MODIFICATION
65 -- Pentoxifylline (PTX) Extended Release (ER) 400 mg
- Notice Date
- 2/26/2021 9:59:26 AM
- Notice Type
- Solicitation
- NAICS
- 325412
— Pharmaceutical Preparation Manufacturing
- Contracting Office
- RPO EAST (36C24E) PITTSBURGH PA 15212 USA
- ZIP Code
- 15212
- Solicitation Number
- 36C24E21Q0039
- Response Due
- 3/16/2021 9:00:00 AM
- Archive Date
- 06/23/2021
- Point of Contact
- Lynn M Portman, Contracting Officer
- E-Mail Address
-
lynn.portman@va.gov
(lynn.portman@va.gov)
- Awardee
- null
- Description
- THIS IS A SOURCES SOUGHT SYNOPSIS ONLY. This is not a solicitation announcement. The purpose of this synopsis is to gain knowledge of potential qualified sources for can provide and ship Pentoxifylline (PTX) Extended Release (ER) 400 mg tablets in bulk containers to the CSPCRPCC and will provide a Certificate of Analysis for each lot of pentoxifylline supplied. Required Shelf-Life is a minimum of 18- months at time of receipt to CSPCRPCC. BACKGROUND: The Cooperative Studies Program Clinical Research Pharmacy Coordinating Center (CSPCRPCC) is supporting clinical trial CSP 2008 Pentoxifylline in Diabetic Kidney Disease (VA PTXRx) to determine if Pentoxifylline extended release, compared with placebo, when added to standard of care treatment, leads to reduction in the incidence of adverse renal outcomes in type 2 diabetic patients with Diabetic Kidney Disease (DKD). A sample size of 2,510 participants will be followed until 111 months is up. The sample size may increase during the study if the primary endpoint event rate is lower than anticipated. The study will be conducted under a research Investigational New Drug (IND) application but will not be applying for a new indication or a labeling change. CSPCRPCC can receive bulk containers and package the pharmaceutical product into study desired configuration. REQUIREMENTS: The purpose of this synopsis is to gain knowledge of potential qualified sources to provide and ship Pentoxifylline (PTX) Extended Release (ER) 400 mg tablets in bulk containers to the CSPCRPCC and will provide a Certificate of Analysis for each lot of pentoxifylline supplied. Required Shelf-Life is a minimum of 18- months at time of receipt to CSPCRPCC. Vendor to be compliant with current Good Manufacturing Practices (cGMP) as detailed in 21 CFR, Chapter 1, Subchapter C, Parts 210-211 and the product must be Trade Agreement Act (TAA) compliant. 7.1 Vendor is to supply the CSPCRPCC with active Pentoxifylline (PTX) Extended Release (ER) 400 mg tablets (5,676,850 tablets across the life of the contract) from a Manufacturer that is FDA-approved with a therapeutic equivalence evaluation. Therapeutic equivalency requires that the active Pentoxifylline (PTX) Extended Release (ER) tablets be classified as a pharmaceutical equivalent expected to have the same clinical effect and safety profile when administered to study participants under the conditions specified in the official prescribing information. 7.1.1 Active Pentoxifylline tablets will contain identical amounts (400 mg) of the same active pharmaceutical ingredient in the same dosage form (extended release formulation) as the reference listed drug (21 CFR 314.94(a)(3)). 7.1.2 Active Pentoxifylline tablets will meet compendia or other applicable standards of strength, quality, purity, and identity. 7.1.3 Active Pentoxifylline tablets will be bioequivalent to the reference listed drug and meet all acceptable in-vitro standards. Tablets also must meet all necessary bioequivalence requirements and have a therapeutic equivalence code of at least AB. 7.1.4 Supplier must have and must provide the CSPCRPCC with tracer documentation proving the pedigree of Pentoxifylline 400 mg ER active pharmaceutical ingredient and Trade Agreement Act (TAA) compliance. If exempted for any reason, provide documentation attesting to this fact. 7.1.5 Vendor will ship active drug in appropriately sealed bulk containers for repackaging. 7.2 The vendor must obtain and forward the Manufacturer s evidence of performed release testing and stability testing (industry standard Certificates of Analysis and Stability Reports) to CSPCRPCC by lot number (regardless of whether portions of the lot have previously been sent) no later than 5 business days prior to shipping. Certificates of Analysis and Stability Reports may be provided to the CSPCRPCCC by fax or e-mail. CSPCRPCC will provide contact information. Stability testing must include testing at vendor recommended storage conditions for time points to specified durations or expiration of product. 7.3 Shipments to CSPCRPCC will occur after receiving an order. Orders will be placed as a single order during contract period of performance to allow for adjustments to study performance date. Vendor is responsible for shipping costs of Pentoxifylline 400 mg ER to the CSPCRPCC. 7.3.1 The CSPCRPCC will perform acceptance inspections of shipments, ensure Certificates of Analysis and Packing Lists are included and complete, and containers are properly labeled and sealed. Failure of a Lot, Shipment, or Container to meet contract requirements may result in a rejection of the Lot, Shipment, or Container. 7.3.2 Each shipment must be accompanied with a packing list that describes the product and quantity shipped, lot number and expiration date that clearly identifies the product shipped. MISSING DOCUMENT/INFORMATION CAN RESULT IN REJECTION OF A SHIPMENT. 7.3.3 Remediation for damaged/unacceptable lots, shipments: Vendor will replace any identified unacceptable lots, shipments and/or containers at vendor expense. Examples (but not limited to these) include broken tablets, incorrect/improper labeling, damaged containers, and/or missing documentation. 7.4 Vendor will provide the CSPCRPCC with up-to-date, FDA-approved, official prescribing information. INSTRUCTIONS TO INTERESTED VENDORS: If you are interested and capable of providing the required services, please provide the requested information as indicated below. Provide a detailed capability document that explains how your company could meet the requirements listed in this notice and provide your business size and status? (Large business, small business, veteran owned small business) Send responses to this notices to Lynn.Portman@va.gov and David.Older@va.gov by Wednesday, January 20th at 12pm EST. This notice is to assist the VA in determining sources only. After review of the responses to this sources sought synopsis, a solicitation announcement may be published on FBO.gov. All interested offers will have to respond to the solicitation announcement, in addition to responding to this sources sought announcement. Responses to this synopsis will be used by the Government to make appropriate acquisition decisions.
- Web Link
-
SAM.gov Permalink
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- Record
- SN05927907-F 20210228/210226230110 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
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