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About Apalutamide (Amorphous & Form B) API

Product
  • Therapeutic Category抗がん/腫瘍

  • API Technology

    Synthetic

  • Dose Form

    Oral Solid/Tablets

  • Dr Reddy's Development Status

    Available (Commercial)

  • Available Regulatory Filing

    Brazil DMF, USDMF

Mechanism of Action

Apalutamide is an Androgen Receptor (AR) inhibitor that binds directly to the ligand-binding domain of the AR. Apalutamide inhibits AR nuclear translocation, inhibits DNA binding, and impedes AR-mediated transcription. A major metabolite, N-desmethyl apalutamide, is a less potent inhibitor of AR, and exhibited one-third the activity of apalutamide in an in vitro transcriptional reporter assay. Apalutamide administration caused decreased tumor cell proliferation and increased apoptosis leading to decreased tumor volume in mouse xenograft models of prostate cancer.

Indication

ERLEADA is an androgen receptor inhibitor indicated for the treatment of patients with non-metastatic castration-resistant prostate cancer.

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。

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FAQs

What are the steps in monitoring and testing while taking Apalutamide?
  • This medicine may cause dizziness, tiredness, seizures, and an increase risk for falls and fractures. Do not drive or do anything else that could be dangerous until you know how this medicine affects you. If you plan to have children, talk with your doctor before using this medicine.

How do you store Apalutamide API ?
  • Amorphous form is stable for 3 months at room temperature and recommended storage conditions of 2-8°C. Extended stability will be established.

What is the polymorph form available for Apalutamide API?
  • We offer Crystalline Form-B

What is the dosage form available for Apalutamide ?
  • Available in Tablet dosage form with strength of 60 Mg

What are the DMFs available for Apalutamide API ?
  • Dr.Reddys is the early mover in Apalutamide API manufacturing and files the USDMF

What is the BCS classification for Apalutamide API?
  • Apalutamide belongs to class 2 of BCS classification.


     

What is primary purpose of using the Apalutamide API?
  • Apalutamide is an androgen receptor inhibitor used to treat non metastatic, castration resistant prostate cancer.


     

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.