Drug Master File (DMF)

A Drug Master File (DMF) is a confidential document submitted to regulatory authorities, like the FDA, that contains detailed information about a drug's ingredients, manufacturing processes, and quality controls. It serves as a reference for companies that want to use those drug components in their products. The DMF helps ensure that the drugs are safe and effective without disclosing proprietary information. Essentially, it provides a way for manufacturers to comply with regulations while protecting their intellectual property.