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Filing a DMF for 1-Gallon HDPE Container with the U.S. FDA

Filing a drug master file (DMF) for 1-Gallon HDPE Container can be a useful mechanism to market your 1-Gallon HDPE Container to the U.S. Drug Industry. Typical 1-Gallon HDPE Container producers who have filed a DMF for 1-Gallon HDPE Container include:

  - Liquid Container*Plaxicon

Registrar Corp can help you to properly prepare and submit your 1-Gallon HDPE Container DMF to FDA.

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

  - Format, assemble and deliver your 1-Gallon HDPE Container DMF to FDA
  - Submit letters of authorization regarding your 1-Gallon HDPE Container to FDA
 - Provide changes, additions and maintenance of your 1-Gallon HDPE Container DMF
  - Respond to issues relating to ownership of your 1-Gallon HDPE Container DMF
  - Assist with submission of responses to FDA concerning your 1-Gallon HDPE Container DMF
  - Perform any required annual updates for your 1-Gallon HDPE Container DMF

For more information about filing a DMF for 1-Gallon HDPE Container, 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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