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Filing a DMF for Ampoule and Vial with the U.S. FDA

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

  - Naigai Glass Industry Co Ltd

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

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

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

For more information about filing a DMF for Ampoule and Vial, 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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