FDA drug company registration is a mandatory regulatory step for any pharmaceutical business involved in manufacturing, processing, repacking, relabeling, or distributing drug products for the U.S. market. Whether the facility is based in the United States or overseas, registration with the U.S. Food and Drug Administration is required before drugs can be legally marketed or imported into the USA.
The FDA drug establishment registration system allows the FDA to identify drug manufacturing and handling facilities and maintain regulatory oversight. Alongside establishment registration, FDA drug listing is compulsory for every commercial drug product. Drug listing submissions include detailed product information such as active ingredients, dosage form, strength, route of administration, and approved labeling. This ensures transparency, traceability, and effective regulatory monitoring across the drug supply chain.
FDA drug company registration is completed online using the FDA’s electronic submission platforms. Once the submission is accepted, the FDA assigns a Facility Establishment Identifier (FEI) number to the site. The FEI number is a permanent identifier used for inspections, compliance reviews, and official FDA communications. It is important to note that FDA registration confirms regulatory listing only and does not mean the drug has received FDA approval, which is handled separately through NDA, ANDA, or other approval pathways.
All registered drug establishments must renew their FDA registration annually during the renewal period from October 1 to December 31. Failure to renew or maintain accurate drug listings may result in inactive status, product delisting, warning letters, or import refusals for foreign manufacturers.
For non-U.S. drug companies, appointing a U.S. Agent is a legal requirement. The U.S. Agent acts as the FDA’s authorized domestic contact and supports communication during inspections, compliance inquiries, and emergency situations.
Because FDA drug registration involves technical data accuracy, regulatory timelines, and evolving compliance rules, many pharmaceutical companies choose expert assistance. XPRO America, a trusted US FDA Consultancy, provides complete support for FDA drug company registration, drug listing, U.S. Agent services, and long-term compliance management.
Pharmaceutical companies looking for reliable regulatory support or corrective FDA registration services can get in touch with the expert team at support@xproamerica.com to ensure smooth, compliant, and timely FDA submissions.
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