6505--RX - PYLARIFY (PIFLUFOLASTAT F 18 INJECTION) Brand name or Equal
Overview
Buyer
Place of Performance
NAICS
PSC
Set Aside
Original Source
Timeline
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 Combined Synopsis/Solicitation for the procurement of Pylarify (Piflufolastat F 18 Injection) or an equal radiopharmaceutical product. This requirement is for diagnostic PET imaging at multiple VA Medical Centers (VAMCs) within VISN 2 South. This acquisition is a Total Small Business Set-Aside. Offers are due by March 12, 2026, at 10:00 AM EDT.
Scope of Work & Requirements
The solicitation seeks a diagnostic PET radiopharmaceutical, specifically Pylarify (piflufolastat F-18 intravenous) or an equivalent product, for daily delivery of 9.0 mCi doses to specified VAMCs, Monday through Friday before 12:00 PM (noon). Key salient characteristics for an equal product include:
- Half-life greater than 100 minutes.
- High tumor-to-background ratio and sensitivity of 85% or more.
- FDA Approved, high spatial resolution.
- Contains Fluorine-18 (F-18) radiolabeled prostate-specific membrane antigen inhibitor.
- Sterile, non-pyrogenic, clear colorless solution for intravenous injection.
- Radiochemical purity of at least 95% up to 10 hours post-synthesis.
- Specific activity of at least 1000mCi/µmol at time of administration.
- Ability to bind to cells expressing prostate-specific membrane antigen (PSMA).
- Must not contain gallium-68.
The 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. Additional requirements include providing a quality control manual, MSDS sheets, current package inserts, and assigning a sales representative for each VAMC. Ordering will be available via Phone, Fax, and Web-based methods (Web-based preferred).
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
Submission & Evaluation
- Offer Submission Deadline: March 12, 2026, 10:00 AM EDT
- Questions Deadline: March 9, 2026, 10:00 AM EDT
- Evaluation Factors: Technical, Past Performance, Price, and Veterans Participation Credit.
- Offer Acceptance Period: 60 calendar days from the offer due date.
- Submission Format: Proposals must be submitted electronically in PDF or Microsoft Excel format.
Contact Information
- Contracting Officer: Aleta Jennette
- Email: Aleta.Jennette@va.gov
- Phone: (914) 737-4400 ext 2068