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HomeDrugsDrug Master Files (DMF) › DMF Examples

DMF Examples

The following lists provide examples of DMFs filed with the U.S. Food and Drug Administration (U.S. FDA).

NOTE: These DMF lists are for informational purposes only, and are not comprehensive. If you have questions about specific DMFs, please contact us.
  
Examples of Type II DMFs (Drug Substance, Drug Substance Intermediate, and Material Used in their Preparation, or Drug Product) Type II DMFs comprise 70% of all active DMF filings.
  
Examples of Type III DMFs (Packaging Material) Type III DMFs comprise 20% of all active DMF filings.
  
Examples of Type IV DMFs (Excipient, Colorant, Flavor, Essence, or Material Used in their Preparation) Type IV DMFs comprise 8% of all active DMF filings.
  
Examples of Type V DMFs (FDA Accepted Reference Information, Manufacturing Site, Facilities, Operating Procedures, and Personnel) Type V DMFs comprise 2% of all active DMF filings.




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U.S. FDA Regulations:

U.S. FDA DMF Regulation: 21 C.F.R. Section 314.420


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