Active Pharmaceutical Ingredient

Rituximab — CAS 174722-31-7

Also known as: Rituxan; MabThera; IDEC-C2B8

GMP Certified IP / BP / EP / USP Monoclonal Antibody / CD20 Antagonist Aurangabad, India
Rituximab API Supplier Manufacturer Aurangabad Maharashtra India — Mediocon Inc
Rituximab IP / BP / EP / USP  |  GMP Certified  |  Mediocon Inc, Maharashtra, India
CAS No: 174722-31-7

Product Overview

Rituximab is a chimeric monoclonal antibody that targets the CD20 antigen on B lymphocytes. It is widely used in the treatment of B-cell non-Hodgkin lymphoma, chronic lymphocytic leukaemia, and several autoimmune conditions. Mediocon Inc manufactures GMP-compliant Rituximab at its Aurangabad facility.

Therapeutic Applications
  • Non-Hodgkin lymphoma (NHL) treatment
  • Chronic lymphocytic leukaemia (CLL)
  • Rheumatoid arthritis (second-line)
  • Granulomatosis with polyangiitis
  • Pemphigus vulgaris

Technical Specifications

ParameterSpecification
CAS Number174722-31-7
Molecular FormulaC₆₄₁₆H₉₈₇₄N₁₆₈₈O₁₉₉₆S₄₄
Molecular Weight~143,859 Da
GradeIP / BP / EP / USP
CategoryMonoclonal Antibody / CD20 Antagonist
AssayNLT 98.0%
Loss on DryingNMT 0.5%
Heavy MetalsNMT 20 ppm
Residue on IgnitionNMT 0.1%
Microbial LimitsComplies with pharmacopoeia
IdentificationIR, HPLC Compliant
Batch NoRIT/24032026
Mfg DateMAR 2026
Exp DateFEB 2031
Packing25 kg HDPE drums / as per requirement

Quality & Compliance

  • GMP Certified manufacturing facility in Aurangabad, Maharashtra, India
  • Full pharmacopoeial compliance: IP / BP / EP / USP standards
  • Complete documentation: Certificate of Analysis (CoA), MSDS, Certificate of Origin
  • Stringent in-process quality control at every manufacturing stage
  • HPLC purity testing and spectroscopic identification (IR, NMR)
  • Cold-chain and controlled-environment storage facilities available
  • Exported to 40+ countries with full regulatory support
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