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Mizolastine
CAS No.: 108612-45-9
Synonym: Mizollen
Mol. Formula: C₂₄H₂₅FN₆O
Mol. Weight: 432.50 g/mol
ATC Code: R06AX25
Therapeutic Category: Antihistamine
DMF Available: Yes
COA Available: Yes
FDA Approved: Yes
API Grade: IP/BP/USP
WHO GMP Approved: Yes

1) API Quality
Mizolastine API in Indonesia quality is defined by its high purity, consistent potency, and strict adherence to international regulatory standards. Manufacturers ensure rigorous in-process controls, validated analytical methods, and batch-to-batch uniformity. The API undergoes thorough testing for impurities, residual solvents, particle size distribution, and stability. GMP-certified facilities and controlled manufacturing conditions help maintain chemical integrity and product safety.

2) Comprehensive Documentation
Complete documentation is essential for regulatory approvals and customer compliance needs. This includes DMF/CTD dossiers, Certificates of Analysis (CoA), stability data, impurity profiles, and method validation reports. Manufacturers also provide batch manufacturing records, equipment qualification data, and quality risk assessments. Robust documentation ensures transparency, supports global submissions, and simplifies audits for formulators.

3) Secure Supply Chain
A secure supply chain ensures consistent availability of Mizolastine API without disruption. Qualified raw-material sourcing, multi-vendor strategies, and stringent supplier audits reduce supply risks. APIs are stored and transported under validated conditions to preserve quality. Tamper-proof packaging, inventory tracking, and regulatory-compliant logistics further strengthen supply reliability and product safety.

4) Manufacturer & Supplier Expertise
Experienced manufacturers bring deep technical knowledge, optimized synthesis routes, and proven QA/QC systems. Their expertise ensures efficient production, cost-effectiveness, and regulatory readiness. Reliable suppliers provide technical support, audit facilitation, custom specifications, and responsive customer service. Their understanding of global regulatory frameworks supports smooth market submissions.

5) Amber Lifesciences’ Role
Amber Lifesciences acts as a trusted partner for procuring high-quality Mizolastine API. They ensure dependable sourcing from certified manufacturers, maintain strong documentation support, and enable a secure supply chain. With technical expertise and customer-centric service, Amber Lifesciences delivers consistent API availability, helping formulators meet global quality and regulatory standards.

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