Drug Approval | August 23, 2024
Wanbury receives EIR from FDA for Patalganga facility
USFDA has determined that the inspection classification of this facility is "No Action Indicated" (NAI) with zero 483 observation
USFDA has determined that the inspection classification of this facility is "No Action Indicated" (NAI) with zero 483 observation
Stringent regulatory environments can make OEMs reluctant to change processes and materials for approved medical devices
Sigachi's entry into the coatings market is strategically timed to capitalize on the industry's growth potential
These digital initiatives are expected to enhance the accessibility and efficiency of drug safety monitoring and standards compliance
Glycopyrrolate Oral Solution is an anticholinergic medication indicated for pediatric patients
Revenue up 16.3% to Rs 5,600 crore versus Rs 4,814 crore
The inspection was concluded with zero observations
Research & Development (R&D) investments for the quarter stood at Rs. 392.5 crore which is 6.3% of its revenues
The EIR was issued post the last inspection of the facility conducted from May 6-10, 2024 which concluded with zero FDA 483 observations
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