The Department of Health and Human Services Food and Drug Administration awarded a firm-fixed-price definitive contract to the Regents of the University of Michigan, Office of Research and Sponsored Projects, doing business as the University of Michigan, to set patient-centric quality standards (PCQS) for modified release (MR) oral drug products with biopredictive in vitro dissolution-models. The contract has a potential value of $2,212,490.00 and a completion date of September 29, 2025. The University of Michigan, a U.S. state government entity and educational institution, has previously received prime and subcontract awards from federal agencies like the Department of Veterans Affairs, Department of Defense, and National Aeronautics and Space Administration to conduct research and provide services. This contract does not have a set-aside designation.
The prime contractor, University of Michigan, has awarded a subcontract to Cambridge Isotope Laboratories, Inc., a foreign-owned, for-profit manufacturer, to provide 0.1 grams of custom-synthesized, microbiological/pyrogen-tested glipizide with 99% 13C6 labeling. Cambridge Isotope Laboratories is a major supplier of custom chemicals and isotopically labeled compounds to U.S. federal agencies, supporting biomedical research programs at the National Institutes of Health.
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