A bio-analytical Remote Regulatory Assessment was also conducted from October 30 to November 7, 2025, and concluded with no observations
New test expands access to early Alzheimer’s assessment, streamlining diagnostic pathways and improving referral efficiency
Lupin's partnership program is designed to foster collaborations with companies looking to extend their product lifecycles
Rifaximin tablets are a rifamycin antibacterial indicated for reducing the risk of overt hepatic encephalopathy
The NDA submission follows the successful completion of a pivotal Phase III global clinical trial
This milestone marks the first-ever NDA submission to the U.S. FDA for a drug, fully discovered and developed by an Indian pharmaceutical company
The product will be manufactured at Lupin’s Chhatrapati Sambhajinagar facility in India
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