FDA Drug Registration and Listing

Domestic and Foreign drug manufacturing and distributing firms must at the time of drug establishemnt registration, list all drugs manufactured, prepared, propagated, compounded, or processed for commercial distribution in the United States of America.  Additionally, foreign establishments must identify a US Agent and importers at the time of their drug establishemnt registration and FDA Drug Listing.  ( Check who need to Register & List )

API and Homeopathic Drugs also should complete FDA Drug Listing before distribution.

We help manufactures and Distributors to complete Drug Establishment Registration, NDC Code request to FDA will complete in a matter of 14 working days approximately. We also review the drug label before listing.

Fees and Registration Form
Drug Listing Form
Please contact us for any US FDA Drug Listing guidance

INDIA – Bangalore
+ 91 994 591 2081
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USA – Chicago
+1 630 696 1293
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mail enquiry@i3cglobal.com

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