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Filing a DMF for Elastomeric Closures with the U.S. FDA

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

  - Masataka Yanai
  - Pyunghwa Special Rubber Co Ltd

Registrar Corp can help you to properly prepare and submit your Elastomeric Closures DMF to FDA.

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

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

For more information about filing a DMF for Elastomeric Closures, 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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