6505--RX - Brand name or Equal to Pylarify

SOL #: 36C24226Q0246Pre-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
Apr 2, 2026
3
Response Deadline
Mar 4, 2026, 9:30 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 Solicitation (36C24226Q0246) for the procurement of Pylarify (Piflufolastat F 18 Injection) or an equal radiopharmaceutical. This Firm-Fixed-Price contract is for diagnostic PET imaging at multiple VISN 2 South VAMCs. This acquisition is a Total Small Business Set-Aside. Offers are due by March 12, 2026, at 10:00 AM EDT.

Scope of Work

The requirement is for Pylarify (piflufolastat F-18 intravenous) diagnostic PET radiopharmaceutical, or an equal product, in 9.0 mCi doses. Key salient characteristics include:

  • Half-life > 100 minutes, high tumor-to-background ratio, sensitivity > 85%.
  • FDA Approved, contains Fluorine-18 (F-18) radiolabeled prostate-specific membrane antigen inhibitor.
  • Sterile, non-pyrogenic, clear colorless solution for intravenous injection.
  • Radiochemical purity > 95% up to 10 hours post-synthesis.
  • Specific activity > 1000mCi/µmol at administration, binds to PSMA, and must not contain gallium-68. Daily deliveries are required to specified VAMCs, Monday-Friday before 12:00 PM (noon). The contractor must possess a Nuclear Regulatory Commission License and comply with relevant regulations (DOT, NRC/NHPP, FDA, OSHA, USP 797). Quality control manuals, product testing, MSDS sheets, and package inserts are also required. An assigned sales representative for each VAMC is mandatory.

Contract Details

  • Contract Type: Firm-Fixed-Price
  • Period of Performance: April 1, 2026, to March 31, 2027
  • Product Service Code (PSC): 6505 (Drugs And Biologicals)
  • NAICS Code: 325412 (Pharmaceutical Preparation Manufacturing)
  • Size Standard: 1300 Employees
  • Set-Aside: Total Small Business

Submission & Evaluation

  • Offer Submission Deadline: March 12, 2026, 10:00 AM EDT
  • Questions Deadline: March 9, 2026, 10:00 AM EDT
  • Offer Acceptance Period: 60 calendar days from the offer due date.
  • Submission Format: Electronically in PDF or Microsoft Excel format.
  • Evaluation Factors: Technical, Past Performance, Price, and Veterans Participation Credit. Offerors must submit copies of licenses and certifications (e.g., NRC license), product specifications, and FDA literature with their proposals.

Contact Information

People

Points of Contact

Aleta JennetteContracting OfficerPRIMARY

Files

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Versions

Version 6Viewing
Pre-Solicitation
Posted: Apr 2, 2026
Version 5
Award Notice
Posted: Apr 2, 2026
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Version 4
Combined Synopsis/Solicitation
Posted: Apr 2, 2026
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Version 3
Combined Synopsis/Solicitation
Posted: Mar 5, 2026
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Version 2
Pre-Solicitation
Posted: Mar 4, 2026
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Version 1
Sources Sought
Posted: Dec 31, 2025
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6505--RX - Brand name or Equal to Pylarify | GovScope