Active Pharmaceutical Ingredient

Irsogladine API Manufacturer and Supplier in India

CAS: 57381-39-2 Active Pharmaceutical Ingredient Pharmaceutical Grade GMP Certified Aurangabad, Maharashtra, India
Irsogladine API Manufacturer and Supplier in India — Mediocon Inc
Irsogladine API Manufacturer and Supplier in India

Product Overview

CAS No: 57381-39-2 | Grade: Pharmaceutical Grade | Category: Active Pharmaceutical Ingredient

MEDIOCON INC – Irsogladine is a gastric mucosal protective pharmaceutical active ingredient belonging to the benzylimidazole class. It is primarily associated with protection and maintenance of gastric mucosal integrity and has been used in pharmaceutical formulations for gastrointestinal disorders.

Irsogladine API

Irsogladine is the active moiety of Irsogladine Maleate and is a synthetic benzylimidazole derivative. Unlike conventional acid-suppressing medicines, Irsogladine is primarily associated with enhancement of gastric mucosal defense mechanisms.

It has been studied for its effects on gastric epithelial cells, intercellular communication and maintenance of mucosal integrity.

Chemical Information

Product Name: Irsogladine
CAS Number: 57381-39-2
Molecular Formula: C₉H₁₀ClN₃O
Molecular Weight: 211.65 g/mol
Chemical Class: Benzylimidazole Derivative
Pharmacological Class: Gastric Mucosal Protective Agent
Parent Salt Form: Irsogladine Maleate
Synonyms: Irsogladine, Irsogladine Free Base

Mechanism of Action

Irsogladine is associated with gastric mucosal protective activity.

Its pharmacological effects have been linked to improvement of gastric epithelial cell function, maintenance of intercellular communication and enhancement of mucosal defense against damaging factors.

Unlike proton pump inhibitors, Irsogladine does not primarily work by directly inhibiting 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 quality evaluation may include:

  • Identification
  • Assay by HPLC
  • Related substances
  • Residual solvents
  • Loss on drying
  • Residue on ignition
  • Heavy metals
  • Water content
  • pH
  • Melting point
  • 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 may be relevant to:

  • Gastric mucosal protective formulations
  • Gastrointestinal pharmaceutical research
  • Gastric ulcer research
  • Duodenal ulcer research
  • Mucosal defense research
  • Pharmaceutical research and development

Clinical indications and regulatory status vary according to country and applicable product authorization.

Product Characteristics

Irsogladine 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 API Manufacturer and Supplier in India
CAS Number57381-39-2
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 API Manufacturer and Supplier in India (CAS 57381-39-2) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Irsogladine 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 API Manufacturer and Supplier in India

What is Irsogladine?
Irsogladine is a benzylimidazole derivative associated with gastric mucosal protective activity.
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