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Nicotinamide
CAS No.: 98-92-0
Synonym: Same as Niacinamide
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
Nicotinamide API is manufactured with a focus on exceptional purity, stability, and consistency to meet international pharmaceutical standards. Each batch undergoes rigorous testing, including assay, impurity analysis, and microbial limit checks. Advanced quality control ensures the API complies with WHO-GMP, USP, EP, and ICH guidelines, making it suitable for diverse formulations such as tablets, capsules, topical creams, and dietary supplements.

2) Comprehensive Documentation
Amber Lifesciences provides complete regulatory and technical documentation for Nicotinamide API in France. This includes Certificates of Analysis (CoA), Material Safety Data Sheets (MSDS), Technical Data Sheets (TDS), stability reports, and detailed manufacturing records. Such documentation ensures transparency, traceability, and smooth regulatory approvals for global pharmaceutical and cosmetic applications.

3) Secure Supply Chain
The supply chain of Nicotinamide API is designed to maintain product integrity from production to delivery. Strict protocols govern raw material sourcing, controlled manufacturing, validated packaging, and storage. Temperature-controlled and tamper-evident packaging, along with reliable logistics, ensure the API reaches clients safely and retains its quality during transit.

4) Manufacturer & Supplier Expertise
Amber Lifesciences leverages extensive experience in API development and pharmaceutical manufacturing. Their state-of-the-art facilities, skilled workforce, and robust quality systems allow for scalable, reproducible production while adhering to stringent regulatory standards. Clients benefit from technical support, formulation guidance, and consistent batch-to-batch quality.

5) Amber Lifesciences’ Role
As a trusted global manufacturer and supplier, Amber Lifesciences ensures the delivery of high-quality Nicotinamide API. Their commitment to innovation, regulatory compliance, and secure supply chain management supports pharmaceutical and cosmetic companies in producing safe, effective, and reliable products worldwide.

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