Granules India Limited has announced that its wholly owned subsidiary, Granules Life Sciences Private Limited (GLS), has successfully concluded a recent US Food and Drug Administration (US FDA) inspection at its manufacturing facility in Shamirpet, Telangana. The inspection resulted in a Voluntary Action Indicated (VAI) classification, indicating that while minor observations were noted, the agency does not recommend any regulatory action.
US FDA Issues Establishment Inspection Report (EIR)
As per the press release, the US FDA issued the Establishment Inspection Report (EIR) following a current Good Manufacturing Practice (cGMP) and Pre-Approval Inspection (PAI) of the facility’s oral solid dosage manufacturing operations. The inspection took place between December 15 and December 19, 2025.
Furthermore, the inspection process has now been formally closed, and the regulator has not recommended any enforcement or regulatory action.
Leadership Reaffirms Commitment to Quality
Commenting on the development, Dr. Krishna Prasad Chigurupati, Chairman and Managing Director of Granules India Limited, emphasized the company’s continued focus on maintaining high quality standards.
He said, “While receiving this classification is a step in the right direction, we recognize that quality is not a one-time milestone but an ongoing commitment. It will continue to remain a core pillar of utmost importance across all Granules sites, guiding our actions, investments, and culture every day.”
Strengthening Manufacturing Capabilities
Moreover, this regulatory outcome strengthens Granules India’s finished dosage manufacturing capabilities. With the Shamirpet facility now cleared, the company can further enable multisite manufacturing for approved pharmaceutical products, thereby improving operational flexibility and supporting global supply chains.