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HomeDrugsU.S. FDA Active Pharmaceutical Ingredients (API)API Examples › U.S. FDA Regulations: Capecitabine

U.S. FDA Requirements: Capecitabine

Pharmaceutical / Drug Definition : Enzymatically converts to 5-fluorouracil, which injures cells by interfering with DNA synthesis, cell division, RNA processing, and protein synthesis

In the United States, Capecitabine is regulated by the U.S. Food and Drug Administration (FDA). FDA has specific requirements regarding the registration and listing of Capecitabine.

Registrar Corp assists Capecitabine companies with:

  • FDA Registration Capecitabine
  • FDA Listing Capecitabine
  • FDA Label Requirements and Exceptions Capecitabine
  • FDA Import Information Capecitabine
  • FDA Detentions Capecitabine (Capecitabine Entry Refusal)
  • General U.S. Food and Drug Administration Guidelines for:
       - Manufacturers Capecitabine (Capecitabine Suppliers)
       - Processors Capecitabine
       - Repackers Capecitabine
       - Relabelers Capecitabine
       - Exporters Capecitabine
       - Importers Capecitabine
For more information about Capecitabine, simply click below:

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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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