Tag: How to check if a product is registered in FDA?
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US FDA ANDA Drug Registration: Roadmap for Generic Drug Approval in the USA
Generic medicines provide affordable treatment options while meeting the same standards of quality, safety, and performance as brand-name drugs. To legally market a generic drug in the United States, manufacturers must submit an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA). US FDA ANDA drug registration and approval confirms that…
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FDA OTC Drug Registration: Regulatory Entry Point for Non-Prescription Products
Over-the-counter (OTC) drugs are medicines that consumers can purchase without a prescription, but they are still regulated as drugs under US law. Any company that manufactures, processes, packs, or labels OTC drug products for the US market must comply with FDA OTC drug registration and listing requirements enforced by the U.S. Food and Drug Administration…
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How to Check US FDA Registration Online: Complete Verification Process
Before importing, distributing, or sourcing FDA-regulated products, it is essential to confirm whether a facility is registered with the U.S. Food and Drug Administration (FDA). Checking US FDA registration is a standard regulatory due-diligence activity used by manufacturers, importers, distributors, and compliance professionals to verify that establishments have fulfilled mandatory registration and listing requirements. Knowing…
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US FDA Drug Establishments Current Registration Site: A Practical Verification Resource
The US FDA Drug Establishments Current Registration Site is an official public database that allows users to confirm whether drug manufacturing facilities are registered with the U.S. Food and Drug Administration (FDA). This online system supports transparency by displaying establishments that have completed FDA drug establishment registration and remain in active status. For pharmaceutical manufacturers,…
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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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FDA Drug Registration and Listing Search: Market-Ready Guide
Any pharmaceutical company planning to manufacture, export, or distribute drug products in the United States must comply with US FDA drug registration and listing requirements. Understanding how FDA drug registration and listing search works is essential for verifying compliance, avoiding shipment delays, and maintaining long-term access to the US pharmaceutical market. US FDA Drug Establishment…
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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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US FDA Cosmetic Registration: A Strategic Compliance Guide for Cosmetic Brands Targeting the US
By XPRO America – US FDA Consultancy The US cosmetic market rewards brands that are fast, transparent, and compliant. However, many cosmetic companies underestimate one critical requirement: FDA cosmetic registration. While cosmetics are not approved by the FDA in advance, non-compliance can still stop your product at the border or block it from major buyers.…
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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,…