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