Gland Pharma receives 2 observations under 483 for Pashamylaram facility
The company is committed to address the observations and will submit its response to US FDA within the stipulated time
The company is committed to address the observations and will submit its response to US FDA within the stipulated time
The drug will be manufactured at JB Pharma's formulation manufacturing facility in Panoli, Gujarat
US FDA approval is in line with de-risking strategy for additional API site to service our global customer base
The inspection was conducted at its Goa, Vema manufacturing facility
The inspection closed with zero observations and a classification of No Action Indicated
Acquisition of biologics manufacturing facility in Bangalore to complete by the end of the third quarter in FY 24
Aurobindo will respond to the US FDA within the stipulated timelines
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