FDA Drug listing requirements for API (bulk drugs)

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.

FDA APi drug listing

What  information is required for   API drug listing ?

Below information is required for API drug listing.

  • Name of the product
  • Information about packing configuration
  • Name of active ingredient
  • Product label
  • Information about marketing category

How much time is required for 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 labaler code from FDA. Labaler code request is one time task for the new company.  After receipt of the labaler code , it will take 2 working days for drug listing.

Domestic API manufacture is required to list their products ?

Yes, both domestic and foreign manufacturer, packer and processor of the API must register their facility and list the drugs manufactured in their facility.

API supplied for compounded drug preparation require drug listing ?

Yes,  APIs used in the compounded drug preparation must be listed with FDA.

How I can verify drug listings for my APIs ?

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

 

US Agent is required for  drug listing ?

Foreign companies are required to appoint US Agent to communicate with FDA . Name , contact details and DUNS number of the US Agent should be provided in the labeler code and  drug  establishment registration document.

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.

 

Quick Links

Translate »