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.
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.