USA Market
FDA Drug Establishment Registration & Renewal Services
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Why Is FDA Drug Establishment Registration & Renewal Services Important?
Legal Requirement
Mandatory for all companies manufacturing or processing drugs for U.S. distribution, including domestic and foreign establishments.
Annual Renewal
Registration must be renewed yearly between October 1 and December 31 to maintain compliance and market access.
Non-Compliance Risks
Failing to register or renew can result in penalties, product seizures at ports, and removal from FDA’s public database.
Process Flow for FDA Drug Establishment Registration & Renewal Services
Identification
DUNS numbers for facility and labeler
Representation
U.S. Agent details for foreign companies
Product Details
NDC, dosage form, route of administration
Labeling
Packaging specifications for SPL submission
Declarations
Compliance statements and manufacturing operations
How Can We Help in FDA Drug Establishment Registration & Renewal Services?
Expertise You Can Count On: Our specialized regulatory team understands the nuances of FDA systems, SPL submissions, and complex labeling requirements for pharmaceutical products.
Speed & Accuracy: Get your facility registered in as little as 5–7 business days, with zero submission errors and maximum efficiency.
Dedicated Support: One point of contact throughout your registration process. No ticket systems. Just answers when you need them most.
Global Reach: We support both U.S.-based firms and international companies entering the American pharmaceutical market.
Services
| Service | Details |
|---|---|
| Establishment Registration |
|
| Drug Product Listing |
|
| Annual Renewal |
|
| U.S. Agent Services |
|
Regulatory Requirements for FDA Drug Establishment Registration & Renewal Services
Documents
For Establishment Registration
- DUNS Number (Data Universal Numbering System – for both establishment and labeler)
- Business type and activity (e.g., manufacturer, relabeler, packager)
- Facility contact information
- U.S. Agent details (required for foreign entities)
- Electronic Submissions Gateway (ESG) account (or submission via SPL through a third-party provider)
For Drug Listing
- NDC (National Drug Code) labeler code
- Product name, dosage form, strength, and route of administration
- Proprietary/Nonproprietary names
- Labeling content in Structured Product Labeling (SPL) XML format
- Marketing status (e.g., prescription, OTC, discontinued)
Timeline
Registration must be renewed annually between October 1 and December 31. If submitted within this period, the registration remains valid until the end of the following calendar year.Â
Initial Registration
Must register within *5 days* of beginning manufacturing, repackaging, or relabeling activity for U.S. market
Drug Listing
Should occur *immediately after registration* and prior to commercial distribution
Annual Renewal
Required between *October 1 and December 31* of each calendar year
Please Note: Registration does *not roll over*—renewal is mandatory each year to maintain active status in the FDA’s NDC Directory.
Regulatory Body
The U.S. Food and Drug Administration (FDA), specifically the Center for Drug Evaluation and Research (CDER), is the designated authority overseeing Drug Establishment Registration and Drug Listing requirements under theÂ
Federal Food, Drug, and Cosmetic Act (FDCA) and 21 CFR Part 207.
Fees
There is no FDA fee for Drug Establishment Registration Renewal for human drugs. However, other regulatory filings may have associated costs.
If the establishment is also subject to GDUFA (Generic Drug User Fee Amendments), facility fees may apply separately depending on the type of drug/product and activity performed.
⚠Be aware: Contract manufacturers, API manufacturers, and foreign establishments involved in generics may have annual user fees based on their GDUFA classification.
Validity
Registration is valid from the date of submission until December 31 of the same calendar year. Establishments must renew registration annually to maintain their active status. If an establishment fails to renew by December 31, it will be considered inactive and removed from the FDA’s Establishment Registration database.
Frequently Asked Questions(FAQs)
Is registration mandatory for contract manufacturers or relabelers?​
Yes. If you’re involved in the manufacture, repackaging, or labeling of any drug product for U.S. commerce, you must register.
What if I miss the renewal deadline?
Your registration becomes inactive, and your drug listings will be removed from the FDA’s NDC directory. This can disrupt your U.S. distribution.
How long does registration take?​
Usually 5–7 business days once we have complete and accurate information.​
Do foreign companies need a U.S. Agent?​
Yes. We can serve as your FDA-authorized U.S. Agent and handle all correspondence.​
