Active Pharmaceutical Ingredient

Nafamostat API Manufacturer & Supplier

CAS: 81525-10-2 Active Pharmaceutical Ingredient IP / BP / EP / USP GMP Certified Aurangabad, Maharashtra, India
Nafamostat API Manufacturer & Supplier — Mediocon Inc
Nafamostat API Manufacturer & Supplier

Product Overview

CAS No: 81525-10-2 | Grade: IP / BP / EP / USP | Category: Active Pharmaceutical Ingredient

Nafamostat API Manufacturer & Supplier

MEDIOCON INC is a trusted global manufacturer and supplier of Nafamostat API, offering premium-quality pharmaceutical-grade active pharmaceutical ingredients for pharmaceutical manufacturing, injectable formulation development, analytical testing, quality control, stability studies, and research applications. Every batch is manufactured under stringent quality management systems to ensure exceptional purity, consistency, and compliance with international pharmaceutical standards.

Nafamostat is a synthetic serine protease inhibitor widely used in pharmaceutical formulations and clinical research for the management of acute pancreatitis, disseminated intravascular coagulation (DIC), anticoagulation during extracorporeal circulation, and inflammatory disorders. It inhibits multiple proteases including trypsin, thrombin, plasmin, kallikrein, and complement-associated enzymes, providing potent anticoagulant, anti-inflammatory, and antifibrinolytic effects. Nafamostat has also been extensively investigated for antiviral applications and critical care research. Owing to its broad pharmacological activity, it is widely utilized in pharmaceutical research, formulation development, analytical method validation, process optimization, stability studies, and quality assurance programs.

MEDIOCON INC supplies premium-quality Nafamostat API to pharmaceutical manufacturers, injectable formulation companies, contract research organizations (CROs), contract development and manufacturing organizations (CDMOs), universities, research institutes, and analytical laboratories worldwide. Comprehensive documentation including Certificate of Analysis (COA), Material Safety Data Sheet (MSDS), Technical Data Sheet (TDS), and regulatory support documents is available upon request.

Product Specifications

Product NameNafamostat API Manufacturer & Supplier
CAS Number81525-10-2
CategoryActive Pharmaceutical Ingredient
GradeIP / BP / EP / USP
AppearanceWhite to Off-White Crystalline Powder
StandardsIP / BP / EP / USP Compliant

Analytical Specifications

ParameterSpecification
AppearanceWhite to Off-White Crystalline Powder
IdentificationIR, UV & HPLC Compliant
Assay (HPLC)98.0% – 102.0%
Loss on DryingNMT 0.50%
Residue on IgnitionNMT 0.10%
Heavy MetalsNMT 10 ppm
pH (1% Solution)4.0 – 6.5
Individual ImpurityNMT 0.50%
Total ImpuritiesNMT 1.00%
Water ContentNMT 0.50%
Melting Point210°C – 215°C
SolubilityFreely soluble in water and methanol; slightly soluble in ethanol

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 Nafamostat API Manufacturer & Supplier (CAS 81525-10-2) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Nafamostat API Manufacturer & Supplier 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 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
  • Dedicated QA team for customer audits and regulatory queries

Frequently Asked Questions — Nafamostat API Manufacturer & Supplier

What is Nafamostat API?
Nafamostat API is a synthetic serine protease inhibitor used in pharmaceutical formulations for anticoagulation, acute pancreatitis, disseminated intravascular coagulation (DIC), and inflammatory disorders.
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