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Filing a DMF for Sugar Sphere with the U.S. FDA

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

  - Colorcon Company

Registrar Corp can help you to properly prepare and submit your Sugar Sphere DMF to FDA.

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

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

For more information about filing a DMF for Sugar Sphere, 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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