Active Pharmaceutical Ingredient

Darbepoetin Alfa

Also known as: Aranesp

CAS: 209810-58-2 Hematology / ESA USP / BP / IP / EP Bulk Supply Available
Darbepoetin Alfa API Manufacturer India | Mediocon Inc
Darbepoetin Alfa — Pharmaceutical Grade API

Product Overview

CAS No: 209810-58-2  |  MF: Recombinant Glycoprotein  |  MW: ~37 kDa

Darbepoetin Alfa is a hyperglycosylated analogue of recombinant human erythropoietin (rhEPO) with a longer half-life than epoetin alfa. It stimulates erythropoiesis and is used for anemia associated with chronic kidney disease and chemotherapy-induced anemia. Mediocon Inc supplies pharmaceutical-grade Darbepoetin Alfa 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

  • Anemia of chronic kidney disease (CKD)
  • Chemotherapy-induced anemia (CIA)
  • Pre-dialysis and dialysis patients
  • Biologic injectable formulations

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 NameDarbepoetin Alfa
Also Known AsAranesp
CAS Number209810-58-2
Molecular FormulaRecombinant Glycoprotein
Molecular Weight~37 kDa
CategoryErythropoiesis-Stimulating Agent (ESA) / Hematopoietic Growth Factor
AppearanceClear Colorless Liquid or Lyophilized Powder
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?