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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
Accenture
Medtronic
US Department of Justice
Healthtrust
Chinese Patent Office
Deloitte
Colorcon
Queensland Health

Generated: July 23, 2018


Drug Master File Glossary

STATUS OF DMFS

  • A = Active. This means that the DMF was found acceptable for filing, administratively, and is up-to-date.
  • I = Inactive
  • N = Not an assigned number
  • P = DMF Pending Filing Review

TYPES OF DMFs

  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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

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Serving hundreds of leading biopharmaceutical companies globally:

McKesson
Colorcon
Dow
Merck
Accenture
US Army
Express Scripts
Moodys
Fuji

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