A bio-analytical Remote Regulatory Assessment was also conducted from October 30 to November 7, 2025, and concluded with no observations
The Cranbury facility represents a strategic advancement of the company's operations in the Unted States
The NDA submission follows the successful completion of a pivotal Phase III global clinical trial
Lupin will address the observations and respond to the U.S. FDA within the stipulated timeframe
Zydus will work closely with the USFDA to address and resolve the observations in an expeditious manner
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 inspection, conducted from June 23 to June 25, 2025, concluded with zero Form 483 observations
Macitentan tablets are an endothelin receptor antagonist indicated for the treatment of pulmonary arterial hypertension
The inspection concluded with NIL observations
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