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Filing a DMF for Eudragit L 30 D-55 with the U.S. FDA

Filing a drug master file (DMF) for Eudragit L 30 D-55 can be a useful mechanism to market your Eudragit L 30 D-55 to the U.S. Drug Industry. Typical Eudragit L 30 D-55 producers who have filed a DMF for Eudragit L 30 D-55 include:

  - Evonik Rohm Gmbh

Registrar Corp can help you to properly prepare and submit your Eudragit L 30 D-55 DMF to FDA.

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

  - Format, assemble and deliver your Eudragit L 30 D-55 DMF to FDA
  - Submit letters of authorization regarding your Eudragit L 30 D-55 to FDA
 - Provide changes, additions and maintenance of your Eudragit L 30 D-55 DMF
  - Respond to issues relating to ownership of your Eudragit L 30 D-55 DMF
  - Assist with submission of responses to FDA concerning your Eudragit L 30 D-55 DMF
  - Perform any required annual updates for your Eudragit L 30 D-55 DMF

For more information about filing a DMF for Eudragit L 30 D-55, 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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