Search for DMF (Drug Master File)

DMF Subject Type Status DMF Holder Completeness Assessment (Date) DMF# Submission Date

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.


You can search details of DMF(s) listed at FDA along with below information.

You can search for API DMF listing for any active ingredient to find listing status at FDA. Type II DMF of active ingredient is required to be submitted to FDA in order to submit ANDA. You can predict the potential future competitiveness by reviewing DMF listing of active ingredient.

Completeness Assessment

Type II DMFs to support ANDAs under GDUFA are subject to an initial "Completeness Assessment" under the conditions specified in the below guidance.
Completeness Assessments for Type II API DMFs Under GDUFA.
Completeness assessment of any active ingredient indicate that they are available for reference by ANDAs.

Reference

https://www.fda.gov/drugs/developmentapprovalprocess/formssubmissionrequirements/drugmasterfilesdmfs/default.htm

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