Aurobindo Pharma gets 10 observations for Unit IX from USFDA; Stock dips 1%

21 Nov 2022 , 11:26 AM

Aurobindo Pharma Limited has informed that the United States Food and Drug Administration (USFDA) 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.

In a filing, the company announced that 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.

At around 11:20 AM, Aurobindo Pharma Ltd is currently trading at Rs463.35 per share down by Rs5.4 or 1.15% from its previous closing of Rs468.75 per share on the BSE.

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