Active Pharmaceutical Ingredients (API)
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Registrar Corp can assist you with the following API requirements:
- FDA Establishment Registration
- Drug Listings and Label Submissions
- U.S. Agent Requirement
- Authorizing Official Requirement
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If you do not have an Establishment Registration Number and a Listing for your API with FDA
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If you already have an Establishment Registration Number and a Listing for your API
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Option 1: Update your existing API Registration and Listing information
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Click the Update button below for any of the following:
- Update your Establishment Registration
- Update an existing API Listing
- List another API
- Change U.S. Agent or Authorizing Official
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Option 2:
Order a Certificate of Registration issued by Registrar Corp
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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 API Drug Registration and Listing requirements.
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Applicable U.S. Regulations:
FDA Regulation: 21 C.F.R. Part 207
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| Registrar Corp assists businesses with FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling FDA registration requirements. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the US Food and Drug Administration.
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