Granules India Limited announced that its US step-down subsidiary, Granules Consumer Health, LLC, has successfully completed a Good Manufacturing Practice (GMP) inspection by the US Food and Drug Administration (FDA) with zero observations, marking a significant regulatory milestone for the company.
This was the facility’s second FDA inspection, following the March 2023 audit that also concluded with a No Action Indicated (NAI) classification.
Dr. Krishna Prasad Chigurupati, Chairman and Managing Director of Granules India, said the achievement underscores the company’s commitment to quality, safety and regulatory compliance, especially as the US site plays a critical role in packaging and distribution.
Located in the United States, Granules Consumer Health handles controlled substances and over-the-counter (OTC) products across three advanced packaging lines. The facility serves as the front-end division for Granules’ OTC business in the US, supported by the parent company’s integrated supply chain and manufacturing efficiencies.
Granules India, headquartered in Hyderabad, operates across the entire pharmaceutical value chain, including APIs, PFIs, finished dosages and peptides CDMO. The company has a global presence with 11 manufacturing facilities across India, the US, and Switzerland, and its products are distributed in more than 80 countries.
