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Sterile Manufacturing and Aseptic Fill-Finish Services

Active
Federal

Contract Overview

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

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The contract involves providing sterile manufacturing services including aseptic filling, lyophilization, and sterile vial packaging for injectable pharmaceuticals, all conducted under current Good Manufacturing Practice (cGMP) conditions. It is classified as a subcontract under the NAICS code 325412, which pertains to pharmaceutical preparation manufacturing. The focus is on ensuring the highest quality standards required for injectable drugs, emphasizing aseptic processing and sterile product handling to maintain product integrity and safety. Issued by the Department of Veterans Affairs through the Nac Federal Supply Schedule, the contract supports the production of injectable pharmaceuticals intended for distribution within federal health programs. While specific geographic locations for performance and points of contact are not detailed, the contract’s scope highlights its critical role in supplying sterile pharmaceutical products consistent with regulatory and quality standards for medical applications.

General Info

Sterile manufacturing subcontract for injectable pharmaceuticals under cGMP, ensuring aseptic processing quality.

Agency

Department Of Veterans Affairs → Nac Federal Supply Schedule (36F797)View Agency

NAICS

325412 - Pharmaceutical Preparation ManufacturingView NAICS

Place of Performance

IL

Set-Aside

NONE

Documents

This scope was carved out of 36F79726D0129.

The full solicitation package (1 document), including the RFP, is on the prime solicitation, not on this scope.

View the prime solicitation

6505--Secura Bio, Inc. Effective: 06-01-2026 - 05-31-2031

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Organization & Contact Information

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AgencyDepartment Of Veterans Affairs → Nac Federal Supply Schedule (36F797)
ContactsNo contacts available
OfficeN/A
Organization / Agency
Department Of Veterans Affairs → Nac Federal Supply Schedule (36F797)
View Agency Profile
Office AddressN/A
ContactsNo contact information available

Full Description

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Aseptic filling, lyophilization, and sterile vial packaging for injectable pharmaceuticals under cGMP conditions.

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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.
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