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About Eribulin (Available For Selected Markets) API

Product
  • Therapeutic CategoryAnti-Cáncer / Oncologico

  • API Technology

    Synthetic

  • Dose Form

    Injectable

  • Dr Reddy's Development Status

    Available (Commercial)

  • Available Regulatory Filing

    USDMF, EUDMF, Canada DMF

Mechanism of Action

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.

Indication

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 Expertise

Headquartered in Hyderabad, India, Dr. Reddy's Laboratories is one of the leading Active Pharmaceutical Ingredients (API) manufacturers and suppliers globally for Eribulin (Available For Selected Markets) API. Dr. Reddy's API business is a preferred partner to pharma companies across the US, Europe, Brazil, Latin America, Japan, China, Korea, Middle East and other emerging markets.

Dr. Reddy's API business thrives on the deep technical strengths established over the last 30+ years in the development and manufacture of complex APIs such as steroids, peptides, complex long chain molecules and highly potent APIs (HPAPIs / oncology drugs). This expertise is complemented by our prowess in intellectual property and regulatory affairs which helps us consistently meet and exceed regulatory standards. Dr. Reddy's Eribulin (Available For Selected Markets) API is the outcome of the extensive expertise in R&D, IP, and Regulatory.

A key component in helping our customers be first to market is a responsive supply chain. We achieve this by making sure that all our facilities are operating efficiently and to the latest standards of quality, safety, and productivity. A strong interconnect between business and factories allows for a quick reaction to dynamic market changes, so that we can avert shortages and meet sudden surges in demand.

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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.