Drug establishment registration and drug listing are mandatory requirements for APIs (bulk drugs) commercially marketed in the USA. Manufacturer of API must register their drug establishment where the product is manufactured, packed or processed and list all the drugs which are in the commercial distribution.
Below information is required for an API drug listing.
If you have never listed any API in the past, it will take about 15 working days. About 10 working days are required to obtain the labeler code from FDA. Labeler code request is a one-time task for the new company. After receipt of the labeler code, it will take 2 working days for a drug listing.
Yes, both domestic and foreign manufacturer, packer, and processor of the API must register their facility and list the drugs manufactured in their facility.
Yes, APIs used in the compounded drug preparation must be listed with FDA.
You can verify API drug listing status on the FDA website in the FDA NDC database. If you need assistance for verification of your existing NDC numbers please email your NDC number, we can verify your NDC drug listing status free of charge
Foreign companies are required to appoint US Agent to communicate with FDA. The name, contact details, and DUNS number of the US Agent should be provided in the labeler code and drug establishment registration document.
The manufacturer must renewal drug establishment registration annually and update the active drug listings. If there is no change to drug listing information you can submit no change certification.