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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.
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.
FOREIGN SUPPLIER VERIFICATION PROGRAM (FSVP)
On March 18, 2023, U.S. Customs (CBP) deployed the Uyghur Forced Labor Prevention Act (UFLPA) Region Alert enhancement to the Automated Commercial Environment (ACE).
This enhancement will provide an early notification to importers and their representative of goods that may have been produced in the Xinjiang Uyghur Autonomous Region (Xinjiang or XUAR) and may be excluded from importation into the United States.
U.S. Food and Drug Administration to discuss whether a nasal spray version of the opioid overdose antidote Narcan should be made available over-the-counter.
About 78 percent of active pharmaceutical ingredients manufacturers are located outside of the U.S.
FDA products are manufactured or handled at nearly 275,000 registered facilities, more than half of which are overseas.
There are over 20,000 prescription drug products approved for marketing.
東京、横浜、大阪、名古屋、札幌、福岡、神戸、または京都に所在する貴社は、今すぐ米国 FDA 登録を更新する必要があります。 米国のエージェントとしてお手伝いします。
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.