FDA Drug Establishment Registration and FDA Drug Listing

FDA Drug Establishment Registration and Drug Listing

According to the United States’ Food and Drug Administration, U.S. FDA Drug Regulations, all drug establishments that formulate, develop, manufacture, distribute, process or pack drugs that are marketed in the U.S. must register with FDA. Furthermore, all drug establishments that formulate, develop, manufacture, process or pack drugs that are marketed in the U.S. must list all of their marketed products through Electronic Drug Registration and Listing System (eDRLS).

This applies to domestic as well as foreign manufacturers, processors, packers and labelers for all OTC, API, generic, homeopathic and prescription drugs . In order to be registered, companies that are based outside the U.S. must have a U.S. agent assigned that will be FDA’s primary point of contact on behalf of a foreign company.

A complete list of who must be registered and list can be accessed here.

Importance of FDA U.S. Agent

The U.S. agent may be called upon to speak with FDA in regards to the registered drug establishment. This can be a time-sensitive matter. Therefore, it is crucial that your us agent understands the FDA regulations and is able to advise the foreign company on FDA requirements that must be followed. Furthermore, having an independent U.S. Agent will prevent a potential conflict of interest that can emerge when assigning a business partner as U.S. Agent.
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FDA Listing Inc. provides FDA drug establishment registration for domestic and foreign companies and can act as U.S. Agent to Non-US companies. We can also help your drug establishment list all of your commercially distributed products through Electronic Drug Registration and Listing System (eDRLS). Click the start button for drug establishment registration and drug listing.

FDA Registration Certificate

After your registration is complete, the registered drug establishment will be allocated a FDA registration number with FDA. In practice FDA does not issue any registration certificate however, as a third party agent, FDA Listing Inc. will provide you with a certificate of FDA registration that can be used as FDA registration confirmation. The FDA registration certificate is good for one year and the copy of the FDA registration certificate can be used as a proof of registration before U.S. custom, importers, distributers and other commercial outlets.

Service & Fees:

  • Registration of Drug Establishment,595 USD
  • Initial Assessment of Drug Classification, Free
  • Listing of Drugs (up to 4 package sizes),495 USD
  • Act as Official Correspondent (U.S. Agent) to FDA, Free
  • Certificate of FDA Registration, Free
  • ​Certificate of Drug Listing (NDC), 195 USD

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