Drug establishment registration: Establishments within any foreign country that engage in the manufacture, preparation, propagation, compounding, or processing (which includes, among other things, repackaging and relabeling) of a drug that is imported or offered for import into the United States
Drug listing: Registrants not exempt under 21 CFR 207.10 must submit the initial listing information for all drugs17 in commercial distribution at the time of their initial registration of their establishment(s). Registrants (and, if applicable, private label distributors) must update their drug listing information, and include drugs that have been introduced for commercial distribution and have not previously been listed
Manufacturer may or may not need state licenses. Need further evaluation. Licensing process may take up to one year.