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U.S and foreign establishments that manufacture, repack, or re-label drug products in the United States are required to register with the FDA. All facilities located outside of the United States must also designate a U.S. Agent for FDA communications. Both companies Manufacture and Importer if different must be registered. FDA requires the DUNS number for every register Establishment. We will provide you with a UREG certificate for the confirmation.
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Yearly between October 1 and December 31
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