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Aurobindo reduces losses following three US FDA observations

Jul 24, 2023

By: BlinkX Research Team

After the business got three observations from the US Food and Drug Administration (USFDA), Aurobindo Pharma shares recovered their initial losses and fluctuated somewhat.

Following an examination of Aurobindo Pharma's Unit III, a formulation manufacturing plant located in Bachupally Village in Telangana's Medchal Malkajgiri district, from July 14 to 21, the US FDA issued the Form 483 with three observations.

The company stated in a statement, "The observations are procedural in nature and we will respond to the USFDA within the stipulated timelines and work closely with USFDA to close the observations at the earliest." 

Additionally, from May 15 to 19, the USFDA performed an examination at the business' Unit XIV at Jawaharlal Nehru Pharma City in the Anakapalli area of Andhra Pradesh. The facility was classified as having suggested voluntary action (VAI) in the establishment inspection report, the business reported on July 17. 

Sevelamer Hydrochloride Tablets 400mg and 800mg, which are intended to be bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Renagel Tablets, 400mg and 800mg, of Genzyme Corporation, were given their final approval to be manufactured and marketed by Aurobindo Pharma's wholly owned subsidiary APL Healthcare on July 12.

Source: Media Reports