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Filing a DMF for Portion Pack A, B, and C with the U.S. FDA

Filing a drug master file (DMF) for Portion Pack A, B, and C can be a useful mechanism to market your Portion Pack A, B, and C to the U.S. Drug Industry. Typical Portion Pack A, B, and C producers who have filed a DMF for Portion Pack A, B, and C include:

  - Kaito Chemical Industry Company Ltd.

Registrar Corp can help you to properly prepare and submit your Portion Pack A, B, and C DMF to FDA.

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

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

For more information about filing a DMF for Portion Pack A, B, and C, 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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