Home  /  Services  /  Drug Establishment Registration
Drug Establishment Registration

FDA Drug Establishment Registration,
NDC & U.S. Agent

Trusted by pharmaceutical exporters as a leading FDA U.S. Agent for drug establishment registration, Orionex handles CDER establishment registration, NDC Labeler Code assignment, drug listing, and Drug Master File (DMF) U.S. Agent representation.

📅 Already registered? Drug establishment registration renews annually — see our 2026 renewal guide (Oct 1 – Dec 31, no FDA fee).

Register Your Drug Establishment → Free Consultation
1,200+
Clients Served
15+
Years Experience
98%
First-Round Acceptance
60+
Countries
Orionex Regulatory Solutions — Licensed FDA U.S. Agent based in Casper, Wyoming USA
✦ Official U.S. Regulatory Partner ✦
U.S. Agent for Drug Establishments
Casper, Wyoming · Incorporated USA
✅ No Hidden Fees — Upfront Pricing
🔒 Secure Stripe & PayPal Checkout
⚡ Work Begins Within 1 Business Day
📜 Certificate of Registration Included
🌐 Serving Clients in 60+ Countries

What's Included

What's Included in Drug Establishment Registration

From NDC assignment through DMF representation, we handle the full CDER registration pathway for pharmaceutical manufacturers.

🏛️

Drug Registration, NDC & U.S. Agent

CDER establishment registration, National Drug Code (NDC) Labeler Code assignment, and U.S. Agent designation for foreign drug manufacturers.

📋

Drug Listing & Label Review

Product listing for each drug product and strength, plus label review against 21 CFR Part 201 labeling requirements.

📁

DMF Submission & U.S. Agent

Drug Master File preparation support and U.S. Agent representation for Type II (drug substance) and other DMF types.

⚗️

CDER Compliance Consulting

Guidance on cGMP expectations, FDA inspection readiness, and ongoing CDER regulatory correspondence.

💊

OTC Monograph Support

Advisory on Over-the-Counter (OTC) monograph compliance for non-prescription drug products entering the U.S. market.

🔁

Renewal & Ongoing Support

Proactive annual registration renewal reminders and a dedicated account manager for ongoing CDER communications.

Who Needs This

Who Needs Drug Establishment Registration?

Any foreign establishment that manufactures, prepares, propagates, compounds, or processes a drug product for the U.S. market must register with FDA's Center for Drug Evaluation and Research (CDER) and obtain an NDC Labeler Code.

This applies to prescription drug manufacturers, OTC monograph drug producers, and Active Pharmaceutical Ingredient (API) facilities alike — each foreign establishment must also designate a U.S. Agent to receive FDA communications on its behalf.

  • Prescription and OTC drug manufacturers exporting to the U.S.
  • Active Pharmaceutical Ingredient (API) and API intermediate producers
  • Facilities filing or referenced in a Drug Master File (DMF)
  • Contract manufacturing organizations (CMOs) producing for U.S. brands
  • Companies needing an NDC Labeler Code for a new drug product
Transparent Pricing

Drug Establishment Registration

$550/year
Typically completed in 7–14 business days
  • CDER Establishment Registration
  • NDC Labeler Code assignment
  • U.S. Agent Designation (1 year)
  • Official Certificate of Registration
Register Your Drug Establishment →

Simple Process

From Inquiry to Certificate in 4 Steps

Our streamlined process gets your drug establishment registered and compliant fast — without the complexity.

1

Free Consultation

Tell us about your product and market. We assess your needs at no cost.

2

Document Collection

We provide a clear checklist and guide you through gathering every required document.

3

FDA Submission

We prepare and file directly with FDA. Our CDER-focused team prepares complete submissions to minimize FDA information requests and delays.

4

Certificate Delivered

You receive your official FDA registration number and Certificate of Registration.

Our Credentials

Why Orionex Is a Trusted FDA Agent for Pharmaceutical Exporters

Orionex is physically incorporated in Casper, Wyoming, with deep regulatory expertise across CDER — from OTC monograph products to DMF-referenced API facilities.

98%
First-Round Acceptance
15+
Years Experience
1,200+
Clients Served
💊
CDER
Drug Establishment Registration & NDC Listing
📁
DMF Support
Drug Master File Preparation & U.S. Agent
⚗️
cGMP Readiness
Inspection & Compliance Consulting
🏷️
Label Review
21 CFR Part 201 Drug Labeling Compliance

FAQ

Drug Establishment Registration — FAQ

Common questions from pharmaceutical manufacturers about FDA CDER registration.

What is an NDC Labeler Code and do I need one?+

The National Drug Code (NDC) Labeler Code is a unique identifier assigned by FDA to every drug manufacturer, repackager, or distributor. Any foreign establishment registering a drug product for the U.S. market needs one — Orionex handles the application as part of your registration package.

What is a Drug Master File (DMF) and when do I need one?+

A DMF is a confidential submission providing FDA with detailed information about a drug substance, facility, or manufacturing process — most commonly used by API manufacturers whose material is referenced in another company's drug application. A U.S. Agent is required for DMF holders based outside the U.S.

How much does drug establishment registration cost?+

Orionex charges $550/year for CDER Establishment Registration, NDC Labeler Code assignment, U.S. Agent designation, and an official Certificate of Registration. DMF preparation and label review are available as add-on services.

Do OTC monograph drugs need the same registration as prescription drugs?+

Yes — both OTC monograph and prescription drug manufacturers must complete CDER establishment registration and drug listing. The distinction matters more for premarket pathway (monograph compliance vs. NDA/ANDA) than for the registration requirement itself.

How long does FDA drug establishment registration take?+

Through Orionex, drug establishment registration is typically completed in 7–14 business days, reflecting CDER's more detailed review compared to food or device registration. Work begins within 1 business day of order confirmation.

What is the best FDA agent for drug establishment registration?+

Look for a U.S. Agent with direct CDER experience, physically incorporated in the USA, transparent fixed pricing, and a track record with both finished-drug and DMF-referenced API facilities. Orionex Regulatory Solutions offers all of this, backed by 15+ years of regulatory expertise across CDER.

☀️ Manufacturing sunscreen? Read our sunscreen-specific registration guide — covers OTC Monograph M020, GRASE active ingredients, and the 2026 bemotrizinol approval.

Ready to Register Your Drug Establishment?

CDER expertise. Transparent pricing. Certificate of Registration included.

Register Your Drug Establishment → Free Consultation