Active Pharmaceutical Ingredient

Sulconazole Nitrate API Manufacturer & Supplier in India

Also known as: Exelderm; Sulconazole Nitrate Salt

CAS: 61318-91-0 Antifungal / Imidazole Salt IP / BP / EP / USP GMP Certified Aurangabad, Maharashtra, India
Sulconazole Nitrate API — Mediocon Inc, Aurangabad Maharashtra India
Sulconazole Nitrate — Pharmaceutical Grade API | Mediocon Inc, Aurangabad, Maharashtra, India

Product Overview

CAS No: 61318-91-0  |  MF: C₁₈H₁₅Cl₃N₂S·HNO₃  |  MW: 460.79 g/mol

Sulconazole Nitrate is the nitrate salt form of Sulconazole, a broad-spectrum imidazole antifungal agent. It is used as the active pharmaceutical ingredient in topical formulations for fungal skin infections. Mediocon Inc supplies pharmaceutical-grade Sulconazole Nitrate conforming to IP / BP / EP / USP specifications.

The nitrate salt form offers improved stability and formulability for topical preparations including creams and solutions used to treat tinea pedis, tinea cruris, tinea corporis, and tinea versicolor.

Key Features

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

Applications

  • Topical antifungal cream formulations
  • Dermatological solution preparations
  • Antifungal pharmaceutical manufacturing
  • Tinea treatment products

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 NameSulconazole Nitrate
Also Known AsExelderm; Sulconazole Nitrate Salt
CAS Number61318-91-0
Molecular FormulaC₁₈H₁₅Cl₃N₂S·HNO₃
Molecular Weight460.79 g/mol
CategoryAntifungal / Imidazole Salt
AppearanceWhite to off-white crystalline powder
SolubilitySlightly soluble in water; 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
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 Sulconazole Nitrate (CAS 61318-91-0) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Sulconazole Nitrate 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 — Sulconazole Nitrate API

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