ITB HOLDINGS LLC | 390 North Orange Avenue, Suite 2300 | Orlando, FL 32801 | United States
+1 855-389-7344
info@itbholdingsllc.com

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FDA REGISTRATION

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 of hand sanitizers,  N95 respirators and other COVID-19 (Coronavirus) personal protective equipment (PPE) covered by Emergency Use Authorizations (EUAs) .

■ OUR SERVICES ARE OFFERED 24/7

For the following products requiring FDA Registration: Foods, Dietary 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.

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    FDA NEWS

    Effective December 31, 2021, companies manufacturing alcohol-based hand sanitizers under the temporary policies must cease production of these products. Hand sanitizers manufactured before or on December 31, 2021, and produced under the temporary guidance can no longer be sold or distributed by manufacturers after March 31, 2022.

    As of today, 419 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs).

    FDA’s Center for Veterinary Medicine (CVM) sent letters to veterinarians and retailers, asking for help in stopping misuse of animal Ivermectin to prevent or treat COVID-19 in Humans.

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    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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