Active Pharmaceutical Ingredient

Sorafenib

Also known as: Sorafenib Tosylate; Nexavar

CAS: 475207-59-1 Multikinase Inhibitor BP / EP / USP / FCC / NF GMP Certified Aurangabad, Maharashtra, India
Sorafenib API — Mediocon Inc
Sorafenib — Pharmaceutical Grade API

Product Overview

CAS No: 475207-59-1  |  MF: C₂₁H₁₆ClF₃N₄O₃  |  MW: 464.83 g/mol

Sorafenib is an oral multikinase inhibitor with both antiproliferative and antiangiogenic properties used as an active pharmaceutical ingredient. Mediocon Inc supplies high-purity Sorafenib API conforming to BP / EP / USP specifications from our GMP-certified facility in Aurangabad, Maharashtra, India.

Sorafenib inhibits multiple kinases including RAF kinases, VEGFR, and PDGFR, blocking tumor cell proliferation and angiogenesis. It is indicated for unresectable hepatocellular carcinoma, renal cell carcinoma, and differentiated thyroid carcinoma.

Key Features

  • High-purity pharmaceutical grade API
  • BP / EP / USP / FCC / NF compliant
  • Full CoA and MSDS documentation
  • GMP certified manufacturing

Applications

  • Hepatocellular carcinoma (HCC) treatment
  • Renal cell carcinoma (RCC)
  • Differentiated thyroid carcinoma
  • Targeted oncology therapy 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 NameSorafenib
Also Known AsSorafenib Tosylate; Nexavar
CAS Number475207-59-1
Molecular FormulaC₂₁H₁₆ClF₃N₄O₃
Molecular Weight464.83 g/mol
CategoryMultikinase Inhibitor — Antineoplastic
AppearanceWhite to yellowish-white powder
SolubilityPractically insoluble in water; slightly soluble in ethanol
GradeBP / EP / USP / FCC / NF

Analytical Specifications

ParameterSpecification
AssayNLT 98.0%
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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