Active Pharmaceutical Ingredient

Sulfamethoxazole API Manufacturer & Supplier in India

Also known as: SMX; Sulphamethoxazole; Co-trimoxazole component

CAS: 723-46-6 Sulfonamide Antibiotic IP / BP / EP / USP GMP Certified Aurangabad, Maharashtra, India
Sulfamethoxazole API — Mediocon Inc, Aurangabad Maharashtra India
Sulfamethoxazole — Pharmaceutical Grade API | Mediocon Inc, Aurangabad, Maharashtra, India

Product Overview

CAS No: 723-46-6  |  MF: C₁₀H₁₁N₃O₃S  |  MW: 253.28 g/mol

Sulfamethoxazole is a sulfonamide antibiotic widely used in combination with trimethoprim (as co-trimoxazole / TMP-SMX) for treating a broad range of bacterial and protozoal infections. Mediocon Inc supplies pharmaceutical-grade Sulfamethoxazole conforming to IP / BP / EP / USP specifications.

Sulfamethoxazole inhibits bacterial dihydropteroate synthase, preventing folate synthesis. The TMP-SMX combination provides synergistic antibacterial activity and is a first-line treatment for urinary tract infections, Pneumocystis pneumonia, and traveller's diarrhoea.

Key Features

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

Applications

  • Co-trimoxazole tablet and suspension manufacturing
  • UTI and respiratory infection therapy
  • PCP prophylaxis formulations
  • Broad-spectrum antibiotic production

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 NameSulfamethoxazole
Also Known AsSMX; Sulphamethoxazole; Co-trimoxazole component
CAS Number723-46-6
Molecular FormulaC₁₀H₁₁N₃O₃S
Molecular Weight253.28 g/mol
CategorySulfonamide Antibiotic
AppearanceWhite to off-white crystalline powder
SolubilityVery slightly soluble in water; soluble in acetone
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
Mfg DateMAR 2025
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 Sulfamethoxazole (CAS 723-46-6) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Sulfamethoxazole 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 — Sulfamethoxazole API

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