The US FDA issued four observations to Gland Pharma’s formulation facility near Hyderabad

The US Food and Drug Administration (US FDA) has issued four comments on Gland Pharma’s formulation facility near Hyderabad.

The four Form 483 comments followed an unannounced current good manufacturing practice (cGMP) inspection at the Dundigal plant between October 12 and 23. The comments are procedural in nature, and corrective and preventive actions will be submitted to the US FDA within a specified period.

The observations released are neither repeated observations nor related to data integrity, the company said on Friday (October 24, 2026).

Shares of Gland Pharma closed 1.17% lower at ₹2,825.35 apiece on the BSE.

Published – 24 Oct 2026 11:06 AM IST