Granules’ packaging facility in US completes FDA inspection with zero observations
Granules Consumer Health serves as Granules’ front-end division for OTC products in the US
Granules Consumer Health serves as Granules’ front-end division for OTC products in the US
Lupin will address the observations and respond to the U.S. FDA within the stipulated timeframe
The Unit is approved by major regulators like EMA, Europe; Health Canada, Anvisa, Brazil and TGA, Australia
The observations are procedural in nature and will be responded to within the stipulated time
A bio-analytical Remote Regulatory Assessment was also conducted from October 30 to November 7, 2025, and concluded with no observations
The Cranbury facility represents a strategic advancement of the company's operations in the Unted States
The inspection concluded with zero form 483 observations
Zydus will work closely with the USFDA to address and resolve the observations in an expeditious manner
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