Product information
Buprenorphine Hydrochloride is a synthetic thebaine-derived semi-synthetic opioid — a partial mu-opioid receptor agonist and kappa antagonist with high receptor-binding affinity and a ceiling effect on respiratory depression. Manufactured to USP and Ph. Eur. monograph specifications. Primary applications are opioid use disorder (OUD) treatment (sublingual formulations, typically combined with naloxone) and chronic pain management (transdermal patches). Schedule III in the US since 2002 — lower diversion risk than full agonists.
Product specifications
- CAS Registry Number
- 53152-21-9
- 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 Buprenorphine Hydrochloride-relevant molecules. Letter of Authorization (LoA) and CEP / DMF / ASMF references are issued at no charge to qualified buyers.
Frequently asked questions about Buprenorphine Hydrochloride
What is Buprenorphine Hydrochloride used for?
Buprenorphine 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 Buprenorphine Hydrochloride typically reference it under CAS Registry Number 53152-21-9.
What quality and regulatory standards does Longshine Boi-Tech's Buprenorphine Hydrochloride meet?
Our Buprenorphine 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 Buprenorphine Hydrochloride?
Quote requests for Buprenorphine 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 Buprenorphine Hydrochloride to?
We export Buprenorphine 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.