One Step, One Observation: Granules India Keeps U.S. Doors Open

Granules India Ltd has announced the successful completion of a US FDA inspection at its Bonthapally manufacturing facility, concluding with just one Form 483 observation. The inspection, which focused on Current Good Manufacturing Practices (cGMP), was conducted as part of the routine regulatory oversight for facilities exporting to the United States.

 

Key Highlights:

The outcome is seen as a relatively positive development, especially in the context of heightened regulatory scrutiny across the Indian pharma sector. Investors and stakeholders are likely to view the limited observation as manageable and nondisruptive.

 

Sources: Redica Systems, FDA.gov, Granules India Exchange Filings