Amiodarone HCl
CAS No.: 1951-25-3
Synonym: Cordarone
Mol. Formula: C₂₅H₂₉I₂NO₃·HCl
Mol. Weight: 681.79 g/mol
ATC Code: C01BD01
Therapeutic Category: Antiarrhythmic
DMF Available: Yes
COA Available: Yes
FDA Approved: Yes
API Grade: IP/BP/USP
WHO GMP Approved: Yes

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

2) Comprehensive Documentation
Amber Lifesciences provides complete regulatory documentation including COA, MSDS, stability data, GMP certificates, and DMF support. These documents comply with international standards to enable smooth product registration and 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 every stage—from production to final packaging—is monitored to ensure safety, quality, and timely delivery globally.

4) Manufacturer & Supplier Expertise
Amber Lifesciences has extensive experience in cardiovascular APIs. The company ensures optimized production processes, large-scale manufacturing capabilities, and adherence to international quality norms for reliable supply to pharmaceutical markets.

5) Amber Lifesciences’ Role
As a trusted CMO and API manufacturer, Amber Lifesciences supplies Amiodarone Hydrochloride 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.