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

U.S. FDA Requirements: Bosentan

Pharmaceutical / Drug Definition : Binds to and blocks receptor sites for endothelin A and B in endothelium and vascular smooth muscle. This action reduces elevated endothelin levels in patients with pulmonary arterial hypertension, and inhibits vasoconstriction resulting from endothelin-1 (ET-1).

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

Registrar Corp assists Bosentan companies with:

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