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FBO DAILY ISSUE OF MAY 11, 2012 FBO #3821
DOCUMENT

68 -- Active Pharmaceutical Ingredient (API) Quetiapine Fumarate - Attachment

Notice Date

5/9/2012
 

Notice Type

Attachment
 

NAICS

325998 — All Other Miscellaneous Chemical Product and Preparation Manufacturing
 

Contracting Office

Department of Veterans Affairs;Carlos Jaquez, Contract Specialist;SAO West VISN 18 NCO;5001 N Piedras St;El Paso TX 79930-4210
 

ZIP Code

79930-4210
 

Solicitation Number

VA25812I0444
 

Response Due

5/18/2012
 

Archive Date

8/16/2012
 

Point of Contact

Carlos Jaquez
 

E-Mail Address

Contract Specialist
(carlos.jaquez@va.gov)
 

Small Business Set-Aside

N/A
 

Description

This is not a request for proposal or quote announcement. This is a sources sought notice only, do not submit pricing. Not responding to this sources sought does not preclude participation in any future and potential solicitation. The purpose of this notice is to gain knowledge of potential qualified sources and their business size classification relative to NAICS code 325998 and the small business size standard is 500 employees. Consistent with the VA's Veterans First Contracting Program, VA is particularly interested in identifying Service-Disabled Veteran-Owned Small Businesses and/or Veteran-Owned Small Businesses with the capability to perform. This notice is to identify potential vendors that can provide active pharmaceutical ingredient (API), Quetiapine Fumarate, at a firm-fixed price for three (3) years starting on 07/20/2012 and ending on 09/30/2014 to the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center. SOW Task#Deliverable TitleQty.Delivery 1Base Year (FY12): Purchase of the active pharmaceutical ingredient (API), Quetiapine Fumarate1 - 25Kg DrumOn or before 07/20/12 2Option Year One (FY13): Purchase of the active pharmaceutical ingredient (API), Quetiapine Fumarate1 - 25Kg DrumOn or before 09/30/13 3Option Year Two (FY14): Purchase of the active pharmaceutical ingredient (API), Quetiapine Fumarate 1 - 25Kg DrumOn or before 09/30/14 The company manufacturing the API (Quetiapine Fumarate) must have a Drug Master File (DMF) on file with the U.S. Food and Drug Administration (FDA). The DMF demonstrates to the FDA how the manufacturer meets the regulatory, processing, quality and safety requirements for manufacturing the API. The study Sponsor, the Office of the Surgeon General, Department of the Army (Army) must submit an Investigational New Drug Application (IND) to the FDA to obtain permission to conduct the P313 Study. The information contained in the DMF assures the FDA employee reviewing the IND that the API used to make the clinical research product is made under the appropriate regulatory, process, quality and safety conditions. All interested and capable respondents are requested to provide the information below. All responses to this notice shall include: company name, address, point of contact, phone number, email address, business size, DUNS number (www.dnb.com), and list of available products. Responses to this notice should be sent electronically to carlos.jaquez@va.gov. Telephone responses will not be accepted. Responses must be received by 15:00 ET, Friday, May 18, 2012. All contractors interested in doing business with the Government must be registered in the Central Contractor Registration (CCR) database. The website for registration is www.ccr.gov. Service-Disabled Veteran-Owned Small Businesses and Veteran-Owned Small Businesses should also indicate whether the company is verified by the VA in the Vendor Information Pages (VIP) Database at www.vetbiz.gov.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/VAEPHCC756/VAEPHCC756/VA25812I0444/listing.html)
 

Document(s)

Attachment
 

File Name: VA258-12-I-0444 VA258-12-I-0444.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=337385&FileName=VA258-12-I-0444-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=337385&FileName=VA258-12-I-0444-000.docx

 

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

Place of Performance

Address: Department of Veterans Affairs;Cooperative Studies Program Clinical Research;Pharmacy Coordinating Center (CSPCRPCC);2401 Central Avenue SE;Albuquerque, NM

Zip Code: 87106-4180
 

Record

SN02743358-W 20120511/120509235300-8ec0be3f846e872f287c489e25e47fb4 (fbodaily.com)
 

Source

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

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