Granules India Limited has announced that its US-based packaging facility in Manassas, Virginia, successfully cleared a US Food and Drug Administration (FDA) inspection with a "No Action Indicated" (NAI) status.

The Establishment Inspection Report (EIR) follows an audit conducted from December 1 to 3, 2025.

The inspection concluded with zero observations, confirming the facility's compliance with current Good Manufacturing Practices (cGMP).

"Granules Consumer Health plays a critical role in our global operations as a packaging and distribution site. We process controlled substances and over-the-counter (OTC) products across three advanced packaging lines. Achieving zero observations in this inspection reflects the stron culture of quality, safety and regulatory excellence demonstrated by our teams," said Dr. Krishna Prasad Chigurupati, Chairman and Managing Director of Granules India.

Granules Consumer Health serves as Granules’ front-end division for OTC products in the U.S., leveraging Granules India’s manufacturing efficiencies, regulatory compliance, and integrated supply chain. This facility is responsible for packaging both OTC and prescription (Rx) products and serving as a distribution hub for OTC products across the US.