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

U.S. FDA Requirements: Lubiprostone

Pharmaceutical / Drug Definition : Enhances chloride-rich intestinal fluid secretion without altering sodium and potassium serum concentrations; increases intestinal fluid secretion and intestinal motility, which promotes stool passage and relieves symptoms of chronic idiopathic constipation

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

Registrar Corp assists Lubiprostone companies with:

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