What Does DMF Stand For?

DMF stands for Drug Master File

DMF, or Drug Master File, is a submission to the U.S. Food and Drug Administration (FDA) that contains detailed information about the manufacturing, processing, and packaging of a drug product or its ingredients. It serves as a repository of critical data, such as quality control, stability, and safety information, which can be referenced by drug applicants to support their submissions for new drug applications or abbreviated new drug applications. The DMF is intended to facilitate regulatory review while protecting the confidential information of the entity that submits it.