FDAbasics Offers Complete FDA Compliance and Registration Services for the Drug Industry

All establishments follow the same core process. Differences between foreign and domestic establishments are noted inline. Drug establishment registration itself has no government fee. However, generic drug manufacturers subject to GDUFA and OTC monograph drug manufacturers subject to OMUFA must pay those fees separately. FDABasics assists with all required submissions.

Step 1: Obtain a DUNS Number and FEI Number A valid DUNS number (Dun and Bradstreet Data Universal Numbering System number) must be included in your establishment registration SPL submission. The FDA uses it to identify your facility in the eDRLS system. The FDA also assigns a Facility Establishment Identifier (FEI) number to each registered drug establishment. The FEI number is used to track inspections and, for generic drug manufacturers, to track GDUFA facility fee obligations. FDABasics assists with DUNS number requests and FEI number requests for both foreign and domestic establishments. Foreign generic drug manufacturers who need their FEI number before or during GDUFA self-identification can contact us for assistance. Foreign establishments only. Domestic establishments use an Employer Identification Number (EIN) in place of a DUNS number. Domestic establishments are also assigned an FEI number upon registration.

Step 2: Designate a US FDA Agent Your US Agent is your official contact with the FDA, receives inspection notices and regulatory correspondence, and must be physically located in the United States and available during US business hours. Foreign establishments only. All foreign drug manufacturers must designate a US FDA Agent before registration can be completed. Domestic establishments do not require a US Agent.

Step 3: Register Your Drug Establishment with the FDA Drug establishment registration is submitted through the FDA Electronic Drug Registration and Listing System (eDRLS) in SPL format. FDABasics handles the entire submission for foreign and domestic establishments. Registration must be renewed annually between October 1 and December 31. There is no government fee for basic drug establishment registration.

Step 4: Obtain an NDC Labeler Code An NDC Labeler Code is required before you can list any drug product with the FDA or place an NDC number on a drug label. The Labeler Code is assigned by the FDA and is specific to your company. FDABasics assists with Labeler Code applications for both foreign and domestic companies.

Step 5: Submit Drug Product Listings in SPL Format Every drug product commercially distributed in the United States must be listed with the FDA in Structured Product Labeling (SPL) format. Listings must include the NDC number, product name, dosage form, active ingredients, and labeling. FDABasics handles SPL submission for each product for foreign and domestic establishments.

Step 6: Complete GDUFA Self-Identification if Applicable Generic drug manufacturers whose facilities are referenced in an approved ANDA must complete annual GDUFA Self-Identification in SPL format. This triggers annual GDUFA facility fee obligations paid directly to the FDA. For FY2026, a foreign Finished Dosage Form (FDF) facility pays $253,943 per year and a foreign API facility pays $58,549 per year. FDABasics assists with GDUFA Self-Identification submissions. Generic drug manufacturers only. If you do not yet have an approved ANDA, GDUFA facility fees generally do not apply.

Step 7: File a Drug Master File if Required A Drug Master File (DMF) is a confidential submission to the FDA providing detailed information about your manufacturing facility, processes, or components. A Type II API DMF is required when your active pharmaceutical ingredient is referenced in an ANDA or NDA submitted by a customer. FDABasics provides DMF filing in eCTD format for foreign and domestic facilities.