Ormeloxifene
CAS No.: 65389-51-1
Synonym: Centron, Saheli
Mol. Formula: C₃₀H₃₂O₄
Mol. Weight: 456.58 g/mol
ATC Code: G03XC02
Therapeutic Category: Selective Estrogen Receptor Modulator
DMF Available: Yes
COA Available: Yes
FDA Approved: Yes
API Grade: IP/BP/USP
WHO GMP Approved: Yes

1) API Quality
Ormeloxifene API is produced with a strong focus on purity, stability, and potency to meet global pharmaceutical standards. Advanced synthesis and purification techniques ensure minimal impurities, consistent assay values, and reliable physicochemical properties. Each batch undergoes rigorous testing, including identity verification, analysis for related substances, detection of residual solvents, and assessment of microbial limits. Compliance with WHO-GMP and ICH guidelines ensures suitability for formulations used as contraceptives and in hormone-related therapies. Batch-to-batch consistency guarantees safe and effective therapeutic performance.

2) Comprehensive Documentation
Each batch of Ormeloxifene API is supplied with complete regulatory documentation, including CoA, MSDS, technical dossiers, and stability reports. Documentation includes validated analytical methods, impurity profiling, process validation, and safety information. Transparent and detailed documentation supports pharmaceutical companies in regulatory submissions, product registration, and formulation development across global markets. Full traceability ensures strong compliance with international standards.

3) Secure Supply Chain
Amber Lifesciences maintains a secure and efficient supply chain for Ormeloxifene API. Temperature-controlled storage, tamper-proof packaging, and validated logistics safeguard the API during transportation. Real-time shipment tracking minimizes risks of delays, mishandling, or exposure to unsuitable conditions. Robust inventory planning ensures uninterrupted supply for large-scale pharmaceutical manufacturing.

4) Manufacturer and Supplier Expertise
Amber Lifesciences operates advanced manufacturing facilities with skilled technical teams and regulatory specialists. Their expertise ensures precise process control, consistent production, and continuous quality improvement. Clients receive guidance and support throughout formulation development and regulatory approval stages.

5) Amber Lifesciences’ Role
Amber Lifesciences is a trusted global supplier of Ormeloxifene API, providing high-quality manufacturing, complete documentation, and reliable logistics. Their commitment ensures a consistent, compliant, and premium-grade API Argentina supply for pharmaceutical companies worldwide.

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