Granules India Limited announced that its US subsidiary, Granules Consumer Health, LLC, successfully completed a GMP inspection by the U.S. Food and Drug Administration (FDA) with zero observations. This was the facility’s second FDA inspection, following the March 2023 audit that resulted in a No Action Indicated (NAI) classification, and reflects the company’s unwavering focus on quality and regulatory excellence.
FDA Inspection Success
Granules India’s packaging facility in the United States, operated by its subsidiary Granules Consumer Health, LLC, has successfully completed an inspection by the U.S. Food and Drug Administration (FDA) with zero observations. The announcement was made on December 4, 2025.
Details of the Inspection
The GMP (Good Manufacturing Practice) inspection by the FDA confirms that the facility adheres to the highest standards of quality and compliance. This marks the second successful FDA inspection for the facility; the first one in March 2023, resulting in a No Action Indicated (NAI) classification.
Strategic Importance
According to Dr. Krishna Prasad Chigurupati, Chairman and Managing Director of Granules India, Granules Consumer Health plays a critical role in their global operations as a packaging and distribution site. The facility processes controlled substances and over-the-counter (OTC) products across three advanced packaging lines, underscoring the company’s commitment to quality, safety, and regulatory excellence. Granules Consumer Health serves as Granules’ front-end division for OTC products in the U.S., leveraging Granules India’s manufacturing efficiencies and integrated supply chain.
Source: BSE