Gefitinib API Manufacturer India

Name: Gefitinib
Brand: Mediocon Inc
Availability: InStock

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

Parameter	Specification
Assay	≥98.0% (as per pharmacopoeia)
Loss on Drying	NMT 0.5%
Heavy Metals	NMT 20 ppm
Residue on Ignition	NMT 0.1%
Microbial Limits	Complies with pharmacopoeia
Identification	IR, HPLC Compliant
Packing	25 kg HDPE drums / as per requirement

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 Gefitinib (CAS 184475-35-2) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Gefitinib 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 — identity (IR/HPLC), assay, related substances, residual solvents (ICH Q3C), heavy metals, and microbial limits — 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
Stability data available (ICH Q1A guidelines) for regulatory submissions
Dedicated QA team for customer audits and regulatory queries

Frequently Asked Questions — Gefitinib API

What is the minimum order quantity for Gefitinib API?

Mediocon Inc supplies Gefitinib with a minimum order quantity of 1 kg (sample packs available for R&D). We accommodate both small R&D quantities and large commercial-scale orders. Contact our sales team at akshay@mediocon.com or +91 9309999757 for a tailored quote.

What pharmacopoeial grades of Gefitinib does Mediocon supply?

We supply Gefitinib conforming to IP / BP / EP / USP pharmacopoeial standards. Each batch is tested against full pharmacopoeial specifications and released with a Certificate of Analysis. Custom specifications can be accommodated for regulated markets.

What documentation is provided with Gefitinib API?

Every shipment of Gefitinib comes with: Certificate of Analysis (CoA), MSDS/SDS, Certificate of Origin (COO), and Drug Master File (DMF) support on request. We also provide GMP certification, ISO 9001:2015 compliance documentation, and full regulatory support for filings in USA (FDA), Europe (EMA), and other markets.

What is the lead time and shipping for Gefitinib bulk orders?

Standard lead time for Gefitinib is 2–4 weeks for standard orders; expedited shipments possible for urgent requirements. We ship to 40+ countries worldwide using approved pharmaceutical-grade packaging (25 kg HDPE drums / aluminium foil bags). All shipments include temperature-controlled logistics options where required by the product's storage conditions.

Company

Product Catalog

Gefitinib API Manufacturer & Supplier in India

Product Overview

Product Specifications

Analytical Specifications

Sourcing, Regulatory & Export Information

Frequently Asked Questions — Gefitinib API

Request a Quote

Quick Reference

Related APIs