FDA drug company registration is a legal requirement for pharmaceutical companies that manufacture, process, repack, relabel, or distribute drug products for the United States market. Any domestic or foreign facility involved in these activities must be registered with the U.S. Food and Drug Administration before commercial distribution begins.
The purpose of FDA drug establishment registration is to provide regulatory visibility of drug manufacturing sites and ensure compliance with U.S. safety and quality standards. Along with establishment registration, companies are also required to complete FDA drug listing, which involves submitting detailed information about each drug product being marketed, including dosage form, strength, route of administration, and labeling content.
FDA drug company registration is completed online through the FDA’s electronic submission systems. Once the registration is accepted, the FDA assigns a Facility Establishment Identifier (FEI) number. This number is used by the agency for inspections, audits, and official correspondence. It is important to understand that FDA registration does not equal FDA approval; it simply confirms that the facility and products are properly listed with the FDA.
All registered drug establishments must renew their registration every year during the annual renewal window from October 1 to December 31. Missing this deadline can result in inactive registration status, product delisting, shipment delays, or import refusals for foreign manufacturers.
For companies based outside the United States, appointing a U.S. Agent is mandatory. The U.S. Agent serves as the FDA’s local contact and plays a critical role during inspections, compliance inquiries, and emergency communications.
Due to strict regulatory requirements, technical submission formats, and frequent FDA updates, many pharmaceutical companies choose expert support to avoid costly compliance errors. XPRO America, a reliable US FDA Consultancy, assists drug manufacturers with FDA drug company registration, drug listing, U.S. Agent services, and ongoing regulatory compliance.
To get professional help with FDA drug registration or to resolve complex listing issues, pharmaceutical companies can directly connect with the compliance team by writing to support@xproamerica.com, ensuring accurate and timely FDA submissions.
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