6505--RX - PYLARIFY (PIFLUFOLASTAT F 18 INJECTION)

Solicitation / RFP / RFQ

This is a Brand Name or Equal Solicitation for RX - PYLARIFY (PIFLUFOLASTAT F 18 INJECTION). The Department of Veterans Affairs, Network Contracting Office 2, is issuing this solicitation.

Procurement of PYLARIFY (PIFLUFOLASTAT F 18 INJECTION) or an equal product.

• Product Service Code: 6505

• NAICS Code: 325412

• Response Date/Time/Zone: 03-12-2026 10 AM EASTERN TIME, NEW YORK, USA

• Archive: 10 days after the response date.

• Set-Aside: SBA (Small Business Administration)

• Contracting Office Address: Department of Veterans Affairs, Network Contracting Office 2, James J. Peters VA Medical Center, 130 West Kingsbridge Road, Bronx NY 10468-3904.

• Point of Contact: Aleta Jennette, Contracting Officer, Aleta.Jennette@va.gov, (914) 737-4400 ext 2068.

• Place of Performance: Multiple sites.

• Additional Information: Agency URL is https://www.va.gov.

• See attached document: 36C24226Q0246_1.

Solicitation / RFP / RFQ

This solicitation is for the procurement of Pylarify F-18 or an equal radiopharmaceutical injection. The product is required for diagnostic PET imaging and will be delivered to multiple Veterans Administration Medical Centers (VAMCs) within the Vision Integrated Supported Network (VISN) 2 South.

• Product: Pylarify (piflufolastat F-18 intravenous) diagnostic PET radiopharmaceutical, or an equal product meeting specific salient characteristics.

• Salient Characteristics:

  • Half-life > 100 minutes.
  • High tumor-to-background ratio.
  • Sensitivity of 85% or more.
  • FDA Approved.
  • High spatial resolution.
  • Contains Flourine-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.

• Quantity: 9.0 mCi doses.

• Deliveries: Daily deliveries to specified VAMCs, Monday-Friday before 12:00 PM (noon).

• Licenses & Certifications: Contractor must possess a Nuclear Regulatory Commission License and comply with DOT, NRC/NHPP, FDA, OSHA, USP 797, and other relevant regulations. Copies of licenses and certifications are required with proposals.

• Quality Control: Contractor must provide a quality control manual and test all products.

• Documentation: MSDS sheets and current package inserts must be provided.

• Sales Representative: An assigned sales representative for each VAMC is required.

• Ordering: PYLARIFY is available via Phone, Fax, and Web-based ordering (Web-based preferred).

• Period of Performance: 04/01/2026 to 03/31/2027.

• Contract Type: Firm-Fixed-Price.

• Offer Submission Deadline: 03/12/2026, 10:00 AM EDT.

• Questions Deadline: 03/09/2026, 10 AM EDT.

• Evaluation Factors: Technical, Past Performance, Price, and Veterans Participation Credit.

• Offer Acceptance Period: 60 calendar days from the offer due date.

• This acquisition is set aside for Small Business.

• NAICS Code: 325412 (Pharmaceutical Preparation Manufacturing).

• Size Standard: 1300 Employees.

• This is a brand name or equal requirement.

• Offerors must submit proposals electronically in PDF or Microsoft Excel format.

• Specific requirements for submission of product specifications, LOA, NRC license, FDA literature, and other documentation are detailed in the solicitation.

Solicitation / RFP / RFQ

This is a pre-solicitation notice for a requirement related to "RX - Brand name or Equal to Pylarify". The official solicitation is expected to be posted on 03/05/2026 at 10 AM.

Details regarding the specific product or service (Pylarify or equivalent) will be provided in the official solicitation.

Not specified in this notice.

• The response date for the official solicitation is 03-04-2026 at 4:30 PM Eastern Time, New York, USA.
• The document is archived 20 days after the response date.

This opportunity is set aside for SBA (Small Business Administration).

• Solicitation Number: 36C24226Q0246
• Product/Service Code (PSC): 6505
• NAICS Code: 325412
• Contracting Office Address: Department of Veterans Affairs, Network Contracting Office 2, James J. Peters VA Medical Center, 130 West Kingsbridge Road, Bronx NY 10468-3904.
• Point of Contact: Aleta Jennette, Contracting Officer, Aleta.Jennette@va.gov, (914) 737-4400 ext 2068.

Form / Attachment / Pricing Sheet

This document is a Sources Sought Notice, intended for informational and planning purposes only. It is not a solicitation and does not obligate the Government to issue a solicitation. The purpose is to conduct market research to determine interest and capability of potential Large and Small Business firms.

• NAICS Code: 325412 (Pharmaceutical Preparation Manufacturing)
• Product of Interest: Pylarify Piflufolastat F 18 Injection-National Drug Code (NDC 71258-0022-01)-Imaging Agents (IN VIVO) Radiopharmaceuticals.
• Delivery Location: VISN 2 Downstate Hospitals (addresses to be provided later).
• Information Requested: Name of firm, Socio-Economic category of the firm, complete address, and phone & fax numbers of contacts.

This notice helps potential vendors understand the Government's interest in specific radiopharmaceuticals and allows them to express their capability. It is crucial for firms interested in this market segment to respond to inform the Government's acquisition planning. Responses are due via e-mail to Aleta.Jennette@va.gov or via GSA E-buy. The Government will not pay for any information submitted.

Form / Attachment / Pricing Sheet

This document is a "Sources Sought Template" used to gather information from potential sources regarding their capability to provide a specific radiopharmaceutical injection. It is intended to help the government determine if a sufficient number of small businesses can provide the required product or service, which may influence the acquisition strategy (e.g., set-aside).

• Product: Pylarify (Piflufolastat F 18 Injection)
• National Drug Code (NDC): 71258-0022-01
• Product Service Code (PSC): 6505
• NAICS Code: 325412 (Pharmaceutical and Medicine Manufacturing)
• Contracting Office: Department of Veterans Affairs, Network Contracting Office 2, Bronx, NY.
• Response Date: January 12, 2026, 10 AM Eastern Time.

Vendors interested in providing Pylarify (NDC 71258-0022-01) should review this notice. Responding to this sources sought may indicate interest and capability, potentially influencing future solicitations. The NAICS code 325412 suggests the procurement is for manufacturers. The VA is seeking to understand market capabilities for this specific radiopharmaceutical injection for Downstate Hospitals within VISN 2.