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Valproic Acid
CAS No.: 99-66-1
Synonym: Depakote
Mol. Formula: C₈H₁₆O₂
Mol. Weight: 144.21 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
Valproic Acid API in Indonesia is a key active ingredient in the treatment of epilepsy, bipolar disorder, and other neurological conditions. The API must meet stringent pharmacopeial and regulatory standards for purity, assay, residual solvents, and impurity profiles. Amber Lifesciences ensures the highest quality Valproic Acid API through GMP-compliant manufacturing, validated synthesis processes, and advanced analytical testing. Batch-to-batch consistency and stability are rigorously maintained, ensuring therapeutic efficacy and patient safety.

2) Comprehensive Documentation
Amber Lifesciences provides comprehensive documentation to support regulatory compliance and market approvals. This includes Drug Master Files (DMF), Certificates of Analysis (COA), stability data, method validation reports, impurity profiling, and traceability records. These documents assist pharmaceutical manufacturers during regulatory submissions, audits, and quality assurance processes, enabling faster approvals and smooth market entry.

3) Secure Supply Chain
A secure and uninterrupted supply chain is essential for the continuous availability of Valproic Acid API. Amber Lifesciences ensures reliable raw material sourcing, stringent quality control in manufacturing, GDP-compliant storage, and real-time shipment tracking. These practices minimize the risks of contamination, supply chain disruptions, and delays, ensuring consistent availability for pharmaceutical companies.

4) Manufacturer & Supplier Expertise
Amber Lifesciences works with highly skilled manufacturers with deep technical expertise in synthesizing Valproic Acid. Their knowledge ensures optimized yields, impurity control, scalable production, and global regulatory compliance, allowing for cost-effective manufacturing and high-quality API production.

5) Amber Lifesciences’ Role
Amber Lifesciences provides top-tier Valproic Acid API, complete with comprehensive documentation, a secure supply chain, and technical support. Their commitment to quality and reliability helps pharmaceutical companies develop safe, effective, and competitive formulations for epilepsy and other neurological disorders.

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