Naltrexone HCl API – High Purity, GMP Certified

Product Overview: Naltrexone HCl API is a high-purity opioid antagonist indicated for the treatment of opioid and alcohol dependence. Our product is a pharmaceutical-grade Naltrexone Hydrochloride API that conforms to GMP and applicable regulatory and pharmacopoeia standards ensuring high quality, efficacy, and safety in 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

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Mechanism of Action

Naltrexone HCl is an opioid antagonist that will be binding in competition with mu-opioid receptor ligands in the CNS of individuals with opioid use disorder to reduce craving and the harmful consequences of the relapse process. The exact mechanism of action is not known because of course, the action of Naltrexone HCl does not occur through mu-opioid receptor binding. Naltrexone HCl also can bind to the kappa-opioid receptor system, activating the kappa-opioid receptor system in this manner in a dose-dependent fashion which possibly develops the ability to reduce craving and modify the approach incentive-related behavior scourge associated with drug use problems, and may serve to encourage the selective treatment of individuals with opioid use disorder.

Pharmacokinetics:

• Peak plasma concentration after oral: 1-2 hours
• Bioavailability: 50-60%
• Half-life: 4-11 hours
• Metabolism: Extensively metabolized by the liver via phase II-microconjugation to inactive metabolites
• Excretion: Mostly in feces and some in urine Indications: Naltrexone HCl is indicated for opioid use disorder (indicated for prescribing for opioid dependence and heroin use disorder).

Naltrexone HCl comes in tablets, an injectable implant, and an injectable formulation that offers the extended-release. Naltrexone HCl is indicated for reduction of alcohol relapse for alcohol-dependent individuals.

Uses:

• Naltrexone HCl is a narcotic antagonist used to help boost rates of recovery from opioid use disorder, including prescriptions for opioids and heroin use.
• It comes in various formulations including a tablet, long acting injectable, and injectable implant.
• It is also used to help improve recovery outcomes including risk of relapse, in individuals experiencing alcohol dependence.

Contraindications:

• Naltrexone HCl is contraindicated in individuals with its allergy or acute addiction/intoxication to opioids.
• Use caution in individuals with liver or kidney dx, during pregnancy (or breastfeeding), and in individuals with other medicines that may cause respiratory depression.

Cautions and Warnings:

• Naltrexone HCl may precipitate withdrawal from physical dependence on opioids. Therefore, when recommending initiation of treatment, it is recommended to start with and titrate downward as needed low dose levels to try and avoid the withdrawal syndrome.
• Naltrexone HCl does have side effects that may include nausea, vomiting, abdominal pain, headache and fatigue. Side effects are generally mild and self-limited.

Disclaimer: The content in this blog is for educational purposes only and is not intended to be considered or serve as a substitute for the advice and assessment of your physician. The physician or pharmacist should be your physician or pharmacist doctor if you have any further questions or information about Naltrexone HCl, and if it is appropriate for you.