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Filing a DMF for Capsules with the U.S. FDA

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

  - Capsugel

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

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

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

For more information about filing a DMF for Capsules, 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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