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Filing a DMF for Mica M-1164 with the U.S. FDA

Filing a drug master file (DMF) for Mica M-1164 can be a useful mechanism to market your Mica M-1164 to the U.S. Drug Industry. Typical Mica M-1164 producers who have filed a DMF for Mica M-1164 include:

  - Mica Corporation

Registrar Corp can help you to properly prepare and submit your Mica M-1164 DMF to FDA.

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

  - Format, assemble and deliver your Mica M-1164 DMF to FDA
  - Submit letters of authorization regarding your Mica M-1164 to FDA
 - Provide changes, additions and maintenance of your Mica M-1164 DMF
  - Respond to issues relating to ownership of your Mica M-1164 DMF
  - Assist with submission of responses to FDA concerning your Mica M-1164 DMF
  - Perform any required annual updates for your Mica M-1164 DMF

For more information about filing a DMF for Mica M-1164, 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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