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Filing a DMF for Ampoules and Bottles with the U.S. FDA

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

  - Lutz Gmbh & Co Kg

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

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

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

For more information about filing a DMF for Ampoules and Bottles, 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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