Active Pharmaceutical Ingredient

Naftifine API Manufacturer & Supplier

CAS: 65473-13-4 Active Pharmaceutical Ingredient IP / BP / EP / USP GMP Certified Aurangabad, Maharashtra, India
Naftifine API Manufacturer & Supplier — Mediocon Inc
Naftifine API Manufacturer & Supplier

Product Overview

CAS No: 65473-13-4 | Grade: IP / BP / EP / USP | Category: Active Pharmaceutical Ingredient

Naftifine API Manufacturer & Supplier

MEDIOCON INC is a trusted global manufacturer and supplier of Naftifine API, offering premium-quality pharmaceutical-grade active pharmaceutical ingredients for pharmaceutical manufacturing, topical formulation development, analytical testing, quality control, stability studies, and research applications. Every batch is manufactured under stringent quality management systems to ensure exceptional purity, consistency, and compliance with international pharmaceutical standards.

Naftifine is a synthetic allylamine antifungal active pharmaceutical ingredient widely used in topical pharmaceutical formulations for the treatment of dermatophyte infections, including tinea pedis (athlete's foot), tinea corporis (ringworm), tinea cruris (jock itch), and other superficial fungal infections. It acts by selectively inhibiting the enzyme squalene epoxidase, disrupting ergosterol biosynthesis and compromising fungal cell membrane integrity, ultimately leading to fungal cell death. In addition to its potent antifungal activity, Naftifine exhibits anti-inflammatory properties, making it highly effective in dermatological formulations. It is extensively utilized in pharmaceutical research, formulation development, analytical method validation, process optimization, stability studies, and quality assurance programs.

MEDIOCON INC supplies premium-quality Naftifine API to pharmaceutical manufacturers, dermatology formulation companies, contract research organizations (CROs), contract development and manufacturing organizations (CDMOs), universities, research institutes, and analytical laboratories worldwide. Comprehensive documentation including Certificate of Analysis (COA), Material Safety Data Sheet (MSDS), Technical Data Sheet (TDS), and regulatory support documents is available upon request.

Product Specifications

Product NameNaftifine API Manufacturer & Supplier
CAS Number65473-13-4
CategoryActive Pharmaceutical Ingredient
GradeIP / BP / EP / USP
AppearanceWhite to Off-White Crystalline Powder
StandardsIP / BP / EP / USP Compliant

Analytical Specifications

ParameterSpecification
AppearanceWhite to Off-White Crystalline Powder
IdentificationIR, UV & HPLC Compliant
Assay (HPLC)98.0% – 102.0%
Loss on DryingNMT 0.50%
Residue on IgnitionNMT 0.10%
Heavy MetalsNMT 10 ppm
pH (1% Solution)4.5 – 6.5
Individual ImpurityNMT 0.50%
Total ImpuritiesNMT 1.00%
Water ContentNMT 0.50%
Melting Point118°C – 123°C
SolubilitySlightly soluble in water; freely soluble in methanol, ethanol, and chloroform

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 Naftifine API Manufacturer & Supplier (CAS 65473-13-4) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Naftifine API Manufacturer & Supplier 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 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
  • Dedicated QA team for customer audits and regulatory queries

Frequently Asked Questions — Naftifine API Manufacturer & Supplier

What is Naftifine API?
Naftifine API is an allylamine antifungal active pharmaceutical ingredient used in topical pharmaceutical formulations for the treatment of superficial fungal skin infections.
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