Active Pharmaceutical Ingredient

Saperconazole API Manufacturer & Supplier in India

Also known as: Saperconazol; R66905

CAS: 91421-42-0 Antifungal / Triazole IP / BP / EP / USP GMP Certified Aurangabad, Maharashtra, India
Saperconazole API — Mediocon Inc, Aurangabad Maharashtra India
Saperconazole — Pharmaceutical Grade API | Mediocon Inc, Aurangabad, Maharashtra, India

Product Overview

CAS No: 91421-42-0  |  MF: C₃₂H₃₃Cl₂FN₄O₄  |  MW: 649.54 g/mol

Saperconazole is a broad-spectrum triazole antifungal agent with potent activity against a wide range of pathogenic fungi including Aspergillus and Candida species. Mediocon Inc supplies pharmaceutical-grade Saperconazole conforming to IP / BP / EP / USP specifications from our GMP-certified facility in Aurangabad, Maharashtra, India.

Saperconazole inhibits ergosterol biosynthesis by blocking the cytochrome P450-dependent enzyme lanosterol 14α-demethylase. It demonstrates high potency against both common and drug-resistant fungal strains.

Key Features

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

Applications

  • Systemic fungal infection therapy
  • Aspergillosis treatment
  • Antifungal R&D
  • Dermatophyte infection research

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 NameSaperconazole
Also Known AsSaperconazol; R66905
CAS Number91421-42-0
Molecular FormulaC₃₂H₃₃Cl₂FN₄O₄
Molecular Weight649.54 g/mol
CategoryAntifungal / Triazole
AppearanceWhite to pale yellow crystalline powder
SolubilitySparingly soluble in water; soluble in DMSO and 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 2030
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 Saperconazole (CAS 91421-42-0) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Saperconazole 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 — Saperconazole API

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