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

U.S. FDA Requirements: Acetylcysteine

Pharmaceutical / Drug Definition : Decreases viscosity of secretions, promoting secretion removal through coughing, postural drainage, and mechanical means. In acetaminophen overdose, maintains and restores hepatic glutathione, needed to inactivate toxic metabolites.

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

Registrar Corp assists Acetylcysteine companies with:

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