Granules India Limited has announced that its wholly-owned US subsidiary, Granules Pharmaceuticals, Inc. (GPI), received the Establishment Inspection Report (EIR) from the US Food and Drug Administration (FDA) for its Chantilly, Virginia facility. The classification issued is Voluntary Action Indicated (VAI).
The USFDA inspection of the Chantilly facility was conducted from March 30 to April 3, 2026, during which four Form 483 observations were issued. Granules Pharmaceuticals, Inc. plays a key role in Granules India's global manufacturing and supply network as a facility focused on quality systems, regulatory compliance, and patient safety.
Granules India Limited operates 10 manufacturing facilities globally, with seven in India, two in the United States, and one in Switzerland. Granules India has received regulatory approvals from multiple international agencies including US FDA, EDQM, EU GMP, COFEPRIS, WHO GMP, TGA, K FDA, DEA, and MCC.
Granules India Limited serves over 300 customers across regulated and semi-regulated markets, with a presence extending to more than 80 countries. Granules India was incorporated in 1991 and is headquartered in Hyderabad, Telangana, India.
Granules India Limited is among a small number of pharmaceutical companies globally with a presence across the entire pharmaceutical value chain, from Active Pharmaceutical Ingredients (APIs) and Pharmaceutical Formulation Intermediates (PFIs) to Finished Dosages (FDs) and Peptides CDMO.
Disclaimer: This article is based on company filings submitted to the Bombay Stock Exchange (BSE) and National Stock Exchange of India (NSE) and is for informational purposes only. It does not constitute investment advice or a recommendation. Investors should conduct their own research and consult a qualified financial advisor before making investment decisions.