Active Pharmaceutical Ingredient

Nimotuzumab API Manufacturer & Supplier

CAS: 220578-59-6 Active Pharmaceutical Ingredient Pharmaceutical Grade GMP Certified Aurangabad, Maharashtra, India
Nimotuzumab API Manufacturer & Supplier — Mediocon Inc
Nimotuzumab API Manufacturer & Supplier

Product Overview

CAS No: 220578-59-6 | Grade: Pharmaceutical Grade | Category: Active Pharmaceutical Ingredient

Nimotuzumab API Manufacturer & Supplier

MEDIOCON INC is a trusted global manufacturer and supplier of Nimotuzumab API, providing premium-quality biopharmaceutical active pharmaceutical ingredients for pharmaceutical manufacturing, biologics formulation development, analytical testing, quality control, stability studies, and research applications. Manufactured under stringent quality management systems, our products deliver exceptional purity, consistency, and compliance with international pharmaceutical standards.

Nimotuzumab is a recombinant humanized monoclonal antibody that specifically targets the epidermal growth factor receptor (EGFR). It is widely used in oncology pharmaceutical formulations for the treatment of EGFR-expressing cancers, including head and neck cancer, glioma, nasopharyngeal carcinoma, and other solid tumors. By selectively binding to EGFR, Nimotuzumab inhibits tumor cell proliferation, angiogenesis, and metastasis while preserving normal tissues due to its favorable binding characteristics. It is extensively utilized in pharmaceutical research, biosimilar development, analytical method validation, process optimization, stability studies, and quality assurance programs.

MEDIOCON INC supplies premium-quality Nimotuzumab API to pharmaceutical manufacturers, biotechnology companies, contract development and manufacturing organizations (CDMOs), contract research organizations (CROs), universities, research institutes, and analytical laboratories worldwide. Complete documentation including Certificate of Analysis (COA), Material Safety Data Sheet (MSDS), Technical Data Sheet (TDS), and regulatory support documents is available upon request.

Product Specifications

Product NameNimotuzumab API Manufacturer & Supplier
CAS Number220578-59-6
CategoryActive Pharmaceutical Ingredient
GradePharmaceutical Grade
AppearanceClear to Slightly Opalescent Colorless Solution
StandardsPharmaceutical Specifications

Analytical Specifications

ParameterSpecification
AppearanceClear to Slightly Opalescent Colorless Solution
IdentificationELISA, SEC-HPLC & SDS-PAGE Compliant
Assay (HPLC)95.0% – 105.0%
Heavy MetalsNMT 10 ppm
pH (1% Solution)6.0 – 7.5
Individual ImpurityNMT 1.00%
Total ImpuritiesNMT 2.00%
Melting Point2°C to 8°C.
SolubilityFreely soluble in aqueous buffer solutions

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 Nimotuzumab API Manufacturer & Supplier (CAS 220578-59-6) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Nimotuzumab API Manufacturer & Supplier 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 — Nimotuzumab API Manufacturer & Supplier

What is Nimotuzumab API?
Nimotuzumab API is a recombinant humanized monoclonal antibody targeting the epidermal growth factor receptor (EGFR), widely used in oncology pharmaceutical formulations and cancer research.
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