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

U.S. FDA Requirements: Mannitol

Pharmaceutical / Drug Definition : Increases osmotic pressure of plasma in glomerular filtrate, inhibiting tubular reabsorption of water and electrolytes (including sodium and potassium). These actions enhance water flow from various tissues and ultimately decrease intracranial and intraocular pressures; serum sodium level rises while potassium and blood urea levels fall. Also protects kidneys by preventing toxins from forming and blocking tubules.

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

Registrar Corp assists Mannitol companies with:

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