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

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

  - Peter Greven Nederland C.V.
  - Vasa Pharmachem Pvt Ltd
  - Mallinckrodt Inc

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

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

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

For more information about filing a DMF for Magnesium Stearate, 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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