Product information
Naloxone Hydrochloride is a synthetic pure mu-opioid receptor antagonist with negligible intrinsic activity — the reference agent for reversal of opioid overdose (respiratory depression) and diagnosis of opioid dependence. Manufactured to USP and Ph. Eur. monograph specifications as the dihydrate form (CAS 51481-60-8 for the dihydrate, 357-08-4 for the anhydrous). Not a controlled substance in the US (removed from CSA scheduling) — actively deployed as OTC nasal spray in many jurisdictions to expand overdose-reversal access.
Product specifications
- CAS Registry Number
- 357-08-4
- 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 Naloxone Hydrochloride-relevant molecules. Letter of Authorization (LoA) and CEP / DMF / ASMF references are issued at no charge to qualified buyers.
Frequently asked questions about Naloxone Hydrochloride
What is Naloxone Hydrochloride used for?
Naloxone 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 Naloxone Hydrochloride typically reference it under CAS Registry Number 357-08-4.
What quality and regulatory standards does Longshine Boi-Tech's Naloxone Hydrochloride meet?
Our Naloxone 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 Naloxone Hydrochloride?
Quote requests for Naloxone 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 Naloxone Hydrochloride to?
We export Naloxone 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.