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Levothyroxine Sodium
CAS No.: 55-03-8
Synonym: Synthroid, Euthyrox
Mol. Formula: C₁₅H₁₀I₄NNaO₄
Mol. Weight: 798.86 g/mol
ATC Code: H03AA01
Therapeutic Category: Thyroid Hormone
DMF Available: Yes
COA Available: Yes
FDA Approved: Yes
API Grade: IP/BP/USP
WHO GMP Approved: Yes

1) API Quality
Levothyroxine Sodium API is manufactured with strict control over purity, assay accuracy, and consistent particle size to meet global pharmacopeial standards. Each batch undergoes thorough testing, including identification, related substances, residual solvents, moisture content, and microbial limits. Advanced production methods ensure chemical stability, bioavailability, and suitability for oral tablets, capsules, and combination thyroid formulations. The API complies with GMP guidelines and international pharmacopoeial specifications to maintain therapeutic reliability.

2) Comprehensive Documentation
Complete regulatory documentation is provided to support seamless approvals across multiple markets. This includes DMF-ready dossiers, stability studies, impurity profiling, validation reports, manufacturing flowcharts, and safety data sheets. All documentation adheres to ICH, WHO, and regional standards, ensuring smooth regulatory submissions for formulation manufacturers. Comprehensive paperwork aids in simplified registration and compliance.

3) Secure Supply Chain
Levothyroxine Sodium API Mexico supply is backed by a secure, transparent, and traceable supply chain. Raw materials are sourced from qualified and audited suppliers, and every production stage is monitored under controlled conditions. Climate-controlled storage, robust packaging, and efficient logistics ensure product integrity and timely delivery worldwide. This ensures uninterrupted availability even during high-demand periods.

4) Manufacturer & Supplier Expertise
Manufacturers of Levothyroxine Sodium API have expertise in endocrine and hormone-based APIs. Facilities utilize advanced equipment, automated systems, and stringent quality control processes. Skilled technical teams ensure consistent production, regulatory compliance, and reliable distribution to pharmaceutical partners globally.

5) Amber Lifesciences’ Role
Amber Lifesciences provides a dependable supply of Levothyroxine Sodium API with strict GMP compliance and robust quality assurance. The company offers technical support, regulatory documentation, and reliable global distribution. With consistent bulk supply and client-focused services, Amber Lifesciences supports formulation manufacturers in producing high-quality thyroid hormone therapies.

Active Pharmaceutical Ingredient (API) – Not for Direct Human or Veterinary Use.