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HomeU.S. FDA Drug Regulation U.S. FDA Drug Registration and Listings › Active Pharmaceutical Ingredients (API)

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.

Registrar Corp assists companies with the following API requirements:
Drug Certificates Issued By Registrar Corp
  • 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

If you do not have an Establishment Registration Number and a Listing for your API with U.S. FDA

New U.S. FDA API Drug Registration and Listings  ››

If you already have an Establishment Registration Number and a Listing for your API with U.S. FDA

Option 1:  Update your existing API Registration and Listing information
Click the Update button below for any of the following:
  • Update your API Establishment Registration
  • Update an existing API Listing with U.S. FDA
  • List another API with U.S. FDA
  • Change U.S. Agent or Registrant Contact
Update API Drug Registration and Listing Information  ››

Option 2:   Order a Certificate of Registration issued by Registrar Corp
Companies registered with U.S. FDA often are asked by their customers and suppliers to verify their registration and listings. A Certificate of Registration issued by Registrar Corp serves to verify your compliance with API Drug Registration and Listing requirements.

Order Your API Drug Certificate  ››

U.S. FDA Regulations:

U.S. FDA Regulation: 21 C.F.R. Part 207

Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.
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