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

U.S. FDA Requirements: Montelukast Sodium

Pharmaceutical / Drug Definition : Blocks action of leukotrienes, decreasing smooth muscle contractions and edema in bronchial airways and preventing inflammation and bronchospasm

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

Registrar Corp assists Montelukast Sodium companies with:

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