Active Pharmaceutical Ingredient

Irofulven API Manufacturer and Supplier in India

CAS: 158800-63-6 Active Pharmaceutical Ingredient Pharmaceutical Grade GMP Certified Aurangabad, Maharashtra, India
Irofulven API Manufacturer and Supplier in India — Mediocon Inc
Irofulven API Manufacturer and Supplier in India

Product Overview

CAS No: 158800-63-6 | Grade: Pharmaceutical Grade | Category: Active Pharmaceutical Ingredient

MEDIOCON INC – Irofulven is a synthetic antineoplastic compound derived from the natural product illudin S. It has been investigated as a DNA-damaging anticancer agent and belongs to a class of compounds that form reactive intermediates capable of interacting with cellular DNA.

Irofulven API

Irofulven is a semisynthetic derivative of illudin S, a sesquiterpene compound originally identified from Omphalotus mushroom species. It was developed as an investigational anticancer compound because of its ability to cause DNA damage selectively in cells with active nucleotide excision repair pathways.

Irofulven has been investigated in oncology research, including studies involving solid tumors, and has been evaluated as a potential pharmaceutical anticancer agent.

Chemical Information

Product Name: Irofulven
CAS Number: 158800-63-6
Molecular Formula: C₁₅H₁₈O₄
Molecular Weight: 262.30 g/mol
Chemical Class: Illudin Derivative / Sesquiterpene Derivative
Pharmacological Class: Antineoplastic / DNA-Damaging Agent
Synonyms: Irofulven, MGI-114, Acylfulvene

Mechanism of Action

Irofulven is converted into reactive intermediates that can interact with cellular macromolecules, particularly DNA.

Its anticancer activity is associated with DNA damage and disruption of DNA replication and transcription. Irofulven has also been studied in relation to nucleotide excision repair (NER) pathways, which can influence cellular sensitivity to the compound.

Manufacturing and Quality

MEDIOCON INC focuses on supplying pharmaceutical and research-grade active ingredients with emphasis on quality, consistency, technical documentation and reliable supply.

Irofulven quality evaluation may include:

  • Identification
  • Assay by HPLC
  • Related substances
  • Degradation products
  • Residual solvents
  • Loss on drying
  • Residue on ignition
  • Heavy metals
  • Water content
  • Optical / stereochemical purity where applicable
  • Other product-specific analytical parameters

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

Applications

Irofulven may be relevant to:

  • Oncology research
  • Anticancer drug research
  • DNA-damage research
  • Nucleotide excision repair studies
  • Solid-tumor research
  • Drug discovery and development
  • Pharmaceutical research and development

Irofulven is primarily recognized as an investigational anticancer compound, and its regulatory status and approved therapeutic applications should be confirmed for the intended market.

Product Characteristics

Irofulven is generally described as a yellow to orange solid or crystalline material.

Appearance: Yellow to orange solid

The exact commercial appearance specification should be confirmed against the applicable MEDIOCON INC product 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 customer requirements and applicable regulatory standards.

Product Specifications

Product NameIrofulven API Manufacturer and Supplier in India
CAS Number158800-63-6
CategoryActive Pharmaceutical Ingredient
GradePharmaceutical Grade
AppearanceYellow to orange solid
StandardsPharmaceutical Specifications

Analytical Specifications

ParameterSpecification
AppearanceYellow to orange 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 Irofulven API Manufacturer and Supplier in India (CAS 158800-63-6) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Irofulven 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 — Irofulven API Manufacturer and Supplier in India

What is Irofulven?
Irofulven is an investigational antineoplastic compound derived from the illudin family and studied for its DNA-damaging anticancer activity.
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