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About Fexofenadine Hydrochloride (Form 1) API

Product
  • Therapeutic Category呼吸器

  • API Technology

    Synthetic

  • Dose Form

    Oral Solid/Tablets

  • Dr Reddy's Development Status

    Available (Commercial)

  • 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

Dr. Reddy’sの専門知識・技術

ハイデラバード(インド)に本社を構えるDr. Reddy’s Laboratoriesは、世界的に有名な原薬(API)供給業者です。Dr. Reddy’sのAPIビジネスは米国、ヨーロッパ、ブラジル、南米、日本、中国、韓国、その他の新興市場において製薬会社の推奨パートナーとなっています。

Dr. Reddy’sのAPIビジネスは、ステロイド、ペプチド、複合長鎖分子、高薬理活性API(HPAPI /腫瘍学薬)など、複合APIの開発・製造において、30年以上にわたり高度な技術的実績を築き上げ、成長しています。この専門知識・技術は弊社の知的財産および規制関連業務の実績と共に、一貫して規制基準を満たし、それを超える優れた価値を生み出しています。Dr. Reddyの(-) API, R&D (研究開発)、IP、規制の高度な専門知識・技能の結果です。

顧客が真っ先に市場に参入するのに重要な要素は、機敏な供給網です。弊社は全施設を効率的に、そしてコストを最適化して稼働させ、品質と安全性、また、生産性の最新基準に従うことで、そうした供給網を実現させます。オフィスと工場の結びつきを強化し、ダイナミックな市場の変化に迅速に対応しています。そうした理由から、弊社は不足を解消して突発的な供給を満たすことができるのです。

RFQ Form

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Related Resources

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FAQs

What are the precautions needs to be taken for Fexofenadine Hydrochloride?
  • Do not take it with juice such as grapefruit, orange, or apple juice . And also should not take antacids that contain aluminum or magnesium hydroxide within 15 minutes of taking this medicine.

What is main purpose of using the Fexofenadine Hydrochloride?
  • Fexofenadine is a second generation antihistamine that is used for the treatment of allergic rhinitis, angioedema and chronic urticaria.

What is the BCS classification for Fexofenadine Hydrochloride API ?
  • Fexofenadine hydrochloride is a BCS class II drug having low bioavailability of 30-40% and a half life of 14 hours.

What are the DMFs available for Fexofenadine Hydrochloride API ?
  • Fexofenadine Hydrochloride have DMFs in the US, Brazil, CEP, Europe, Japan and Korea.

How do you store Fexofenadine Hydrochloride API?
  • Fexofendaine should be stored at 25ºC room temperature.

What is the dosage form available for Fexofenadine Hydrochloride?
  • Fexofenadine is available in oral capsule form with 30mg, 120mg and 180 mg strengths.

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.