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U.S. FDA Drug Intermediates Establishment Registration

Drug Intermediates are materials produced during the steps in the synthesis of an Active Pharmaceutical Ingredient (API) that must undergo further molecular change or processing before becoming an API.

Intermediates intended for use as a drug component may be considered drugs by the U.S. FDA. As such, establishments that manufacturer or process Drug Intermediates are considered drug manufacturers. Therefore, Drug Intermediate Establishments are subject to U.S. FDA drug registration requirements.

Registrar Corp assists companies with the following Drug Intermediate requirements:
Drug Certificates Issued By Registrar Corp
  • U.S. FDA Drug Intermediate Establishment Registration
  • Obtaining a DUNS Number
  • U.S. Agent Requirements
  • Registrant Contact Requirements

If you do not have an Establishment Registration Number for your Drug Intermediate with U.S. FDA

New U.S. FDA Drug Intermediate Registration  ››

If you already have an Establishment Registration Number for your Drug Intermediate with U.S. FDA

Option 1:  Update your existing Drug Intermediate Registration information
Click the Update button below for any of the following:
  • Update your Drug Intermediate Establishment Registration
  • Change U.S. Agent or Registrant Contact
Update Drug Intermediate Registration Information  ››

Option 2:   Order a Certificate of Registration issued by Registrar Corp
Companies registered with 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 Drug Intermediate Registration requirements.

Order Your Drug Intermediate 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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