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Filing a DMF for Beta-Cyclodextrin with the U.S. FDA

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

  - Wacker Biochem Corp

Registrar Corp can help you to properly prepare and submit your Beta-Cyclodextrin DMF to FDA.

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

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

For more information about filing a DMF for Beta-Cyclodextrin, 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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