Drug Approval | February 21, 2025
USFDA issues Form-483 for Piramal Pharma's facility at Turbhe
Observations are largely around improvement of procedures and practices
Observations are largely around improvement of procedures and practices
The USFDA has determined the inspection classification status of this warehousing facility as 'Official Action Indicated
The Alathur facility specializes in the production of Cephalosporin antibiotics
The safety profile of Opdualag observed in this analysis was consistent with the known profiles of nivolumab and relatlimab
Approval is based on positive data from the Phase 3 ECHELON-3 trial
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Hikal Limited announces the completion of the US Food and Drug Administration (USFDA) inspection at its Jigani unit, Bengaluru
Based on DESTINY-Breast06 Phase III trial results which showed Enhertu demonstrated superiority vs. chemotherapy with a median progression-free survival of more than one year
The company said it voluntarily paused production at the Gagillapur plant in September 2024 for risk assessment on account of the USFDA observations
Reported revenue from operations up by 11% to Rs. 944 crores Reported PAT (after exceptional items) up by 18% to Rs. 131 crore
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Mesalazine is used to treat inflammatory bowel disease
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