Benserazide HCl
CAS No.: 14919-77-8
Synonym: Madopar
Mol. Formula: C₁₀H₁₅N₃O₅·HCl
Mol. Weight: 293.70 g/mol
ATC Code: N04BA02
Therapeutic Category: Antiparkinsonian
DMF Available: Yes
COA Available: Yes
FDA Approved: Yes
API Grade: IP/BP/USP
WHO GMP Approved: Yes

1) API Quality:
Benserazide Hydrochloride (HCl) API, a key component in Parkinson’s disease therapy, is manufactured under strict GMP and ISO 9001:2015 standards to ensure high purity, potency, and stability. Each batch is tested for assay, impurities, and residual solvents using validated analytical methods to meet international pharmacopoeial specifications and deliver consistent performance.

2) Comprehensive Documentation:
Amber Lifesciences provides extensive regulatory documentation, including Certificate of Analysis (COA), Material Safety Data Sheet (MSDS), stability data, and CTD/ACTD dossiers. These comprehensive documents ensure global registration readiness and streamline regulatory submissions across diverse markets.

3) Secure Supply Chain:
A secure, transparent, and traceable supply chain guarantees uninterrupted availability of Benserazide HCl API. Temperature-controlled logistics, validated packaging, and continuous quality checks preserve product integrity and compliance from manufacturing to global distribution.

4) Manufacturer & Supplier Expertise:
With expertise in chemical synthesis, process validation, and regulatory compliance, Amber Lifesciences ensures reliable large-scale production. Their R&D-driven approach optimizes process efficiency and quality, ensuring consistent delivery to pharmaceutical partners worldwide.

5) Amber Lifesciences’ Role:
Amber Lifesciences Pvt. Ltd. serves as a global leader in the manufacturing and supply of Benserazide HCl API. Their commitment to GMP compliance, robust documentation, and secure logistics positions them as a trusted partner delivering quality, reliability, and regulatory assurance to the global pharmaceutical industry.

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