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Fluvoxamine Maleate
CAS No.: 54739-18-3
Synonym: Luvox
Mol. Formula: C₁₅H₂₁F₃N₂O₂·C₄H₄O₄
Mol. Weight: 434.40 g/mol
ATC Code: N06AB08
Therapeutic Category: Antidepressant
DMF Available: Yes
COA Available: Yes
FDA Approved: Yes
API Grade: IP/BP/USP
WHO GMP Approved: Yes

1) API Quality
Fluvoxamine Maleate API from Amber Lifesciences is manufactured to meet the highest pharmaceutical standards, ensuring excellent purity, stability, and consistency. Each batch undergoes rigorous testing for assay, impurity profiling, and microbial limits, complying with WHO-GMP, ICH, USP, and Ph. Eur. guidelines. Advanced in-process controls guarantee uniformity, making the API suitable for tablets, capsules, and other oral formulations.

2) Comprehensive Documentation
Every batch of Fluvoxamine Maleate API Italy comes with detailed Certificates of Analysis (CoA) that include assay results, impurity profiles, and stability data. Complete Manufacturing Batch Records (MBR) ensure full traceability and reproducibility. Safety Data Sheets (SDS) and handling instructions are provided for safe storage and usage. This comprehensive documentation supports regulatory submissions, audits, and global pharmaceutical compliance.

3) Secure Supply Chain
Amber Lifesciences maintains a secure and transparent supply chain for Fluvoxamine Maleate API. Storage, handling, and logistics are closely monitored to prevent contamination or delays. Temperature-controlled transport is implemented when required to preserve API stability. Trusted logistics partners ensure timely delivery worldwide, while adherence to WHO-GMP standards guarantees authenticity, reliability, and uninterrupted supply.

4) Manufacturer & Supplier Expertise
The company leverages extensive experience in chemical synthesis and process engineering to optimize production for efficiency and scalability. Suppliers are carefully selected based on quality, compliance, and reliability. Ongoing R&D initiatives improve processes and enable customization for specific pharmaceutical formulations. Technical support is also provided to assist with handling, formulation, and regulatory requirements.

5) Amber Lifesciences’ Role
Amber Lifesciences acts as a trusted partner and CMO for Fluvoxamine Maleate API, delivering high-quality material with full regulatory documentation. The company ensures consistent supply, robust quality control, and technical assistance for pharmaceutical manufacturers. Supporting third-party manufacturing and bulk API supply, Amber Lifesciences caters to over 50 countries, ensuring efficiency and compliance in global pharmaceutical production.

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