Drug Formulation and Manufacturing Contracts 2019

Award Date 9/27/2019
Last Date To Order 9/27/2024
Shared Ceiling $45M
Contract Type
Master IDIQ
Predecessor
Not listed
Successors

The Drug Formulation and Manufacturing Contracts (DFMC) 2019 is a multiple-award Indefinite Delivery/Indefinite Quantity (IDIQ) contract vehicle established by the National Institutes of Health (NIH) to support pharmaceutical research and development. The contract enables NIH Institutes and Centers to procure specialized drug development services, focusing on the formulation, manufacturing, and testing of investigational drug products across various dosage forms. Specifically, the vehicle supports the development of small molecule drug candidates suitable for preclinical efficacy studies, Investigational New Drug (IND) enabling studies, and clinical trials, with a shared ceiling value of $45,000,250.

Task orders under this IDIQ consistently involve pharmaceutical development and manufacturing services, primarily for the National Cancer Institute (NCI), with contract values ranging from $10,000 to over $2.3 million. Frequently awarded contractors include Mriglobal (Midwest Research Institute), Societal CDMO San Diego, LLC, and Alchem Laboratories Corporation, who perform services such as drug toxicity testing, shelf-life studies, current Good Manufacturing Practice (cGMP) production, and investigational drug product manufacturing. Most task orders are firm fixed-price contracts without specific small business set-asides, though some contractors are self-certified small disadvantaged businesses. Performance locations appear concentrated in California and Maryland, with work supporting various cancer research initiatives, including the production of novel drug candidates like AZA-TDC, Triapine, and z-endoxifen.

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