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Filing a DMF for Isomalt with the U.S. FDA

Filing a drug master file (DMF) for Isomalt can be a useful mechanism to market your Isomalt to the U.S. Drug Industry. Typical Isomalt producers who have filed a DMF for Isomalt include:

  - Sudzucker Ag

Registrar Corp can help you to properly prepare and submit your Isomalt DMF to FDA.

As your Agent, Registrar Corp will perform the following administrative functions:

  - Format, assemble and deliver your Isomalt DMF to FDA
  - Submit letters of authorization regarding your Isomalt to FDA
 - Provide changes, additions and maintenance of your Isomalt DMF
  - Respond to issues relating to ownership of your Isomalt DMF
  - Assist with submission of responses to FDA concerning your Isomalt DMF
  - Perform any required annual updates for your Isomalt DMF

For more information about filing a DMF for Isomalt, simply click below:




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U.S. FDA Regulations:

U.S. FDA DMF Regulation: 21 C.F.R. Section 314.420


Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.
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