Caplin Point announces completion of unannounced USFDA inspection
The inspection was concluded with zero observations
The inspection was concluded with zero observations
Being the first approved applicant, Lupin is eligible for 180 days of CGT exclusivity
The inspection scope included 6 separate Biologics manufacturing units comprising 4 Drug Substance and 2 Drug Product manufacturing plants
The inspection was concluded with two 483 observations
The inspections concluded with no Form 483 observations or significant critical findings
Contepo offers a unique mechanism of action and has the potential to address increasing antibiotic resistance and gaps in the current antibiotic treatment landscape
Lupin can receive a potential total consideration of up to USD 84 million based on future contingent milestones
The company will address these observations within the stipulated timeline
KIMS already have a multi-specialty hospital and gastro unit at Vizag
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