Active Pharmaceutical Ingredient

Naftifine Hydrochloride API Manufacturer & Supplier

CAS: 65473-14-5 Active Pharmaceutical Ingredient IP / BP / EP / USP GMP Certified Aurangabad, Maharashtra, India
Naftifine Hydrochloride API Manufacturer & Supplier — Mediocon Inc
Naftifine Hydrochloride API Manufacturer & Supplier

Product Overview

CAS No: 65473-14-5 | Grade: IP / BP / EP / USP | Category: Active Pharmaceutical Ingredient

Naftifine Hydrochloride API Manufacturer & Supplier

MEDIOCON INC is a trusted global manufacturer and supplier of Naftifine Hydrochloride 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 Hydrochloride is a synthetic allylamine antifungal active pharmaceutical ingredient widely used in topical pharmaceutical formulations for the treatment of dermatophyte infections, tinea pedis (athlete's foot), tinea corporis (ringworm), tinea cruris (jock itch), and cutaneous candidiasis. It acts by inhibiting the enzyme squalene epoxidase, thereby blocking ergosterol biosynthesis and disrupting fungal cell membrane formation, leading to fungal cell death. In addition to its potent antifungal activity, Naftifine Hydrochloride exhibits anti-inflammatory properties, making it highly effective in managing fungal skin infections. 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 Hydrochloride 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 Hydrochloride API Manufacturer & Supplier
CAS Number65473-14-5
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 Point175°C – 180°C
SolubilityFreely soluble in methanol and ethanol; slightly soluble in water

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 Hydrochloride API Manufacturer & Supplier (CAS 65473-14-5) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Naftifine Hydrochloride 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 Hydrochloride API Manufacturer & Supplier

What is Naftifine Hydrochloride API?
Naftifine Hydrochloride API is an allylamine antifungal active pharmaceutical ingredient used in topical formulations for the treatment of fungal skin infections.
💬
Mediocon AI
Hello 👋 How can I help you today?