Lupin receives 7 observations from USFDA for Goa manufacturing facility
Lupin will address the observations and respond to the U.S. FDA within the stipulated timeframe
Lupin will address the observations and respond to the U.S. FDA within the stipulated timeframe
This marks Lupin’s first commercial product leveraging PrecisionSphere, a proprietary long-acting injectable (LAI) technology
This remarkable increase from 17 in 2021 ranks among the fastest for pharmaceutical companies, establishing Lupin as a leader in sustainable growth
The EIR follows a product-specific Pre-Approval Inspection from September 1 to September 5, 2025.
A bio-analytical Remote Regulatory Assessment was also conducted from October 30 to November 7, 2025, and concluded with no observations
AI-powered cardiometabolic wellness platform for India’s workforce
The product is indicated for the chronic management of patients with Urea Cycle Disorders
The presentation will provide qualitative insights into its safety, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity in patients with solid tumors
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