Gdufa Self Identification Spl
Get complete assistance for GDUFA self identification and FEI number for your firm.
GDUFA SELF IDENTIFICATION
GDUFA self-identification is an annual FDA requirement for any facility, site, or organization involved in the manufacturing or processing of generic drugs. If your facility is referenced in a generic drug submission, you are required to self-identify with the FDA each year between May and June. Missing this window can affect your facility's standing and delay generic drug submissions that reference your site.
The process involves submitting structured product labeling (SPL) or XML files through the FDA's electronic systems, and getting the technical details right matters. FDABasics handles the full process for you, including verifying your FEI and DUNS numbers, preparing and converting your SPL or XML files, and submitting on your behalf. We stay with you through every step until self-identification is complete and confirmed.
Our fee is $299 per submission. Discounts are available for small companies and multiple facility submissions. If you are not sure whether your facility is required to self-identify, contact us and we will tell you straight away.
Why choose FDAbasics for GDUFA Self Identification?
We have handled GDUFA self-identification for facilities across multiple countries and know exactly where the process can go wrong. We get it right the first time, respond to your questions promptly, and turn around most submissions within four business days.
To get started, complete the short form on our website and we will be in touch quickly.
Get Started with these Top Drug Establishment Forms
- US Agent for Foreign Establishment
- Drug Establishment Registration Form
- NDC Labeler Code Form
- Drug Listing Form
- GDUFA Self Identification Form
- Drug Establishment FEI Number Form
Not Sure Where To Start?
FDA compliance requirements can be complex, and the right path depends on your specific product, your role in the supply chain, and whether you are a foreign or domestic company. The FDABasics team is happy to point you in the right direction. Contact us for a free consultation and we will help you identify exactly what your business needs to stay compliant and keep products moving into the US market.
