Sotax automated HPLC-dissolution platform
Past New Requirement Updated
- Agency
-
Food and Drug Administration
Department of Health and Human Services
- Solicitation expected
- Estimated value
- $250,000 to $700,000
- Set-aside
- No set-aside
Forecast facts
- Anticipated award
- NAICS code
- 334516 Analytical Laboratory Instrument Manufacturing
- Points of contact
-
- CDER Acquisition Liaison cderacquisitions@fda.hhs.gov
Forecast details come from HHS's procurement forecast. Agencies' dates and values are estimates.
About this forecast
The Food and Drug Administration is forecasting a new requirement for the procurement of a Sotax automated HPLC-dissolution platform to enhance analytical laboratory testing capabilities for generic drugs. This instrument will replace the current Waters Alliance dissolution platform and USP 2 apparatus, which are over 15 years old and no longer vendor-supported, with parts procurement becoming increasingly difficult. The equipment is essential for OPQR laboratory operations to conduct dissolution studies that directly support the OPQ mission objectives and the GDUFA program. The estimated solicitation release date is July 1, 2025, with an anticipated award date of January 1, 2026.
The estimated award value for this contract ranges from $250,000 to $700,000. This procurement falls under NAICS code 334516 (Analytical Laboratory Instrument Manufacturing) and carries no set-aside designation. Inquiries regarding this forecasted opportunity should be directed to the Food and Drug Administration's Acquisition Liaison at cderacquisitions@fda.hhs.gov.
Forecast text
The purrchase of this instrument enhances OPQ lab testing capability for generic drugs. Replacement of the current Waters Alliance dissolution platform as well as the USP 2 apparatus, which is over 15 years old and no longer supported by the vendor with increasingly difficult parts procurement. This equipment is essential for OPQR laboratory operations to conduct dissolution studies that directly support OPQ mission objectives and research goals, ensuring continued analytical capability for drug product testing. The work performed with this instrument will support GDUFA program needs.
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