Active Pharmaceutical Ingredient

Diloxanide Furoate Manufacturer & Supplier in India

Also known as: Furamide

CAS: 3736-81-0 Antiamoebic Agent (Luminal Amoebicide) IP / BP / EP / USP GMP Certified Aurangabad, Maharashtra, India
Diloxanide Furoate API — Mediocon Inc
Diloxanide Furoate — Pharmaceutical Grade API

Product Overview

CAS No: 3736-81-0  |  MF: C14H11Cl2NO4  |  MW: 328.14

Diloxanide Furoate is a pharmaceutical-grade active ingredient classified as Antiamoebic Agent (Luminal Amoebicide). Mediocon Inc supplies high-purity Diloxanide Furoate API conforming to IP / BP / EP / USP specifications, manufactured in our GMP-certified facility in Aurangabad, Maharashtra, India.

Diloxanide Furoate is hydrolyzed in the gut to release diloxanide, which acts as a luminal amoebicide against Entamoeba histolytica cysts and trophozoites. It is used as a critical raw material in finished dosage form manufacturing for global pharmaceutical markets.

Key Features

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

Applications

  • Intestinal amoebiasis treatment
  • Asymptomatic cyst carrier therapy
  • Combination therapy with metronidazole
  • Antiparasitic formulation development

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 NameDiloxanide Furoate
CAS Number3736-81-0
Molecular FormulaC14H11Cl2NO4
Molecular Weight328.14
CategoryAntiamoebic Agent (Luminal Amoebicide)
AppearanceWhite to off-white crystalline powder
GradeIP / BP / EP / USP
Batch NoMDCDIL2503181
Mfg DateMAR 2025
Exp DateFEB 2030
Quantity25.00 Kg
Gross Weight26.00 Kg

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
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 Diloxanide Furoate (pharmaceutical grade) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Diloxanide Furoate 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 — Diloxanide Furoate API

What is the minimum order quantity for Diloxanide Furoate API?
Mediocon Inc supplies Diloxanide Furoate 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 Diloxanide Furoate does Mediocon supply?
We supply Diloxanide Furoate 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 Diloxanide Furoate API?
Every shipment of Diloxanide Furoate 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 Diloxanide Furoate bulk orders?
Standard lead time for Diloxanide Furoate 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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