Send Inquiry
Divalproex Sodium
CAS No.: 76584-70-8
Synonym: Depakote
Mol. Formula: (C₈H₁₅NaO₂)ₙ(C₈H₁₆O₂)ₙ
Mol. Weight: 166.20 g/mol
ATC Code: N03AG01
Therapeutic Category: Anticonvulsant
DMF Available: Yes
COA Available: Yes
FDA Approved: Yes
API Grade: IP/BP/USP
WHO GMP Approved: Yes

1) API Quality
Divalproex Sodium API Mexico is manufactured with a focus on high purity, chemical stability, and consistent therapeutic performance. Advanced synthesis and purification techniques ensure minimal impurities, precise assay values, and optimal chemical integrity. Each batch undergoes rigorous testing for identity, assay, related substances, residual solvents, particle size distribution, and microbial limits. Production complies with WHO-GMP and international pharmacopoeial standards, making it suitable for tablet, capsule, and injectable formulations.

2) Comprehensive Documentation
A complete regulatory documentation package is provided to support approvals in both regulated and semi-regulated markets. This includes DMF/CTD dossiers, stability studies, validation reports, COA, MSDS, impurity profiling, and technical specifications. Detailed analytical methods and packaging information facilitate smooth regulatory submissions and efficient formulation development. Documentation is continuously updated to maintain compliance with global standards.

3) Secure Supply Chain
Divalproex Sodium API is supplied through a secure, traceable, and well-managed supply chain. GMP-compliant storage, controlled conditions, tamper-proof packaging, and reliable logistics partners ensure safe and timely deliveries. Advanced inventory planning, demand forecasting, and real-time tracking help maintain uninterrupted global supply for pharmaceutical companies.

4) Manufacturer & Supplier Expertise
Experienced manufacturers utilize modern production facilities, optimized processes, and skilled R&D teams to ensure consistent API quality. Their expertise in regulatory compliance, quality assurance, and international distribution guarantees reliable supply and technical support for pharmaceutical partners.

5) Amber Lifesciences’ Role
Amber Lifesciences provides trusted sourcing and supply of Divalproex Sodium API with strict adherence to WHO-GMP guidelines and international quality standards. They offer comprehensive documentation, regulatory guidance, and secure logistics, enabling pharmaceutical companies to access high-grade API with confidence, consistency, and compliance.

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