Active Pharmaceutical Ingredient

Ketotifen API Manufacturer and Supplier in India

CAS: 34580-13-7 Active Pharmaceutical Ingredient Pharmaceutical Grade GMP Certified Aurangabad, Maharashtra, India
Ketotifen API Manufacturer and Supplier in India — Mediocon Inc
Ketotifen API Manufacturer and Supplier in India

Product Overview

CAS No: 34580-13-7 | Grade: Pharmaceutical Grade | Category: Active Pharmaceutical Ingredient

MEDIOCON INC – Ketotifen is a synthetic antihistamine and mast-cell stabilizing pharmaceutical active ingredient belonging to the tricyclic compound class. It is primarily used in pharmaceutical formulations for the management of allergic conditions and is commonly supplied commercially in salt forms such as Ketotifen Fumarate. PubChem identifies Ketotifen with CAS 34580-13-7, molecular formula C₁₉H₁₉NOS, and molecular weight approximately 309.4 g/mol.

Ketotifen API

Ketotifen is an H1-histamine receptor antagonist with mast-cell stabilizing properties. It has been used in pharmaceutical preparations for allergic disorders and is particularly well known in ophthalmic formulations for temporary relief of itchy eyes associated with allergies. Current U.S. labeling identifies ketotifen fumarate as the active ingredient in ophthalmic products.

Chemical Information

Product Name: Ketotifen
CAS Number: 34580-13-7
Molecular Formula: C₁₉H₁₉NOS
Molecular Weight: 309.40 g/mol
Chemical Class: Tricyclic antihistamine
Therapeutic Class: Antihistamine / Mast-cell stabilizer
IUPAC Name: 2-(1-methylpiperidin-4-ylidene)-6-thiatricyclo[8.4.0.0³,⁷]tetradeca-1(14),3(7),4,10,12-pentaen-8-one
Synonyms: Ketotifen, Ketotifene, Ketotifenum
PubChem CID: 3827

PubChem lists CAS 34580-13-7, formula C₁₉H₁₉NOS, and molecular weight 309.4 g/mol.

Ketotifen Salt Forms

Ketotifen is commonly encountered in pharmaceutical products as Ketotifen Fumarate. The free-base Ketotifen and Ketotifen Fumarate should be maintained as separate product records because their molecular compositions and molecular weights differ.

Ketotifen:
CAS: 34580-13-7
Molecular Weight: 309.40 g/mol

Ketotifen Hydrochloride:
Molecular Formula: C₁₉H₂₀ClNOS
Molecular Weight: 345.90 g/mol

Mechanism of Action

Ketotifen acts primarily as an H1-histamine receptor antagonist and also has mast-cell stabilizing activity. These properties help reduce histamine-mediated allergic responses.

In ophthalmic applications, ketotifen is used as an antihistamine to temporarily relieve itching associated with allergic conjunctival conditions.

Manufacturing and Quality

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

Ketotifen quality evaluation may include:

  • Identification
  • Assay by HPLC
  • Related substances
  • Residual solvents
  • Loss on drying
  • Residue on ignition
  • Heavy metals
  • Water content
  • Optical/physical characteristics
  • Other product-specific analytical parameters

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

Applications

Ketotifen may be used in:

  • Antihistamine formulations
  • Ophthalmic formulations
  • Allergy-related pharmaceutical products
  • Mast-cell stabilizing formulations
  • Pharmaceutical research and development

Commercial ophthalmic products commonly use Ketotifen Fumarate, with the labeled strength expressed in terms of ketotifen active moiety.

Product Characteristics

PubChem describes Ketotifen as crystals.

Appearance: Crystalline solid / crystals

For the exact commercial API appearance, the approved MEDIOCON INC specification and batch COA should be used.

Packaging and Documentation

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

Product Specifications

Product NameKetotifen API Manufacturer and Supplier in India
CAS Number34580-13-7
CategoryActive Pharmaceutical Ingredient
GradePharmaceutical Grade
AppearanceCrystalline solid / crystals
StandardsPharmaceutical Specifications

Analytical Specifications

ParameterSpecification
AppearanceCrystalline solid / crystals

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 Ketotifen API Manufacturer and Supplier in India (CAS 34580-13-7) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Ketotifen 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 — Ketotifen API Manufacturer and Supplier in India

What is Ketotifen?
Ketotifen is an H1 antihistamine and mast-cell stabilizer used in pharmaceutical formulations for allergic conditions.
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