FDA Registration for Drug and Pharmaceutical Manufacturers
Drug establishment registration, NDC Labeler Code, and US Agent services. Contact us for a custom quote.
Individual Services
If you already know which filing you need, request a quote for a single drug service instead of a full bundle.
Drug Establishment Registration + US Agent Year 1
$499
NDC Labeler Code
$249
Drug Listing
$149 per product
Drug bundles
These bundles cover the core setup most foreign pharmaceutical manufacturers need before listing drug products for the US market.
Drug Full Setup
$799
- FEI Number Acquisition
- Drug Establishment Registration
- US Agent (Year 1 included)
Drug Full Setup + Listings
$1,399
- FEI Number Acquisition
- Drug Establishment Registration
- NDC Labeler Code
- US Agent (Year 1 included)
- 5 Drug Listings
Year 1 is 12 months from acceptance of FDABridge’s U.S. Agent designation in the FDA record. No automatic renewal; continued coverage needs a separate written scope, quote and payment before the period ends.
Unless separately agreed in writing, Agent coverage excludes DUNS/FEI, filings and renewals, amendments, listings, label review, Prior Notice, FSVP/importer, laboratory, customs/broker, legal, inspection response and Import Alert/detention work.
Completion evidence is the applicable FDA record and accepted Agent designation. DUNS/FEI evidence comes only with bundles that include it. This is not FDA approval or guaranteed import clearance.
How the drug quote flow works
Drug services are handled through a review-first process so pricing and scope are confirmed before payment is requested.
Send your facility and product details through the quote form.
Our team reviews the scope and confirms what filings apply to your case.
You receive pricing confirmation and the next payment step within 24 hours.
Questions drug manufacturers ask before starting
These are the common questions we hear from foreign pharmaceutical manufacturers before they begin US registration work.
Do foreign drug manufacturers need FDA establishment registration?+
In many cases, yes. If you manufacture drug products for the US market, FDA establishment registration is often part of the required setup.
What is an FEI number for drug filings?+
An FEI number is a facility identifier used in FDA-related systems. It is commonly needed before or during establishment registration work.
What is an NDC Labeler Code?+
The NDC Labeler Code is part of the product identification structure used for drug listings in the US market. It is usually needed before listing products.
Do I need to list every drug product?+
If your products need to be listed, each product should be handled correctly. That is why we offer both individual listings and bundle options that include multiple listings.
Why does the Drug page use a quote flow instead of direct checkout?+
Drug work is more case-specific than standard food or cosmetics filings. We review the scope first so you get the correct pricing and process before payment is requested.
Do foreign drug facilities need a US Agent?+
A US Agent is commonly part of the setup for foreign drug manufacturers. We include Year 1 coverage in the main registration bundle and service option.
How long does the quote response take?+
The brief requires a response within 24 hours. After you send the form, our team reviews the details and follows up with pricing confirmation and next steps.
What happens after I request a quote?+
We review your details, confirm the filing scope, send pricing, and provide the next payment step so the work can begin on the correct path.