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Filing a DMF for Plastic Colorants with the U.S. FDA

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

  - Penn Color Inc

Registrar Corp can help you to properly prepare and submit your Plastic Colorants DMF to FDA.

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

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

For more information about filing a DMF for Plastic Colorants, 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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