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Filing a DMF for B18196 with the U.S. FDA

Filing a drug master file (DMF) for B18196 can be a useful mechanism to market your B18196 to the U.S. Drug Industry. Typical B18196 producers who have filed a DMF for B18196 include:

  - Colors for Plastics Inc

Registrar Corp can help you to properly prepare and submit your B18196 DMF to FDA.

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

  - Format, assemble and deliver your B18196 DMF to FDA
  - Submit letters of authorization regarding your B18196 to FDA
 - Provide changes, additions and maintenance of your B18196 DMF
  - Respond to issues relating to ownership of your B18196 DMF
  - Assist with submission of responses to FDA concerning your B18196 DMF
  - Perform any required annual updates for your B18196 DMF

For more information about filing a DMF for B18196, 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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