The company stated that it will work closely with the regulator to address the observations within the stipulated timeframe
The study included four independent genetic substudies targeting obesity caused by heterozygous variants in the POMC/PCSK1, LEPR, SRC1 (NCOA1), and SH2B1 genes
There are limited treatment options available for patients living with non-diabetic CKD, and the unmet need is high for new treatments to delay kidney disease progression and reduce cardiovascular risk
The EIR was issued following an inspection of the facility from November 10 to November 21, 2025
Lupin will address the observations and respond to the U.S. FDA within the stipulated timeframe
The said inspection concluded with Zero Form 483 observation
We are taking Ayurveda to the world as a sustainable healthcare solution: Union Minister Prataprao Jadhav
The trial is the largest to date evaluating Leqvio and the first to focus on patient-centered outcomes
This GMP certification for our sterile drug product manufacturing facility, Goa Plant II is a testament to our relentless efforts to supply quality and affordable medicines across geographies
The products will be manufactured in Goa India and marketed & distributed in Australian markets
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