Active Pharmaceutical Ingredient

Darbepoetin Alfa API Manufacturer & Supplier in India

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

Sourcing, Regulatory & Export Information

Mediocon Inc is a GMP-certified API manufacturer and bulk pharmaceutical ingredient supplier based in Aurangabad, Maharashtra, India. We specialise in supplying Darbepoetin Alfa (CAS 209810-58-2) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Darbepoetin Alfa is manufactured under strict quality management protocols compliant with WHO-GMP, ISO 9001:2015, and major pharmacopoeial standards (IP, BP, USP, EP). Every batch undergoes full analytical testing — identity (IR/HPLC), assay, related substances, residual solvents (ICH Q3C), heavy metals, and microbial limits — before release with a Certificate of Analysis.

Export Markets

  • USA — FDA-registered facility; DMF support available for ANDA/NDA filings
  • Europe — EMA-compliant documentation; CEP/EDMF support on request
  • Africa & Middle East — WHO-GMP certified; competitive pricing for emerging markets
  • Southeast Asia — established logistics network; temperature-controlled shipments
  • India domestic — schedule H/X compliance; all state licensing documentation provided

Quality & Compliance

  • ISO 9001:2015 certified quality management system
  • GMP-certified manufacturing facility, Aurangabad, Maharashtra
  • Full batch traceability from raw material to finished API
  • Stability data available (ICH Q1A guidelines) for regulatory submissions
  • Dedicated QA team for customer audits and regulatory queries

Frequently Asked Questions — Darbepoetin Alfa API

What is the minimum order quantity for Darbepoetin Alfa API?
Mediocon Inc supplies Darbepoetin Alfa with a minimum order quantity of 1 kg (sample packs available for R&D). We accommodate both small R&D quantities and large commercial-scale orders. Contact our sales team at akshay@mediocon.com or +91 9309999757 for a tailored quote.
What pharmacopoeial grades of Darbepoetin Alfa does Mediocon supply?
We supply Darbepoetin Alfa conforming to USP / BP / IP / EP pharmacopoeial standards. Each batch is tested against full pharmacopoeial specifications and released with a Certificate of Analysis. Custom specifications can be accommodated for regulated markets.
What documentation is provided with Darbepoetin Alfa API?
Every shipment of Darbepoetin Alfa comes with: Certificate of Analysis (CoA), MSDS/SDS, Certificate of Origin (COO), and Drug Master File (DMF) support on request. We also provide GMP certification, ISO 9001:2015 compliance documentation, and full regulatory support for filings in USA (FDA), Europe (EMA), and other markets.
What is the lead time and shipping for Darbepoetin Alfa bulk orders?
Standard lead time for Darbepoetin Alfa is 2–4 weeks for standard orders; expedited shipments possible for urgent requirements. We ship to 40+ countries worldwide using approved pharmaceutical-grade packaging (25 kg HDPE drums / aluminium foil bags). All shipments include temperature-controlled logistics options where required by the product's storage conditions.
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