deadline for offers. The new closing date for bids is December 9, 2025, at 2:30 PM CST. This modification, signed by Contracting Officer Diana Martinez, specifically extends the "HOUR & DATE for Receipt of Offers" and is officially documented on a Standard Form 30, "Amendment of Solicitation/Modification of Contract." All other terms and conditions of the original solicitation remain unchanged.
    The Department of Veteran Affairs (VA) National Acquisition Center intends to issue an unrestricted Request for Proposal (RFP) 36E79726R0003 for Dimethyl Fumarate Delayed Release Capsules. The contract will supply the VA, Department of Defense (DoD), Bureau of Prisons (BOP), Indian Health Service (IHS), and Federal Health Care Center (FHCC). The VA will award a single contract for one year with four one-year option periods, ensuring an uninterrupted supply of the capsules. Offerors must provide the exact drug name and a unique NDC number. Packaging requirements include safety-caps and specific bottle dimensions. The solicitation will be issued electronically around November 12, 2025, with a tentative closing date of November 26, 2025. The NAICS code for this procurement is 325412. Interested parties should monitor sam.gov for updates. Kenneth Lay is the point of contact for inquiries.
    This government solicitation, 36E79726R0003, issued by the Department of Veterans Affairs, outlines requirements for pharmaceutical products, specifically Tadalafil tablets in various strengths (2.5mg, 5mg, 10mg, 20mg). It covers a base year and four one-year option periods. The solicitation details packaging, barcoding, and Drug Supply Chain Security Act (DSCSA) requirements, including the need for 11-digit National Drug Codes (NDCs) and manufacturer commitments. All offerors must comply with FDA Good Manufacturing Practices (cGMP) and have existing Master Agreements and Pharmaceutical Pricing Agreements for covered drugs. A 0.5% Cost Recovery Fee, embedded in prices, and quarterly sales reporting are mandatory. The contract facilitates purchases through VA and DoD Pharmaceutical Prime Vendor Programs, with payment made by the PPVs, not directly by the Government. The document also addresses backorder procedures and potential contract termination for non-compliance.
    Lifecycle
    Title
    Type
    Presolicitation
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