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Filing a DMF for Zytan (Galloquinate) with the U.S. FDA

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

  - Samsung Medical Rubber Co Ltd

Registrar Corp can help you to properly prepare and submit your Zytan (Galloquinate) DMF to FDA.

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

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

For more information about filing a DMF for Zytan (Galloquinate), 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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