Budesonide is indicated for mild to moderate active Crohn's disease involving the ileum and/or the ascending colon in adults and children 8 years of age and olde
Nicardipine Hydrochloride in 0.9% Sodium Chloride Injection is indicated for the short-term treatment of hypertension when oral therapy is not feasible or desirable
Lupin's partnership program is designed to foster collaborations with companies looking to extend their product lifecycles
Deflazacort oral suspension is indicated for treating Duchenne Muscular Dystrophy in patients 5 years of age and older
The product will be manufactured at Lupin’s Chhatrapati Sambhajinagar facility in India
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
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