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

U.S. FDA Requirements: Estradiol

Pharmaceutical / Drug Definition : Binds to nuclear receptors in responsive tissues (such as female genital organs, breasts, and pituitary gland), enhancing DNA, RNA, and protein synthesis. In androgen-dependent prostate cancer, competes for androgen receptor sites, inhibiting androgen activity. Also decreases pituitary release of follicle-stimulating hormone and luteinizing hormone.

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

Registrar Corp assists Estradiol companies with:

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