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Niacinamide
CAS No.: 98-92-0
Synonym: Nicobion, Niamid
Mol. Formula: C₆H₆N₂O
Mol. Weight: 122.12 g/mol
ATC Code: A11HA01
Therapeutic Category: Vitamin (B3)
DMF Available: Yes
COA Available: Yes
FDA Approved: Yes
API Grade: IP/BP/USP
WHO GMP Approved: Yes

1) API Quality
Niacinamide API is produced with high standards of purity, stability, and consistency to meet global pharmaceutical and nutraceutical requirements. Each batch undergoes stringent quality checks, including assay validation, impurity profiling, particle size analysis, and microbial testing. Advanced manufacturing techniques ensure uniformity and compliance with WHO-GMP, USP, EP, and ICH guidelines. This guarantees that the API meets the necessary specifications for use in formulations such as tablets, capsules, creams, serums, and dermatological products.

2) Comprehensive Documentation
Amber Lifesciences provides complete regulatory documentation for Niacinamide API, ensuring smooth approval and registration across global markets. This includes Certificate of Analysis (CoA), Material Safety Data Sheet (MSDS), Technical Data Sheet (TDS), stability data, and manufacturing process outlines. Full traceability and transparency help clients meet audit requirements effortlessly and simplify dossier preparation.

3) Secure Supply Chain
The supply chain for Niacinamide API is designed to ensure product integrity from production to delivery. Amber Lifesciences follows strict protocols for raw material sourcing, controlled manufacturing, and validated packaging processes. Temperature-controlled storage, tamper-proof packaging, and reliable logistics ensure that the API maintains its quality during transit, minimizing any risk of degradation or contamination.

4) Manufacturer & Supplier Expertise
With extensive experience in API manufacturing, Amber Lifesciences utilizes advanced equipment, controlled environments, and skilled professionals to ensure consistent batch-to-batch quality. Their technical expertise allows support for formulation development, troubleshooting, and customization based on client needs.

5) Amber Lifesciences’ Role
Amber Lifesciences plays a key role as a trusted global manufacturer and supplier of Niacinamide API. Their commitment to high-quality production, regulatory compliance, and efficient supply chain management helps pharmaceutical and cosmetic companies create safe, effective, and reliable products for worldwide markets.

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