Active Pharmaceutical Ingredient

Nalmefene Hydrochloride API Manufacturer & Supplier

CAS: 58895-64-0 Active Pharmaceutical Ingredient IP / BP / EP / USP GMP Certified Aurangabad, Maharashtra, India
Nalmefene Hydrochloride API Manufacturer & Supplier — Mediocon Inc
Nalmefene Hydrochloride API Manufacturer & Supplier

Product Overview

CAS No: 58895-64-0 | Grade: IP / BP / EP / USP | Category: Active Pharmaceutical Ingredient

Nalmefene Hydrochloride API Manufacturer & Supplier

MEDIOCON INC is a trusted global manufacturer and supplier of Nalmefene Hydrochloride 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.

Nalmefene Hydrochloride is a potent opioid receptor modulator and opioid antagonist widely used in pharmaceutical formulations for the treatment of alcohol dependence and opioid overdose research. It exhibits high affinity for μ (mu), δ (delta), and κ (kappa) opioid receptors, effectively reducing alcohol consumption by modulating the brain's reward pathways while also reversing opioid-induced effects. Due to its favorable pharmacological profile and prolonged duration of action, Nalmefene Hydrochloride is extensively utilized in pharmaceutical research, formulation development, analytical method validation, process optimization, stability studies, and quality assurance programs.

MEDIOCON INC supplies premium-quality Nalmefene Hydrochloride 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 NameNalmefene Hydrochloride API Manufacturer & Supplier
CAS Number58895-64-0
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 Point255°C – 260°C
SolubilityFreely soluble in water; slightly 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 Nalmefene Hydrochloride API Manufacturer & Supplier (CAS 58895-64-0) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Nalmefene 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 — Nalmefene Hydrochloride API Manufacturer & Supplier

What is Nalmefene Hydrochloride API?
Nalmefene Hydrochloride API is an opioid receptor antagonist and modulator used in pharmaceutical formulations for alcohol dependence management and opioid-related therapeutic research.
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