Drug Master File (DMF)
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Registrar Corp can assist you with the following:
- File a new DMF
- Update or Amend an existing DMF
- Appoint Registrar Corp as your Agent
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If you would like to file a new Drug Master File (DMF) with FDA
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If you already have a DMF number with FDA
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| Option 1: Update your existing DMF
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Click the Update button below for any of the following:
- Amend your DMF
- File an Annual Update
- Reactivate a DMF
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Option 2: Order a Certificate of Filing issued by Registrar Corp for your existing DMF
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Companies registered with FDA often are asked by their customers and suppliers to verify their DMF filing. A Certificate of Filing issued by Registrar Corp serves to verify your DMF.
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Applicable U.S. Regulations:
FDA Regulation: 21 C.F.R. Section 314.420
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A drug master file is a submission of information to the Food and Drug Administration by a person (the drug master file holder) who intends it to be used for one of the following purposes: To permit the holder to incorporate the information by reference when the holder submits an investigational new drug application under part 312 or submits an application or an abbreviated application or an amendment or supplement to them under this part, or to permit the holder to authorize other persons to rely on the information to support a submission to FDA without the holder having to disclose the information to the person.
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| Registrar Corp assists businesses with FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling FDA registration requirements. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the US Food and Drug Administration.
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