Granules India’s US Facility Passes FDA Inspection with Zero Observations

Granules India Limited reported that its US step-down subsidiary, Granules Consumer Health, LLC, successfully completed a Good Manufacturing Practice (GMP) inspection by the U.S. Food and Drug Administration (FDA) with zero observations. This marks the second FDA inspection for the facility, following a previous audit in March 2023 that resulted in a No Action Indicated (NAI) classification. The facility plays a significant role in Granules’ global operations as a packaging and distribution site.

The financial terms related to this inspection were not disclosed in the filing. The focus of the announcement was on the operational success of the inspection, which did not result in any observations from the FDA. This indicates compliance with the regulatory standards set by the FDA for pharmaceutical manufacturing and packaging facilities.

The scope of operations at the Granules Consumer Health facility includes the processing of controlled substances and over-the-counter (OTC) products. The facility is equipped with three advanced packaging lines, which are integral to its role as a packaging and distribution site. The successful completion of the FDA inspection reflects the company’s adherence to quality and safety standards in its operations.

Granules Consumer Health serves as the front-end division for OTC products in the U.S., leveraging Granules India’s manufacturing efficiencies and integrated supply chain. The facility’s operations are aligned with Granules India’s strategic focus on regulatory compliance and operational excellence. The company distributes its products to over 300 customers in regulated and semi-regulated markets, extending its global presence to more than 80 countries.

The timeline for the FDA inspection was not specified beyond the completion date of December 4, 2025. The inspection was conducted as part of the FDA’s routine audits to ensure compliance with GMP standards. The successful outcome of the inspection underscores the facility’s commitment to maintaining high-quality standards in its operations.

Granules India Limited, incorporated in 1991, is a vertically integrated pharmaceutical company headquartered in Hyderabad. The company is involved in the manufacturing of the entire pharmaceutical value chain, including Active Pharmaceutical Ingredients (APIs), Pharmaceutical Formulation Intermediates (PFIs), Finished Dosages (FDs), and Peptides CDMO. Granules India operates 11 manufacturing facilities, with regulatory approvals from various international bodies, including the US FDA, EDQM, and EU GMP.