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

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

  - Pharmaceutical Coatings Pvt Ltd

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

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

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

For more information about filing a DMF for Aerolac, 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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