Bictegravir, Emtricitabine, and Tenofovir Alafenamide Tablets are indicated for the treatment of human immunodeficiency virus infection in adults and pediatric patients weighing at least 25 kg
The facility has been classified as Voluntary Action Indicated
The inspection concluded with zero form 483 observations
Lenalidomide Capsules are indicated for the treatment of adult patients with Multiple myeloma
Zydus will work closely with the USFDA to address and resolve the observations in an expeditious manner
This is Lupin's first product using proprietary Nanomi's technology and has a 180-day CGT exclusivity
Milrinone is indicated for the short-term intravenous treatment of patients with acute decompensated heart failure
At the end of the current inspection, a 'Form 483' was issued with 5 observations which are procedural in nature and no data integrity issues were reported
The sudden subsequent decision to suspend IXCHIQ is based on updated VAERS data
The US generic market is crucial for Indian pharma, contributing about 35% to its total revenue, around US$ 10.7 billion
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