Granules India Virginia facility clears USFDA inspection with zero observations

Granules India Limited said its US-based step-down subsidiary has received an Establishment Inspection Report (EIR) with a No Action Indicated (NAI) status from the US Food and Drug Administration (USFDA) following an inspection of its packaging facility in Virginia.In an exchange filing on Thursday, March 5, the company said the inspection was conducted at the Manassas, Virginia facility of Granules Consumer Health LLC, a wholly owned subsidiary of Granules Pharmaceuticals Inc., between December 1 and December 3, 2025.

The regulator issued the Establishment Inspection Report with a No Action Indicated status, meaning the inspection concluded without any regulatory observations requiring action. This marks the facility’s second inspection by the FDA, after a March 2023 audit that also ended with zero observations.
Also read: Granules India expects better March quarter; US FDA decision crucial for FY27 growth
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, said the outcome reflects the company’s focus on quality, safety and regulatory compliance across its operations.

For the December quarter, the company’s net profit rose 27.7% to ₹150.2 crore from ₹117.6 crore in the year-ago period. Revenue was up 22% to ₹1,387.9 crore, and EBITDA increased 33.4% to ₹308.4 crore, lifting margins to 22.2% from 20.3% a year earlier.

Shares of Granules India were trading 2.35% up at ₹566.50 as of 12.13 pm.

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