Tag: How to check if a product is registered in FDA?
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US FDA Establishment Identifier (FEI) for Cosmetics: What It Is and Why It Matters Under MoCRA
As cosmetic regulation in the United States becomes more structured under the Modernization of Cosmetics Regulation Act (MoCRA), identification and traceability of manufacturing facilities have become central to compliance. One of the key identifiers used by the US FDA is the FDA Establishment Identifier (FEI). The FEI number is a unique numeric identifier assigned by…
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US FDA ANDA Drug Registration: Complete Guide for Generic Drug Approval
An Abbreviated New Drug Application (ANDA) is the regulatory pathway used to obtain approval for generic drug products in the United States. Any company planning to market a generic drug in the US must submit an ANDA to the U.S. Food and Drug Administration (FDA) and demonstrate that the product is therapeutically equivalent to a…
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US FDA OTC Drug Registration: Complete Guide for Over-the-Counter Drug Compliance
Over-the-counter (OTC) drugs are widely sold in the United States without a prescription, but they are still subject to strict regulatory control. Any company manufacturing, processing, packing, or labeling 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 (FDA).…
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How to Check US FDA Registration: Step-by-Step Verification Guide
Verifying whether a company, facility, or product is registered with the U.S. Food and Drug Administration (FDA) is an essential part of regulatory due diligence. Manufacturers, importers, distributors, and compliance teams routinely check US FDA registration status to confirm whether a facility has completed required registration and listing obligations. Understanding how to properly check US…
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US FDA Drug Establishments Current Registration Site: How to Search and Verify Drug Facilities
The US FDA Drug Establishments Current Registration Site is an official online database that allows users to search and verify drug manufacturing facilities registered with the U.S. Food and Drug Administration (FDA). This system plays a critical role in regulatory transparency by providing access to up-to-date information on establishments involved in manufacturing, processing, packing, or…
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US FDA Drug Registration: Complete Guide to FDA Drug Registration and Listing
The United States pharmaceutical market is highly regulated, and compliance with US FDA Drug Registration requirements is mandatory for any company planning to manufacture, export, or distribute drugs in the US. This regulatory process is administered by the U.S. Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Failure…
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US FDA/USP Substance Registration System (SRS): Complete Guide
The FDA/USP Substance Registration System (SRS) is a critical regulatory framework used in the United States to uniquely identify and standardize information about substances found in FDA-regulated products. Whether you manufacture pharmaceuticals, biologics, excipients, or combination products, understanding SRS is essential for compliant submissions and smooth regulatory interactions. What Is the FDA/USP Substance Registration System…
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FDA Drug Registration and Listing Search: A Practical Guide for Global Manufacturers
Entering the US pharmaceutical market requires strict compliance with US FDA drug registration and listing rules. Before a drug can be legally manufactured, processed, or distributed in the United States, the facility and the product must appear in the official FDA systems. This is where FDA drug registration and listing search becomes a critical compliance…
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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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US FDA Cosmetic Registration: Complete Guide for Cosmetic Brands Selling in the US Market
By XPRO America – US FDA Consultancy The global cosmetic industry is growing rapidly, but when it comes to selling cosmetics in the United States, FDA cosmetic registration is a critical compliance requirement that brands cannot ignore. Many cosmetic manufacturers and brand owners believe cosmetics are “free from regulation,” only to face shipment delays, buyer…