Drug Approval | March 13, 2026
Shilpa Biologicals and mAbTree Biologics secure ODD from USFDA
Marks significant milestone for breakthrough biologic to treat rare blood cancers
Marks significant milestone for breakthrough biologic to treat rare blood cancers
New partnership combines Shilpa Biologicals’ development and manufacturing capabilities with SteinCares’ regional commercialization platform
he inspection covering the sterile drug product filling and packaging line, quality systems and quality control laboratories concluded compliance with the principles and guidelines of Good Manufacturing Practice
This program aims to develop a fully human monoclonal antibody against a novel immune checkpoint protein that enables T cell activation
She brings an overall Techno Commercial experience of 22+ Years in various Organizations
Shilpa Biologicals has developed high concentration adalimumab (100 mg/mL)
This novel recombinant has been developed and is a patented novel recombinant Human Albumin 20% process
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Shilpa Biologicals has tie-ups with Zydus to supply ZyCoV-D vaccine drug substance and Dr Reddy’s to make Sputnik V from its facility in Dharwad
The pioneering monoclonal antibody is for Essential Thrombocythemia (ET) and Polycythemia Vera (PV), rare chronic blood cancers with limited treatment options
India's pharmaceutical sector is rapidly shifting from a generics-led foundation to an innovation-driven ecosystem
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