Granules India's Packaging Facility in US gets FDA EIR with No Action Indicated Status

Granules India Limited announced that its US step-down subsidiary, Granules Consumer Health, LLC, a wholly-owned subsidiary of Granules Pharmaceuticals, Inc. has received an Establishment Inspection Report (EIR) with a No Action Indicated (NAI) Status from the US Food and Drug Administration (FDA).

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.

"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," said Dr. Krishna Prasad Chigurupati, Chairman and Managing Director of Granules India.

Granules Consumer Health serves as Granules' front-end division for OTC products in the U.S., leveraging Granules India's manufacturing efficiencies, regulatory compliance, and integrated supply chain. This facility is responsible for packaging both OTC and prescription (Rx) products and serving as a distribution hub for OTC products across the US.

Shares of Granules India Limited was last trading in BSE at Rs. 576.80 as compared to the previous close of Rs. 573.80. The total number of shares traded during the day was 25584 in over 1249 trades.

The stock hit an intraday high of Rs. 587.15 and intraday low of 573.85. The net turnover during the day was Rs. 14891422.00.

Source : Equity Bulls

Keywords

GranulesIndia INE101D01020 Pharmaceuticals PackagingFacility USFDA EIR NAI