Drug Establishment Registration & Renewal Services

Domestic and foreign establishments that manufacture, repack, or re-label drug products in the United States are required to register with the FDA. Domestic and foreign drug manufacturers, repackers or re-labelers are also required to list all of their commercially marketed drug products. This information helps the FDA maintain a catalog of all drugs in commercial distribution in the United States.

Domestic and foreign establishments registered with the FDA can be accessed at the FDA establishment registration database

FDA drug establishment current registration site

FDA Drug Establishment registration is a mandatory requirement for establishments that manufacture, process, or test drugs, including finished dosage forms, bulk drugs (API), and OTC products for commercial distribution purposes in the United States. Domestic and foreign establishments are required to register within five days starting operations, and must renew their establishment registration between October to December each year. Failure to renew the FDA registration may result in the cancelation of establishment registration, and such establishments will be removed from the FDA establishment registration database.

Catain can provide Establishment Registration services at just $250. There are no additional FDA charges for registration.

Click here ==> Drug Establishment Registration Form

If you have questions, please get in touch.