DMF stands for Drug Master File, which is a document prepared by a pharmaceutical manufacturer and submitted to the appropriate regulatory authority in the intended drug market. The document provides the regulatory authority with confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs. Typically, a drug master file is filed when two or more firms work in partnership on developing or manufacturing a drug product. The DMF filing allows a firm to protect its intellectual property from its partner while complying with regulatory requirements for disclosure of processing details.
It is important to note that DMF can also stand for Dimethylformamide, which is an organic compound used as a solvent for chemical reactions. Dimethylformamide is an irritant and can harm the eyes, skin, lungs, liver, and heart.
In summary, DMF can refer to two different things: Drug Master File, which is a document submitted by a pharmaceutical manufacturer to provide detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs; and Dimethylformamide, which is an organic compound used as a solvent for chemical reactions and can be harmful to human health.