News | December 12, 2025
Granules Life Sciences facility receives EIR from USFDA
This approval confirms the facility's compliance with FDA quality standards and regulatory requirements
This approval confirms the facility's compliance with FDA quality standards and regulatory requirements
The company will respond to the US FDA within the stipulated timelines
The Phase 2 study tested two dose levels of pumitamig alongside four standard chemotherapy regimens across first
The investigational therapy uses SteadyTeq, a proprietary copolymer technology from Medincell designed to release olanzapine steadily over time
Roche says its new assay “resolves this challenge by delivering accurate and specific results
The approval follows strong results from Roche’s phase II NOBILITY and phase III REGENCY studies
India has deep strengths in reverse engineering and API development, while Russia has strong capabilities in certain vaccines, biologicals, and niche therapeutic segments. Collaboration can significantly shorten R&D timelines
The new site will produce next-generation synthetic medicine active pharmaceutical ingredients
This strategic investment aims to bolster the company's position as a global leader in Vitamin D3 manufacturing
Formycon AG will develop, register, manufacture and supply the product, while Zydus Lifesciences Global FZE, United Arab Emirates will be responsible for the commercialization of FYB206 in the defined territories
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