Granules India Limited announced that the US Food and Drug Administration (US FDA) has completed a Pre-Approval Inspection (PAI) at the manufacturing facility of its wholly owned subsidiary, Granules Life Sciences Private Limited, located in Shamirpet Mandal, Hyderabad.
The inspection was conducted between July 28 and August 1, 2025, and concluded with a single observation issued under Form 483. The company clarified that the observation is procedural in nature. Granules India has stated its intention to address and respond to the FDA within the stipulated timeframe.
Granules Life Sciences is involved in the production of Pharmaceutical Formulation Intermediates (PFIs) and finished dosage forms.
This development is part of Granules India’s ongoing efforts to ensure global regulatory compliance as it continues to strengthen its presence in regulated markets like the US.
