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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.

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