Fexofenadine HCl API Manufacturer & Supplier in India

Swapnroop Pharma · WHO-GMP Certified · +91 87670 62101

Fexofenadine Hydrochloride (Fexofenadine HCl) is a second-generation antihistamine and selective peripheral H1-receptor antagonist used in pharmaceutical formulations for the management of allergic conditions. It is the hydrochloride salt of fexofenadine and is associated with relief of symptoms of seasonal allergic rhinitis and urticaria.

Fexofenadine Hydrochloride has the molecular formula C₃₂H₃₉NO₄·HCl, molecular weight 538.12 g/mol, and CAS Number 153439-40-8.

About Fexofenadine Hydrochloride

Fexofenadine Hydrochloride is a relatively non-sedating antihistamine that selectively blocks peripheral histamine H1 receptors. Histamine is an important mediator of allergic symptoms, and blocking its interaction with H1 receptors helps reduce symptoms associated with allergic reactions.

Fexofenadine HCl is used as an active pharmaceutical ingredient in oral pharmaceutical formulations.

Mechanism of Action

Fexofenadine acts primarily as a selective antagonist of peripheral H1 histamine receptors. By preventing histamine from activating these receptors, it reduces the physiological effects of histamine associated with allergic reactions.

This activity contributes to relief from symptoms such as sneezing, rhinorrhea, nasal and ocular itching, watery eyes and urticaria.

Pharmaceutical Applications

Fexofenadine Hydrochloride is used in pharmaceutical formulations for:

  • Seasonal allergic rhinitis
  • Allergic rhinitis symptoms
  • Chronic idiopathic urticaria
  • Sneezing
  • Runny nose
  • Nasal itching
  • Itchy or watery eyes
  • Allergy-associated itching

The specific indication, dosage and formulation should follow the applicable approved regulatory labeling.

Detailed Specifications

Parameter Specification
Appearance White to off-white crystalline powder
Identification IR & HPLC compliant
Loss on Drying NMT 1.0%
Residue on Ignition NMT 0.5%
Heavy Metals NMT 20 ppm
pH (1% Solution) 2.0 – 4.0
Individual Impurity NMT 0.5%
Total Impurities NMT 1.0%
Water Content NMT 1.0%
Get Bulk Quote via WhatsApp