Granules’ packaging facility in US completes FDA inspection with zero observations

Granules Consumer Health serves as Granules’ front-end division for OTC products in the US

Granules India Limited announced that its US step-down subsidiary, Granules Consumer Health, a wholly-owned subsidiary of Granules Pharmaceuticals, 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.

"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 our unwavering focus on quality, safety, and regulatory excellence," 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 US, leveraging Granules India’s manufacturing efficiencies, regulatory compliance, and integrated supply chain.