6505--RX - PYLARIFY (PIFLUFOLASTAT F 18 INJECTION) Brand name or Equal

SOL #: 36C24226Q0246Combined Synopsis/Solicitation

Overview

Buyer

Veterans Affairs
Veterans Affairs, Department Of
242-NETWORK CONTRACT OFFICE 02 (36C242)
ALBANY, NY, 12208, United States

Place of Performance

Place of performance not available

NAICS

Pharmaceutical Preparation Manufacturing (325412)

PSC

Drugs And Biologicals (6505)

Set Aside

Total Small Business Set-Aside (FAR 19.5) (SBA)

Timeline

1
Posted
Dec 31, 2025
2
Last Updated
Mar 5, 2026
3
Submission Deadline
Mar 12, 2026, 2:00 PM

Qualification Details

Fit reasons
  • NAICS alignment with historical contract wins in similar service areas.
  • Scope strongly matches core technical capabilities and delivery model.
Risks
  • Past performance thresholds may require one additional teaming partner.
  • Potential clarification needed on staffing minimums before bid/no-bid.
Next steps

Validate eligibility requirements, assign capture owner, and schedule partner outreach to confirm teaming strategy before submission planning.

Quick Summary

The Department of Veterans Affairs (VA), Network Contracting Office 2, has issued a Firm Fixed-Price solicitation for the procurement of Pylarify (Piflufolastat F 18 Injection) or an equal diagnostic PET radiopharmaceutical. This Total Small Business Set-Aside opportunity aims to secure daily deliveries to multiple VAMCs within VISN 2 South. Offers are due by March 12, 2026, at 10:00 AM EDT.

Scope of Work

The contractor will provide Pylarify (piflufolastat F-18 intravenous) or an equivalent product for diagnostic PET imaging. Key requirements include:

  • Product Specifications: Must meet salient characteristics such as a half-life > 100 minutes, high tumor-to-background ratio, sensitivity > 85%, FDA approval, high spatial resolution, containing Fluorine-18 (F-18) radiolabeled prostate-specific membrane antigen inhibitor, sterile, non-pyrogenic, clear colorless solution, radiochemical purity of at least 95% up to 10 hours post-synthesis, specific activity of at least 1000mCi/µmol, ability to bind to PSMA, and must not contain gallium-68.
  • Quantity: 9.0 mCi doses.
  • Deliveries: Daily, Monday-Friday, before 12:00 PM (noon) to specified VAMCs.
  • Compliance: Contractor must possess a Nuclear Regulatory Commission License and comply with DOT, NRC/NHPP, FDA, OSHA, and USP 797 regulations. Copies of licenses and certifications are required with proposals.
  • Support: Provision of a quality control manual, product testing, MSDS sheets, current package inserts, and an assigned sales representative for each VAMC. Ordering is preferred via web-based system, also available by phone and fax.

Contract & Timeline

  • Contract Type: Firm-Fixed-Price.
  • Period of Performance: April 1, 2026, to March 31, 2027.
  • Set-Aside: Total Small Business Set-Aside (FAR 19.5).
  • NAICS Code: 325412 (Pharmaceutical Preparation Manufacturing) with a size standard of 1300 employees.
  • Product Service Code (PSC): 6505 (Drugs And Biologicals).
  • Offer Submission Deadline: March 12, 2026, 10:00 AM EDT.
  • Questions Deadline: March 9, 2026, 10 AM EDT.
  • Offer Acceptance Period: 60 calendar days from the offer due date.

Evaluation

Proposals will be evaluated based on Technical capability, Past Performance, Price, and Veterans Participation Credit.

Additional Notes

This is a brand name or equal requirement. Offerors must submit proposals electronically in PDF or Microsoft Excel format, including specific documentation such as product specifications, Letter of Authorization (LOA), NRC license, and FDA literature.

People

Points of Contact

Aleta JennetteContracting OfficerPRIMARY

Files

Files

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Versions

Version 3Viewing
Combined Synopsis/Solicitation
Posted: Mar 5, 2026
Version 2
Pre-Solicitation
Posted: Mar 4, 2026
View
Version 1
Sources Sought
Posted: Dec 31, 2025
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6505--RX - PYLARIFY (PIFLUFOLASTAT F 18 INJECTION) Brand name or Equal | GovScope