Generic Drug Manufacturers              

It's time again to self-identify FDA deadline is May 31

The Generic Drug User Fee Amendment (GDUFA) requires sites identified in the production of generic drug products to self-identify each year with the FDA during the annual reporting period, May 1 to May 31.

Products manufactured at sites that do not self-ID will be deemed misbranded.  

Self-Identification submissions must be made in Structured Product Labeling (SPL) format and there are several steps you must take before you can make your submission to FDA. 

If you're not familiar with GDUFA or need a quick refresher, download our Self-ID Checklist with step-by-step instructions and helpful links to complete the  GDUFA Self-ID process: 

• Getting a D-U-N-S Number
• Contacting FDA for a Facility Establishment Identifier
• Collecting and entering your Self-ID data
• Submitting to FDA

Reed Tech offers complete assistance for GDUFA Self-ID submissions to the FDA. We'll explain what data you need to collect, convert your data to electronic SPL format and submit your information to the FDA for approval and confirmation.

 If you have any questions or would like to start preparing for your GDUFA Self-ID submission, please contact us at Pharma@ReedTech.com and we'll be happy to help.