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Filing a DMF for Sodium Alginate with the U.S. FDA

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

  - Pronova Biomedical As

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

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

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

For more information about filing a DMF for Sodium Alginate, 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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