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cGMP Manufacturing and Scaling Services

Active
Federal

Contract Overview

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

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This subcontract, titled cGMP Manufacturing and Scaling Services and issued by the Department of Defense under agency W6QK Acc-Apg, provides critical manufacturing capacity for prime contractors working on CPE CBRND projects. The scope of work focuses on the production of medical countermeasures within cGMP certified environments, specifically managing the transition of biologics or small molecules from small-batch laboratory production to large-scale commercial manufacturing. To qualify, providers must maintain FDA facility certifications and strict cGMP compliance. The primary deliverables for this contract include the final manufactured drug substances or products along with detailed scale-up reports. The opportunity is categorized under NAICS code 325412 and was posted on August 19, 2026.

General Info

DoD subcontract for cGMP manufacturing and scaling of medical countermeasures for CPE CBRND projects.

Agency

Department Of Defense → W6QK Acc-ApgView Agency

NAICS

325412 - Pharmaceutical Preparation ManufacturingView NAICS

Place of Performance

MD

Set-Aside

NONE

Documents

This scope was carved out of W911SR-26-R-HEAL.

The full solicitation package (3 documents), including the RFP, is on the prime solicitation, not on this scope.

View the prime solicitation

Chemical, Biological, Radiological, and Nuclear (CBRN) Medical Countermeasure (MCM) Participant Basic Agreement (PBA)

AI Contract Breakdown

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Timeline

Posted

subcontract

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Organization & Contact Information

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AgencyDepartment Of Defense → W6QK Acc-Apg
ContactsNo contacts available
OfficeN/A
Organization / Agency
Department Of Defense → W6QK Acc-Apg
View Agency Profile
Office AddressN/A
ContactsNo contact information available

Full Description

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Supplies manufacturing capacity for prime contractors on CPE CBRND projects. Produces medical countermeasures in cGMP certified environments and executes the transition from small-batch lab production to large-scale commercial production for biologics or small molecules. Requires FDA facility certifications and cGMP compliance. Delivers manufactured drug substances/products and scale-up reports.

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Same NAICS industry code

NAICS: 325412
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The Department of Health and Human Services, through the Administration for Strategic Preparedness and Response, is soliciting proposals under solicitation 75A50326R00007 for the replenishment of expired or expiring pharmaceuticals for the Strategic National Stockpile. This is a full and open competition resulting in a twelve-month Firm Fixed Price contract. The scope includes the procurement of various FDA-approved pharmaceuticals, such as Dopamine Hydrochloride, Norepinephrine, and Morphine Sulfate, with the government reserving the right to increase awarded quantities by up to 20 percent. Deliveries are FOB Destination and may be required at up to nine locations across the contiguous United States and Hawaii. Award decisions will be based on a best-value tradeoff, prioritizing technical capability and past performance significantly over price. Technical evaluation focuses on product compliance, regulatory requirements, and the ability to meet delivery schedules. Strict quality standards are mandated, including adherence to current Good Manufacturing Practice regulations, specific temperature controls between 20C and 25C during storage and transit, and a requirement that products retain at least 90 percent of their FDA-approved shelf life upon receipt. Proposals must be submitted in two volumes by September 18, 2026, including a technical volume, a pricing volume, and a proposal submission worksheet. Large businesses are additionally required to submit subcontracting plans via the SBCX system.
Aspr/orm-Sns

POSTED

1 day ago

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in 6 days
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