Drugs | Registration & Listing

All drug manufacturers, processors, packers, repackers, labelers, and relabelers who offer drugs for sale or distribution in the United States are required to register their drug establishments with FDA. The FDA drug establishment registration regulations apply to domestic drug companies and foreign drug facilities alike. Foreign drug firms must also identify a U.S. Agent for FDA purposes. Every drug establishment registered with FDA must submit, in the English language, a list of every drug they have in commercial distribution.

FDA's electronic drug registration and drug listing system provides information to FDA on all drug companies manufacturing, processing, packing and labeling drugs for U.S. distribution.

FDAImports.com, LLC performs drug registration and drug listing services and U.S. Agent services for its clients. Having FDAImports.com, LLC perform drug registration and drug listing and act as U.S. Agent for your foreign drug manufacturing facility ensures you have representatives who have worked directly with and for FDA performing those services that are critical for successfully distributing drugs in the U.S.

FDAImports.com, LLC can register your drug establishment, list your drug products, and act as the U.S. Agent for foreign drug manufacturers. Additionally, the firm can provide counsel regarding drug manufacturing and drug labeling compliance, which is key to successfully importing legal drugs into the U.S.