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FBO DAILY - FEDBIZOPPS ISSUE OF OCTOBER 04, 2015 FBO #5063
DOCUMENT

65 -- Purchase of Allopurinol - Attachment

Notice Date

10/2/2015
 

Notice Type

Attachment
 

NAICS

325412 — Pharmaceutical Preparation Manufacturing
 

Contracting Office

Department of Veterans Affairs;VISN/18PHX;777 E. Missouri, Suite 300;Phoenix AZ 85014
 

ZIP Code

85014
 

Solicitation Number

VA25816Q0001
 

Response Due

10/16/2015
 

Archive Date

11/6/2015
 

Point of Contact

William Corson
 

Small Business Set-Aside

Total Small Business
 

Description

CONTRACT TITLE. Purchase of allopurinol, USP 1.BACKGROUND. The VACSPCRPCC must purchase allopurinol, USP Active Pharmaceutical Ingredient (Allopurinol API) to manufacture 100 mg, 300 mg and 400 mg allopurinol tablets (Product) for VA research clinical trial CSP594 to study the use of allopurinol and febuxostat in veterans suffering from gout. This new VACSPCRPCC clinical trial that is expected to provide patients with allopurinol tablets. 2.SCOPE. This is a contract for the purchase of Allopurinol API which will be used to manufacture Product for VA research clinical trial CSP594, with option quantities for purchase during four additional years. The amount of Allopurinol API to be purchased will be variable and could range from a minimum order of approximately 25 kgs a year to the maximum order indicated under item number 1, Schedule of Services and/or Supplies. Because each vendor's product has different physical characteristics which impact how we manufacture the product in addition to characteristics of the finished tablets, we must use the same vendor for the life of the study. Switching Allopurinol API vendors in the middle of the study will require extensive additional costs that have not been budgeted for items such as revising regulatory submissions to the Food and Drug Administration, reformulating the product because it has different physical characteristics, additional stability testing, etc. Delivery time is an important factor as a long delivery time would delay the study. Purchasing from the company with the longer time frame would extend the study start-up date past our mid-March ship date. This would delay the start of a multi-million dollar study, delay veterans from obtaining the study drug and potentially impact jobs at the clinical locations. The proposed schedule includes time for Allopurinol API procurement; formulating or preparing the recipe for each Product (3 active and 3 placebo); the manufacture of pilot placebo batches for each Product; the manufacture of pilot batches for each of the three strengths of allopurinol Product; analytical testing for each Product and placebo; stability testing for each Product to determine how long the Product meets its specifications, and the manufacture, bottling, packaging and shipping of each Product and matching placebo to clinical sites throughout the U.S. in time for the initial patient enrollment. In addition the CSPCRPCC will be manufacturing other products in this time period. The Allopurinol API manufacturer must hold a Drug Master File (DMF) with the Food and Drug Administration. A DMF describes to the FDA the manufacturing processes and quality systems the vendor uses to manufacture the Allopurinol API. There are many vendors of Allopurinol API that do not have DMFs with the FDA. We cannot purchase from them for quality and safety reasons. Holding a DMF with the FDA provides the first layer of assurance that we will provide our veterans with tablets that meet our quality expectations and requirements. Because the VA does not buy commercial tablets and capsules manufactured in India or China, we also cannot buy active ingredient manufactured in India or China. Many Allopurinol API manufacturers sell product in the U.S. solely through a distributor. Thus the purchase may be directly with the manufacturer or indirectly through the distributor.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/PhVAMC/HMC/VA25816Q0001/listing.html)
 

Document(s)

Attachment
 

File Name: VA258-16-Q-0001 VA258-16-Q-0001_1.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2351357&FileName=VA258-16-Q-0001-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2351357&FileName=VA258-16-Q-0001-000.docx

 

Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
 

Record

SN03912980-W 20151004/151002234428-e1ba76942b96ec4a40f7d940a04197b1 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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