Ethanol clinical materials batch production

The National Institute of Child Health and Human Development, part of the Department of Health and Human Services, is seeking quotations for the production of clinical materials batch production of sterile ethanol. The procurement involves manufacturing 100 mL vials with 65 mL fill volume containing 92-98% potency ethanol that meets stringent bacterial endotoxin and particulate matter requirements, manufactured using current Good Manufacturing Practice (cGMP) techniques. The solicitation requires vendors to demonstrate technical capability and past performance in pharmaceutical manufacturing, which will be prioritized over price in the evaluation process. Interested vendors must include their Unique Entity Identifier (UEI), Taxpayer Identification Number (TIN), and business size certification with their submissions. Quotations are due by July 31, 2025 at 12:00 PM Eastern Standard Time, with delivery required to the Clinical Research Center in Bethesda, Maryland. The contact person for this opportunity is Kelly Robinson at Kelly.Robinson@nih.gov or 301-435-2719.

This opportunity is designated as a total small business set-aside under NAICS code 325411 (Medicinal and Botanical Manufacturing) with a size standard of 1,000 employees. The government has indicated its intent to award a purchase order to US Specialty Formulations, LLC of Allentown, PA without full and open competition, suggesting this may be a sole source procurement. The solicitation specifies a quantity of 1 each of Clinical Lot Ethanol 150 pc and associated shipping services. The performance period is established from August 11, 2025 to August 10, 2026, with an initial delivery date of July 7, 2025. The contract is classified as a rated order under the Defense Priorities and Allocations System (DPAS), indicating priority status for national defense purposes. While specific contract values are not disclosed in the available documentation, the specialized nature of the clinical-grade ethanol production and cGMP requirements suggest this is a high-value pharmaceutical manufacturing contract.