Following ten observations from the US FDA, Aurobindo Pharma's shares decline

 Following ten observations from the US FDA, Aurobindo Pharma's shares decline

Following ten observations from the US FDA, Aurobindo Pharma's shares decline

Although the facility has not yet begun commercial operations, the business said that the concerns are of a procedural nature and will get a response within the allotted time frame.

Aurobindo Pharma: From December 11 to 22, the US Food and Drug Administration (US FDA) carried out a pre-approval inspection (PAI) at Yugea US Manufacturing LLC, a fully owned subsidiary of Aurobindo Pharma, at its new injectable plant in East Windsor, New York, Jersey. After the examination, ten comments were made. Responses to the procedural comments will be provided within the allotted time frame. Commercial activities have not yet commenced at the facility.

Early on December 26, Aurobindo Pharma's stock price fell as a result of ten comments the US Food and Drug Administration (USFDA) had for the company's arm.

Aurobindo Pharma was down Rs 6.15, or 0.58%, on the BSE at 9:31 p.m. trading at Rs 1,060.00.

The USFDA visited Eugeia US Manufacturing LLC, a step-down fully owned subsidiary of Aurobindo Pharma Limited, at its new injectable plant in East Windsor, New Jersey, USA, as part of a Pre-Approval Inspection (PAI).

Ten observations were made after the examination, which took place between December 11 and December 22, 2023. It also said that while the facility has not yet begun commercial operations, the comments are of a procedural nature and will get a response within the allotted period.

Although it was not authorized by the official Does not guarantee regulatory action, the USFDA last week designated a plant run by its subsidiary APL Healthcare in Tirupati, Andhra Pradesh, as "Voluntary Action Indicated" (VAI) after finding notable deficiencies during its inspection.

The inspection took place at APL Healthcare Limited's Unit IV, a fully owned subsidiary situated in Menkuru village under Naidupeta mandal in the Andhra Pradesh district of Tirupati.

In the July–September quarter of the current fiscal year, the firm recorded an 85% year-over-year increase in consolidated net profit, coming in at Rs 757 crore.