Active Pharmaceutical Ingredient

Irsogladine Maleate API Manufacturer and Supplier in India

CAS: 84504-69-8 Active Pharmaceutical Ingredient Pharmaceutical Grade GMP Certified Aurangabad, Maharashtra, India
Irsogladine Maleate API Manufacturer and Supplier in India — Mediocon Inc
Irsogladine Maleate API Manufacturer and Supplier in India

Product Overview

CAS No: 84504-69-8 | Grade: Pharmaceutical Grade | Category: Active Pharmaceutical Ingredient

MEDIOCON INC – Irsogladine Maleate is the maleate salt of Irsogladine, a gastric mucosal protective pharmaceutical active ingredient. It is associated with gastroprotective activity and has been used in pharmaceutical formulations for the management of gastric and duodenal mucosal disorders.

Irsogladine Maleate API

Irsogladine Maleate is a synthetic benzylimidazole derivative formulated as the maleate salt of Irsogladine. It is primarily recognized for its ability to support gastric mucosal defense rather than acting through direct suppression of gastric acid secretion.

Irsogladine has been studied for its effects on gastric mucosal integrity, epithelial cell function and cellular protective mechanisms.

Chemical Information

Product Name: Irsogladine Maleate
CAS Number: 84504-69-8
Molecular Formula: C₁₈H₂₀ClN₅O₄
Molecular Weight: 405.84 g/mol
Chemical Class: Benzylimidazole Derivative
Pharmacological Class: Gastric Mucosal Protective Agent
Salt Form: Maleate
Parent Compound: Irsogladine
Parent CAS Number: 57381-39-2
Synonyms: Irsogladine Maleate, Irsogladine Maleate Salt

Mechanism of Action

Irsogladine is considered a gastric mucosal protective agent.

Its activity has been associated with enhancement of gastric mucosal defense mechanisms, including effects on epithelial cellular integrity and intercellular communication. It may help maintain mucosal resistance against damaging factors.

Unlike proton pump inhibitors and H₂-receptor antagonists, its principal pharmacological role is mucosal protection rather than direct inhibition of gastric acid secretion.

Manufacturing and Quality

MEDIOCON INC focuses on supplying pharmaceutical active ingredients with emphasis on quality, consistency, technical documentation and reliable supply.

Irsogladine Maleate quality evaluation may include:

  • Identification
  • Assay by HPLC
  • Related substances
  • Maleic acid / salt-related determination
  • Residual solvents
  • Loss on drying
  • Residue on ignition
  • Heavy metals
  • Water content
  • pH
  • Other product-specific analytical parameters

The exact acceptance criteria should be confirmed against the applicable approved specification and batch-specific Certificate of Analysis.

Applications

Irsogladine Maleate may be used in:

  • Gastric mucosal protective pharmaceutical formulations
  • Gastric ulcer-related formulations
  • Duodenal ulcer-related formulations
  • Gastrointestinal pharmacology research
  • Mucosal protection research
  • Pharmaceutical research and development

Approved indications and regulatory status may vary by country and applicable product labeling.

Product Characteristics

Irsogladine Maleate is generally described as a white to pale yellow crystalline powder.

Appearance: White to pale yellow crystalline powder

The exact commercial appearance specification should be confirmed against the applicable MEDIOCON INC product specification and batch COA.

Packaging and Documentation

Product availability, packaging configuration, Certificate of Analysis (COA), Safety Data Sheet (SDS/MSDS), technical specifications and analytical documentation should be confirmed with MEDIOCON INC according to customer requirements and applicable regulatory standards.

Product Specifications

Product NameIrsogladine Maleate API Manufacturer and Supplier in India
CAS Number84504-69-8
CategoryActive Pharmaceutical Ingredient
GradePharmaceutical Grade
AppearanceWhite to pale yellow crystalline powder
StandardsPharmaceutical Specifications

Analytical Specifications

ParameterSpecification
AppearanceWhite to pale yellow crystalline powder

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 Irsogladine Maleate API Manufacturer and Supplier in India (CAS 84504-69-8) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Irsogladine Maleate API Manufacturer and Supplier in India 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 — Irsogladine Maleate API Manufacturer and Supplier in India

What is Irsogladine Maleate?
Irsogladine Maleate is the maleate salt of Irsogladine, a pharmaceutical ingredient associated with gastric mucosal protection.
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