Active Pharmaceutical Ingredient

Isoniazide API Manufacturer and Supplier in India

CAS: 54-85-3 Active Pharmaceutical Ingredient Pharmaceutical Grade GMP Certified Aurangabad, Maharashtra, India
Isoniazide API Manufacturer and Supplier in India — Mediocon Inc
Isoniazide API Manufacturer and Supplier in India

Product Overview

CAS No: 54-85-3 | Grade: Pharmaceutical Grade | Category: Active Pharmaceutical Ingredient

MEDIOCON INC – Isoniazide is a synthetic antitubercular active pharmaceutical ingredient (API) widely used as a key component of tuberculosis treatment regimens. It is particularly effective against actively growing Mycobacterium tuberculosis.

Isoniazide API

Isoniazide, also known as Isonicotinic Acid Hydrazide (INH), is a hydrazide derivative of isonicotinic acid. It is one of the established first-line antituberculosis medicines and is commonly used in combination with other anti-TB agents to help prevent the development of drug resistance.

Isoniazide is available for pharmaceutical formulations in accordance with applicable pharmacopoeial and regulatory requirements.

Chemical Information

Product Name: Isoniazide
CAS Number: 54-85-3
Molecular Formula: C₆H₇N₃O
Molecular Weight: 137.14 g/mol
Chemical Class: Isonicotinic Acid Hydrazide
Therapeutic Class: Antitubercular Agent
IUPAC Name: Pyridine-4-carbohydrazide
Synonyms: Isoniazid, Isoniazide, Isonicotinic Acid Hydrazide, INH, Isonicotinic Acid Hydrazide

Mechanism of Action

Isoniazide is a prodrug that is activated by mycobacterial enzymes, particularly the catalase-peroxidase enzyme KatG.

Its activated metabolites interfere with the synthesis of mycolic acids, which are essential components of the Mycobacterium tuberculosis cell wall. This disruption contributes to inhibition of bacterial growth and killing of susceptible organisms.

Manufacturing and Quality

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

Isoniazide 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

Isoniazide may be used in:

  • Tuberculosis pharmaceutical formulations
  • First-line anti-TB treatment regimens
  • Latent tuberculosis infection treatment
  • Combination tuberculosis therapy
  • Antimycobacterial research
  • Pharmaceutical research and development

Isoniazide is generally used in combination with other antituberculosis medicines for active tuberculosis to reduce the risk of resistance.

Product Characteristics

Isoniazide is generally described as a white to colorless crystalline powder or white crystalline solid.

Appearance: White to colorless 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 NameIsoniazide API Manufacturer and Supplier in India
CAS Number54-85-3
CategoryActive Pharmaceutical Ingredient
GradePharmaceutical Grade
AppearanceWhite to colorless crystalline powder
StandardsPharmaceutical Specifications

Analytical Specifications

ParameterSpecification
AppearanceWhite to colorless 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 Isoniazide API Manufacturer and Supplier in India (CAS 54-85-3) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Isoniazide 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 — Isoniazide API Manufacturer and Supplier in India

What is Isoniazide?
Isoniazide is an antitubercular pharmaceutical active ingredient also known as Isonicotinic Acid Hydrazide or INH.
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