The inspection closed with five observations which were more of procedural changes with none of these related to data integrity
Vonoprazan is a potassium-competitive acid blocker (P-CAB) used for the treatment of acid-related disorders
The company will address these observations within the stipulated timeline
Selexipag is a prostacyclin receptor agonist indicated for the treatment of pulmonary arterial hypertension
Enhanced collaboration under the Memorandum of Cooperation (MoC) between India and Japan in medical product regulations
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
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