DRUGS

 

Domestic or Foreign Establishments registration with the U.S. Food and Drug Administration

 

Drug Establishment

$350.00

Any establishment engaged in the manufacture, repacking, relabeling, or salvaging of drugs for commercial distribution in the United States, is required to register with the FDA, and list its products.

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We expect you to provide the following with your payment:

  • Full company name, complete physical address (street, city, state, postal code, country)
  • Company DUNS Number
  • Name, telephone and email of CEO / Manager
  • Products details
FDA REGISTRATION
LOW ANNUAL SERVICE | FEES

LIMITED
OFFER

$350.00

U.S. Agent Service included.

Fluoride toothpaste, antiperspirants, dandruff shampoos, sunscreens, hand sanitizers are considered over-the-counter (OTC) drugs by the U.S. Food and Drug Administration, and available to consumers without a doctor’s prescription. Therefore, manufacturers of these products must register as a drug establishment.