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About Eribulin (Available For Selected Markets) API

Product
  • Therapeutic Category抗癌/抗肿瘤

  • API Technology

    Synthetic

  • Dose Form

    Injectable

  • Dr Reddy's Development Status

    Available (Commercial)

  • Available Regulatory Filing

    USDMF, EUDMF, Canada DMF

作用机制

Eribulin inhibits the growth phase of microtubules without affecting the shortening phase and sequesters tubulin into nonproductive aggregates. Eribulin exerts its effects via a tubulin-based antimitotic mechanism leading to G 2/M cell-cycle block, disruption of mitotic spindles, and, ultimately, apoptotic cell death after prolonged mitotic blockage.

In addition, eribulin treatment of human breast cancer cells caused changes in morphology and gene expression as well as decreased migration and invasiveness in vitro. In mouse xenograft models of human breast cancer, eribulin treatment was associated with increased vascular perfusion and permeability in the tumor cores, resulting in reduced tumor hypoxia, and changes in the expression of genes in tumor specimens associated with a change in phenotype.

适应症

HALAVEN is a microtubule inhibitor indicated for the treatment of patients with:

  • Metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting.
  • Unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen.

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 艾日布林 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 precautions needs to be taken for Eribulin Mesylate ?
  • Precautions with history of liver, kidney, heart problems, any allergy, who are taking other medications, during pregnancy and breastfeeding.


     

What is main purpose of using the Eribulin Mesylate ?
  • Eribulin injection is used to treat metastatic (cancer that has already spread to other parts of the body) breast cancer

What is the BCS classification for Eribulin Mesylate?
  • Eribulin belongs to class-III of BCS classification.

What are the DMFs available for Eribulin Mesylate API ?
  • Eribulin API have DMFs available for USDMF, Europe and Canada.

How do you store Eribulin Mesylate API ?
  • Eribulin should be stored at -65 ± 10 ºC temperature.

What is the dosage form available for Eribulin Mesylate ?
  • The available dosage form for Eribulin is 1 mg/2mL (0.5MG/ML).

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.