temsirolimus Injection 25 mg
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.
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