The U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER), examines and analyzes samples of imported drugs, to ensure they comply with applicable standards and or label requirements.
Establishment Registration and Products Listing with the U.S. Food and Drug Administration
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