Drug establishment registrations must be renewed annually between October and December. Missing this window results in an inactive registration, which can halt manufacturing and distribution. We track every deadline and file on time, every time.
Annual Drug Establishment Renewal
We proactively reach out before your annual renewal window, collect updated information, and submit your drug establishment renewal to FDA. If your facility manufactures generic drug API or finished dosage forms, we also track the separate GDUFA self-identification and facility fee cycle each spring.
- Advance deadline reminders
- Updated establishment information
- Timely DRLS renewal submission
- User fee payment guidance
Drug Listing Updates
Drug listings must reflect current marketed products. We update your DRLS listings when products are reformulated, discontinued, or reintroduced.
- Annual drug listing review
- New product additions
- Discontinued product updates
- Formulation & labeling changes
U.S. Agent Annual Renewal
Your U.S. Agent designation renews annually alongside your drug establishment registration. We handle both simultaneously no gaps in coverage.
- Automatic annual U.S. Agent renewal
- Continued FDA communication coverage
- Updated registration records
- No interruption in representation
Registration Amendments
Changes to your drug establishment, such as new personnel, facility expansions, or ownership changes, require timely FDA updates.
- Official correspondent updates
- Facility address amendments
- Drug activity type changes
- Ownership transfer support
Ready to Renew Your Drug Registration?
Miss the October to December window and your registration goes inactive immediately.
Let us track the deadline so you never do.
Drug Registration Renewal FAQs
Registrations must be renewed annually between October 1 and December 31. Missing the window causes the FDA to deactivate the registration automatically on January 1.
No. For drug establishments, U.S. Agent designation renews on the same annual cycle as the registration itself, so both are handled together without a separate filing.
Not exactly. GDUFA self-identification for generic drug API and finished dosage form facilities runs on a separate annual cycle, typically in the spring, ahead of the October to December registration renewal. We track both deadlines for applicable clients.
Any change to your facility’s information, such as a new official correspondent, address change, drug activity type, or ownership transfer, must be reported to the FDA promptly rather than waiting for the next renewal cycle.