Product information
Naltrexone Hydrochloride is a long-acting synthetic pure mu-opioid receptor antagonist used in the maintenance treatment of opioid use disorder (OUD) and alcohol use disorder (AUD). Manufactured to USP monograph specifications. Available as oral (50 mg daily) and long-acting injectable microspheres (Vivitrol, 380 mg monthly IM). Not a controlled substance in the US.
Product specifications
- CAS Registry Number
- 16676-29-2
- Therapeutic Category
- Human APIs
- API Technology
- Synthetic / Semi-synthetic (per molecule)
- Development Status
- Commercial — stocked
- Manufacturer
- Longshine Boi-Tech Pvt. Ltd.
- Facility
- Pune, Maharashtra, India 411001
Regulatory filings & documentation
We maintain regulatory dossiers in the following jurisdictions for Naltrexone Hydrochloride-relevant molecules. Letter of Authorization (LoA) and CEP / DMF / ASMF references are issued at no charge to qualified buyers.
Frequently asked questions about Naltrexone Hydrochloride
What is Naltrexone Hydrochloride used for?
Naltrexone Hydrochloride is supplied as a pharmaceutical-grade human apis for use by regulated pharmaceutical manufacturers, contract development and manufacturing organisations (CDMOs), and research institutions. Buyers using Naltrexone Hydrochloride typically reference it under CAS Registry Number 16676-29-2.
What quality and regulatory standards does Longshine Boi-Tech's Naltrexone Hydrochloride meet?
Our Naltrexone Hydrochloride is manufactured under WHO-GMP and ISO 9001:2015 conditions in Pune, India. Per-batch Certificate of Analysis (CoA) is released against USP / Ph. Eur. / IP / JP specifications depending on destination market. We hold US FDA Drug Master File and EDQM Certificate of Suitability dossiers for the molecules where regulatory recognition is required; Letter of Authorization (LoA) is issued at no charge to qualified buyers.
How do I request a quote, sample, or proforma invoice for Naltrexone Hydrochloride?
Quote requests for Naltrexone Hydrochloride are turned around within 24 business hours (IST, Pune). Bulk APIs typically ship within 7-10 business days of confirmed PO; air freight to North America and Europe runs 4-5 days door-to-door. Sample agreements are signed before shipping QC-grade material to your formulation laboratory.
Which countries does Longshine Boi-Tech supply Naltrexone Hydrochloride to?
We export Naltrexone Hydrochloride to 50+ countries including the United States, Canada, Mexico, Brazil, the European Union, the United Kingdom, Japan, Australia, South Korea, the GCC and across South-East Asia. All regulatory documents (DMF / CEP / LoA) and shipping incoterms (EXW, FCA, CIP, DAP, DDP) are negotiated per buyer.
Related Human APIs APIs
Other human apis molecules from Longshine Boi-Tech's WHO-GMP catalogue — each with active regulatory filings, audit-ready CoA, and samples available under CDA.
Related categories & resources
Browse the full Human APIs catalogue or all 560+ products. Reference documents: certifications portfolio · quality system · FDA DMF buyer guide · EU CEP supplier guide · complete product index.