1) API Quality:
Apixaban API, a potent anticoagulant used for preventing and treating thromboembolic disorders, is produced under stringent GMP and ISO 9001:2015 standards. Amber Lifesciences ensures consistent purity, particle size control, and impurity profiling to meet global pharmacopeial specifications. Each batch undergoes rigorous analytical validation to guarantee safety, efficacy, and reproducibility in finished formulations.
2) Comprehensive Documentation:
Amber Lifesciences provides a full regulatory documentation package, including Certificate of Analysis (COA), Material Safety Data Sheet (MSDS), stability data, and detailed DMF/CTD/ACTD dossiers. This comprehensive documentation ensures seamless regulatory submissions and compliance across international markets.
3) Secure Supply Chain:
A robust, traceable supply chain ensures uninterrupted Apixaban API availability. Controlled logistics, validated storage conditions, and real-time tracking systems maintain product integrity from manufacturing to delivery, supporting both regulated and semi-regulated markets.
4) Manufacturer & Supplier Expertise:
Amber Lifesciences’ technical expertise encompasses advanced synthesis, process optimization, impurity control, and regulatory support. Their manufacturing excellence and global supply experience ensure reliable, large-scale production with consistency and compliance.
5) Amber Lifesciences’ Role:
Amber Lifesciences Pvt. Ltd. is a leading global manufacturer and supplier of Apixaban API, known for its commitment to quality, regulatory transparency, and dependable logistics. With strong R&D and documentation support, Amber Lifesciences enables pharmaceutical partners worldwide to develop and market high-quality formulations with confidence and regulatory assurance.