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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.

Manufacturer usually replies in 8 days

l-asparaginase

Injection 5000 IU, 10000 IU

Dossier type
CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
EU GMP, PICS, COFEPRIS, MHRA, Canada, South Africa, United Arab Emirates, Turkey
Manufacturer #36255

Established in 2013, this manufacturer specializes in oncology, focusing on the research, manufacturing, and marketing of high-quality specialty formulations. As a CTD dossier owner and manufacturer, it holds GMP certifications from international regulatory authorities, including USFDA, MHRA, and PIC/S, ensuring compliance with stringent quality standards. The manufacturer operates a state-of-the-art facility in Hyderabad, India, designed to meet global regulatory requirements. As a CTD dossier owner and manufacturer, its products are distributed worldwide. With a commitment to innovation and quality, the manufacturer aims to provide the best options to oncologists and their patients.

Manufacturer usually replies in 31 days

l-asparaginase

Injection 10000 IU

Dossier type
CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
EU GMP
Manufacturer #38728

Established in 2012, this Manufacturer is a CTD dossier owner and manufacturer and GMP manufacturer with products sold in over 39 countries across four continents. With multiple WHO-GMP and other regulatory approvals (e.g., Ghana FDA, Philippines FDA, Kenya PBB, Tanzania TFDA, Nigeria NAFDAC), it operates several finished dosage and R&D production lines (tablets, capsules, injectables, liquids, softgels, effervescent, suppositories). As a CTD dossier owner and manufacturer, it supports regulatory filings worldwide. Headquartered in India and employing a global workforce, it serves diverse markets as a CTD dossier owner and manufacturer and GMP manufacturer.

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