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

U.S. FDA Requirements: Amifostine

Pharmaceutical / Drug Definition : Undergoes conversion to free thiol, an active metabolite that reduces toxic effects of cisplatin on renal tissue

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

Registrar Corp assists Amifostine companies with:

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