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About Apalutamide (Amorphous & Form B) API

Product
  • Therapeutic Category抗癌/抗肿瘤

  • API Technology

    Synthetic

  • Dose Form

    Oral Solid/Tablets

  • Dr Reddy's Development Status

    Available (Commercial)

  • Available Regulatory Filing

    Brazil DMF, USDMF

作用机制

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.

适应症

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

Dr. Reddy's的专长

Dr. Reddy's总部位于印度海得拉巴,是全球领先的活性药物成分(API)供应商之一。 Dr. Reddy's的API业务是美国、欧洲、巴西、拉丁美洲、日本、中国、韩国和新兴市场的制药公司的首选合作伙伴。

Dr. Reddy's博士的API业务在过去30多年来在开发和制造复杂API(如类固醇,多肽,复杂长链分子和高效API(HPAPI /肿瘤药物))方面所建立的深厚技术优势中茁壮成长。 我们在知识产权和法规事务方面的实力可以帮助我们始终如一地达到并超越监管标准,从而为这一专业知识提供补充。 Dr. Reddy's博士 阿帕鲁胺(无定型及晶型B) API是研发,知识产权和监管方面广泛专业知识的结果。

帮助我们的客户率先进入市场的关键组成部分是响应式供应链。 我们通过确保所有设施都高效运行并达到最新的质量,安全和生产率标准来实现这一目标。 业务和工厂之间的强大互联可以快速响应动态的市场变化,从而避免短缺并满足需求的突然激增。

RFQ Form

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Related Resources

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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.