The FDA inspection was conducted at the company’s packaging facility in Manassas, Virginia, from December 1 to 3, 2025. This marks the facility’s second FDA inspection, following the March 2023 audit, which also concluded with zero observations.

Krishna Prasad Chigurupati, chairman and managing director of Granules India, said, “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 the strong culture of quality, safety and regulatory excellence demonstrated by our teams.”

Granules India is primarily involved in the manufacturing and sale of active pharmaceutical ingredients (APIs), pharmaceutical formulation intermediates (PFIs), and finished dosages (FDs). The company reported a 27.73% jump in consolidated net profit to Rs 150.21 crore on 22% increase in revenue from operations to Rs 1,387.94 crore in Q3 FY26 over Q3 FY25.