Aurobindo Pharma Ltd receives 10 observations for Unit IX

The United States Food and Drug Administration (US FDA) inspected the Company's Unit - IX, an intermediate facility situated at Gundlamachnoor Village, Sangareddy District, Telangana, from November 10 to November 18, 2022.

The said Unit had been classified as OAI on May 17, 2019 and the Company had responded to the agency and carried out the required corrective actions. The US FDA Authorities have reinspected the facility as mentioned above.

At the end of the inspection, the Company has been issued a 'Form 483' with 10 observations. In our view, these observations are procedural in nature and not related to data integrity. The Company will respond to the US FDA, within the stipulated timeline and shall work closely with the agency to address the observations at the earliest.

Shares of Aurobindo Pharma Limited was last trading in BSE at Rs. 468.75 as compared to the previous close of Rs. 474.10. The total number of shares traded during the day was 40379 in over 1631 trades.

The stock hit an intraday high of Rs. 478.95 and intraday low of 465.95. The net turnover during the day was Rs. 18966932.00.

Source : Equity Bulls

Keywords

AurobindoPharma INE406A01037 Form483 10Observations Reinspection USFDA