Aurobindo Pharma shares fall as USFDA issues ‘Form 483’ with 2 observations

We will respond to the USFDA within the stipulated timelines and work closely with the regulator to close the observations at the earliest, Aurobindo Pharma said.

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Aurobindo Pharma share price fell marginally in the early trade on January 19 after United States Food and Drug Administration (US FDA) issued ‘Form 483’ to its subsidiary.

The US FDA inspected the Aurobindo Pharma‘s wholly owned subsidiary, APL Health Care Limited’s Unit I & III, an Orals (Tablets, Capsules and Soft gel Capsules) and Derma Manufacturing facility located at Jadcherla, Mahabub Nagar District, Telangana, Aurobindo Pharma said in its release.

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The inspection carried during from January 9 to January 18, 2023.

At the end of the inspection, ‘Form 483’ with 2 observations have been issued by USDA.

The observations are procedural in nature.

We will respond to the USFDA within the stipulated timelines and work closely with USFDA to close the observations at the earliest, Aurobindo Pharma added.

At 09:26 hrs Aurobindo Pharma was quoting at Rs 442.50, down Rs 1.55, or 0.35 percent on the BSE.