Hyderabad: Granules India Limited announced that its US step-down subsidiary, Granules Consumer Health, LLC—a wholly-owned arm of Granules Pharmaceuticals, Inc.—has successfully completed a Good Manufacturing Practice (GMP) inspection by the U.S. Food and Drug Administration (FDA) with zero observations.
This marks the facility’s second FDA audit, following the March 2023 inspection that concluded with a No Action Indicated (NAI) classification, reaffirming the company’s strong compliance track record.
Granules Consumer Health operates as a critical packaging and distribution hub for the company’s U.S. operations. The site handles both controlled substances and over-the-counter (OTC) products across three advanced packaging lines.
“Granules Consumer Health plays a critical role in our global operations as a packaging and distribution site. 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.
The facility serves as Granules’ front-end division for OTC products in the U.S., leveraging the parent company’s manufacturing efficiencies, regulatory compliance, and integrated supply chain to strengthen its market presence.
