Product information
Codeine Phosphate Hemihydrate is the phosphate salt of codeine — a natural phenanthrene alkaloid from Papaver somniferum and the reference mu-opioid partial agonist for moderate pain and cough suppression. Manufactured to USP and Ph. Eur. monograph specifications with full opioid alkaloid impurity profile. Distribution requires appropriate national controlled-substance licensing — Schedule II in US (per gram), Schedule V in specific low-dose combinations (mixed with acetaminophen or aspirin), and equivalent controlled-drug scheduling globally.
Product specifications
- CAS Registry Number
- 41444-62-6
- 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 Codeine Phosphate Hemihydrate-relevant molecules. Letter of Authorization (LoA) and CEP / DMF / ASMF references are issued at no charge to qualified buyers.
Frequently asked questions about Codeine Phosphate Hemihydrate
What is Codeine Phosphate Hemihydrate used for?
Codeine Phosphate Hemihydrate 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 Codeine Phosphate Hemihydrate typically reference it under CAS Registry Number 41444-62-6.
What quality and regulatory standards does Longshine Boi-Tech's Codeine Phosphate Hemihydrate meet?
Our Codeine Phosphate Hemihydrate 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 Codeine Phosphate Hemihydrate?
Quote requests for Codeine Phosphate Hemihydrate 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 Codeine Phosphate Hemihydrate to?
We export Codeine Phosphate Hemihydrate 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.