This Solicitation opportunity from Department Of Health And Human Services was posted on November 8, 2024. The submission period has ended. Browse the details below for market research, or find similar active opportunities.

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Chemistry, Manufacturing and Controls and Related Services for Development of Drug Substances

Closed

75N95024R00094Federal

Submission Closed12/03/2024, 08:00:00 PM UTC

Contract Overview

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

Active Opportunities Like This One

NAICS: 325411

New

DIBBS

BENZOCAINE AND MENTHOL

Solicitation # SPE2DP-27-T-0129

Solicitation SPE2DP-27-T-0129, issued by the DLA Troop Support Medical Supply Chain Pharm FSA, is for the procurement of 10 packages of Cepacol Extra Strength Sore Throat Honey Lemon Lozenges (NSN 6505017081449). Each package contains 16 oral pain relievers with 15mg Benzocaine and 2.6mg Menthol. The items must be stored between 20-25 C (68-77 F) and protected from humidity. Delivery is required within 5 days after the order, with a required delivery date of October 21, 2026, shipped FOB Destination to Fort Campbell, Kentucky. Packaging must be commercial, utilizing suitable sealed unit containers and exterior shipping containers to prevent damage. Marking must strictly adhere to Medical Marking Standard No. 1, which supersedes MIL-STD-129. The contract specifies a non-extendable shelf life of 36 months for this Type I (Code Q) item. Administrative requirements include the use of the Wide Area WorkFlow (WAWF) system for invoicing and payment. The procurement is governed by NAICS code 325411 and incorporates various FAR and DFARS clauses, including those regarding the Buy American Act, Berry Amendment, and cybersecurity reporting under DFARS 252.204-7012.

MEDICAL SUPPLY CHAIN PHARM FSA

POSTED

DEADLINE

REHYDRATION SALTS FOR

Solicitation # SPE2DP-27-T-0087

Solicitation SPE2DP-27-T-0087 is a fixed-price request for quotations issued by the DLA Troop Support Medical Supply Chain Pharm FSA for the procurement of five cases of strawberry lemonade flavored electrolyte oral hydration powder. Each case must contain 100 packets of 21 grams each, with each packet providing sodium, potassium, chloride, citrate, magnesium, zinc, 16 grams of carbohydrates, and 65 calories. The product is FDA regulated and requires a shelf life of 60 months, which may be extendable. Delivery is required within five days after order to a destination in Oklahoma City, Oklahoma, with inspection and acceptance occurring at the destination. The contractor must adhere to strict packaging and marking standards, specifically utilizing the Medical Marking Standard No. 1, which supersedes MIL-STD-129. Packaging must be commercial grade, utilizing suitable sealed unit containers and exterior shipping containers in accordance with DLA packaging requirements and MIL-STD-2073-1E. Administrative requirements include the use of the Wide Area WorkFlow system for invoicing and compliance with various FAR and DFARS clauses, including those regarding the safeguarding of covered defense information, the Buy American Act, and prohibitions on covered defense telecommunications equipment.

MEDICAL SUPPLY CHAIN PHARM FSA

POSTED

DEADLINE

REHYDRATION SALTS FOR

Solicitation # SPE2DP-27-T-0120

Solicitation SPE2DP-27-T-0120 is a fixed-price procurement issued by the DLA Troop Support Medical Supply Chain Pharm FSA for the supply of orange-flavored electrolyte oral rehydration salts. The requirement consists of two packages of 21 gram units, provided in 100-count packages, under NSN 6505016871441. The items are subject to a non-extendable shelf life of 36 months and must be delivered within 20 days of order, with an original required delivery date of October 19, 2026. Delivery is FOB Destination, with shipping directed to the USNS Cody T-EPF-14 via either a freight warehouse in the US or a parcel post address in FPO AE. The contract mandates strict adherence to commercial packaging and packing standards, requiring sealed unit containers to prevent damage and exterior shipping containers suitable for the lowest carrier rate. Marking must comply with Medical Marking Standard No. 1, which supersedes MIL-STD-129. Inspection and acceptance will occur at the destination. Administrative requirements include electronic invoicing through the Wide Area WorkFlow system and compliance with various FAR and DFARS clauses, including the Buy American Act, Berry Amendment, and NIST SP 800-171 cybersecurity assessment requirements. Offerors must be registered in the System for Award Management and are categorized under NAICS code 325411.

MEDICAL SUPPLY CHAIN PHARM FSA

POSTED

DEADLINE

Supplier of Blue Pressure-Sensitive Adhesive Tape (NSN 7510-01-679-4381)This subcontract involves the supply of blue pressure-sensitive adhesive tape, specifically matching NSN 7510-01-679-4381, to support prime contractors delivering DLA Troop Support supply contracts. The requirement consists of 8 rolls of tape, each measuring 1 inch by 72 yards, with a mandatory 24-month shelf-life. All materials must be packaged according to MIL-STD-2073-1E and MIL-STD-129 standards and must comply with the Buy American Act. The contract is issued by the Department of Defense under NAICS code 325411. Delivery is specified as FOB Origin to San Diego, California. Interested parties must respond by October 26, 2026, following the posting date of October 14, 2026.

CONSTRUCTION & EQUIPMENT T & IFO EQ

POSTED

DEADLINE

Lidocaine API SupplierThis subcontract involves the supply of pharmaceutical-grade active lidocaine powder and concentrate to prime contractors supporting Department of Veterans Affairs National CMOP Office projects. The selected supplier is responsible for the chemical synthesis and purification of the lidocaine to ensure it meets USP standards, utilizing synthesis reactors and HPLC purity testing to verify quality. To maintain compliance, the supplier must hold GMP certification and provide a Certificate of Analysis for every batch of the bulk active ingredient delivered. The opportunity is categorized under NAICS code 325411, with a response deadline set for November 3, 2026.

National Cmop Office (36C770)

POSTED

DEADLINE

High Char Yield Polymer Resin DevelopmentThis subcontract, issued by the NASA SBIR/STTR Program, focuses on the research, design, and synthesis of a novel polymer resin formulation. The primary technical objective is to develop a material capable of achieving a char yield exceeding 80 percent to facilitate the rapid manufacturing of carbon fiber–carbon matrix composites. The project is designated as a Total Small Business Set-Aside under the SBIR/STTR mandate, restricting eligibility to firms with fewer than 500 employees. Performance of the contract is centered in Huntsville, Alabama, and falls under NAICS code 325411 for polymer resin development.

NASA SBIR/STTR Program

POSTED

DEADLINE

Supply of Adhesive TapesThis subcontract, titled Supply of Adhesive Tapes, is issued by the Government of Jamaica under the JCA Project and Initiatives Implementation agency. The contractor is responsible for sourcing, packaging, and delivering various adhesive tapes that meet the specific requirements of the General Stores Unit for maintenance and utility purposes. The scope of work involves the supply and delivery of these materials to prime contractors working on JCA Project and Initiatives Implementation facility projects. The contract is categorized under NAICS code 325411 and was posted on August 20, 2026.

JCA Project and Initiatives Implementation

POSTED

DEADLINE

Supplier of Raw Active Pharmaceutical Ingredient (API) – DiazepamThe Defense Logistics Agency, under the Department of Defense, has established a subcontract for the supply of bulk Diazepam Active Pharmaceutical Ingredient. The material must adhere to USP standards to ensure suitability for the formulation of 5 mg tablets. The supplier is required to provide a Certificate of Analysis and necessary regulatory support to maintain compliance. This procurement falls under NAICS code 325411 and was posted on August 11, 2026.

Defense Logistics Agency

POSTED

DEADLINE

Supplier of Active Pharmaceutical Ingredient (API) – Promethazine HydrochlorideThe contract pertains to the supply of USP-grade promethazine hydrochloride active pharmaceutical ingredient for use in the final formulation of a pharmaceutical product, specifically under a subcontract arrangement. The procurement is managed by the Defense Logistics Agency within the Department of Defense, with the NAICS code 325411 indicating classification under pharmaceutical and biological product manufacturing. Although the solicitation number and specific point of contact are not provided, the posting date is August 9, 2026, and the performance location details are unspecified. The API must meet United States Pharmacopeia standards to ensure quality and compliance with regulatory requirements for drug manufacturing. The contract reference number SPE2DX25D8022 and delivery identifier SPE2D926F8075 are linked through the DIBBS system, facilitating tracking and award administration for the supplier.

Defense Logistics Agency

POSTED

DEADLINE

Insect Repellent Supply for DoD UseThe contract entails the supply of 20 boxes of insect repellent standardized under NSN 6840016567707 for use by the Department of Defense, ensuring full compliance with Defense Logistics Agency packaging and delivery specifications. The product is classified under NAICS code 325411, indicating its origin in the manufacturing of other chemical products, and is being procured as a subcontract under the broader defense supply chain. Delivery must adhere strictly to DLA standards to ensure operational readiness and compatibility with military logistics systems. The contract was posted on July 21, 2026, and is tied to the award contract SPE4AX16D9008 with delivery identifier SPE4A626FCWRC, though no specific location or point of contact is provided. The effort supports the Department of Defense's mission-critical need for pest protection in deployment environments.

Defense Logistics Agency

POSTED

DEADLINE

Pharmaceutical Repackaging and Labeling ServicesThe contract involves the repackaging of fluconazole tablets into containers that meet Department of Defense compliance standards, ensuring proper military-specific labeling with National Stock Number, Technical Control Number, and military identification blocks. This work requires strict adherence to DoD packaging and labeling protocols to ensure accurate traceability, inventory control, and field distribution within military supply chains. The contractor must handle pharmaceuticals under appropriate conditions to maintain product integrity and regulatory compliance throughout the repackaging process. The performance of this subcontract falls under NAICS code 325411 for pharmaceutical and medicine manufacturing and is managed by the Defense Logistics Agency on behalf of the Department of Defense. While specific location details for performance or contact information are not provided, the contract is tied to a defined delivery and award mechanism through DLA’s procurement system, indicating it supports routine military pharmaceutical supply needs. The work is scheduled to be active following a public posting in July 2026, and the nature of the task suggests the contractor must possess experience in regulated pharmaceutical repackaging and familiarity with military logistical requirements.

Defense Logistics Agency

POSTED

DEADLINE

Manufacturer Sourcing for NDC-Specified ItemsThe contract authorizes the supply of surgical detergent exclusively from manufacturers holding active NDC listings and approved CAGE codes 1LZX9 or 3LDD7, ensuring strict federal compliance and integration into prime contract deliverables. This procurement is tightly regulated to maintain quality and regulatory standards within the Defense Logistics Agency’s supply chain, with all products required to meet mandated criteria for use in medical and surgical settings under Department of Defense requirements. The solicitation, classified as a subcontract under NAICS code 325411, is managed by the Defense Logistics Agency and was posted on July 17, 2026. While no specific place of performance or point of contact is provided, the contract is linked to prime contract deliverables and is accessible through the DIBBS system under contract SPE2DX25D9900 and delivery order SPE2DP26F7735, emphasizing its role in supporting federal medical logistics operations.

Defense Logistics Agency

POSTED

3 months ago

DEADLINE

N/A

AI Contract Overview

This contract involves providing Chemistry, Manufacturing, and Control (CMC) services for drug substances, with the primary goal of ensuring the availability of high-quality and adequately quantified Drug Substances (DS) to support preclinical and Investigational New Drug (IND)-enabling studies. The services are essential for the development and manufacturing processes related to drug substances, ensuring compliance with regulatory standards and facilitating the progression of drug candidates through early-stage research. The contract is issued by the National Institutes of Health (NIH), specifically through the National Institute on Drug Abuse (NIDA), under the Department of Health and Human Services, and is posted with a response deadline of December 3, 2024. The solicitation, titled "Chemistry, Manufacturing and Controls and Related Services for Development of Drug Substances," is open and does not specify set-aside categories. It is categorized under NAICS code 325411, which pertains to pharmaceutical and medicine manufacturing. The contract aims to support the development of drug substances by providing specialized services that encompass manufacturing, quality control, and regulatory compliance. The point of contact for inquiries includes Samson Shifaraw and Valerie Whipple, based in Bethesda, Maryland. The overarching objective is to facilitate the timely and compliant production of drug substances critical for advancing preclinical research, ultimately supporting the NIH’s mission to develop safe and effective therapeutics.

General Info

Contract for CMC services supporting drug substance development for preclinical studies, NIH solicitation.

Agency

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

NAICS

325411 - Medicinal and Botanical Manufacturing

Place of Performance

MD, USA

Set-Aside

NONE

Documents

75N95024R00094 - Chemistry, Manufacturing and Controls Services RFP

84 pages · rfp

High

Additional Business Proposal Instructions

18 pages · instructions

High

Additional Technical Proposal Instructions

15 pages · sow

High

Amendment 1 to RFP 75N95024R00094 - Storage Facility and Q&A Updates

10 pages · amendment

High

Amendment No. 2 - RFP 75N95024R00094

1 page · amendment

High

Attachment 13 - Breakdown of Proposed Estimated Costs (Plus Fee)

25 pages · cost-proposal-template

High

Attachment 24 Q&A Original RFP

4 pages · q-and-a

High

Attachment 4 – Sample Statement of Work for SMDC Small Molecule Development

8 pages · sow

High

Attachment 5 Sample Statement of Work – SPDC Peptides

7 pages · sow

High

Attachment 8 Technical Proposal Cost Information/Summary of Labor

1 page · other

High

BIOL001 Biologics Statement of Work

4 pages · sow

High

General Clauses for Cost-Reimbursement Contract

14 pages · clauses

High

NIH-2043 Proposal Summary and Data Record - RFP 75N95024R00094

2 pages · proposal-summary-data-record

High

NIH Fixed-Price Contract Invoice Instructions (NIH(RC)-2)

3 pages · sow

High

Packaging and Delivery of Proposals for NIH eCPS

2 pages · sow

High

Statement of Work: Chemistry, Manufacturing and Controls for Drug Substances (Aug 28, 2024)

8 pages · sow

High

NIH RC-1 Invoice/Financing Request Instructions

7 pages · instructions

Medium

RFP 75N95024R00094 Proposal Intent Response Form

1 page · rfi

Medium

15 Disclosure of Lobbying Activities

1 page · other

Low

21-CMO Supplier Audit Questionnaire

10 pages · questionnaire

Low

Attachment 14 - Offeror’s Points of Contact

1 page · other

Low

Attachment 16 - Annual Representations and Certifications (May 2024)

5 pages · other

Low

Attachment 20 - Quality Agreement

19 pages · quality-agreement

Low

Attachment 9 - Summary of Related Activities

1 page · proposal-attachment

Low

FAR Clause Deviation Acknowledgement Form

1 page · other

Low

NIH(RC)-1 Exhibit A NIDA Supplemental Billing Instructions

1 page · other

Low

NIH Supplier Qualification Questionnaire Supplemental

1 page · questionnaire

Low

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

2 updates

PhaseClosed

PostedOct 9

Solicitation

Notice updatedOct 29

Notice details unchanged. Attachments may have changed.

Notice updatedNov 8

Notice details unchanged. Attachments may have changed.

Response DeadlineDec 3

Deadline has passed

Submission Closed

12/03/2024, 08:00:00 PM UTC

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Organization & Contact Information

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

Contacts2 people available

OfficeBethesda, MD, 20892, USA

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

Office AddressBethesda, MD, 20892, USA

Contacts

Samson Shifaraw

Valerie Whipple

Full Description

The scope of this requirement is Chemistry, Manufacturing, and Control (CMC) services for drug substances. The objective of these support services is to ensure receipt of Drug Substances (DS) of sufficient quality and quantity to support preclinical and IND-enabling studies.