USFDA issues Form 483 with 3 observations to Gland Pharma's Sterile APIs unit

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 February 19, 2025 and February 25, 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.

Shares of Gland Pharma Limited was last trading in BSE at Rs. 1595.50 as compared to the previous close of Rs. 1525.05. The total number of shares traded during the day was 36214 in over 3034 trades.

The stock hit an intraday high of Rs. 1632.00 and intraday low of 1545.90. The net turnover during the day was Rs. 57994574.00.

Source : Equity Bulls

Keywords

GlandPharma INE068V01023 USFDA Inspection PAI SterileAPIs JNPC Visakhapatnam