6505--RX - PYLARIFY (PIFLUFOLASTAT F 18 INJECTION) (NDC 71258-0022-01)
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 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.