Granules India Limited announced that its US step-down subsidiary, Granules Consumer Health, LLC, received an Establishment Inspection Report (EIR) with a No Action Indicated (NAI) Status from the US FDA. The inspection covered the Manassas, Virginia packaging facility, which underwent scrutiny from December 1 to 3, 2025. This marks the facility’s second successful FDA inspection, achieving zero observations, validating its commitment to quality and regulatory excellence.
Successful US FDA Inspection Concluded
Granules India Limited confirmed that its US-based operations have achieved a significant regulatory milestone. Granules Consumer Health, LLC, a wholly-owned subsidiary, was issued an Establishment Inspection Report (EIR) bearing a No Action Indicated (NAI) Status by the US Food and Drug Administration (FDA).
Facility Details and History
The inspection took place at the company’s packaging facility located in Manassas, Virginia, spanning from December 1 to 3, 2025. This outcome is particularly noteworthy as it represents the facility’s second consecutive successful FDA inspection, following a prior audit in March 2023 that also concluded with zero observations.
Strategic Importance and Leadership Statement
The packaging site plays a critical role in global operations, handling both controlled substances and over-the-counter (OTC) products across three advanced packaging lines. Dr. Krishna Prasad Chigurupati, Chairman and Managing Director of Granules India, stated that achieving zero observations reflects the strong culture of quality, safety and regulatory excellence demonstrated by the teams.
Granules Consumer Health functions as the front-end division for OTC products in the U.S., managing packaging for both OTC and prescription (Rx) products, in addition to serving as a distribution hub for OTC goods throughout the country.
Company Profile Overview
Granules India Limited, established in 1991, is a vertically integrated pharmaceutical company headquartered in Hyderabad. It covers the entire value chain, including APIs, PFIs, Finished Dosages (FDs), and Peptides CDMO. The company maintains a significant global footprint, distributing products to over 300+ customers across more than 80+ countries, supported by 11 manufacturing facilities, including two in the USA and one in Switzerland.
Source: BSE
