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Efepoetin alfa manufacturers

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Country of origin : Indonesia

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1 products found
Novel Long-acting EPO for Anemia in CKD

efepoetin alfa

Injection, pre-filled syringe 0.3 mg/0.3 ml, 0.6 mg/0.6 ml

Dossier type
EU CTD
Dossier status
Ready to file
Country of origin
Indonesia
GMP approvals
FDA, EU GMP, WHO
Comments
Patented hyFC technology. Less frequent dosing - Biweekly to monthly. Optimized Efficacy & Bioactivity. Minimized Immunogenicity. Multinational clinical trial in 10+ countries across Europe, Oceania and Asia.
Manufacturer #7833

Established in 1966, this manufacturer is a leading CTD dossier owner and manufacturer with a strong presence in over 30 countries and regions worldwide. As a GMP manufacturer, it adheres to stringent quality standards, boasting multiple GMP approvals. With a diverse range of production lines, the manufacturer specializes in pharmaceuticals, nutrition, and consumer health products. Employing thousands of dedicated professionals, this CTD dossier owner and manufacturer continues to innovate and expand its global reach while maintaining its commitment to quality as a GMP manufacturer.

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