阿帕鲁胺（无定型及晶型B） API
CAS Number: 956104-40-8
About 阿帕鲁胺（无定型及晶型B） API
Therapeutic Category
Anti-Cancer/ Oncology
API Technology
Synthetic
Dose Form
Oral Solids
Dr Reddy's Development Status
Available
Available Regulatory Filing
Brazil DMF
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。
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免责声明
本目錄中的任何信息（包括對任何產品或服務的任何引用）均不構成銷售要約，或被解釋為代表銷售要約。受有效專利保護的產品不提供或供應用於商業用途。但是，只要存在此類監管豁免，就可以出於監管提交的目的提供此類產品的研究數量。買方應對各自市場的專利方案進行獨立評估，並承擔所有與專利相關的責任。在印度受有效專利保護的產品不可用於商業用途，但可用於第 107A 節。
FAQs
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.
Amorphous form is stable for 3 months at room temperature and recommended storage conditions of 2-8°C. Extended stability will be established.
We offer Crystalline Form-B
Available in Tablet dosage form with strength of 60 Mg
Dr.Reddys is the early mover in Apalutamide API manufacturing and files the USDMF
Apalutamide belongs to class 2 of BCS classification.
Apalutamide is an androgen receptor inhibitor used to treat non metastatic, castration resistant prostate cancer.
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