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

U.S. FDA Requirements: Dutasteride

Pharmaceutical / Drug Definition : Inhibits 5-alpha-reductase, an intracellular enzyme present in liver, skin, and prostate that's required for conversion of testosterone to 5-alpha-dihydrotestosterone (DHT). DHT appears to be the principal androgen responsible for stimulating prostatic growth.

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

Registrar Corp assists Dutasteride companies with:

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