Gland Pharma Limited has disclosed the conclusion of an unannounced inspection by the United States Food and Drug Administration (USFDA) at its formulation facility located in Dundigal.
The inspection focused on Current Good Manufacturing Practice (cGMP) compliance and was conducted over a period from October 12, 2026, to October 23, 2026.
The inspection concluded with the issuance of a Form 483 containing four (4) observations. The company characterizes these observations as procedural in nature. Importantly, the disclosure specifies that these observations are neither repeated from previous inspections nor related to data integrity issues.
The company has committed to submitting corrective and preventive actions (CAPA) for these observations to the USFDA within the stipulated timeframe.
As detailed in the enclosed Annexure A, which fulfills the requirements of Regulation 30 read with Schedule III Para A Sub Para 20 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015, the following specifics are confirmed:
- Name of Authority: United States Food and Drug Administration (USFDA)
- Nature of Action: Form 483 with four (4) Observations
- Date of Receipt of Communication: October 23, 2026
- Details of Violations/Contraventions: Not Applicable
- Financial/Operational Impact: Not Applicable; quantifiable monetary impact is stated as not applicable.
The disclosure was signed and submitted by Pallerlamudi Sampath Kumar, Company Secretary & Compliance Officer, on October 23, 2026.