Drug Establishment Registration + US Agent
$499
Required for all foreign pharmaceutical manufacturers distributing drug products in the United States. Quote reviewed before filing. Includes US Agent Year 1.
What's included
- ✓ Drug establishment registration via CDER (21 CFR Part 207)
- ✓ FEI number acquisition if not already held
- ✓ US Agent appointment (Year 1 coverage)
- ✓ Registration number confirmation
- ✓ Annual re-registration support
How It Works
Send your facility and product details
Share your facility name, address, type of drug products manufactured (finished, API, repackaging), and current US market plans. We review scope before proceeding.
We confirm pricing and file
Drug registration scope varies by facility type. Once scope is confirmed, we file the establishment registration through FDA's drug registration system.
Registration confirmed
Your establishment appears in FDA's drug registration database. US Agent is active. Annual re-registration is required each year.
Common questions
Who needs drug establishment registration?+
Any facility that manufactures, prepares, propagates, compounds, or processes a drug product that will be sold in the United States must register with FDA under 21 CFR Part 207. This includes foreign manufacturers of finished drugs, APIs, and repackaging facilities.
What types of drug manufacturers must register?+
Registration applies to manufacturers of prescription drugs, OTC drugs, biologics, generics, APIs (active pharmaceutical ingredients), and finished dosage forms. Contract manufacturers producing for US-bound drugs also need their own registration.
When must drug establishment registration be renewed?+
Drug establishment registration must be renewed annually, generally between October 1 and December 31 each year. We track your renewal dates and contact you well in advance of each deadline.
Does this include NDC Labeler Code or drug listings?+
No. Establishment registration is separate from NDC Labeler Code and drug product listings. These are available as separate services or bundled in the Drug Full Setup + Listings package ($1,399).
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Need registration + NDC + drug listings together?
The Drug Full Setup + Listings bundle ($1,399) includes FEI acquisition, drug establishment registration, NDC Labeler Code, US Agent, and 5 drug listings.