Active Pharmaceutical Ingredient

Heparin (CAS 9005-49-6) API Manufacturer & Supplier in India

Also known as: Unfractionated Heparin (UFH)

CAS: 9005-49-6 Anticoagulant IP / BP / EP / USP GMP Certified Aurangabad, Maharashtra, India
Heparin API — Mediocon Inc
Heparin — Pharmaceutical Grade API

Product Overview

CAS No: 9005-49-6  |  MF: Polysaccharide  |  MW: ~12,000–15,000 g/mol

Heparin is a pharmaceutical-grade active ingredient classified as a Anticoagulant. Mediocon Inc supplies high-purity Heparin API conforming to IP / BP / EP / USP specifications, manufactured in our GMP-certified facility in Aurangabad, Maharashtra, India.

Key Features

  • Gold-standard parenteral anticoagulant
  • Rapid onset of action by IV/SC route
  • IP/BP/EP/USP compliant
  • Full CoA and MSDS documentation

Applications

  • Prophylaxis and treatment of deep vein thrombosis (DVT)
  • Pulmonary embolism management
  • Extracorporeal circuit anticoagulation (dialysis, bypass)
  • Injectable and infusion 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 NameHeparin
Also Known AsUnfractionated Heparin (UFH)
CAS Number9005-49-6
Molecular FormulaPolysaccharide
Molecular Weight~12,000–15,000 g/mol
CategoryAnticoagulant
AppearanceWhite to off-white amorphous powder
SolubilityFreely soluble in water
GradeIP / BP / EP / USP

Analytical Specifications

ParameterSpecification
Assay≥98.0% (as per pharmacopoeia)
Loss on DryingNMT 0.5%
Heavy MetalsNMT 20 ppm
Residue on IgnitionNMT 0.1%
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 Heparin (CAS 9005-49-6) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Heparin 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 — Heparin API

What is the minimum order quantity for Heparin API?
Mediocon Inc supplies Heparin 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 Heparin does Mediocon supply?
We supply Heparin conforming to IP / BP / EP / USP 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 Heparin API?
Every shipment of Heparin 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 Heparin bulk orders?
Standard lead time for Heparin 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.
💬
Mediocon AI
Hello 👋 How can I help you today?