Active Pharmaceutical Ingredient

Mubritinib API Manufacturer & Supplier

CAS: 366017-09-6 Active Pharmaceutical Ingredient Pharmaceutical Grade GMP Certified Aurangabad, Maharashtra, India
Mubritinib API Manufacturer & Supplier — Mediocon Inc
Mubritinib API Manufacturer & Supplier

Product Overview

CAS No: 366017-09-6 | Grade: Pharmaceutical Grade | Category: Active Pharmaceutical Ingredient

Mubritinib API Manufacturer & Supplier

MEDIOCON INC is a trusted global manufacturer and supplier of Mubritinib API, offering premium-quality pharmaceutical-grade active pharmaceutical ingredients for pharmaceutical manufacturing, oncology research, formulation development, analytical testing, quality control, stability studies, and drug discovery applications. Every batch is manufactured under stringent quality management systems to ensure exceptional purity, consistency, and compliance with international pharmaceutical standards.

Mubritinib is a potent small-molecule tyrosine kinase inhibitor initially developed as a HER2 (ErbB2) inhibitor and is now widely utilized in advanced oncology research. Recent studies have demonstrated its unique ability to inhibit mitochondrial electron transport chain Complex I, making it a valuable compound in leukemia research, cancer metabolism studies, and targeted anticancer drug development. Mubritinib is extensively employed in pharmaceutical research, medicinal chemistry, formulation development, analytical method validation, process optimization, stability studies, and quality assurance programs.

MEDIOCON INC supplies premium-quality Mubritinib API to pharmaceutical manufacturers, biotechnology companies, contract research organizations (CROs), contract development and manufacturing organizations (CDMOs), universities, cancer research institutes, and analytical laboratories worldwide. Comprehensive 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 NameMubritinib API Manufacturer & Supplier
CAS Number366017-09-6
CategoryActive Pharmaceutical Ingredient
GradePharmaceutical Grade
AppearanceWhite to Pale Yellow Crystalline Powder
StandardsPharmaceutical Specifications

Analytical Specifications

ParameterSpecification
AppearanceWhite to Pale Yellow Crystalline Powder
IdentificationIR, UV & HPLC Compliant
Assay (HPLC)≥99.0%
Loss on DryingNMT 0.50%
Residue on IgnitionNMT 0.10%
Heavy MetalsNMT 10 ppm
pH (1% Solution)5.0 – 7.5
Individual ImpurityNMT 0.50%
Total ImpuritiesNMT 1.00%
Water ContentNMT 0.50%
Melting Point205°C – 210°C
SolubilitySlightly soluble in water; freely soluble in DMSO and methanol

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 Mubritinib API Manufacturer & Supplier (CAS 366017-09-6) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Mubritinib 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 — Mubritinib API Manufacturer & Supplier

What is Mubritinib API?
Mubritinib API is a small-molecule tyrosine kinase inhibitor widely used in oncology research, cancer metabolism studies, and targeted anticancer drug development.
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