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Filing a DMF for Cal-Carb with the U.S. FDA

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

  - Colorcon Company

Registrar Corp can help you to properly prepare and submit your Cal-Carb DMF to FDA.

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

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

For more information about filing a DMF for Cal-Carb, 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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