Active Pharmaceutical Ingredients (API)
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Registrar Corp can assist you with the following API requirements:
- FDA Fabrika Kayıt
- 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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Seçenek 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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Seçenek 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 FDA düzenlemeleri ile ilgili konularda danışmanlık hizmeti verir. Registrar Corp tarafından yayınlanan Kayıt sertifikanız sizin FDA kayıt gereklerine uygunluğunuzu doğrular. FDA kayıt sertifikası yayınlamaz veya kabul görmez. Registrar Corp, ABD Gıda ve İlaç İdaresine bağlı değildir.
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