Logo
Logo

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

Mecanismo de acción

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.

Indicación

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.

Experiencia de Dr. Reddy

Con sede en Hyderabad, India, Dr. Reddy's Laboratories es uno de los principales proveedores de ingredientes farmacéuticos activos (API) a nivel mundial. El negocio API de Dr. Reddy es considerado como un socio preferido de las compañías farmacéuticas en los Estados Unidos, Europa, Brasil, América Latina, Japón, China, Corea y los mercados emergentes.

El negocio de API de Dr. Reddy se nutre de las fortalezas técnicas profundas establecidas en los últimos 30 años en el desarrollo y fabricación de API complejas como esteroides, péptidos, moléculas complejas de cadena larga y API altamente potentes (HPAPI / medicamentos oncológicos). Esta experiencia se complementa con nuestra destreza en propiedad intelectual y asuntos regulatorios que nos ayudan a cumplir y superar los estándares regulatorios de manera consistente. Los APIs de Dr. Reddy´s Mesilato De Eribulina es el resultado de la amplia experiencia en R&D, IP y Normatividad Aplicable.

Un componente clave para ayudar a nuestros clientes a ser los primeros en comercializar es una cadena de suministro receptiva. Logramos esto al asegurarnos de que todas nuestras instalaciones funcionen de manera eficiente y con los últimos estándares de calidad, seguridad y productividad. Una fuerte interconexión entre las empresas y las fábricas permite una reacción rápida a los cambios dinámicos del mercado, de modo que podamos evitar la escasez y satisfacer los repentinos aumentos de la demanda.

RFQ Form

Phone

Related Resources

Description not provided

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.