Active Pharmaceutical Ingredient

Dabigatran

Also known as: Pradaxa

CAS: 211914-51-1 Anticoagulant / Cardiovascular USP / BP / IP / EP Bulk Supply Available
Dabigatran API Manufacturer India | Mediocon Inc
Dabigatran — Pharmaceutical Grade API

Product Overview

CAS No: 211914-51-1  |  MF: C₂₅H₂₅N₇O₃  |  MW: 471.52 g/mol

Dabigatran etexilate is a prodrug that is rapidly converted to Dabigatran, a direct, reversible inhibitor of thrombin, used in prevention of stroke and systemic embolism in atrial fibrillation, and treatment/prevention of DVT and pulmonary embolism. Mediocon Inc supplies pharmaceutical-grade Dabigatran meeting IP, BP, EP, and USP standards.

Key Features

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

Applications

  • Stroke prevention in non-valvular AF
  • Deep vein thrombosis (DVT) treatment
  • Pulmonary embolism prevention
  • Post-surgical thromboprophylaxis

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 NameDabigatran
Also Known AsPradaxa
CAS Number211914-51-1
Molecular FormulaC₂₅H₂₅N₇O₃
Molecular Weight471.52 g/mol
CategoryDirect Thrombin Inhibitor / Anticoagulant
AppearanceWhite to Off-White Powder
GradeUSP / BP / IP / EP

Analytical Specifications

ParameterSpecification
Assay99.0% Min.
Loss on DryingNMT 0.5%
Melting PointN/A
Heavy MetalsNMT 20 ppm
pHN/A
Microbial LimitsComplies with pharmacopoeia
IdentificationIR, HPLC Compliant
Packing25 kg HDPE drums / as per requirement
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