Domestic and foreign establishments that manufacture, repack, or re-label drug products to export to the United States are required to register with the FDA and must appoint a U.S. Agent.
Manufacturers of drugs to be imported into the U.S. from a foreign country also need to list all their marketed drug products. The compliance of drugs being sold to customers in the U.S. – whether it is over the counter or prescription drugs, including generic drugs and homeopathic therapeutics must be verified. This way, the drug products that enter the U.S.-market can be labeled as ‘safe’ as they comply with the applicable label requirements as established by the FDA. This means that if you are a drug manufacturer from a foreign country, and you would like to market your drugs in the U.S., these pharmaceutical goods must meet certain requirements, and you have completed your FDA registration.
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