A Drug Master File (DMF) is a submission to the FDA, which may be
used to provide confidential detailed information about facilities,
process or articles used in the manufacturing, processing, packaging,
and storing of one or more human drugs. Primary types:
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Type II: drug substance, drug substance intermediate, and material used in their preparation, or drug product
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Type III: packaging material
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Type IV: excipient, colorant, flavor essence, or material used in their preparation
Role of DMF
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DMFs are generally created to allow a party other
than the holder of the DMF to reference material without disclosing to
that party the contents of the file.
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The information contained in the DMF may be used
to support an Investigational New Drug Application (IND), a New Drug
Application (NDA), and Abbreviated New Drug Application (ANDA), another
DMF and an Export Application, or amendments and supplements to any of
these.
Service
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Determining the starting material covered by GMP regulations
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Organizing and reviewing the original materials and product information
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Organizing and reviewing manufacturing process and control materials
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Preparing DMF package
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Submitting DMF materials to FDA
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Correspondence with FDA
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Routine maintenance of approved DMF (Annual report, change report, and notification…)
Link to "Services" for more information.
