Granules India Limited has informed that its wholly owned subsidiary, Granules Life Sciences Private Limited (GLS), has successfully completed a Good Manufacturing Practices (GMP) and Prior Approval Inspection conducted by the U.S. Food and Drug Administration (US FDA). The inspection was carried out at the subsidiary’s manufacturing facility located in Hyderabad, bearing FEI number 3030495702.
The US FDA inspection took place from December 15 to December 19, 2025, and concluded with five observations. According to the company, these observations are related to procedural requirements and do not involve any concerns around data integrity or product safety, which are critical aspects for pharmaceutical manufacturing compliance.
Granules India stated that it remains fully committed to regulatory compliance and quality standards. The company has confirmed that it will address the observations in a timely manner and submit its detailed response to the US FDA within the stipulated timeframe.