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

U.S. FDA Requirements: Azacitidine

Pharmaceutical / Drug Definition : Thought to exert antineoplastic effect by causing DNA hypomethylation and direct cytotoxicity on abnormal hematopoietic bone marrow cells. Cytotoxicity causes death of rapidly growing cells, including cancer cells no longer responsive to normal growth control mechanisms.

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

Registrar Corp assists Azacitidine companies with:

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