Establishments must be registered within 5 days of beginning operations. In addition, establishments must renew registration annually between October 1st and December 31st of each year.

Firms that send their initial or annual registrations during October 1st to December 31st period are considered registered until the end of following year. If a firm submits its initial, updated or annual registration outside this time frame, it is considered registered until the end of the current year and shall renew before December 31.

In addition, at the time of annual registration, firms must list any drugs not previously listed.

U.S. FDA Active Pharmaceutical Ingredients (API) Drug Establishment Registration & Listing Requirements

An Active Pharmaceutical Ingredient is any substance or mixture of substances intended to be used in the manufacture of a drug (medicinal) product and that, when used in the production of a drug, becomes an active ingredient of the drug product. Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or function of the body.

MEDERA assists companies with the following API requirements:

  • U.S. FDA API Establishment Registration
  • U.S. FDA API Drug Listings and Label Submissions
  • Obtaining a DUNS Number
  • U.S. Agent Requirements
  • Registrant Contact Requirements
  • U.S. FDA API Labeling Requirements

To find out more about marketing a therapeutic product in US, please click here to receive a copy of our free white paper. For assistance with drug establishment registration and listing please contact us.