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This Sources Sought opportunity was posted on October 27, 2008. The submission period has ended. Browse the details below for market research, or find similar active opportunities.

GMP Synthesis of Bulk Drug Substances

Closed
N01DA-9-8881Federal

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

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NAICS: 325411
New
Federal
NOI - B2B Award entitled - Developing Red Cell-Sp
Solicitation # 75N98027Q00017
Solicitation 75N98027Q00017 is a combined synopsis and notice of intent for a non-competitive award by the National Institutes of Health (NIH) to Purdue University, specifically the Purdue Institute for Drug Discovery. The contract supports the Bench-to-Bedside study Developing Red Cell-Specific Spleen Tyrosine Kinase (SYK) Inhibitors for Treating Sickle Cell Disease. The scope of work for the Year 1 requirement involves the synthesis, scale-up, characterization, and optimization of lead SYK inhibitors S1115 and S1213, with a delivery requirement of approximately 3 to 5 grams of each compound along with supporting analytical and potency data. The award is justified as non-competitive because Purdue University possesses the project-specific knowledge and prior research experience necessary to avoid technical risk and duplication of effort. The acquisition is conducted under FAR 12.603 for commercial items and is not expected to exceed the simplified acquisition threshold. Research activities will be performed at Purdue University in West Lafayette, Indiana, with deliverables sent to the National Heart, Lung, and Blood Institute in Bethesda, Maryland. The associated NAICS code is 325411 for Medicinal and Botanical Manufacturing, and the requirement is not set aside for small businesses. Administrative requirements include active registration in the System for Award Management and the use of the Invoicing Processing Platform for three-way match payments. Responses were due by November 4, 2026, to the contracting specialist, Nicholas Capobianco.
National Institutes Of Health Olao

POSTED

1 day ago

DEADLINE

in 14 days

General Info

Agency

N/A

NAICS

325411 - Medicinal and Botanical Manufacturing

Place of Performance

Not specified

Set-Aside

NONE

Documents

0

No documents available

Documents will appear here when they are available.

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Timeline

1 update
PhaseClosed
Posted

Sources Sought

Notice updated

Notice details unchanged. Attachments may have changed.

Response Deadline

Deadline has passed

Submission Closed

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Organization & Contact Information

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AgencyN/A
Contacts2 people available
OfficeN/A
Organization / Agency
N/A
Office AddressN/A
Contacts
Pedro M GodinezContract Specialist
Kenneth E GoodlingContracting Officer

Full Description

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The National Institute of Drug Abuse (NIDA) intends to solicit for the manufacture of bulk drug substances under Good Manufacturing Practices (GMP). The regulations and guidelines are in the Code of Federal Regulations, Food and Drugs, 21, Part 211, "Current Good Manufacturing Practice for Finished Pharmaceuticals". These bulk drug substances support NIDA preclinical safety testing and subsequent safety and efficacy clinical trials. Offerors must be experienced in producing GMP drug substance in batch sizes of at least one kilogram or larger, able to store GMP materials, and be in good standing with the FDA. Offerors must have immediate access to state-of-the-art equipment for analytical testing such as HPLC, GC/MS, IR, NMR. In order to handle substances under the Controlled Substances Act of 1970, the successful offeror must possess a current DEA registration for Schedules II-V substances, and demonstrate the capability to obtain DEA registration for Schedule I controlled substances. NIDA anticipates the award of two 3-year task order contracts, each with two 1-year options. RFP No. N01DA-9-8881 will be available electronically about November 17, 2008 and interested sources may access it through the Internet at: www.fbo.gov or through the NIDA website address: www.nida.nih.gov/RFP/RFPList.html. The electronic RFP contains all information needed to submit an offer. No printed version of the solicitation document or bidders list available. Proposals will be due about January 5, 2009. NIDA will consider proposals submitted by any responsible offeror. This advertisement does not commit the Government to award a contract. Based upon market research, the Government is not using the policies contained in Part 12, Acquisition of Commercial Items, in its solicitation for the described supplies or services. However, interested persons may identify to the contracting officer their interest and capability to satisfy the Government's requirement with a commercial item within 15 days of this notice.

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