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Filing a DMF for Vials and Ampules with the U.S. FDA

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

  - Taisei Kako Co Ltd

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

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

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

For more information about filing a DMF for Vials and Ampules, 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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