This Sources Sought opportunity from Department Of Health And Human Services was posted on May 5, 2025. The submission period has ended. Browse the details below for market research, or find similar active opportunities.

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Drug Formulation and Manufacturing Contract II (DFMC)

Closed

NIHOD20250424WILLIAMETTIFederal

Submission Closed05/19/2025, 09:00:00 PM UTC

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

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NAICS: 325412

New

International

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Supplier of Red Sealing Compound (NSN 8030015650423)This subcontract involves the supply of red sealing compound, identified by NSN 8030015650423, for prime contractors working under the Defense Logistics Agency. The material must be provided in 10.00 milliliter containers and strictly adhere to the DLA Master List of Technical and Quality Requirements RA001. The supplier is responsible for managing TYPE I (CODE H) shelf-life requirements and ensuring all packaging complies with MIL-STD-2073-1E and MIL-STD-129 standards. Additionally, the contractor must provide all necessary safety documentation, including SDS and HazCom labels in accordance with 29 C.F.R. 1910.1200. The performance of this contract is centered in FPO 09591-0100, with the primary objective being the delivery of packaged sealing compound and its associated safety certifications to the Department of Defense.

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Active Pharmaceutical Ingredient (API) SupplyThis subcontract for Active Pharmaceutical Ingredient (API) Supply involves the synthesis, purification, and bulk delivery of pharmaceutical-grade Benzocaine and Menthol. The provider supports prime contractors fulfilling requirements for the Department of Defense Medical Supply Chain Pharm FSA, ensuring all raw chemical components meet strict USP and ISO manufacturing standards through the use of HPLC purity testing. The performance of this contract is centered at Fort Campbell, Kentucky, under NAICS code 325412. The solicitation was posted on October 19, 2026, with a response deadline of October 26, 2026.

MEDICAL SUPPLY CHAIN PHARM FSA

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Benzocaine and Menthol Lozenge SupplyThis subcontract involves the manufacture and supply of finished Benzocaine and Menthol lozenges to prime contractors supporting the Department of Defense Medical Supply Chain Pharm FSA. The provider is responsible for producing and quality-testing pharmaceutical lozenges within FDA-compliant facilities adhering to Good Manufacturing Practice standards to ensure all delivered quantities meet strict government specifications. Administrative processes for this requirement are managed through the DLA Internet Bid Board System for quote submissions. The performance of the contract is centered at Fort Campbell, and the procurement falls under NAICS code 325412 for pharmaceutical preparation.

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Supply of Moxifloxacin Hydrochloride Tablets (400 MG)This subcontract, managed by the Medical Supply Chain Pharm FSA under the Department of Defense, involves the manufacture and supply of pharmaceutical-grade Moxifloxacin Hydrochloride Tablets (400 MG). The contractor is responsible for providing the antibiotic tablets in 30-count bottles, ensuring all products are sourced or manufactured in accordance with Good Manufacturing Practices and FDA approval and registration requirements. Logistical compliance is critical, as the contract mandates adherence to RP001 DLA Packaging Requirements and the use of climate-controlled storage and transport to maintain product integrity. Performance will take place in FPO 09591, with the primary objective of supporting prime contractors on DLA supply contracts.

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Supply of Activated Charcoal, SuspensionThis subcontract, issued by the Medical Supply Chain Pharm FSA under the Department of Defense, requires the provision of activated charcoal in suspension form, identified by NSN 6505012828880. The materials must be delivered to the USS Lewis B Puller ESB 3, with all shipments adhering to strict DLA packaging requirements and technical specifications. The contract falls under NAICS code 325412 and is intended for prime contractors supporting DLA supply operations. Resellers are specifically required to comply with the Non-Manufacturer Rule to ensure eligibility. The performance location is designated as FPO 09591, with a response deadline set for October 26, 2026.

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Supply of 4% Chlorhexidine Gluconate Surgical DetergentThis subcontract involves the supply of FDA-regulated 4% Chlorhexidine Gluconate surgical detergent for prime contractors supporting Department of Defense supply contracts. The provider is responsible for manufacturing or sourcing the chemical compound in strict accordance with NSN 6505-01-101-3759 specifications and DLA Packaging Requirements RP001. To maintain quality and regulatory compliance, the product must be produced in FDA-approved pharmaceutical manufacturing facilities. The contract mandates a total shelf life of 24 months, with a requirement that the detergent possesses at least 21 months of remaining shelf life at the time of delivery. Managed under the Medical Supply Chain Pharm FSA, the performance of this contract is centered in FPO 96660, falling under NAICS code 325412.

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Supply of Bupivacaine and Epinephrine InjectionThis subcontract involves the supply of Bupivacaine and Epinephrine Injection to prime contractors supporting DLA Troop Support medical supply contracts. The provider must deliver end items compliant with NSN 6505-01-189-3973, utilizing pharmaceutical-grade materials and medical-grade packaging. To qualify, the supplier is required to hold all necessary pharmaceutical manufacturing licenses and maintain FDA approval for the specific drug formulation. Managed by the Department of Defense under the Medical Supply Chain Pharm FSA, the contract specifies the delivery of injectable medication quantities as outlined in the award. The performance location is designated as FPO 09591, and the procurement falls under NAICS code 325412.

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Isoniazid Tablet ManufacturingThis subcontract involves the manufacturing of Isoniazid 300 MG tablets for prime contractors supporting Department of Defense pharmaceutical supply contracts through the Medical Supply Chain Pharm FSA. The manufacturer is responsible for producing tablets that conform to United States Pharmacopeia standards, packaged in bottles of 100 units. To execute this contract, the provider must utilize pharmaceutical grade API, specialized tablet pressing equipment, and a USP-compliant quality control laboratory. Strict regulatory adherence is required, including the maintenance of active FDA registration and continuous USP compliance. The performance of this contract is centered in FPO 09591, with the primary objective of delivering finished pharmaceutical products that meet all specified government quality and safety benchmarks.

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Tetrahydrozoline Hydrochloride Ophthalmic Solution SupplierThis subcontract involves the supply of Tetrahydrozoline Hydrochloride Ophthalmic Solution, USP (0.05%, 15 ML) to support prime contractors under DLA Troop Support medical supply contracts. The selected provider is responsible for manufacturing or sourcing the pharmaceutical solution in accordance with USP standards, utilizing sterile ophthalmic bottling and packaging. All operations must comply with FDA approval and registration requirements for pharmaceutical manufacturing. The contract is managed by the Department of Defense under the Medical Supply Chain Pharm FSA. Physical deliveries of the ophthalmic solution are to be made to either the prime contractor or the Naval Med Readiness Logistics Command, with the place of performance located in Williamsburg, Virginia.

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POSTED

DEADLINE

Supply of Tolnaftate Powder, USP 1%This subcontract through the Department of Defense Medical Supply Chain Pharm FSA involves the supply of Tolnaftate Powder, USP 1%, to prime contractors on DLA Troop Support medical supply contracts. The requirement is for 15 bottles of 45 GM powder, identified by NSN 6505014807897, which must strictly adhere to USP 1% standards and the DLA Master List of Technical and Quality Requirements. Eligible providers must possess the necessary pharmaceutical manufacturing and distribution licenses to fulfill the order. The performance of this contract is designated for FPO 09591, with a response deadline set for October 26, 2026.

MEDICAL SUPPLY CHAIN PHARM FSA

POSTED

1 day ago

DEADLINE

in 5 days

General Info

Agency

Department Of Health And Human Services → National Institutes Of Health Olao

NAICS

325412 - Pharmaceutical Preparation Manufacturing

Place of Performance

Rockville, MD, 20852, USA

Set-Aside

SBP

Documents

New+DFMC+SOW_DRAFT+01Feb25+clean.docx

AI Contract Breakdown

Uniform Contract Format

Contract not broken down yet

CLEATUS splits the solicitation into Uniform Contract Format (UCF) sections: scope, pricing, deliverables, and evaluation criteria.

Timeline

4 updates

PhaseClosed

PostedApr 24

Sources Sought

Notice updatedApr 28

Response deadline changed from May 9, 2025 to May 12, 2025. The notice title changed. NAICS code changed from 325 to 325412. The notice description changed.

Notice updatedApr 28

Response deadline changed from May 12, 2025 to May 9, 2025. NAICS code changed from 325412 to 325.

Notice updatedMay 5

Response deadline changed from May 9, 2025 to May 19, 2025. NAICS code changed from 325 to 325412. The notice description changed.

Notice updatedMay 5

The notice description changed.

Response DeadlineMay 19

Deadline has passed

Submission Closed

05/19/2025, 09:00:00 PM UTC

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Organization & Contact Information

AgencyDepartment Of Health And Human Services → National Institutes Of Health Olao

Contacts1 person available

OfficeBETHESDA, MD, 20892, USA

Organization / AgencyDepartment Of Health And Human Services → National Institutes Of Health Olao

Office AddressBETHESDA, MD, 20892, USA

Contacts

Dr. William H. M. Etti

contact@example.gov

+1 (555) 000-0000

Full Description

Please take a moment to thoroughly review the attached Statement of Work (SOW), which outlines the full scope and details of the drug formulation and manufacturing contract requirement. The goal of the contract is to complete all the manufacturing, documentation, formulation, fill and finish, packaging, and labeling required for investigational drug products. Throughout the period of performance (PoP) of the contract, the contractor must maintain the technical capabilities, minimum resources and organizational compliances with which to successfully conduct any awarded contract activity. The contractor must also maintain a good standing as a - Qualified Vendor as determined by ORSC. Additionally, unless otherwise requested, any assigned research must be performed in compliance with all current FDA, World Health Organization (WHO), USP, ISO, and International Committee on Harmonization (ICH) policies, practices, procedures, guidelines and regulations specific to current good manufacturing practices (cGMP) as may be applicable. Responses: Vendors responding to the National Institutes of Health (NIH) issued Sources Sought Note, should review the provided draft Statement of Work (SOW) to identify requirements and deliverables. The vendor's response should identify and describe how their capabilities and resources will meet the requirements and deliverables they identified in the SOW. While there is no set limit in pages, it is expected that the vendor will be able to briefly respond in an efficient and effective manner. Clarification on Drug Formulation and Manufacturing Notices Please note that the Sources Sought notice titled - Drug Formulation and Manufacturing Contract (DMFC) is an active posting as of April 28, 2025. This notice is distinct from the pre-solicitation notice 75N95024R00077 titled - Drug Manufacturing and Formulation Program (DMFP), which has been inactive since or around September 2024. As of now, there is no active contract in place for either the DFMC or the DMFP. The initial contract, DFMC-I, was written and awarded in response to sudden changes to the capabilities and resources of the NIH Clinical Center Central Pharmacy. The current proposed contract, DFMC-II, is to build upon the success of DFMC-I. It is expected that for DFMC-II there will be an increase in awarded Task Orders (TOs) due to the current goal of centralizing contracts to support across the National Institutes of Health.