Granules India's US Arm Gets 4 USFDA Observations
New Delhi: Granules India Limited has announced that its US-based subsidiary, Granules Pharmaceuticals, Inc. (GPI), has successfully completed a routine US Food and Drug Administration (USFDA) cGMP audit at its Chantilly, Virginia facility, with four Form 483 observations and no data integrity issue reported.
The inspection was conducted between March 30 and April 3, 2026, marking the second USFDA inspection at the Chantilly site within a year. The company clarified that the observations raised are procedural in nature and do not involve any data integrity concerns.
Granules India stated that it remains committed to maintaining high standards of quality, safety, and regulatory compliance, and will address the observations within the stipulated timelines.
The development reflects the company’s continued focus on strengthening compliance and operational excellence across its global manufacturing network.
Granules India Limited, headquartered in Hyderabad, is a vertically integrated pharmaceutical company involved in the manufacturing of Active Pharmaceutical Ingredients (APIs), Pharmaceutical Formulation Intermediates (PFIs), finished dosages, and peptides CDMO services. The company serves over 300 customers across regulated and semi-regulated markets, with a presence in more than 80 countries.
The company operates 10 manufacturing facilities globally, including seven in India, two in the United States, and one in Switzerland. Its facilities are approved by multiple global regulatory authorities, including the USFDA, EDQM, EU GMP, WHO GMP, TGA, COFEPRIS, KFDA, DEA, MCC, and HALAL.
Granules India emphasized that the audit outcome underscores its commitment to regulatory adherence and continuous improvement in manufacturing standards.
