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
Bayer remains a key partner in Ginkgo Bioworks’ growing agricultural biologicals 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
It will help upgrade the infrastructure and technologies of the country's biopharmaceuticals and in-vitro diagnostic industry
Subject Expert Committee(SEC) of Central Drugs Standard Control Organization (CDSCO)
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