l-asparaginase Injection 5000 IU, 10000 IU

Dossier type
CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
WHO
Manufacturer #21110

This CTD dossier owner and manufacturer focuses on providing high-quality oncology drugs to over 20 countries worldwide. With more than two decades of experience, they specialize in manufacturing sterile oncology dosage forms, including liquid vials, lyophilized formulations, and complex NDDS-based products. Their product portfolio includes over 35 products targeting various solid tumors and hematological malignancies, with a commitment to palliative care formulations as well. They prioritize research and development, particularly in advanced lyophilized, liposomal, and nanoparticle-based drug delivery systems. Their manufacturing facilities adhere to strict GMP certifications, ensuring product quality and safety. Key therapy areas include oncology, with a focus on solid tumors and hematological malignancies. Principal dosage forms include liquid vials, lyophilized formulations, and complex NDDS (New Drug Delivery Systems) based products. The company emphasizes partnerships with academia, healthcare institutions, and the local community to drive research and development efforts.

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