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Filing a DMF for Phospholipid DMPC with the U.S. FDA

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

  - Nippon Fine Chemical Company Ltd

Registrar Corp can help you to properly prepare and submit your Phospholipid DMPC DMF to FDA.

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

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

For more information about filing a DMF for Phospholipid DMPC, 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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