Amisulpride
CAS No.: 71675-85-9
Synonym: Solian
Mol. Formula: C₁₇H₂₇N₃O₄S
Mol. Weight: 369.48 g/mol
ATC Code: N05AL05
Therapeutic Category: Antipsychotic
DMF Available: Yes
COA Available: Yes
FDA Approved: Yes
API Grade: IP/BP/USP
WHO GMP Approved: Yes

1) API Quality
Amisulpride API is manufactured with high purity, precise particle size, and controlled impurity levels to ensure consistent therapeutic performance. Each batch undergoes validated analytical testing, stability studies, and in-process quality checks in compliance with international pharmaceutical standards.

2) Comprehensive Documentation
Amber Lifesciences provides complete regulatory documentation including COA, MSDS, stability data, GMP certificates, and DMF support. These documents meet global regulatory standards to facilitate smooth product registration and market approvals worldwide.

3) Secure Supply Chain
The API is produced through a fully traceable and controlled supply chain. Raw materials are sourced from qualified suppliers, and each stage—from synthesis to packaging—is monitored to ensure safety, consistency, and timely delivery globally.

4) Manufacturer & Supplier Expertise
Amber Lifesciences has strong expertise in CNS APIs. The company ensures optimized production processes, large-scale manufacturing capacity, and adherence to international quality norms, providing reliable API supply for global pharmaceutical markets.

5) Amber Lifesciences’ Role
As a trusted CMO and API manufacturer, Amber Lifesciences supplies Amisulpride API to over 50 countries. Supported by WHO-GMP certification and robust regulatory compliance, the company ensures consistent quality, full documentation, and dependable long-term supply.

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