Granules India Limited announced that its US-based step-down subsidiary has received an Establishment Inspection Report (EIR) with No Action Indicated (NAI) status from the US Food and Drug Administration (USFDA) following an inspection of its packaging facility in Virginia. According to the company's exchange filing on Thursday, March 5, the inspection was conducted at the Manassas, Virginia facility of Granules Consumer Health LLC between December 1 and December 3, 2025. This marks the facility's second inspection by the FDA, after a March 2023 audit that also ended with zero observations.
The regulator issued the Establishment Inspection Report with a No Action Indicated status, meaning the inspection concluded without any regulatory observations requiring action. As reported by CNBC TV18, Granules Consumer Health operates as the company's front-end division for over-the-counter (OTC) products in the United States and serves as a packaging and distribution hub. The facility packages both OTC and prescription medicines and processes controlled substances across three packaging lines.
Krishna Prasad Chigurupati, Chairman and Managing Director of Granules India, stated that the outcome reflects the company's focus on quality, safety and regulatory compliance across its operations. According to the exchange filing, shares of Granules India were trading 2.35% up at ₹566.50 as of 12.13 pm following the announcement. The company's strong regulatory performance comes amid positive financial results, with net profit rising 27.7% to ₹150.2 crore in the December quarter from ₹117.6 crore in the year-ago period.
For the December quarter, the company's revenue was up 22% to ₹1,387.9 crore, while EBITDA increased 33.4% to ₹308.4 crore, lifting margins to 22.2% from 20.3% a year earlier. As reported by CNBC TV18, the company expects better performance in the March quarter with the US FDA decision being crucial for FY27 growth prospects.
