Gland Pharma announced that the United States Food and Drug Administration (US FDA) has conducted a Pre-approval inspection (PAI) for Sterile APIs at the Company's Facility at JNPC, Visakhapatnam
between 19 February 2025 and 25 February 2025.
The said inspection was concluded with THREE (3) Form 483 Observations. These observations are procedural in nature. The corrective and preventive actions for these observations will be submitted to the US FDA within the stipulated period. The observations issued are neither repeated observations nor related to data integrity.
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