Active Pharmaceutical Ingredient

Cetuximab API Manufacturer & Supplier in India

Also known as: Erbitux (brand)

CAS: 205923-56-4 EGFR Inhibitor Oncology mAb Bulk Supply Available
Cetuximab API Manufacturer India | Mediocon Inc
Cetuximab — Pharmaceutical Grade API

Product Overview

CAS No: 205923-56-4  |  MF: N/A (Monoclonal Antibody)  |  MW: ~152 kDa

Cetuximab is a chimeric IgG1 monoclonal antibody targeting the epidermal growth factor receptor (EGFR). It is used in the treatment of KRAS wild-type metastatic colorectal cancer and squamous cell carcinoma of the head and neck (SCCHN). It inhibits tumor cell proliferation by blocking EGFR signaling. Mediocon Inc supplies pharmaceutical-grade Cetuximab API for oncology drug manufacturers.

Key Features

  • Anti-EGFR chimeric monoclonal antibody
  • IP/BP/EP/USP compliant quality
  • Colorectal cancer and SCCHN treatment
  • IV infusion formulation

Applications

  • KRAS WT metastatic colorectal cancer
  • Squamous cell carcinoma of head & neck
  • Combination with FOLFIRI/FOLFOX
  • Biopharmaceutical manufacturing

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 NameCetuximab
Also Known AsErbitux (brand)
CAS Number205923-56-4
Molecular FormulaN/A (Monoclonal Antibody)
Molecular Weight~152 kDa
CategoryOncology / EGFR Inhibitor / Monoclonal Antibody
AppearanceLyophilized Powder / Solution
GradeIP / BP / EP / USP

Analytical Specifications

ParameterSpecification
Purity≥ 98% (by SEC-HPLC)
EndotoxinNMT 1 EU/mg
BioburdenComplies
IdentificationPeptide Mapping Compliant
Storage2–8°C
PackingAs 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 Cetuximab (CAS 205923-56-4) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Cetuximab 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 — Cetuximab API

What is the minimum order quantity for Cetuximab API?
Mediocon Inc supplies Cetuximab 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 Cetuximab does Mediocon supply?
We supply Cetuximab 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 Cetuximab API?
Every shipment of Cetuximab 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 Cetuximab bulk orders?
Standard lead time for Cetuximab 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.
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