Bepotastine Besilate
CAS No.: 190786-44-8
Synonym: Talion
Mol. Formula: C₂₁H₂₅ClN₂O₃·C₆H₆O₃S
Mol. Weight: 547.03 g/mol
ATC Code: R06AX27
Therapeutic Category: Antihistamine
DMF Available: Yes
COA Available: Yes
FDA Approved: Yes
API Grade: IP/BP/USP
WHO GMP Approved: Yes

1) API Quality
Bepotastine Besilate API from Amber Lifesciences is manufactured under strict quality control standards to ensure high purity, potency, and consistency. Each batch undergoes rigorous testing for identity, assay, and impurities in compliance with pharmacopeial standards such as USP, EP, and BP. Advanced analytical techniques, including HPLC and GC, verify stability, particle size, and chemical integrity, ensuring the API’s efficacy and reliability in antihistamine and allergy treatment formulations.

2) Comprehensive Documentation
Amber Lifesciences provides detailed documentation for every batch of Bepotastine Besilate API. This includes Certificates of Analysis (CoA), Material Safety Data Sheets (MSDS), regulatory compliance certificates, and full product specifications. Complete traceability of raw materials, production processes, and quality control data allows clients to meet international regulatory requirements and integrate the API smoothly into their manufacturing processes.

3) Secure Supply Chain
The supply chain for Bepotastine Besilate API South Korea is managed to ensure maximum security and integrity. The API is stored in controlled conditions and transported using tamper-proof, temperature-stable packaging. Amber Lifesciences partners with reliable logistics providers and follows Good Distribution Practices (GDP), ensuring timely delivery and product stability for clients across global markets.

4) Manufacturer & Supplier Expertise
Amber Lifesciences has extensive experience in producing high-quality ophthalmic and antihistamine APIs. Their skilled team of chemists, quality assurance professionals, and regulatory experts ensures precise synthesis, stringent quality control, and compliance with international standards, delivering consistent and reliable API supply.

5) Amber Lifesciences’ Role
As a trusted global supplier and Contract Manufacturing Organization (CMO), Amber Lifesciences guarantees the consistent availability of Bepotastine Besilate API. The company provides technical support, regulatory guidance, and scalable production capabilities, enabling pharmaceutical companies to develop safe, effective, and compliant formulations worldwide.

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