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Filing a DMF for Calcium Silicate with the U.S. FDA

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

  - Evonik Degussa Corporation
  - JM Huber Corp

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

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

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

For more information about filing a DMF for Calcium Silicate, 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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