U.S. FDA Active Pharmaceutical Ingredients (API) Drug Establishment Registration & Listing Requirements
An Active Pharmaceutical Ingredient is any substance or mixture of substances indended 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 affec the structure or function of the body.
Registrar Corp assists companies with the following API requirements:
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- 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
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If you already have an Establishment Registration Number and a Listing for your API with U.S. FDA
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Option 1: Update your existing API Registration and Listing information
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Option 2:
Order a Certificate of Registration issued by Registrar Corp
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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 ››
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U.S. FDA Regulations:
U.S. FDA Regulation: 21 C.F.R. Part 207
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| 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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