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Filing a DMF for Dispensing Closure with the U.S. FDA

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

  - Weatherchem Corporation

Registrar Corp can help you to properly prepare and submit your Dispensing Closure DMF to FDA.

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

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

For more information about filing a DMF for Dispensing Closure, 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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