ITB HOLDINGS LLC | 390 North Orange Avenue, Suite 2300 | Orlando, FL 32801 | United States

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YOUR MARKET
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Join thousands of satisfied clients in more than 100 countries. Reach millions more customers willing and able to buy your products.

FDA REGISTRATION SERVICES

Companies can export or import products to or from the United States as long as the facilities that produce, store, or otherwise handle them are registered with the U.S. Food and Drug Administration (U.S. FDA), and prior notice of incoming shipments is provided to the FDA.

ITB HOLDINGS LLC assists companies around the world, including manufacturers, exporters, importers, distributors, and warehouses.

■ OUR SERVICES ARE OFFERED 24/7

For the following products requiring FDA RegistrationFoodsDietary Supplements, Alcoholic Beverages, Medical Devices, Medical Apps, Prescription Drugs, Over-the-Counter (OTC) Drugs, Active Pharmaceutical Ingredients (APIs), Cosmetics, Radiation-Emitting Products, Vaccines, Blood & Biologics, Animal & Veterinary Products.

Just in case you feel the need to switch U.S. Agent, we make the process easy. Get the better service your company deserves.

    FDA NEWS

    FDA issued Warning Letters to 11 companies illegally selling adulterated dietary supplements containing, in some cases, new dietary ingredients (NDIs), or are unsafe food additives.


    FDA amended the Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine, authorizing the use of a single booster dose for administration to children 5-11 at least five months after completion of a primary series with the Pfizer-BioNTech COVID-19 Vaccine.


    There are no FDA-approved drugs containing delta-8 THC. Any delta-8 THC product claiming to diagnose, cure, mitigate, treat, or prevent diseases is considered an unapproved new drug. The FDA has not evaluated whether these unapproved drug products are effective for the uses manufacturers claim, what an appropriate dose might be, how they could interact with FDA-approved drugs or other products, or whether they have dangerous side effects or other safety concerns.


    www.m.itbhdg.com
    www.fda.itbhdg.com
    www.itbhdg.com

    Exporting Hand Sanitizers or PPEs?
    Contact ITB HOLDINGS LLC, today, to register your company and list your products, with extra savings. Make sure your DUNS Number is current.

    Don’t take a chance assuming that regulations in the United States, Canada, Mexico, Brazil, Australia, India, South Korea, China, Japan, Russia, European Union, are the same or similar.
    CURRENT FDA REGISTRATION TRENDS
    Food Facilities
    0%
    Medical Devices
    0%
    OTC Drugs
    0%
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    FDA REGISTRATION

    &

    BIENNIAL RENEWAL OF 2022