Active Pharmaceutical Ingredient

Nivolumab

Also known as: Opdivo; BMS-936558; MDX-1106

CAS: 946414-94-4 Antineoplastic / Immune Checkpoint Inhibitor IP / BP / EP / USP GMP Certified Aurangabad, Maharashtra, India
Nivolumab API — Mediocon Inc
Nivolumab — Pharmaceutical Grade API

Product Overview

CAS No: 946414-94-4  |  MF: Monoclonal Antibody  |  MW: ~146 kDa

Nivolumab is a pharmaceutical-grade active ingredient classified as Antineoplastic / Immune Checkpoint Inhibitor. Mediocon Inc supplies high-purity Nivolumab 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 NameNivolumab
Also Known AsOpdivo; BMS-936558; MDX-1106
CAS Number946414-94-4
Chemical NameNivolumab
Molecular FormulaMonoclonal Antibody
Molecular Weight~146 kDa
CategoryAntineoplastic / Immune Checkpoint Inhibitor
AppearanceLyophilized powder or solution for injection
SolubilitySoluble 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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