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Aurobindo Pharma Recover Losses After 3 US FDA Observations

Aurobindo Pharma received three observations from the US Food and Drug Administration (USFDA).

Shares of Aurobindo Pharma recovered their initial losses and traded higher at Rs 788.30 at 1:30 pm after the company received three observations from the US Food and Drug Administration (USFDA).

During an inspection at Aurobindo Pharma’s Unit 3, a formation manufacturing facility at Bachupally Village in Medchal Malkajgiri district of Telangana, the US FDA issued Form 483 with three observations during this inspection during July 14-21.

The company issued a statement saying, “The observations are procedural in nature and we will respond to the US FDA within the stipulated timelines and work closely with USFDA to close the observations at the earliest,”.

An inspection was also conducted at Unit XIV at Jawaharlal Nehru Pharma City in the Anakapalli district of Andhra Pradesh from May 15-19.

Aurobindo Pharma’s wholly owned subsidiary APL Healthcare received final approval from the US FDA to manufacture and market Sevelamer Hydrochloride Tablets 400mg and 800mg, Sevelamer Hydrochloride Tablets 400mg and 800mg on July 12.

At 1:40 pm, shares of Aurobindo Pharma were trading at Rs 788.55 or 1.15% higher than its previous close.

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