6505--Hydralazine HCL Injections Award - Hikma Pharmaceuticals 36E79725R0048

PRE-SOLICITATION NOTICE: The VA National Acquisition Center intends to issue Request for Proposal (RFP) 36E79725R0048 for a restricted procurement for Hydralazine Hydrochloride Injections, for the Department of Veterans Affairs (VA) (inclusive of Federal Health Care Center (FHCC) and Option 2 State Veterans Homes (SVH)). Competition for this procurement is limited to offerors proposing U.S.-made products in accordance with FAR 6.302-7 Public Interest. A U.S.-made product is defined as an article that is mined, produced, or manufactured in the United States or that is substantially transformed in the United States into a new and different article of commerce with a name, character, or use distinct from that of the article or articles from which it was transformed. In order to be eligible for award, offerors shall certify that their proposed product is U.S.-made, as defined above, within this solicitation s Addendum to FAR 52.212-1 Instructions to Offerors -- Commercial Products and Commercial Services. Offerors of products that are not U.S.-made will not be considered for award. VA will award one contract to the responsible offeror proposing U.S.-made products as defined above who will be able to provide an uninterrupted source of supply for the contracted items meeting all solicitation requirements. The contract period will be for one year plus four pre-priced one-year option periods. The contract items will be distributed through the VA s Pharmaceutical Prime Vendor Program. Offerors must state the exact name (name that appears on label) by which the drug will be supplied and have an NDC number that is unique to the offeror. The successful offeror/contractor's label with its unique NDC shall be the only label on the product. Contractors shall not affix their label over another label on the product. The awarded contractor shall provide the awarded product in the case/outer pack size offered commercially (e.g., case of 25 vials). However, the annual estimated quantities are expressed in individual vials and the price analysis will be based on the proposed vial price. While the Contractor may provide the awarded product in case/outer pack sizes offered commercially, each vial must contain the bar code. Solicitation # 36E79725R0048 will be electronically issued in commercial item format in accordance with FAR Part 12 on or about July 29, 2025, with a tentative closing date of August 29, 2025. The NAICS code for this procurement is 325412. Any future amendments and other miscellaneous documents will be available electronically for download at sam.gov. No paper copies of the solicitation will be available, and no telephone requests for paper copies of the solicitation will be accepted. Interested offerors are advised to continuously check Contracting Opportunities at SAM.gov for any changes to this solicitation. All responsible sources may submit an offer that if timely received, will be considered. The point of contact for this procurement is Nicholas McGregor. Questions can be emailed to Nicholas.McGregor@va.gov. The estimated annual requirements are as follows: ESTIMATED VA ANNUAL REQUIREMENTS INCLUDES SVH OPTION 2 AND FHCC ITEM DESCRIPTION PKG SIZE TOTAL EST. ANNUAL USAGE (VIALS) 1 Hydralazine HCL 20mg/mL Injections, 1 mL Vials 1 Vial 82,630 The awarded contractor shall provide the awarded product in the case/outer pack size offered commercially (e.g., case of 25 vials). However, the annual estimated quantities are expressed in individual vials and the price analysis will be based on the proposed vial price.

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This acquisition did not provide for full and open competition in accordance with FAR 6.302-7. While this acquisition did not provide for full and open competition, the solicitation was posted to SAM.gov and all offerors of U.S.-made product were considered. See the attached justification document for details.