DMF (Drug Master File)

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DMF

A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.

Important facts regarding DMFs

  • It is submitted to FDA to provide confidential information
  • Its submission is not required by law or regulations
  • It is neither approved nor disapproved
  • It is filed with FDA to support NDA, IND, ANDA another DMF or amendments and supplements to any of these
  • It is provided for in the 21 CFR (Code of Federal Regulations) 314. 420
  • It is not required when applicant references its own information

Types of DMF

Type I: Manufacturing Site, Facilities, Operating Procedures, and Personnel (No longer accepted by FDA)

Type II: Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product

Type III: Packaging Material

Type IV : Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation

Type V: FDA Accepted Reference Information (FDA discourages its use)

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