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Filing a DMF for Tabcoat TC* with the U.S. FDA

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

  - Pharmaceutical Coatings Pvt Ltd

Registrar Corp can help you to properly prepare and submit your Tabcoat TC* DMF to FDA.

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

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

For more information about filing a DMF for Tabcoat TC*, 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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