IDIQ for CDER GDUFA research program for brand name and/or generic pharmaceuticals to include small molecule and peptide therapeutics.

Past New Requirement Updated

Agency
Solicitation expected
Not on record
Estimated value
$3,000,000 to $7,000,000
Set-aside
No set-aside

Forecast facts

Anticipated award
NAICS code
325412 Pharmaceutical Preparation Manufacturing
Points of contact

Forecast details come from HHS's procurement forecast. Agencies' dates and values are estimates.

About this forecast

The Food and Drug Administration's Center for Drug Evaluation and Research (CDER) is seeking a pharmaceutical manufacturer or supplier to provide brand name and/or generic pharmaceuticals, including small molecule and peptide therapeutics, under a single-award IDIQ contract. This requirement is designed to support the GDUFA research program and will involve procurement of approximately 75 types of pharmaceutical drugs. The estimated award date for this new requirement is August 1, 2026, with the opportunity having been posted on March 28, 2026.

The contract award value is estimated to range between $3,000,000 and $7,000,000, with no set-aside restrictions applied. The procurement falls under NAICS code 325412 (Pharmaceutical Preparation Manufacturing). For inquiries regarding this opportunity, interested contractors should contact Nick Sartain, the Contracting Officer at the Food and Drug Administration, via email at nick.sartain@fda.hhs.gov or by phone at (301) 796-1988.

Forecast text

The Center for Drug Evaluation and Research (CDER), requires Pharmaceutical Manufacturer/Supplier to provide brand name and/or generic pharmaceuticals to include small molecule and peptide therapeutics. A Single award IDIQ contract is anticipated to provide multiple types of pharmaceutical drugs (approximately 75 types) to support the GDUFA research program.

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