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Doxorubicin
CAS No.: 23214-92-8
Synonym: Adriamycin
Mol. Formula: C₂₇H₂₉NO₁₁
Mol. Weight: 543.52 g/mol
ATC Code: L01DB01
Therapeutic Category: Anticancer
DMF Available: Yes
COA Available: Yes
FDA Approved: Yes
API Grade: IP/BP/USP
WHO GMP Approved: Yes

1) API Quality
Doxorubicin API is produced with strict control over purity, potency, and stability to ensure consistent therapeutic performance. Each batch undergoes advanced analytical testing to maintain low impurity levels, accurate assay values, and defined particle characteristics. Quality checks include identification, related substances, residual solvents, sterility, endotoxin levels, and microbial limits. The API complies with global pharmacopeial standards and is suitable for injectable oncology formulations.

2) Comprehensive Documentation
A complete documentation package is available to support domestic and international regulatory submissions. This includes DMF/CTD formats, stability studies under ICH conditions, validation reports, Certificates of Analysis, safety data sheets, impurity profiles, and method validation documents. The documentation is structured to support smooth regulatory approval and efficient formulation development for cancer treatment medications.

3) Secure Supply Chain
Doxorubicin API France is managed through a controlled and traceable supply chain designed for sensitive oncology products. GMP-certified storage, cold-chain or temperature-controlled logistics, tamper-proof packaging, and transparent shipment tracking ensure product safety. Reliable inventory systems support uninterrupted supply to global pharmaceutical manufacturers.

4) Manufacturer & Supplier Expertise
Manufacturers use modern facilities, optimized synthesis pathways, and strict QA/QC systems to ensure high-quality and consistent production. Their expertise in oncology APIs, regulatory knowledge, and technical support helps formulation companies maintain stable production and compliance across multiple markets.

5) Amber Lifesciences’ Role
Amber Lifesciences supports pharmaceutical manufacturers by supplying high-purity Doxorubicin API with adherence to WHO-GMP and global quality standards. Their team provides full documentation support, dependable logistics, and quality-assured batches for scalable oncology drug manufacturing.

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