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Filing a DMF for Azone(R), an Inactive Ingredient with the U.S. FDA

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

  - Albemarle Corp

Registrar Corp can help you to properly prepare and submit your Azone(R), an Inactive Ingredient DMF to FDA.

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

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

For more information about filing a DMF for Azone(R), an Inactive Ingredient, 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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