Granules' US packaging facility achieves zero FDA observations

Granules India Limited announced today that its US step-down subsidiary, Granules Consumer Health, LLC, received zero observations during a recent GMP inspection by the U.S. Food and Drug Administration. This marks the facility's second FDA inspection, following a March 2023 audit that resulted in a No Action Indicated classification.

The facility serves as a packaging and distribution site for controlled substances and over-the-counter products, utilizing three advanced packaging lines. Dr. Krishna Prasad Chigurupati, chairman and managing director of Granules India, highlighted the significance of achieving zero observations as a reflection of the company's commitment to quality, safety, and regulatory excellence.

Granules Consumer Health functions as Granules' front-end division for over-the-counter products in the U.S., leveraging the parent company's manufacturing efficiencies, regulatory compliance, and integrated supply chain. Granules India Limited, incorporated in 1991, is a vertically integrated pharmaceutical company headquartered in Hyderabad.