Active Pharmaceutical Ingredient

Sulfadiazine (CAS 68-35-9) API Manufacturer & Supplier in India

Also known as: Sulphadiazine; 2-Sulfanilamidopyrimidine

CAS: 68-35-9 Sulfonamide Antibiotic IP / BP / EP / USP GMP Certified Aurangabad, Maharashtra, India
Sulfadiazine API — Mediocon Inc, Aurangabad Maharashtra India
Sulfadiazine — Pharmaceutical Grade API | Mediocon Inc, Aurangabad, Maharashtra, India

Product Overview

CAS No: 68-35-9  |  MF: C₁₀H₁₀N₄O₂S  |  MW: 250.28 g/mol

Sulfadiazine is a sulfonamide antibiotic used in the treatment of various bacterial infections. It is also used in combination with pyrimethamine for the treatment of toxoplasmosis. Mediocon Inc supplies pharmaceutical-grade Sulfadiazine conforming to IP / BP / EP / USP specifications.

Sulfadiazine inhibits dihydropteroate synthase, blocking folate synthesis in bacteria. It is effective against a range of gram-positive and gram-negative bacteria and has applications in veterinary medicine as well.

Key Features

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

Applications

  • Antibiotic tablet and suspension formulations
  • Toxoplasmosis combination therapy
  • Urinary tract infection treatment
  • Veterinary pharmaceutical manufacturing

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 NameSulfadiazine
Also Known AsSulphadiazine; 2-Sulfanilamidopyrimidine
CAS Number68-35-9
Molecular FormulaC₁₀H₁₀N₄O₂S
Molecular Weight250.28 g/mol
CategorySulfonamide Antibiotic
AppearanceWhite to slightly yellowish crystalline powder
SolubilityVery slightly soluble in water; soluble in dilute HCl
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 Sulfadiazine (CAS 68-35-9) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Sulfadiazine 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 — Sulfadiazine API

What is the minimum order quantity for Sulfadiazine API?
Mediocon Inc supplies Sulfadiazine 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 Sulfadiazine does Mediocon supply?
We supply Sulfadiazine 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 Sulfadiazine API?
Every shipment of Sulfadiazine 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 Sulfadiazine bulk orders?
Standard lead time for Sulfadiazine 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.
💬
Mediocon AI
Hello 👋 How can I help you today?