Drug Approval | April 13, 2024
USFDA completes inspection of Lupin's Dabhasa facility with no observations
The inspection was conducted from April 8 to April 12, 2024 and concluded with no observations
The inspection was conducted from April 8 to April 12, 2024 and concluded with no observations
The company will respond to the Warning Letter within the stipulated timelines
These observations are procedural in nature and will be responded within the stipulated time
The observations are procedural in nature and will be responded to within the stipulated time
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The regulator carried out a routine current Good Manufacturing Practices (cGMP) inspection from March 28 to April 4.
Executes the first project for developing and manufacturing a novel anticancer mAb
The facility will manufacture tablets, capsules, and injections for the oncology segment
Additional capacity broadens Grace’s fine chemical capabilities for API production
New facility includes 20KL of single use drug substance capacity coupled with drug product filling capacity of up to one million vials per day
The company is confident of addressing the concern raised by the USFDA
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