FDA DRUG ESTABLISHMENT REGISTRATION AND LISTING

How to register facilities and products, and how to update registrations
December 9, 2013
CE Marking
January 10, 2014

Domestic and foreign establishments that manufacture, repack, or re-label drug products in the United States are required to register with the FDA. Domestic and foreign drug manufacturers, repackers or re-labelers are also required to list all of their commercially marketed drug products. This information helps the FDA maintain a catalog of all drugs in commercial distribution in the United States.

  • Drug Registration and Listing System Fees – Click here

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