Product information
Methadone Hydrochloride is a long-acting synthetic full mu-opioid receptor agonist with NMDA antagonist activity (methadone base — racemic mixture; only the R-enantiomer contributes significantly to mu-agonism). Manufactured to USP and Ph. Eur. monograph specifications. Primary use is opioid maintenance therapy (methadone maintenance treatment programmes) and severe chronic pain. Schedule II in US with additional distribution restrictions — methadone for OUD is dispensed only through federally-certified Opioid Treatment Programs (OTPs). Long QT prolongation risk requires ECG monitoring.
Product specifications
- CAS Registry Number
- 1095-90-5
- 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 Methadone Hydrochloride-relevant molecules. Letter of Authorization (LoA) and CEP / DMF / ASMF references are issued at no charge to qualified buyers.
Frequently asked questions about Methadone Hydrochloride
What is Methadone Hydrochloride used for?
Methadone 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 Methadone Hydrochloride typically reference it under CAS Registry Number 1095-90-5.
What quality and regulatory standards does Longshine Boi-Tech's Methadone Hydrochloride meet?
Our Methadone 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 Methadone Hydrochloride?
Quote requests for Methadone 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 Methadone Hydrochloride to?
We export Methadone 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.