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Filing a DMF for Magnesium Stearate USP with the U.S. FDA

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

  - Nitika Chemicals

Registrar Corp can help you to properly prepare and submit your Magnesium Stearate USP DMF to FDA.

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

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

For more information about filing a DMF for Magnesium Stearate USP, 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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