Tag: What is FDA called in India?
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US FDA ANDA Drug Registration Form: How Generic Drug Companies File for Approval
Generic pharmaceutical companies seeking access to the United States market must submit an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA). The ANDA drug registration form and supporting documentation serve as the official regulatory submission through which a company demonstrates that its generic drug is equivalent to a previously approved…
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FDA U.S. Agent ID: Why Foreign Companies Must Appoint a U.S. Agent
Foreign companies that manufacture or supply regulated products to the United States must appoint a U.S. Agent as part of their compliance obligations with the U.S. Food and Drug Administration (FDA). The appointment of this representative generates an internal record commonly referred to as the FDA U.S. Agent ID, which links the foreign establishment to…
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US FDA Drug Registration: Step-by-Step FDA Registration & Drug Listing Guide
Entering the United States pharmaceutical market requires strict regulatory compliance. US FDA Drug Registration is a mandatory process regulated by the U.S. Food and Drug Administration (FDA) for companies involved in manufacturing, processing, or distributing drug products in the US. Without proper FDA registration and drug listing, drug products may be denied entry into the…
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US Drug Registration Process: How to Register Drugs with the FDA
The United States pharmaceutical market is one of the most tightly regulated in the world. Any company planning to manufacture, export, or distribute drug products in the US must comply with US Drug Registration requirements enforced by the U.S. Food and Drug Administration (FDA). Without proper registration and listing, drugs cannot be legally sold or…
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Understanding the US FDA Drug Registration and Listing Database for Market Access
For pharmaceutical companies planning to sell drugs in the United States, compliance with the US FDA Drug Registration and Listing Database is not optional—it is a legal requirement. This database serves as the official record of drug establishments and products that are manufactured, processed, packed, or distributed for the US market. Every domestic and foreign…
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FDA U.S. Agent UEI Number Explained for Foreign Drug Companies
Introduction Entering the United States pharmaceutical market requires more than product quality and manufacturing capability. Regulatory compliance with the Food and Drug Administration is mandatory for every foreign drug establishment. One of the most important compliance requirements is appointing an FDA U.S. Agent and completing registration using a valid UEI number. Many companies struggle to…
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US FDA Drug Firm Registration Explained for Pharmaceutical Companies
US FDA drug firm registration is a compulsory regulatory step for any company involved in the manufacturing, repackaging, relabeling, processing, or storage of drug products intended for the United States market. This obligation applies equally to domestic manufacturers and foreign pharmaceutical firms exporting drugs to the US. Through this registration system, the U.S. Food and…
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FDA US Agent for Drugs Complete Guide for Foreign Manufacturers
For pharmaceutical companies operating outside the United States, appointing an FDA US Agent for drugs is a mandatory regulatory requirement. The US FDA requires every foreign drug manufacturer, relabeler, repacker, and exporter to designate a US based agent who acts as the official communication link with the U.S. Food and Drug Administration. Without a properly…
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Professional US FDA Establishment Registration Database Services for Global Manufacturers by XPRO America
Introduction Entering or operating in the United States market requires more than product quality it demands precise regulatory compliance. For companies dealing in FDA-regulated products, US FDA establishment registration and database accuracy are fundamental compliance obligations that directly affect imports, inspections, and business continuity. The US FDA Establishment Registration Database is the FDA’s primary reference…