Active Pharmaceutical Ingredient

Naftopidil API Manufacturer & Supplier

CAS: 57149-07-2 Active Pharmaceutical Ingredient IP / BP / EP / USP GMP Certified Aurangabad, Maharashtra, India
Naftopidil API Manufacturer & Supplier — Mediocon Inc
Naftopidil API Manufacturer & Supplier

Product Overview

CAS No: 57149-07-2 | Grade: IP / BP / EP / USP | Category: Active Pharmaceutical Ingredient

Naftopidil API Manufacturer & Supplier

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

Naftopidil is a selective alpha-1 adrenergic receptor antagonist widely used in pharmaceutical formulations for the treatment of benign prostatic hyperplasia (BPH) and lower urinary tract symptoms (LUTS). It works by selectively blocking alpha-1 receptors in the prostate, bladder neck, and urethra, leading to relaxation of smooth muscle, improved urinary flow, and reduced urinary obstruction. Naftopidil has also been studied for its potential applications in urology and cardiovascular pharmacology. Owing to its favorable safety profile and therapeutic efficacy, 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 Naftopidil API to pharmaceutical manufacturers, 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 NameNaftopidil API Manufacturer & Supplier
CAS Number57149-07-2
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)5.0 – 7.5
Individual ImpurityNMT 0.50%
Total ImpuritiesNMT 1.00%
Water ContentNMT 0.50%
Melting Point124°C – 128°C
SolubilitySlightly soluble in water; freely soluble in methanol and 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 Naftopidil API Manufacturer & Supplier (CAS 57149-07-2) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Naftopidil 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 — Naftopidil API Manufacturer & Supplier

What is Naftopidil API?
Naftopidil API is a selective alpha-1 adrenergic receptor antagonist used in pharmaceutical formulations for the treatment of benign prostatic hyperplasia (BPH) and lower urinary tract symptoms.
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