Tag: What is FDA called in India?
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FDA U.S. Agent ID: U.S. Representation Requirement for Foreign FDA Registrations
Foreign companies that manufacture or supply FDA-regulated products to the United States must appoint a U.S. Agent as part of their regulatory obligations with the U.S. Food and Drug Administration (FDA). This appointment creates an internal identification record commonly referred to as the FDA U.S. Agent ID, linking the foreign establishment to its authorized U.S.-based…
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US FDA Drug Registration: Essential Compliance for Selling Drugs in the USA
Selling drug products in the United States requires strict adherence to federal regulations. US FDA Drug Registration is a mandatory compliance process overseen by the U.S. Food and Drug Administration (FDA). Any company involved in manufacturing, processing, repacking, relabeling, or exporting drugs to the US must complete FDA registration and drug listing before entering the…
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US Drug Registration Guide: FDA Compliance for Drug Manufacturers
Any company planning to manufacture or supply drugs to the United States must comply with US Drug Registration requirements. These regulations are enforced by the U.S. Food and Drug Administration (FDA) and apply equally to US-based and foreign pharmaceutical companies. FDA drug registration is a legal prerequisite for market entry. Without it, drug products cannot…
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US FDA Drug Registration and Listing Database: A Compliance Essential for Global Pharma Firms
The US FDA Drug Registration and Listing Database is a mandatory regulatory system for companies involved in the manufacturing and commercialization of drugs intended for the United States. For pharmaceutical businesses seeking uninterrupted access to the US market, proper registration and accurate product listing are non-negotiable compliance requirements. Every drug establishment, whether located in the…
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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…
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US FDA Drug Firm Registration for Market Access Compliance
US FDA drug firm registration is a regulatory requirement for any establishment involved in the manufacturing, processing, packaging, labeling, or storage of drugs that are distributed in the United States. This obligation applies to both US-based pharmaceutical companies and foreign drug manufacturers exporting products to the US. Through this system, the U.S. Food and Drug…
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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…
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US FDA Establishment Registration Database Compliance Services by XPRO America
Introduction For manufacturers, exporters, and brand owners targeting the United States, FDA compliance is not limited to product quality—it starts with accurate establishment registration. The US FDA Establishment Registration Database is the backbone of FDA oversight, import screening, and inspection planning. If your facility information is inaccurate, outdated, or improperly classified in the FDA database,…