Filing a drug master file (DMF) for Capsules can be a useful mechanism to market your
Capsules to the U.S. Drug Industry. Typical Capsules producers who have filed a DMF for
Registrar Corp can help you to properly prepare and submit your Capsules DMF to FDA.
As your Agent, Registrar Corp will perform the following administrative functions:
Format, assemble and deliver your Capsules DMF to FDA
Submit letters of authorization regarding your Capsules to FDA
Provide changes, additions and maintenance of your Capsules DMF
Respond to issues relating to ownership of your Capsules DMF
Assist with submission of responses to FDA concerning your Capsules DMF
Perform any required annual updates for your Capsules DMF
For more information about filing a DMF for Capsules, simply click below:
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.