Active Pharmaceutical Ingredient

Mizolastine API Manufacturer & Supplier in India | MEDIOCON INC

CAS: 108612-45-9 Active Pharmaceutical Ingredient IP / BP / EP / USP GMP Certified Aurangabad, Maharashtra, India
Mizolastine API Manufacturer & Supplier in India | MEDIOCON INC — Mediocon Inc
Mizolastine API Manufacturer & Supplier in India | MEDIOCON INC

Product Overview

CAS No: 108612-45-9 | Grade: IP / BP / EP / USP | Category: Active Pharmaceutical Ingredient

Mizolastine API Manufacturer & Supplier in India

MEDIOCON INC is a trusted API manufacturer and supplier in India of Mizolastine API, offering premium-quality pharmaceutical-grade active pharmaceutical ingredients for pharmaceutical manufacturing, 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.

Mizolastine is a second-generation H1 antihistamine active pharmaceutical ingredient widely used in pharmaceutical formulations for the treatment of seasonal allergic rhinitis, perennial allergic rhinitis, chronic idiopathic urticaria, and other allergic disorders. It selectively blocks peripheral histamine H1 receptors, thereby preventing histamine-mediated allergic responses such as sneezing, nasal congestion, rhinorrhea, itching, and skin wheals. Due to its minimal penetration of the blood-brain barrier, Mizolastine provides effective antiallergic activity with a low incidence of sedation compared with first-generation antihistamines. It is extensively utilized in pharmaceutical research, formulation development, analytical method validation, process optimization, stability studies, and quality assurance programs.

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

Product Specifications

Product NameMizolastine API Manufacturer & Supplier in India | MEDIOCON INC
CAS Number108612-45-9
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)4.5 – 6.5
Individual ImpurityNMT 0.50%
Total ImpuritiesNMT 1.00%
Water ContentNMT 0.50%
Melting Point205°C – 210°C
SolubilitySlightly soluble in water; freely soluble in methanol and 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 Mizolastine API Manufacturer & Supplier in India | MEDIOCON INC (CAS 108612-45-9) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Mizolastine API Manufacturer & Supplier in India | MEDIOCON INC 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 — Mizolastine API Manufacturer & Supplier in India | MEDIOCON INC

What is Mizolastine API?
Mizolastine API is a second-generation H1 antihistamine active pharmaceutical ingredient used in pharmaceutical formulations for the treatment of allergic rhinitis, urticaria, and other allergic conditions.
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