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Filing a DMF for Microcrystalline Cellulose with the U.S. FDA

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

  - Gujarat Microwax Ltd

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

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

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

For more information about filing a DMF for Microcrystalline Cellulose, 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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