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Dapsone
CAS No.: 80-08-0
Synonym: Acnesone, Acnedap
Mol. Formula: C₁₂H₁₂N₂O₂S
Mol. Weight: 248.30 g/mol
ATC Code: D10AX05, J04BA02
Therapeutic Category: Antibacterial
DMF Available: Yes
COA Available: Yes
FDA Approved: Yes
API Grade: IP/BP/USP
WHO GMP Approved: Yes

1) API Quality
Dapsone API is manufactured under strict WHO-GMP standards to ensure high purity, consistent potency, and minimal impurities. Each batch undergoes comprehensive testing, including assay, identification, residual solvents, heavy metals, microbial limits, and stability studies. Controlled manufacturing processes maintain uniformity and prevent contamination, making the API suitable for pharmaceutical formulations used in dermatology and antimicrobial therapies.

2) Comprehensive Documentation
Amber Lifesciences provides complete regulatory documentation for Dapsone API Germany, including DMF/CTD dossiers, Certificate of Analysis (COA), MSDS, Method of Analysis (MOA), stability reports, and process validation data. Detailed impurity profiles, batch manufacturing records, and compliance certificates facilitate regulatory submissions. Transparent documentation ensures smooth approvals and simplifies product registration in domestic and international markets.

3) Secure Supply Chain
The supply chain for Dapsone API is fully traceable, secure, and optimized to prevent disruptions. APIs are packaged in contamination-proof, temperature-controlled containers with end-to-end shipment tracking. Vendor qualification, risk mitigation strategies, and inventory monitoring ensure uninterrupted supply and timely delivery to pharmaceutical manufacturers worldwide.

4) Manufacturer & Supplier Expertise
Amber Lifesciences leverages advanced synthesis and purification technologies along with skilled R&D and QC teams. Expertise in specialty APIs ensures consistent quality, regulatory compliance, and efficient large-scale production. Continuous process improvement guarantees high-quality and reproducible API output.

5) Amber Lifesciences’ Role
Amber Lifesciences supplies premium-grade Dapsone API with full documentation, timely delivery, and WHO-GMP certified manufacturing. Through third-party manufacturing and CMO services, the company supports pharmaceutical partners in developing effective dermatology and antimicrobial formulations, establishing a trusted global API supply network.

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