Naltrexone HCl API – High Purity, GMP Certified
Our pharmaceutical-grade Naltrexone Hydrochloride meets GMP and regulatory standards, ensuring high efficacy and safety for formulation.
CAS No: 16590-41-3 | Molecular Formula: C20H23NO4·HCl | Molecular Weight: 341.401 g/mol
Product Overview: Naltrexone HCl API is a high-purity opioid antagonist used for opioid and alcohol dependence treatment. Our pharmaceutical-grade Naltrexone Hydrochloride meets GMP and regulatory standards, ensuring high efficacy and safety for formulation.
Key Features & Benefits
✅ GMP Certified – Manufactured under strict compliance
✅ COA & DMF Available – Full regulatory support
✅ 99%+ Purity – High-quality, pharma-grade material
✅ Bulk Supply Ready – Global shipping & fast delivery
✅ Storage: [15–30°C] | Shipping: [15–30°C]
Regulatory & Compliance
- Pharmacopoeia Standards: USP/EP/BP/JP
- DMF & COA Available upon request
Technical Specifications
| Parameter | Details |
| CAS No. | 16590-41-3 |
| Molecular Formula | C20H23NO4·HCl |
| Molecular Weight | 341.401 g/mol |
| Indications | Opioid & Alcohol Dependence Treatment |
| Storage Temp. | Store at controlled room temperature (15–30°C) |
| Shipping Temp. | Ambient or as required |
| Appearance | White Crystalline Powder |
| Chemical Name | Naltrexone Hydrochloride |
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Mechanism of Action
- Naltrexone HCl is a competitive opioid antagonist. It binds to the mu-opioid receptors in the central nervous system, preventing other opioids from binding and producing their effects. This can help to reduce cravings and prevent relapse in people with opioid use disorder.
- Naltrexone HCl also activates the kappa-opioid receptor system, which may contribute to its effects on reducing cravings and reward-seeking behavior.
Pharmacokinetics:
- Peak plasma concentration: 1-2 hours after oral administration
- Bioavailability: 50-60%
- Half-life: 4-11 hours
- Metabolism: Extensively metabolized in the liver to inactive metabolites
- Excretion: Primarily in the feces, with a small amount excreted in the urine
Uses:
- Naltrexone HCl is used to treat opioid use disorder, including both prescription opioid dependence and heroin addiction. It is available as a tablet, injectable implant, and extended-release injectable formulation.
- It is also used to reduce the risk of alcohol relapse in people with alcohol dependence.
Contraindications:
- Naltrexone HCl is contraindicated in people who are allergic to it or who have acute opioid intoxication.
- It should be used with caution in people with liver or kidney problems, pregnant or breastfeeding women, and people taking other medications that can cause respiratory depression.
Warnings and Precautions:
- Naltrexone HCl can precipitate withdrawal symptoms in people who are physically dependent on opioids. It is important to start treatment with a low dose and gradually increase it to avoid this.
- Naltrexone HCl can also cause other side effects, such as nausea, vomiting, abdominal pain, headache, and fatigue. These side effects are usually mild and go away on their own.
Disclaimer: This information is intended for educational purposes only and should not be construed as medical advice. Please consult your doctor or pharmacist for more information about Naltrexone HCl and whether it is right for you.
As a manufacturer, Vonage Pharma (Former Pluvia Endo) can supply you in grades like USP and BP at competitive prices with the best quality material with Unique Molecules & Know-How. Our Portfolio Contains Several Specific APIs & Finished Dosage Form Medications in The Field of Opioid Medications & Nutraceutical Supplements.
Since Manufacturing of Our Products is done Ourselves and Based on Our Own Specific Know-How from A To Z, Therefore, We Can Support You with Documentation and formulation & Scientific Matters as well as supply you with High-Quality Products at Unrivaled Prices Including Different Types of APIs.
In addition to our high-quality Naltrexone HCl API, Vonage Pharma also offers a Naltrexone HCl 50 mg Finished Dosage Form (FDF), providing a ready-to-use solution for opioid and alcohol dependence treatment. This FDF product is manufactured under strict GMP standards, ensuring consistent quality, safety, and efficacy for your pharmaceutical needs.
Contact us to receive COA and GMP and we will respond to you soon.
FAQs
What is Naltrexone HCl API used for?
Naltrexone HCl is a pharmaceutical API primarily used in medications for opioid and alcohol addiction treatment, helping patients reduce cravings and prevent relapse.
Do you provide COA and regulatory documents?
Yes, we offer COA (Certificate of Analysis), MSDS, and DMF support upon request.
What is the minimum order quantity (MOQ)?
MOQ varies based on region and customer requirements. Contact us for details.
How is the product shipped and stored?
Naltrexone HCl API is shipped under controlled conditions to maintain stability.
Do you supply globally?
Yes! We supply to pharmaceutical manufacturers worldwide, ensuring compliance with regional regulations.
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