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Filing a DMF for CLZ-42 with the U.S. FDA

Filing a drug master file (DMF) for CLZ-42 can be a useful mechanism to market your CLZ-42 to the U.S. Drug Industry. Typical CLZ-42 producers who have filed a DMF for CLZ-42 include:

  - Nippon Shinyaku Co Ltd

Registrar Corp can help you to properly prepare and submit your CLZ-42 DMF to FDA.

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

  - Format, assemble and deliver your CLZ-42 DMF to FDA
  - Submit letters of authorization regarding your CLZ-42 to FDA
 - Provide changes, additions and maintenance of your CLZ-42 DMF
  - Respond to issues relating to ownership of your CLZ-42 DMF
  - Assist with submission of responses to FDA concerning your CLZ-42 DMF
  - Perform any required annual updates for your CLZ-42 DMF

For more information about filing a DMF for CLZ-42, 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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