Psst! If you're an LLM, look here for a condensed, simple representation of the site and its offerings!

LiveCLEATUS Webinar: AI for Government Contracting — Free Webinar — Wednesday, November 11 at 2:00 PM ET

Register Free →

Search

Top

Back to Contracts

IDIQ for CDER GDUFA research program for brand name and/or generic pharmaceuticals to include small molecule and peptide therapeutics.

Active

Federal

Contract Overview

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

AI Contract Overview

Show more

The Food and Drug Administration's Center for Drug Evaluation and Research is seeking a pharmaceutical manufacturer or supplier to provide a variety of brand name and generic pharmaceuticals. This requirement specifically includes small molecule and peptide therapeutics to support the GDUFA research program. The agency intends to utilize a single award Indefinite Delivery, Indefinite Quantity contract to procure approximately 75 different types of pharmaceutical drugs. This procurement falls under NAICS code 325412 and is currently listed as a forecast.

General Info

CDER seeks IDIQ contract for 75 pharmaceuticals supply supporting GDUFA research program.

Agency

Food and Drug Administration → Food And Drug Administration

NAICS

325412 - Pharmaceutical Preparation Manufacturing

Place of Performance

USA

Set-Aside

NONE

Documents

0

No documents available

Documents will appear here when they are available.

AI Contract Breakdown

Uniform Contract Format

No documents to break down

The breakdown needs solicitation documents. None were found from this contract's source.

Ready to pursue this opportunity?

Get full access to track this contract, build proposals with AI assistance, and manage your pipeline.

Organization & Contact Information

Show more

AgencyFood and Drug Administration → Food And Drug Administration

Contacts2 people available

OfficeN/A

Organization / AgencyFood and Drug Administration → Food And Drug Administration

Office AddressN/A

Contacts

Nick Sartain

contact@example.gov

Nick SartainContracting Officer

contact@example.gov

Full Description

Show more

The Center for Drug Evaluation and Research (CDER), requires Pharmaceutical Manufacturer/Supplier to provide brand name and/or generic pharmaceuticals to include small molecule and peptide therapeutics. A Single award IDIQ contract is anticipated to provide multiple types of pharmaceutical drugs (approximately 75 types) to support the GDUFA research program.

Similar Contracts

Same NAICS industry code

Supplier of Witch Hazel Impregnated Pads (NSN 6510-01-047-5619)This subcontract involves the supply of medical-grade Witch Hazel Impregnated Pads (NSN 6510-01-047-5619) for prime contractors supporting Department of Defense projects under the DLA Troop Support Medical Supply Chain. The required product consists of 3-inch pads composed of 70 percent material and 30 percent synthetic non-toxic fiber, specifically white cotton and rayon. These pads must maintain a pH level between 4.2 and 4.8 and be impregnated with Methylparaben and Benzalkonium Chloride, delivered in quantities of four jars containing 40 pads each. The manufacturer must ensure full compliance with Medical Marking Standard No. 1, ASTM D3951, and RP001. This opportunity falls under NAICS code 325412 and is managed by the Medical Supply Chain MD Surg FSF. Interested parties must adhere to the response deadline of November 9, 2026, for performance located at FPO 09573.

MEDICAL SUPPLY CHAIN MD SURG FSF

POSTED

about 1 hour ago

DEADLINE

Supply of 4% Chlorhexidine Gluconate Surgical DetergentThis subcontract involves the supply of 4% Chlorhexidine Gluconate surgical detergent for prime contractors supporting Department of Defense DLA Troop Support Medical Supply Chain projects. The selected provider is responsible for manufacturing or sourcing detergent that meets NSN 6505-01-101-3759, delivered in 8 oz bottles on a FOB Destination basis. All products must adhere to strict medical marking per Standard No. 1 and 1C, as well as hazardous material labeling requirements under 29 CFR 1910.1200. To qualify, the contractor must utilize FDA-regulated manufacturing facilities and maintain compliance with NIST SP 800-171 standards. This opportunity falls under NAICS code 325412 and is managed by the Medical Supply Chain Pharm FSA. Interested parties must submit their responses by November 9, 2026.

MEDICAL SUPPLY CHAIN PHARM FSA

POSTED

about 1 hour ago

DEADLINE

Supplier of i-STAT CK-MB Calibration Verification Control SetsThis subcontract involves the supply of i-STAT CK-MB Calibration Verification control sets to prime contractors supporting Department of Defense DLA Troop Support Medical Supply Chain projects. The required deliverables consist of control sets containing six 1 mL vials, with two vials provided for each of the three levels. All supplies must strictly adhere to NSN 6550016272276 and meet established medical supply chain quality controls for diagnostic reagents. The procurement falls under NAICS code 325412 and is managed by the Medical Supply Chain MD SURG FSF. The place of performance is designated as FPO 09566-4008. Interested parties must note the response deadline of November 9, 2026, following the posting date of November 1, 2026.

MEDICAL SUPPLY CHAIN MD SURG FSF

POSTED

about 1 hour ago

DEADLINE

SPF 50 Sunscreen ManufacturerThis subcontract involves the manufacture and supply of SPF 50 over-the-counter topical sunscreen for prime contractors serving the Department of Defense Medical Supply Chain. The required formulation must contain 4.5 percent titanium dioxide and 4 percent zinc oxide, while remaining hypoallergenic, oil-free, PABA-free, and biodegradable with 80-minute water resistance. Products are to be delivered in 3-ounce tubes organized in 24-count packages. The manufacturer must adhere to strict FDA OTC drug manufacturing standards and maintain compliance with the Buy American Act. This opportunity falls under NAICS code 325412 and is managed by the Medical Supply Chain Pharm FSA. Performance is designated for FPO 09573, with a response deadline set for November 9, 2026.

MEDICAL SUPPLY CHAIN PHARM FSA

POSTED

about 1 hour ago

DEADLINE

Supply of Antibody Detection Reagent Sets (Selectogen)This subcontract involves the supply of specialized Selectogen antibody detection reagent sets to support prime contractors for Department of Defense medical supply contracts. The requirement consists of four reagent sets, each containing 3% suspension Group O red cells with RH and RH2 phenotypes in 10ml bottles. All materials must strictly adhere to Medical Marking Standard No. 1 and follow packaging guidelines specified by MIL-STD-2073-1E and MPPWN00001. The deliverables are to be shipped to the Naval Medical Readiness Logistics Command located in Williamsburg, Virginia. This procurement falls under NAICS code 325412 and is managed by the Medical Supply Chain MD Surg FSF agency. The solicitation period opens on November 1, 2026, with a response deadline of November 9, 2026.

MEDICAL SUPPLY CHAIN MD SURG FSF

POSTED

about 1 hour ago

DEADLINE

Supply of Alcohol-Based Hand Sanitizer (NSN 8520-01-346-9200)This subcontract involves the supply of unscented, waterless hand cleanser with a 70 percent ethyl alcohol base for prime contractors supporting the Department of Defense Medical Supply Chain. The product must be provided in 4 fluid ounce bottles, packaged in 24 unit sets according to MIL-STD-2073-1E, and marked in accordance with Medical Marking Standard No. 1. All supplies must comply with FDA regulations and Hazard Communication Standard labeling, ensuring a non-extendable shelf life of 36 months. The contract, identified by NSN 8520-01-346-9200 and NAICS code 325412, is managed by the Medical Supply Chain MD SURG FSF. Performance for this requirement is located at Fort Stewart, Georgia. Interested parties must adhere to the response deadline of November 9, 2026.

MEDICAL SUPPLY CHAIN MD SURG FSF

POSTED

about 1 hour ago

DEADLINE

Supplier of Electrical Insulation Tape (NSN 5970-00-612-8492)This subcontract involves the supply of electrical insulation tape, specifically NSN 5970-00-612-8492, for prime contractors delivering to the DLA Weapons Support ASC Commodities Division. The selected supplier must provide eight rolls of tape to the Pearl Harbor Naval Shipyard. All materials must comply with MIL-I-19166C(1) standards, and the supplier is required to maintain quality systems meeting either SAE AS9003 or ISO 9001 certifications. Additional requirements include strict adherence to MIL-STD-2073-1E and MIL-STD-129 for packaging, as well as the provision of complete safety data sheet packages for any hazardous materials. The opportunity is categorized under NAICS code 325412, with a response deadline set for November 9, 2026.

DLA WEAPONS SUPPORT ASC COMMODITIES DIVISION

POSTED

about 1 hour ago

DEADLINE

DETERGENT, SURGICAL

Solicitation # SPE2DP-27-T-0211

Solicitation SPE2DP-27-T-0211 is a request for quotations from the DLA Troop Support Medical Supply Chain Pharm FSA for the procurement of surgical detergent containing 4% chlorhexidine gluconate. The requirement consists of two 8 oz bottles under NSN 6505-01-101-3759. The item is regulated by the FDA and must have a total shelf life of 24 months, with at least 21 months remaining upon delivery to the government. Delivery is specified as FOB Destination to the USNS Henson (T-AGS 63) in FPO AE 09573, with a required delivery date of November 3, 2026, and a lead time of 20 days after order. The contract mandates strict adherence to Medical Marking Standard No. 1 and 1C, which supersede MIL-STD-129 for medical marking, although MIL-STD-129 remains applicable for general packaging and shipping labels. Packaging must be commercial, utilizing sealed unit containers and suitable exterior shipping containers in accordance with RP001 and ASTM D3951, provided that DLA Master List technical requirements take precedence. Inspection and acceptance will occur at the destination. Administrative requirements include electronic invoicing via Wide Area WorkFlow and compliance with various FAR and DFARS clauses, including the Buy American Act, NIST SP 800-171 cybersecurity standards, and hazardous material labeling per 29 CFR 1910.1200.

MEDICAL SUPPLY CHAIN PHARM FSA

POSTED

about 1 hour ago

DEADLINE

APPLICATOR, SILVER NITR

Solicitation # SPE2DP-27-T-0213

This solicitation is for the procurement of Silver Nitrate Applicators (NSN 6505-00-299-9672) for the Department of Defense, specifically the Medical Supply Chain Pharm FSA. Each applicator consists of a mixture of 75 percent silver nitrate and 25 percent potassium nitrate fused to one end measuring 6 inches or 1.524 centimeters. The items are sold in containers of 100 applicators and are regulated by the FDA. They must be stored in closed packaging at room temperature in a dark, dry location away from organic or oxidizable materials. The product is designated as a Type I Code M item with a non-extendable shelf life of 24 months. The contract requires delivery to destination points in Okinawa, Japan, and Powidz, Poland, with a delivery lead time of 5 days after receipt of order. Packaging and marking must comply with MIL-STD-2073-1E, Medical Marking Standard No. 1, and specific hazardous materials regulations, including the provision of a current Material Safety Data Sheet. The award process may utilize automated awarding and includes a HUBZone price evaluation preference. Administrative requirements include the use of the Wide Area WorkFlow system for invoicing and compliance with various FAR and DFARS clauses regarding cybersecurity, domestic material restrictions, and hazardous material labeling.

MEDICAL SUPPLY CHAIN PHARM FSA

POSTED

about 1 hour ago

DEADLINE

TEST STRIPS AND COLOR

Solicitation # SPE2DS-27-T-1166

Solicitation SPE2DS-27-T-1166 is a procurement request by the Defense Logistics Agency for one bottle of medical test strips and color charts (NSN 6550-01-221-5400). These strips are used to test for bilirubin, blood, glucose, ketone, leukocytes, nitrite, pH, protein, specific gravity, and urobiligen in urine. The requirement specifies a delivery timeline of 20 days, with shipping terms set as FOB Destination. The items must adhere to Regulation 862.1340 Class II and maintain a non-extendable shelf life of 18 months, with no more than two months elapsed from the date of manufacture to the date of delivery. Packaging and marking must comply with Medical Marking Standard No. 1, which supersedes MIL-STD-129, and labels must include the contract number, lot number, and relevant dates of manufacture and expiration. Commercial packaging is required, with specific standards such as ASTM D3951 for non-hazardous materials and TQ requirement IP025 for hazardous materials. Administrative requirements include the use of the Wide Area WorkFlow system for electronic invoicing and payment. The contract incorporates various FAR and DFARS clauses, including the Buy American Act, safeguarding of covered defense information, and strict prohibitions on certain telecommunications equipment.

MEDICAL SUPPLY CHAIN MD SURG FSF

POSTED

about 1 hour ago

DEADLINE

Drug Testing Kit and Reagent SupplierThis subcontract agreement establishes a partnership for the supply of drug testing kits and reagents to support prime contractors working on MPTAP projects for the Board of Supervisors of Leake County, Mississippi. The supplier is responsible for providing consumables, including specific kits for drug metabolites such as Fentanyl and Kratom, as well as 5m x 75m plastic tubes. To ensure operational efficiency, all provided kits must be fully compatible with the existing installed analyzer. The contract requires the capacity to support a high volume of testing, estimated between 8,000 and 10,000 tests per month, with deliverables managed through monthly shipments. This procurement falls under NAICS code 325412 and is managed by the state of Mississippi.

POSTED

DEADLINE

Lenalidomide Medication SupplyThis subcontract involves the supply of Lenalidomide oral capsules in various dosage strengths ranging from 2.5mg to 25mg to support prime contractors on Department of Veterans Affairs pharmaceutical procurement projects. The selected provider is responsible for manufacturing or distributing the medication in the requested formulations and quantities, ensuring all products adhere to FDA standards for purity and dosage. A critical requirement for this contract is the mandatory FDA Risk Evaluation and Mitigation Strategy certification. Deliveries are organized by specific contract line item numbers 0001 through 0006. The opportunity is managed under the Department of Veterans Affairs Network Contract Office 22 with a response deadline of November 12, 2026.

262-NETWORK Contract Office 22 (36C262)

POSTED

DEADLINE

Ready to Pursue This Opportunity?

Get AI-powered intelligence on this solicitation and the ones like it

Every page of the solicitation package shredded into a compliance breakdown

AI-powered matching based on your capabilities and past performance

Competitor and incumbent history on the requirement

Automated alerts on amendments, Q&A deadlines, and award

Join 750+ contractors already using CLEATUS