Active Pharmaceutical Ingredient

Toltrazuril (CAS 69004-03-1) API Manufacturer & Supplier in India

Also known as: Baycox; (RS)-5-(4-chlorophenyl)-7-(2,4-dichlorophenyl)-1,2,4-triazinane-3,6-dione

CAS: 69004-03-1Anticoccidial Agent / APIIP / BP / EP / USPGMP CertifiedAurangabad, Maharashtra, India
Toltrazuril API — Mediocon Inc
Toltrazuril — Pharmaceutical Grade API | Mediocon Inc, Aurangabad, Maharashtra, India

Product Overview

CAS No: 69004-03-1  |  MF: C₁₈H₁₄Cl₃N₃O₂  |  MW: 425.68 g/mol

Toltrazuril is a high-purity Active Pharmaceutical Ingredient supplied by Mediocon Inc conforming to IP / BP / EP / USP specifications. Manufactured at our GMP-certified facility in Aurangabad, Maharashtra, India.

Toltrazuril is a broad-spectrum triazinetrione anticoccidial agent effective against all intracellular developmental stages of Eimeria species and other apicomplexan parasites. It is widely used in veterinary medicine for coccidiosis prevention and treatment.

Key Features

  • High-purity pharmaceutical grade API
  • IP / BP / EP / USP compliant
  • Full CoA and MSDS documentation
  • GMP certified manufacturing facility

Applications

  • Coccidiosis treatment and prevention
  • Veterinary antiparasitic therapy
  • Eimeria species control
  • Poultry and livestock health

Why Choose Mediocon

  • ISO 9001:2015 & GMP certified manufacturing
  • Consistent batch-to-batch quality with full CoA
  • Export-ready documentation: COO, MSDS, DMF
  • Flexible MOQ for both R&D and commercial scale
  • Dedicated QA support for regulatory filings

Product Specifications

Product NameToltrazuril
Also Known AsBaycox; (RS)-5-(4-chlorophenyl)-7-(2,4-dichlorophenyl)-1,2,4-triazinane-3,6-dione
CAS Number69004-03-1
Molecular FormulaC₁₈H₁₄Cl₃N₃O₂
Molecular Weight425.68 g/mol
CategoryAnticoccidial Agent / Active Pharmaceutical Ingredient
AppearanceWhite to off-white crystalline powder
SolubilitySlightly soluble in water; soluble in DMSO and ethanol
GradeIP / BP / EP / USP

Analytical Specifications

ParameterSpecification
AssayNLT 98.0%
Loss on DryingNMT 0.5%
Heavy MetalsNMT 20 ppm
Residue on IgnitionNMT 0.1%
Microbial LimitsComplies with pharmacopoeia
IdentificationIR, HPLC Compliant
Batch No.TTRZ/24032026
Mfg DateMAR 2026
Exp DateFEB 2031
Packing25 kg HDPE drums / as per requirement

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 Toltrazuril (CAS 69004-03-1) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Toltrazuril 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 — identity (IR/HPLC), assay, related substances, residual solvents (ICH Q3C), heavy metals, and microbial limits — 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
  • Stability data available (ICH Q1A guidelines) for regulatory submissions
  • Dedicated QA team for customer audits and regulatory queries

Frequently Asked Questions — Toltrazuril API

What is the minimum order quantity for Toltrazuril API?
Mediocon Inc supplies Toltrazuril with a minimum order quantity of 1 kg (sample packs available for R&D). We accommodate both small R&D quantities and large commercial-scale orders. Contact our sales team at akshay@mediocon.com or +91 9309999757 for a tailored quote.
What pharmacopoeial grades of Toltrazuril does Mediocon supply?
We supply Toltrazuril conforming to IP / BP / EP / USP pharmacopoeial standards. Each batch is tested against full pharmacopoeial specifications and released with a Certificate of Analysis. Custom specifications can be accommodated for regulated markets.
What documentation is provided with Toltrazuril API?
Every shipment of Toltrazuril comes with: Certificate of Analysis (CoA), MSDS/SDS, Certificate of Origin (COO), and Drug Master File (DMF) support on request. We also provide GMP certification, ISO 9001:2015 compliance documentation, and full regulatory support for filings in USA (FDA), Europe (EMA), and other markets.
What is the lead time and shipping for Toltrazuril bulk orders?
Standard lead time for Toltrazuril is 2–4 weeks for standard orders; expedited shipments possible for urgent requirements. We ship to 40+ countries worldwide using approved pharmaceutical-grade packaging (25 kg HDPE drums / aluminium foil bags). All shipments include temperature-controlled logistics options where required by the product's storage conditions.
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