The inspection closed with five observations which were more of procedural changes with none of these related to data integrity
The company will address these observations within the stipulated timeline
Selexipag is a prostacyclin receptor agonist indicated for the treatment of pulmonary arterial hypertension
The facility is a part of Lupin Manufacturing Solutions
The approved ANDA is therapeutically equivalent to the reference listed drug product
Sacubitril and Valsartan combination is used to treat chronic heart failure in adults
Diroximel Fumarate Delayed-Release Capsules is indicated for the treatment of relapsing forms of multiple sclerosis
This product will be manufactured at Lupin’s Pithampur facility in India
Dabur's consolidated revenue is expected to register mid to high single digit growth during Q1 FY25
Vabysmo PFS is the first and only syringe prefilled with an FDA-approved bispecific antibody to treat retinal conditions that can cause blindness
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