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Filing a DMF for Vials with the U.S. FDA

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

  - Nissho Corp
  - Shinil Pharm Glass Co. Ltd.

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

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

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

For more information about filing a DMF for Vials, 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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