Brivaracetam
CAS No.: 357336-20-0
Synonym: Briviact
Mol. Formula: C₁₁H₂₀N₂O₂
Mol. Weight: 212.29 g/mol
ATC Code: N03AX23
Therapeutic Category: Antiepileptic
DMF Available: Yes
COA Available: Yes
FDA Approved: Yes
API Grade: IP/BP/USP
WHO GMP Approved: Yes

1) API Quality:
Brivaracetam API, an advanced anticonvulsant used in epilepsy management, is manufactured under strict GMP and ISO 9001:2015 standards to ensure superior purity, potency, and consistency. Each batch undergoes rigorous analytical testing for assay accuracy, impurity profiling, and stability, meeting international pharmacopeial specifications and ensuring reliable therapeutic performance.

2) Comprehensive Documentation:
Amber Lifesciences provides complete regulatory documentation, including Certificate of Analysis (COA), Material Safety Data Sheet (MSDS), stability data, and CTD/ACTD dossiers. These documents ensure compliance with global regulatory requirements and facilitate seamless product registration in multiple markets.

3) Secure Supply Chain:
A secure and transparent supply chain guarantees uninterrupted availability of Brivaracetam API. Temperature-controlled logistics, validated packaging, and traceable distribution systems ensure the product’s integrity and quality from manufacturing through delivery.

4) Manufacturer & Supplier Expertise:
Amber Lifesciences combines expertise in complex molecule synthesis, process optimization, and analytical validation. Their experienced R&D and quality assurance teams ensure efficient large-scale production while maintaining global regulatory compliance.

5) Amber Lifesciences’ Role:
As a global leader in API manufacturing and supply, Amber Lifesciences Pvt. Ltd. delivers high-quality Brivaracetam API with strong documentation support and dependable logistics. Their commitment to quality, compliance, and customer satisfaction makes them a preferred partner for pharmaceutical companies worldwide seeking consistent and compliant CNS-active APIs.

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