An FDA Drug Listing Certificate from FDA Registration Assistance is a professional verification document that summarizes drug establishment registration and drug listing information found in applicable FDA records. It is prepared by FDA Registration Assistance for business, due-diligence, distributor, and internal compliance purposes; it is not a certificate issued by FDA.

No. FDA drug establishment registration, drug listing, and NDC assignment do not by themselves mean that FDA has approved a company or product. The certificate offered on this page is prepared by FDA Registration Assistance from available FDA registration and listing records and must not be represented as an FDA approval certificate.

Companies with drug registration and listing information that can be verified in applicable FDA records may request a certificate. If a required registration or listing is missing, inactive, outdated, or incomplete, FDA Registration Assistance can identify the issue and discuss the filing work needed before certificate preparation.

Depending on the verified records and requested scope, the certificate may summarize the company or establishment name, current establishment-registration information, labeler information, listed drug products, NDC information, and the date on which the underlying FDA records were checked.

No. Drug establishment registration, inclusion in FDA listing publications, and possession of an NDC do not denote FDA approval. The certificate is informational and should never be used to imply that FDA has approved a facility or drug merely because it is registered or listed.

A distributor, importer, customer, tender team, marketplace, or business partner may want a concise document showing the registration and listing information that was verified for a company or product. The certificate can make due diligence easier, but it does not replace any FDA filing, approval, import, or compliance requirement.

FDA Registration Assistance reviews applicable FDA registration and listing sources, such as current drug-establishment registration information and drug listing/NDC data, based on the certificate scope. FDA public listing information reflects data submitted to FDA and should not be interpreted as FDA product approval.

Our typical service target is 3–5 business days after we receive the information needed to identify the establishment and drug listings and can verify the applicable FDA records. Complex portfolios, record discrepancies, or inactive listings may require additional time.

This service is custom quoted. Pricing depends on the number of products, NDCs, establishments, and the verification scope required. Send us your company and listing details and we will confirm the professional service fee before proceeding.

Yes. FDA Registration Assistance can prepare verification certificates for eligible foreign drug companies as well as domestic companies when the relevant registration and listing information can be confirmed. Foreign establishments may also need a U.S. Agent as part of their FDA establishment registration obligations.

If the certificate is intended to confirm establishment registration, that registration should be current. Drug establishments that are required to register must renew their registration annually between October 1 and December 31. If your registration is not current, we can assist with renewal before preparing updated verification documentation.

Yes. FDA requires drug listing information to be updated when changes occur, with applicable updates due no later than the following June or December. For listings with no changes during the calendar year, an annual no-change certification may be submitted between October 1 and December 31.

FDA states that human drug listings requiring certification may be inactivated if they are not certified during the October 1–December 31 renewal period. Inactivated listings can be removed from the NDC Directory and other FDA publications of listing data.

No. FDA expressly states that assignment of an NDC number does not denote FDA approval. The NDC is an identifier used in drug listing, and any certificate that references an NDC should be presented only as verification of listing information—not as evidence of product approval.

It may be useful as supporting business documentation when a distributor, foreign authority, customs intermediary, or trading partner asks for evidence of FDA registration or listing information. Acceptance depends on the requesting party, and the certificate is not an FDA import clearance, export certificate, or product approval.

Yes. FDA Registration Assistance can help with drug establishment registration, annual renewal, Labeler Code requests, NDC/product listing work, DUNS assistance, U.S. Agent services, and related drug compliance filings before preparing updated certificate documentation.