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Filing a DMF for Makrolon Resins with the U.S. FDA

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

  - Bayer Materialscience Llc

Registrar Corp can help you to properly prepare and submit your Makrolon Resins DMF to FDA.

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

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

For more information about filing a DMF for Makrolon Resins, 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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