Active Pharmaceutical Ingredient

Denosumab

Also known as: Prolia / Xgeva

CAS: 615258-40-7 Bone Health / Oncology USP / BP / IP / EP Bulk Supply Available
Denosumab API Manufacturer India | Mediocon Inc
Denosumab — Pharmaceutical Grade API

Product Overview

CAS No: 615258-40-7  |  MF: Monoclonal Antibody  |  MW: ~147 kDa

Denosumab is a fully human monoclonal antibody (IgG2) that targets RANKL (receptor activator of nuclear factor kappa-B ligand), inhibiting osteoclast formation and function to reduce bone resorption. It is used for osteoporosis, bone metastases, and giant cell tumor of bone. Mediocon Inc supplies pharmaceutical-grade Denosumab 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

  • Postmenopausal osteoporosis
  • Bone metastases in solid tumors
  • Giant cell tumor of bone
  • Cancer treatment-induced bone loss

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 NameDenosumab
Also Known AsProlia / Xgeva
CAS Number615258-40-7
Molecular FormulaMonoclonal Antibody
Molecular Weight~147 kDa
CategoryAnti-RANKL Monoclonal Antibody / Bone Resorption Inhibitor
AppearanceClear to Opalescent Liquid or Lyophilized
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
💬
Mediocon AI
Hello 👋 How can I help you today?