FDA Drug Establishment Registration
Any company that manufactures, repackages, relabels, or distributes drug products for the U.S. market must register their establishment with the U.S. Food and Drug Administration (FDA). This applies to both domestic and foreign facilities, including those handling over-the-counter (OTC) drugs.
At USAgentPros, we make FDA drug registration fast, reliable, and stress-free — so you can stay focused on bringing safe, effective products to market.
Who Needs to Register?
FDA registration is mandatory for:
- Prescription drug manufacturers
- OTC (over-the-counter) drug manufacturers
- Contract manufacturing facilities
- Repackagers and relabelers
- Distributors of drug products for the U.S.
Every registered establishment must also submit a list of each drug in U.S. commercial distribution.
Registration Timeline
- Facilities must be registered before shipping products into the U.S.
- Registration must be renewed every year between October 1 and December 31
- Drug listings must be updated at the time of renewal or when products change
Our Drug Registration Services
USAgentPros provides complete support to keep your drug facility FDA compliant:
- FDA Establishment Registration and Annual Renewal assistance
- Drug product listing submission and updates
- DUNS number assistance
- 24/7 U.S. Agent representation (required for foreign facilities)
- Ongoing compliance support
Drug Master File (DMF) Preparation & Submission
A Drug Master File (DMF) allows companies to securely submit proprietary product and facility information to FDA without disclosing trade secrets to customers or partners
USAgentPros can help you prepare and submit DMFs in the required eCTD format. Typical DMF content includes:
- Active ingredients and finished drug products
- Excipients and formulation details
- Packaging materials and specifications
- Facility information, equipment, and procedures
We also support DMF submissions to other global regulators when needed.
Why Register with USAgentPros?
- Dedicated Compliance Pro – A real expert assigned to your project
- Fast Turnarounds – Keep your products moving on schedule
- 100% Money-Back Guarantee – Total confidence in your registration
- Competitive Pricing – Transparent, fair rates with no hidden fees
Start Your FDA Drug Registration Today
Bringing drug products into the U.S. requires strict FDA compliance. With USAgentPros, you’ll have a trusted partner ensuring your registration and listings are handled correctly, on time, every year.