Tag: How to check if a product is registered in FDA?
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US FDA ANDA Drug Registration: Regulatory Pathway for Generic Medicines
The Abbreviated New Drug Application (ANDA) is the approval route used for generic medicines in the United States. Companies that wish to market a generic drug must submit an ANDA to the U.S. Food and Drug Administration (FDA) demonstrating that their product is equivalent to a previously approved reference listed drug (RLD). US FDA ANDA…
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FDA OTC Drug Registration: Regulatory Pathway for Non-Prescription Medicines
Over-the-counter (OTC) drugs are medicines that consumers can purchase without a prescription, but they remain fully regulated by the U.S. Food and Drug Administration (FDA). Any company that manufactures, processes, packs, or labels OTC drug products for the United States market must complete FDA OTC drug establishment registration and product listing before commercial distribution. OTC…
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How to Check US FDA Registration Online: Complete Verification Guide
Checking whether a company, facility, or product is registered with the U.S. Food and Drug Administration (FDA) is a critical part of regulatory due diligence. Manufacturers, importers, distributors, and compliance teams regularly verify US FDA registration to confirm that establishments have met mandatory registration and listing obligations. Understanding the correct way to check US FDA…
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US FDA Drug Establishments Current Registration Site: Facility Verification Guide
The US FDA Drug Establishments Current Registration Site is an official online resource used to verify drug manufacturing facilities registered with the U.S. Food and Drug Administration (FDA). This database supports regulatory transparency by allowing stakeholders to confirm whether a pharmaceutical establishment holds an active FDA drug establishment registration. For manufacturers, importers, distributors, and compliance…
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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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FDA Drug Registration and Listing Search: Guide for Compliance
For pharmaceutical companies planning to sell drugs in the United States, US FDA drug registration and listing search is a core regulatory requirement. Before any drug product enters the US supply chain, both the manufacturing establishment and the drug itself must be properly registered and listed with the U.S. Food and Drug Administration. These steps…
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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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US FDA Cosmetic Registration: How Cosmetic Brands Can Achieve US Compliance Without Delays
Selling cosmetics in the United States is a major opportunity but it comes with clear regulatory expectations. Brands that understand FDA cosmetic registration early move faster, clear customs smoothly, and build trust with buyers. Those that misunderstand it often face shipment holds, relabeling costs, or rejected listings. What FDA Cosmetic Registration Really Means FDA cosmetic…
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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…
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US FDA Establishment Registration Database Services by XPRO America – Complete Compliance & Verification Support
Introduction For companies manufacturing, processing, packing, or holding products regulated by the United States Food and Drug Administration (US FDA), establishment registration is not optional—it is a mandatory compliance requirement. Whether you are a food exporter, pharmaceutical manufacturer, cosmetic brand, medical device company, or dietary supplement business, your establishment must be properly registered and accurately…