Active Pharmaceutical Ingredient

Daratumumab

Also known as: Darzalex

CAS: 945721-28-8 Oncology / Monoclonal Antibody USP / BP / IP / EP Bulk Supply Available
Daratumumab API Manufacturer India | Mediocon Inc
Daratumumab — Pharmaceutical Grade API

Product Overview

CAS No: 945721-28-8  |  MF: Monoclonal Antibody  |  MW: ~148 kDa

Daratumumab is a human IgG1κ monoclonal antibody targeting CD38, a glycoprotein highly expressed on multiple myeloma cells. It induces tumor cell death via multiple mechanisms including complement-dependent cytotoxicity (CDC) and antibody-dependent cellular cytotoxicity (ADCC). Mediocon Inc supplies pharmaceutical-grade Daratumumab for bulk pharma manufacturing.

Key Features

  • Analgesic, antipyretic & anti-inflammatory
  • USP/BP/IP compliant quality
  • Widely used in cardiovascular therapy
  • Suitable for tablet and effervescent formulations

Applications

  • Multiple myeloma (relapsed/refractory)
  • First-line multiple myeloma combination regimens
  • Smoldering multiple myeloma (investigational)
  • Oncology biologic formulation R&D

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 NameDaratumumab
Also Known AsDarzalex
CAS Number945721-28-8
Molecular FormulaMonoclonal Antibody
Molecular Weight~148 kDa
CategoryAnti-CD38 Monoclonal Antibody / Antineoplastic
AppearanceLyophilized Powder or Solution
GradeUSP / BP / IP / EP

Analytical Specifications

ParameterSpecification
Assay99.0% Min.
Loss on DryingNMT 1.0%
Melting PointN/A (biologic)
Heavy MetalsComplies
pHN/A
Microbial LimitsComplies with pharmacopoeia
IdentificationIR, HPLC Compliant
Packing25 kg HDPE drums / as per requirement
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