Active Pharmaceutical Ingredient

Gefitinib

Also known as: Iressa

CAS: 184475-35-2 EGFR Inhibitor / Antineoplastic IP / BP / EP / USP GMP Certified Aurangabad, Maharashtra, India
Gefitinib API — Mediocon Inc
Gefitinib — Pharmaceutical Grade API

Product Overview

CAS No: 184475-35-2  |  MF: C22H24ClFN4O3  |  MW: 446.90 g/mol

Gefitinib is a selective EGFR (Epidermal Growth Factor Receptor) tyrosine kinase inhibitor used in the treatment of non-small cell lung cancer (NSCLC). Mediocon Inc supplies pharmaceutical-grade Gefitinib API meeting IP/BP/EP/USP standards.

Key Features

  • Selective EGFR tyrosine kinase inhibitor
  • First-line NSCLC treatment agent
  • IP/BP/EP/USP compliant
  • Full CoA and MSDS documentation

Applications

  • Non-small cell lung cancer (NSCLC)
  • EGFR mutation-positive lung cancer
  • Targeted cancer therapy
  • Oncology formulations

Why Choose Mediocon

  • ISO 9001:2015 & GMP certified manufacturing
  • Consistent batch-to-batch quality with full CoA
  • Export-ready documentation: COO, MSDS, DMF
  • Flexible MOQ for both R&D and commercial scale
  • Dedicated QA support for regulatory filings

Product Specifications

Product NameGefitinib
Also Known AsIressa
CAS Number184475-35-2
Molecular FormulaC22H24ClFN4O3
Molecular Weight446.90 g/mol
CategoryEGFR Inhibitor / Antineoplastic
AppearanceWhite to off-white crystalline powder
GradeIP / BP / EP / USP

Analytical Specifications

ParameterSpecification
Assay≥98.0% (as per pharmacopoeia)
Loss on DryingNMT 0.5%
Heavy MetalsNMT 20 ppm
Residue on IgnitionNMT 0.1%
Microbial LimitsComplies with pharmacopoeia
IdentificationIR, HPLC Compliant
Packing25 kg HDPE drums / as per requirement
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