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news.Pro-Pharmaceuticals has entered into a collaboration with SAFC, the custom manufacturing services division of Sigma-Aldrich to submit a drug master file to the FDA for its lead anticancer product candidate, Davanat.
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The drug master file (DMF) is a submission to the FDA that will be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of drugs for human consumption.
David Feldker, SAFC vice president, sales and manufacturing, said: “SAFC’s strong relationship with Pro-Pharmaceuticals has allowed us to collaborate on numerous projects. In this program, we expect to provide Pro-Pharmaceuticals with critical support for three Davanat batches, which will become a part of their DMF filing in the US SAFC plans to continue to support Davanat to ensure it can advance as efficiently as possible through the NDA process and on to FDA approval.”