Active Pharmaceutical Ingredient

Ixabepilone API Manufacturer and Supplier in India

CAS: 219989-84-1 Active Pharmaceutical Ingredient Pharmaceutical Grade GMP Certified Aurangabad, Maharashtra, India
Ixabepilone API Manufacturer and Supplier in India — Mediocon Inc
Ixabepilone API Manufacturer and Supplier in India

Product Overview

CAS No: 219989-84-1 | Grade: Pharmaceutical Grade | Category: Active Pharmaceutical Ingredient

MEDIOCON INC – Ixabepilone is a semisynthetic epothilone-class antineoplastic agent that acts as a microtubule-stabilizing compound. It was developed as an anticancer drug for the treatment of certain advanced or metastatic breast cancers, particularly in patients whose tumors had progressed following prior chemotherapy.

Ixabepilone API

Ixabepilone is a semisynthetic analog of epothilone B. It binds to tubulin and promotes microtubule stabilization, thereby interfering with the normal dynamic reorganization of microtubules required for cell division.

Ixabepilone is particularly relevant to oncology pharmaceutical development because of its activity against cancer cells and its ability to retain activity in certain models involving resistance to taxane-based chemotherapy.

Chemical Information

Product Name: Ixabepilone
CAS Number: 219989-84-1
Molecular Formula: C₂₇H₄₂N₂O₅S
Molecular Weight: 506.70 g/mol
Chemical Class: Epothilone Analog
Therapeutic Class: Antineoplastic Agent / Microtubule Stabilizer
IUPAC Name: (1S,3S,6R,7R,10S,11S,12S,16R)-7,11-dihydroxy-8,8,10,12,16-pentamethyl-3-[(E)-1-methyl-2-(2-methylthiazol-4-yl)ethenyl]-5-oxa-4-azabicyclo[10.3.1]hexadecane-6,12-dione
Development Code: BMS-247550
Synonyms: Ixabepilone, Ixabepilona

Mechanism of Action

Ixabepilone is a microtubule-stabilizing agent. It binds to tubulin and promotes the formation and stabilization of microtubules.

This interferes with the normal dynamic processes required for mitotic cell division, resulting in cell-cycle arrest and subsequent cancer-cell death.

Manufacturing and Quality

MEDIOCON INC focuses on supplying pharmaceutical and specialty chemical ingredients with emphasis on quality, consistency, technical documentation and reliable supply.

Ixabepilone quality evaluation may include:

  • Identification
  • Assay by HPLC
  • Related substances
  • Degradation products
  • Residual solvents
  • Water content
  • Loss on drying
  • Heavy metals
  • Residue on ignition
  • Specific optical rotation
  • Other product-specific analytical parameters

The exact acceptance criteria should be confirmed against the current approved specification and batch-specific Certificate of Analysis.

Applications

Ixabepilone is associated with:

  • Oncology pharmaceutical formulations
  • Breast cancer treatment
  • Anticancer drug development
  • Microtubule research
  • Epothilone research
  • Pharmaceutical research and development

The U.S. FDA-approved product Ixempra (ixabepilone) was indicated for certain patients with metastatic or locally advanced breast cancer after failure of specified prior chemotherapy regimens.

Product Characteristics

Ixabepilone is generally described as a white to off-white solid/powder.

Appearance: White to off-white powder/solid

The exact commercial appearance specification should be confirmed against the applicable MEDIOCON INC specification and batch COA.

Packaging and Documentation

Product availability, packaging configuration, Certificate of Analysis (COA), Safety Data Sheet (SDS/MSDS), technical specifications and analytical documentation should be confirmed with MEDIOCON INC according to the intended pharmaceutical application.

Product Specifications

Product NameIxabepilone API Manufacturer and Supplier in India
CAS Number219989-84-1
CategoryActive Pharmaceutical Ingredient
GradePharmaceutical Grade
AppearanceWhite to off-white powder/solid
StandardsPharmaceutical Specifications

Analytical Specifications

ParameterSpecification
AppearanceWhite to off-white powder/solid

Sourcing, Regulatory & Export Information

Mediocon Inc is a GMP-certified API manufacturer and bulk pharmaceutical ingredient supplier based in Aurangabad, Maharashtra, India. We specialise in supplying Ixabepilone API Manufacturer and Supplier in India (CAS 219989-84-1) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Ixabepilone API Manufacturer and Supplier in India is manufactured under strict quality management protocols compliant with WHO-GMP, ISO 9001:2015, and major pharmacopoeial standards (IP, BP, USP, EP). Every batch undergoes full analytical testing before release with a Certificate of Analysis.

Export Markets

  • USA — FDA-registered facility; DMF support available for ANDA/NDA filings
  • Europe — EMA-compliant documentation; CEP/EDMF support on request
  • Africa & Middle East — WHO-GMP certified; competitive pricing for emerging markets
  • Southeast Asia — established logistics network; temperature-controlled shipments
  • India domestic — schedule H/X compliance; all state licensing documentation provided

Quality & Compliance

  • ISO 9001:2015 certified quality management system
  • GMP-certified manufacturing facility, Aurangabad, Maharashtra
  • Full batch traceability from raw material to finished API
  • Dedicated QA team for customer audits and regulatory queries

Frequently Asked Questions — Ixabepilone API Manufacturer and Supplier in India

What is Ixabepilone?
Ixabepilone is a semisynthetic epothilone analog and microtubule-stabilizing antineoplastic agent.
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