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Filing a DMF for Hayashibara Pullulan with the U.S. FDA

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

  - Hayashibara Co Ltd

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

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

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

For more information about filing a DMF for Hayashibara Pullulan, 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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