Active Pharmaceutical Ingredient

Naphazoline API Manufacturer & Supplier

CAS: 835-31-4 Active Pharmaceutical Ingredient IP / BP / EP / USP GMP Certified Aurangabad, Maharashtra, India
Naphazoline API Manufacturer & Supplier — Mediocon Inc
Naphazoline API Manufacturer & Supplier

Product Overview

CAS No: 835-31-4 | Grade: IP / BP / EP / USP | Category: Active Pharmaceutical Ingredient

Naphazoline API Manufacturer & Supplier

MEDIOCON INC is a trusted global manufacturer and supplier of Naphazoline API, offering premium-quality pharmaceutical-grade active pharmaceutical ingredients for pharmaceutical manufacturing, ophthalmic and nasal 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.

Naphazoline is a sympathomimetic alpha-adrenergic agonist widely used in ophthalmic and nasal pharmaceutical formulations. It acts by constricting small blood vessels, thereby reducing redness, swelling, congestion, and irritation. Naphazoline is commonly indicated for temporary relief of eye redness caused by minor irritations and nasal congestion associated with allergies, sinusitis, and the common cold. Due to its rapid vasoconstrictive action and proven efficacy, Naphazoline is extensively utilized in pharmaceutical research, formulation development, analytical method validation, process optimization, stability studies, and quality assurance programs.

MEDIOCON INC supplies premium-quality Naphazoline API to pharmaceutical manufacturers, ophthalmic 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 NameNaphazoline API Manufacturer & Supplier
CAS Number835-31-4
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)99.0% – 101.0%
Loss on DryingNMT 0.50%
Residue on IgnitionNMT 0.10%
Heavy MetalsNMT 10 ppm
pH (1% Solution)5.0 – 7.5
Individual ImpurityNMT 0.50%
Total ImpuritiesNMT 1.00%
Water ContentNMT 0.50%
Melting Point245°C – 250°C
SolubilityFreely soluble in water and methanol; slightly soluble in ethanol

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 Naphazoline API Manufacturer & Supplier (CAS 835-31-4) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Naphazoline 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 — Naphazoline API Manufacturer & Supplier

What is Naphazoline API?
Naphazoline API is an alpha-adrenergic agonist used in ophthalmic and nasal pharmaceutical formulations for relieving eye redness and nasal congestion.
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