Drug Master Files | VajraSoft Inc

Executive Summary

Safety Intelligence reports provide insights into safety of biologics and therapeutics drug products.

Drug Master Files (DMFs) provides the information of all DMFs to FDA. The DMF reports listing provides status of all DMFs, be it Active or Inactive, Pending or unassigned.

Type of DMFs

The types of reports include:

  • Type I - Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)
  • 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

DMF reports based on status type, including DMF withdrawals by the holder:

  • Active
  • Inactive
  • Pending
  • Unassigned
  • Type V