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Filing a DMF for Kollidon SR with the U.S. FDA

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

  - BASF Aktiengesellschaft

Registrar Corp can help you to properly prepare and submit your Kollidon SR DMF to FDA.

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

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

For more information about filing a DMF for Kollidon SR, 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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