Active Pharmaceutical Ingredient

Nitazoxanide API Manufacturer & Supplier

CAS: 55981-09-4 Active Pharmaceutical Ingredient IP / BP / EP / USP GMP Certified Aurangabad, Maharashtra, India
Nitazoxanide API Manufacturer & Supplier — Mediocon Inc
Nitazoxanide API Manufacturer & Supplier

Product Overview

CAS No: 55981-09-4 | Grade: IP / BP / EP / USP | Category: Active Pharmaceutical Ingredient

Nitazoxanide API Manufacturer & Supplier

MEDIOCON INC is a trusted global manufacturer and supplier of Nitazoxanide API, offering high-quality pharmaceutical-grade active pharmaceutical ingredients for pharmaceutical manufacturing, formulation development, analytical testing, quality control, stability studies, and research applications. Our APIs are manufactured under stringent quality management systems to ensure exceptional purity, consistency, and compliance with international pharmaceutical standards.

Nitazoxanide is a broad-spectrum antiparasitic and antiviral active pharmaceutical ingredient belonging to the thiazolide class. It is widely used in pharmaceutical formulations for the treatment of protozoal infections such as cryptosporidiosis and giardiasis and has also been investigated for its antiviral activity against a variety of viral pathogens. Due to its excellent efficacy and safety profile, Nitazoxanide is extensively utilized in pharmaceutical research, finished dosage formulation development, process optimization, analytical method validation, stability studies, and quality assurance programs.

MEDIOCON INC supplies premium-quality Nitazoxanide API to pharmaceutical manufacturers, contract manufacturing organizations (CMOs), contract research organizations (CROs), formulation companies, universities, research institutes, and laboratories worldwide, supported with comprehensive documentation including COA, MSDS, and technical data sheets.

Product Specifications

Product NameNitazoxanide API Manufacturer & Supplier
CAS Number55981-09-4
CategoryActive Pharmaceutical Ingredient
GradeIP / BP / EP / USP
AppearanceYellow to Pale Yellow Crystalline Powder
StandardsIP / BP / EP / USP Compliant

Analytical Specifications

ParameterSpecification
AppearanceYellow to Pale Yellow Crystalline Powder
IdentificationIR, UV & HPLC Compliant
Assay (HPLC)98.0% – 102.0%
Loss on DryingNMT 0.50%
Residue on IgnitionNMT 0.20%
Heavy MetalsNMT 10 ppm
pH (1% Solution)5.0 – 7.5
Individual ImpurityNMT 0.50%
Total ImpuritiesNMT 1.50%
Water ContentNMT 0.50%
Melting Point198°C – 202°C
SolubilityPractically insoluble in water; soluble in DMSO and slightly soluble in methanol

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 Nitazoxanide API Manufacturer & Supplier (CAS 55981-09-4) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Nitazoxanide API Manufacturer & Supplier 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 — Nitazoxanide API Manufacturer & Supplier

What is Nitazoxanide API?
Nitazoxanide API is a broad-spectrum antiparasitic and antiviral active pharmaceutical ingredient used in pharmaceutical formulations and research applications.
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