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ITB HOLDINGS LLC assists companies around the world, including manufacturers, exporters, importers, distributors, and warehouses.
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.
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.
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.
BIENNIAL RENEWAL OF 2022