Active Pharmaceutical Ingredient

Naltrexone Hydrochloride — CAS 16676-29-2

Also known as: ReVia; Vivitrol; Naltrexone HCl

GMP Certified IP / BP / EP / USP Opioid Receptor Antagonist Aurangabad, India
Naltrexone Hydrochloride API Supplier Manufacturer Aurangabad Maharashtra India — Mediocon Inc
Naltrexone Hydrochloride IP / BP / EP / USP  |  GMP Certified  |  Mediocon Inc, Maharashtra, India
CAS No: 16676-29-2

Product Overview

Naltrexone Hydrochloride is a high-purity Active Pharmaceutical Ingredient (API) classified as a Opioid Receptor Antagonist. Manufactured by Mediocon Inc in Aurangabad, Maharashtra, India at a GMP-certified facility, it is supplied in bulk for pharmaceutical formulations worldwide. CAS No: 16676-29-2.

Therapeutic Applications
  • Alcohol use disorder (AUD) relapse prevention
  • Opioid use disorder (OUD) maintenance treatment
  • Naltrexone extended-release injectable formulations
  • Gambling disorder (off-label)
  • Self-injurious behavior in autism spectrum disorder (investigational)

Technical Specifications

ParameterSpecification
CAS Number16676-29-2
Molecular FormulaC₂₀H₂₃NO₄·HCl
Molecular Weight377.87 g/mol
GradeIP / BP / EP / USP
CategoryOpioid Receptor Antagonist
AppearanceWhite to off-white crystalline powder
SolubilityFreely soluble in water; soluble in ethanol
AssayNLT 98.0%
Loss on DryingNMT 0.5%
Heavy MetalsNMT 20 ppm
Residue on IgnitionNMT 0.1%
Microbial LimitsComplies with pharmacopoeia
IdentificationIR, HPLC Compliant
Batch NoNAL/24032026
Mfg DateMAR 2026
Exp DateFEB 2031
Packing25 kg HDPE drums / as per requirement

Quality & Compliance

  • GMP Certified manufacturing facility in Aurangabad, Maharashtra, India
  • Full pharmacopoeial compliance: IP / BP / EP / USP standards
  • Complete documentation: Certificate of Analysis (CoA), MSDS, Certificate of Origin
  • Stringent in-process quality control at every manufacturing stage
  • HPLC purity testing and spectroscopic identification (IR, NMR)
  • Cold-chain and controlled-environment storage facilities available
  • Exported to 40+ countries with full regulatory support

Request a Quote

Minimum Order: 1 kg (sample available)
Export to 40+ countries worldwide
Full documentation: CoA, MSDS, COO
Lead Time: 2–4 weeks (standard)
WhatsApp: +91 8055776636
sales@mediocon.com
 Get Bulk Quote  Request CoA / MSDS

Quick Reference

CAS No16676-29-2
FormulaC₂₀H₂₃NO₄·HCl
MW377.87 g/mol
GradeIP / BP / EP / USP
CategoryOpioid Receptor Antagonist

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