Tag: US FDA Agent in India
-
FDA Drug U.S. Agent Requirement for Foreign Pharmaceutical Manufacturers
For foreign pharmaceutical companies planning to manufacture, export, or supply drugs to the United States, appointing an FDA Drug U.S. Agent is a mandatory regulatory obligation. The U.S. Agent serves as the official representative of the foreign drug establishment and acts as the primary communication channel with the United States Food and Drug Administration. Without…
-
FDA U.S. Agent UEI Number Requirements for Drug Establishment Registration
Introduction Foreign pharmaceutical companies planning to supply drugs to the United States must comply with strict regulatory requirements set by the Food and Drug Administration. One of the most critical obligations is the appointment of an FDA U.S. Agent and the use of a valid UEI number during establishment registration. Many manufacturers face confusion regarding…
-
FDA US Agent for Drugs and the Role of XPRO America
Foreign pharmaceutical manufacturers planning to sell drugs in the United States must comply with US FDA regulatory requirements. One of the most critical obligations is appointing an FDA US Agent for drugs. This requirement applies to all non US drug manufacturers, including API producers, finished dosage manufacturers, repackers, and relabelers. The US FDA mandates that…