MUMBAI — Granules India Limited said its U.S. step-down subsidiary, Granules Consumer Health, LLC, has completed a Good Manufacturing Practice (GMP) inspection by the U.S. Food and Drug Administration with zero observations.
According to the announcement, this was the facility’s second FDA inspection. Its previous audit in March 2023 received a No Action Indicated classification.
Granules Consumer Health operates as a packaging and distribution site for the company’s U.S. operations. The facility handles controlled substances and over-the-counter products across three packaging lines.
“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 products across three advanced packaging lines. Achieving zero observations in this inspection reflects our focus on quality, safety, and regulatory excellence,” said Dr. Krishna Prasad Chigurupati, Chairman and Managing Director of Granules India.
The subsidiary functions as the front-end division for the company’s over-the-counter portfolio in the U.S., drawing on Granules India’s manufacturing capabilities, regulatory systems, and supply chain structure.
