Tag: What are the 5 categories of FDA?
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US FDA Drug Registration and Listing Database: A Practical Guide for Manufacturers
The US FDA Drug Registration and Listing Database is a critical compliance tool for any company involved in manufacturing, processing, packing, or distributing drugs intended for the United States market. Whether you are a pharmaceutical manufacturer based in India or a global exporter supplying the US, understanding how this database works is essential for regulatory…
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FDA US Agent for Drugs: Complete Guide for Global Manufacturers
For pharmaceutical companies located outside the United States, appointing an FDA US Agent for drugs is not optional—it is a mandatory regulatory requirement. The US FDA requires every foreign drug manufacturer, repacker, relabeler, and exporter to designate a US-based agent who acts as the official communication bridge between the company and the U.S. Food and…
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US FDA Certificate: Complete Global Guide to FDA Certification, Verification, Cost & Registration
By XPRO America – Global US FDA Consultancy & Compliance Partner Entering the United States market is a major growth milestone for any manufacturer or exporter. Whether you deal in food, pharmaceuticals, medical devices, cosmetics, dietary supplements, or APIs, one requirement stands above the rest: US FDA compliance. Yet, confusion around the term US FDA…