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This Government Contract opportunity from Department Of Veterans Affairs was posted on April 23, 2026. The submission period has ended. Browse the details below for market research, or find similar active opportunities.

Regulatory and Compliance Support for Federal Pharmaceutical Supply

Closed
Federal

Contract Overview

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

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AI Contract Overview

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Nac Pharmaceuticals is seeking a subcontractor to provide regulatory consulting services to ensure full compliance with FDA, VA, and DoD requirements for pharmaceutical products supplied to federal agencies. The scope includes managing NDC registration, adhering to federal labeling standards, and maintaining audit readiness for all aspects of the pharmaceutical supply chain. The contractor must demonstrate expertise in navigating the complex regulatory landscapes of these federal entities, ensuring that all labeling, documentation, and operational practices meet current and evolving standards. This subcontract supports the reliable and compliant delivery of pharmaceuticals to veterans and military personnel, requiring precision in regulatory strategy and proactive risk management. Bids are due by May 19, 2026, with the work governed under NAICS code 541611 for management consulting services, and performance is expected to align with federal pharmaceutical distribution obligations under the Department of Veterans Affairs.

General Info

Regulatory consulting for FDA, VA, DoD compliance, NDC registration, labeling, and audit preparation.

Agency

Department Of Veterans Affairs → Nac Pharmaceuticals (36E797)View Agency

NAICS

541611 - Administrative Management and General Management Consulting ServicesView NAICS

Place of Performance

IL

Set-Aside

NONE

Documents

This scope was carved out of 36E79726R0023.

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

View the prime solicitation

6505--Sevelamer Carbonate Tablets

AI Contract Breakdown

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Timeline

PhaseClosed
Posted

subcontract

Response Deadline

Deadline has passed

Submission Closed

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Organization & Contact Information

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AgencyDepartment Of Veterans Affairs → Nac Pharmaceuticals (36E797)
ContactsNo contacts available
OfficeN/A
Organization / Agency
Department Of Veterans Affairs → Nac Pharmaceuticals (36E797)
View Agency Profile
Office AddressN/A
ContactsNo contact information available

Full Description

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Provide regulatory consulting to ensure compliance with FDA, VA, and DoD requirements, including NDC registration, labeling standards, and audit readiness for federal pharmaceutical supply.

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6505--Ticagrelor Tablets
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The Department of Veterans Affairs National Acquisition Center is seeking an unrestricted procurement to establish an uninterrupted source of supply for Ticagrelor Tablets. This firm-fixed-price, indefinite-delivery requirements contract supports multiple federal health agencies, including the VA, Department of Defense, Bureau of Prisons, Indian Health Service, and Federal Health Care Centers. The award is designated as a HUBZONE small business set-aside and will be granted to the lowest-priced, technically acceptable offeror. The contract structure consists of a base year and four one-year options, with a maximum 60-calendar day implementation period before the ordering period begins. The scope of work includes the supply of Ticagrelor in 60mg and 90mg strengths across various bottle sizes, ranging from 60 to 1,000 tablets. Strict packaging and labeling standards are required, including the use of cylindrical bottles with a minimum 120cc volume and 5.75 inch circumference, safety caps that are convertible or deshelled, and unique 11-digit NDC numbers. All products must be compatible with automated dispensing units and feature GS1-128 or HIBC linear bar codes, as well as two-dimensional data matrix bar codes per the Drug Supply Chain Security Act. To be eligible for award, offerors must maintain an acceptable FDA cGMP status for their manufacturing facilities and provide the necessary NDA, ANDA, or BLA clearances. Those who are not the manufacturer must provide a formal Letter of Commitment ensuring a sufficient source of supply. Distribution will be managed through Government Prime Vendor contracts, with deliveries made to approximately 56 VA and DoD distribution centers nationwide. Proposals must be submitted in PDF or Word format, including a signed SF-1449 and pricing for all line items across the base and option years, with prices held firm for 120 calendar days.
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Solicitation # 36E79726R0035
Solicitation 36E79726R0035 is an unrestricted FAR Part 12 commercial-item procurement issued by the Department of Veterans Affairs National Acquisition Center for the supply of Influenza Virus Vaccines for the 2027-2028 season. The contract requires the delivery of trivalent or quadrivalent vaccines in pre-filled single-dose syringes with plunger and Luer lock needle attachments, provided in boxes of 10. The vaccines must be latex and preservative free, with specific FDA approval and labeling required for pediatric populations (6 to 35 months) and seniors (65 years and older). Final vaccine presentation is based on World Health Organization recommendations, with a preference for Trivalent presentations if both Trivalent and Quadrivalent options are commercially available. The award will be made on a per solicitation line item basis for the VA, Bureau of Prisons, Indian Health Service, and the Captain James A. Lovell Federal Health Care Center. Deliveries are Free On Board Destination to government facilities across the United States, Puerto Rico, and the Philippines. Most facilities require a two-part delivery schedule, with at least 50 percent of the order delivered between August 15 and September 15, 2027, and the remainder by October 15, 2027; however, the FHCC must receive 100 percent of its awarded quantity by September 15, 2027. Offerors must provide the full quantity for any line item bid, and final pricing must include the Cost Recovery Fee and Federal Excise Tax.
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Supply of Tacrolimus CapsulesThis subcontract involves the supply of Tacrolimus Capsules to prime contractors supporting Department of Veterans Affairs pharmaceutical projects. The selected provider is responsible for manufacturing or sourcing the capsules, assigning a unique National Drug Code, and performing primary labeling. All activities must maintain strict FDA regulatory compliance and ensure that no over-labeling occurs. Logistics are managed through the VA and DoD Pharmaceutical Prime Vendor Programs, with final delivery directed to Prime Vendor distribution centers. This opportunity is associated with NAICS code 325412 and was posted by Nac Pharmaceuticals under the Department of Veterans Affairs.
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NAICS: 325412
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6505--Tacrolimus Capsules
Solicitation # 36E79726R0033
The Department of Veterans Affairs, through the National Acquisition Center, is seeking an unrestricted procurement for Tacrolimus Capsules to support multiple federal health agencies, including the VA, Department of Defense, Bureau of Prisons, Indian Health Service, and Federal Health Care Center. This commercial item procurement, conducted under FAR Part 12, will be awarded to a single responsible offeror capable of providing an uninterrupted source of supply. The contract structure consists of a one-year base period with four pre-priced one-year option periods. Distribution of the pharmaceuticals will be managed through the VA and DoD Pharmaceutical Prime Vendor Programs. The scope of work includes the supply of three specific strengths of Tacrolimus capsules, with estimated annual requirements of 51,904 bottles of 0.5mg, 142,788 bottles of 1mg, and 5,207 bottles of 5mg. Strict labeling requirements are mandated, requiring offerors to provide the exact name of the drug as it appears on the label and a unique NDC number. The contractor's label must be the only label on the product, and the practice of affixing labels over existing ones is strictly prohibited. The solicitation is managed by the Enterprise Procurement Office in Hines, Illinois, with a response deadline of September 16, 2026.
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NAICS: 423450
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Pharmaceutical Distribution and FulfillmentThis subcontract for Pharmaceutical Distribution and Fulfillment, managed by Nac Pharmaceuticals for the Department of Veterans Affairs, focuses on the storage and shipment of Lisinopril tablets. The provider is responsible for the warehousing of finished products using climate-controlled facilities and logistics management software to support the Department of Veterans Affairs and DoD Pharmaceutical Prime Vendor Program projects. The scope of work includes coordinating FOB Destination shipments to federal health centers, CMOPs, and TMOPs, ensuring the product is delivered to all designated distribution points. This opportunity falls under NAICS code 423450, with a response deadline set for September 24, 2026.
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NAICS: 325412
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Pharmaceutical Packaging and Labeling ServicesThis subcontract for Pharmaceutical Packaging and Labeling Services involves the filling, labeling, and primary packaging of Lisinopril tablets to support Department of Veterans Affairs pharmaceutical supply projects. The selected provider will be responsible for filling intermediate containers and applying compliant labels, including 11-digit NDC numbers, within a sterile or controlled packaging environment to ensure the tablets are ready for distribution. To qualify for this engagement with Nac Pharmaceuticals, the contractor must possess a valid FEI number and maintain strict FDA cGMP compliance for packaging. The opportunity was posted on September 3, 2026, with a response deadline of September 24, 2026, falling under NAICS code 325412.
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NAICS: 325412
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Lisinopril Tablet ManufacturingNac Pharmaceuticals is seeking a subcontractor for the manufacturing of Lisinopril tablets to support Department of Veterans Affairs pharmaceutical supply projects. The selected provider will be responsible for the entire production process, including the chemical synthesis of the active pharmaceutical ingredient, formulation, compression into tablets, and rigorous quality control testing in accordance with ACS and USP-NF specifications. To qualify, the manufacturer must operate FDA-compliant cGMP facilities and possess a valid FEI number to ensure the delivery of bulk finished tablets that meet all purity and potency standards. This subcontract opportunity was posted on September 3, 2026, with a response deadline of September 24, 2026, falling under NAICS code 325412.
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NAICS: 325412
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36E79726R0032 Lisinopril Tablets (VA-27-00004937)
Solicitation # 36E79726R0032
The Department of Veterans Affairs, through the National Acquisition Center, is soliciting proposals for an unrestricted contract to provide an uninterrupted source of supply for Lisinopril Tablets. This procurement supports multiple federal health agencies, including the VA, Department of Defense, Bureau of Prisons, Indian Health Service, and Federal Health Care Centers, with distribution managed via the VA and DOD Pharmaceutical Prime Vendor Programs. The contract consists of a one-year base period with four pre-priced one-year option periods. Award will be made to a single responsible offeror based on an aggregate evaluation of all 22 line items across the base and option years. The scope of work includes the delivery of Lisinopril in strengths of 2.5mg, 5mg, 10mg, 20mg, 30mg, and 40mg across various package sizes. Strict packaging and labeling requirements are mandated, including the use of a unique NDC number, specific cylindrical bottle dimensions with a minimum 120cc volume and 5.75 inch circumference, and safety-caps that are either convertible or deshellable. Labels must be compatible with VA labels and fit specific dimensions of 5.25 by 2 inches. Offers are due by September 24, 2026, at 2:30 PM CST, and must include pricing for all line items and a 0.5 percent cost recovery fee.
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