Product information
Levothyroxine Sodium is the sodium salt of the synthetic thyroid hormone T4, used as first-line replacement therapy for primary and secondary hypothyroidism and for TSH suppression in differentiated thyroid cancer. Manufactured under stringent moisture and light control per USP monograph — Levothyroxine Sodium is prone to potency loss under humidity, requiring specialised packaging and stability protocols. Full ICH Q1A/Q1B stability programme.
Product specifications
- CAS Registry Number
- 25416-65-3
- 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 Levothyroxine Sodium-relevant molecules. Letter of Authorization (LoA) and CEP / DMF / ASMF references are issued at no charge to qualified buyers.
Frequently asked questions about Levothyroxine Sodium
What is Levothyroxine Sodium used for?
Levothyroxine Sodium 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 Levothyroxine Sodium typically reference it under CAS Registry Number 25416-65-3.
What quality and regulatory standards does Longshine Boi-Tech's Levothyroxine Sodium meet?
Our Levothyroxine Sodium 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 Levothyroxine Sodium?
Quote requests for Levothyroxine Sodium 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 Levothyroxine Sodium to?
We export Levothyroxine Sodium 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.