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About Fexofenadine Hydrochloride (Form 1) API

Product
  • Therapeutic CategoryRespiratory

  • CAS Number

    138452-21-8

  • API Technology

    Synthetic

  • Dose Form

    Oral Solid/Tablets

  • Dr Reddy's Development Status

    Available

  • Available Regulatory Filing

    USDMF, CEP Submitted, Brazil DMF, EUDMF, Japan DMF, Korea DMF

Mechanism of Action

Fexofenadine hydrochloride, the major active metabolite of terfenadine, is an antihistamine with selective H1-receptor antagonist activity. Both enantiomers of fexofenadine hydrochloride displayed approximately equipotent antihistaminic effects. Fexofenadine hydrochloride inhibited antigen-induced bronchospasm in sensitized guinea pigs and histamine release from peritoneal mast cells in rats. The clinical significance of these findings is unknown. In laboratory animals, no anticholinergic or alpha1-adrenergic blocking effects were observed. Moreover, no sedative or other central nervous system effects were observed. Radiolabeled tissue distribution studies in rats indicated that fexofenadine does not cross the blood-brain barrier.

Indication

ALLEGRA is an H1-receptor antagonist indicated for:

  • Relief of symptoms associated with seasonal allergic rhinitis in patients ≥ 2 years of age
  • Treatment of uncomplicated skin manifestations of chronic idiopathic urticaria in patients ≥ 6 months of age

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Desloratadine

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Fexofenadine Hydrochloride (Form 1)

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Levocetirizine Dihydrochloride

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Montelukast Sodium

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Related Resources

Tech Sheet – Dr. Reddy’s Fexofenadine API offerings

Tech Sheet – Dr. Reddy’s Fexofenadine API offerings

Fexofenadine hydrochloride, the major active metabolite of terfenadine, is an antihistamine with selective peripheral H1-receptor antagonist activity. Fexofenadine Hydrochloride is indicated for:The relief of symptoms associated with seasonal allergic rhinitis in patients ≥ 2 years of age.To treat uncomplicated skin manifestations of chronic idiopathic urticaria in patients ≥ 6 months of age.Dr. Reddy's is among the earliest generic API manufacturers globally to file the US DMF for Fexofenadine Hydrochloride API. In addition to the US DMF, considering the requirement of country-specific regulatory filings, we have diversified our DMFs with regulatory filling in countries such as Europe, Japan, Brazil, Australia, and New Zealand.To know more about our API offerings, please read the technical sheet on Fexofenadine Hydrochloride by filling the contact from below.
Disclaimer: Products under patent(s) are offered only for R&D purposes U/S 107A of the Patent Act (Bolar Exemption) and not for commercial sale.