Active Pharmaceutical Ingredient

Rifaximin (CAS 80621-81-4) API Manufacturer & Supplier in India

Also known as: Xifaxan; L-105; DL 473

CAS: 80621-81-4 Non-Absorbable Antibiotic IP / BP / EP / USP GMP Certified Aurangabad, Maharashtra, India
Rifaximin API — Mediocon Inc
Rifaximin — Pharmaceutical Grade API

Product Overview

CAS No: 80621-81-4  |  MF: C₄₃H₅₁N₃O₁₁  |  MW: 785.88 g/mol

Rifaximin is a pharmaceutical-grade active ingredient classified as a Non-Absorbable Rifamycin Antibiotic. Mediocon Inc supplies high-purity Rifaximin API conforming to IP / BP / EP / USP specifications, manufactured in our GMP-certified facility in Aurangabad, Maharashtra, India.

Rifaximin is a semi-synthetic, non-systemic rifamycin-derived antibiotic that acts locally in the gastrointestinal tract. Due to its minimal systemic absorption, it provides targeted antimicrobial activity against gram-positive and gram-negative bacteria in the gut. It is used for traveler's diarrhea, hepatic encephalopathy, and irritable bowel syndrome with predominant diarrhea.

Key Features

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

Applications

  • Traveler's diarrhea (non-invasive E. coli)
  • Hepatic encephalopathy prevention and treatment
  • Irritable bowel syndrome with diarrhea (IBS-D)
  • Small intestinal bacterial overgrowth (SIBO)

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 NameRifaximin
Also Known AsXifaxan; L-105; DL 473
CAS Number80621-81-4
Molecular FormulaC₄₃H₅₁N₃O₁₁
Molecular Weight785.88 g/mol
CategoryNon-Absorbable Antibiotic — Rifamycin Derivative
AppearanceLight orange to orange crystalline powder
SolubilityPractically insoluble in water; slightly soluble in methanol
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
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 Rifaximin (CAS 80621-81-4) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Rifaximin 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 — Rifaximin API

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