Active Pharmaceutical Ingredient

Nintedanib

Also known as: Ofev; BIBF 1120

CAS: 656247-17-5 Antifibrotic / Tyrosine Kinase Inhibitor IP / BP / EP / USP GMP Certified Aurangabad, Maharashtra, India
Nintedanib API — Mediocon Inc
Nintedanib — Pharmaceutical Grade API

Product Overview

CAS No: 656247-17-5  |  MF: C₃₁H₃₃N₅O₄  |  MW: 539.63 g/mol

Nintedanib is a pharmaceutical-grade active ingredient classified as Antifibrotic / Tyrosine Kinase Inhibitor. Mediocon Inc supplies high-purity Nintedanib API conforming to IP / BP / EP / USP specifications, manufactured in our GMP-certified facility in Aurangabad, Maharashtra, India.

Key Features

  • Dihydrofolate reductase inhibitor
  • IP/BP/EP/USP compliant
  • Full CoA and MSDS documentation
  • GMP certified manufacturing

Applications

  • Rheumatoid arthritis
  • Psoriasis
  • Various cancers (ALL, NHL, osteosarcoma)

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 NameNintedanib
Also Known AsOfev; BIBF 1120
CAS Number656247-17-5
Chemical NameNintedanib
Molecular FormulaC₃₁H₃₃N₅O₄
Molecular Weight539.63 g/mol
CategoryAntifibrotic / Tyrosine Kinase Inhibitor
AppearanceLight yellow to yellowish powder
SolubilitySlightly soluble in water
GradeIP / BP / EP / USP

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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